Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10 /2022  Review Due Date: 30/10/2025  
Revision No.:0  Approval date: 24/10/2022  Effective Date: 31/10 /2022  
 
 
 
 
 
 
 
 
 
GUIDELINES  ON SUBMISSION  OF DOCUMENTATION  
FOR  REGISTRATION  OF IN VITRO DIAGNOSTICS 
DEVICES  
 
 
 
 
 
 
 
OCTOBER , 2022  
 
 
 
 
 
 
 
 
 
 
 
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
Revision No.:0  Approval date: 24/10/2022  Effective Date: 31/10 /2022  
   Page 2 of 73 
  
FOREWORD  
 
Rwanda  Food  and Drugs  Authority  (Rwanda  FDA)  is a regulatory  body  established  by Law N° 
003/2018  of 09/02/2018.  One of the functions  of Rwanda  FDA  is to regulate  matters  
related  to quality,  safety , and performance  of In vitro Diagnostics devices  in order  to protect  
public  health  by increasing  their access  and availability.  
 
Considering  the provisions  of the technical  regulat ions No DFAR/HMDAR/TRG/002 Rev_2  
governing  the registration  of Medical Devices including  In vitro Diagnostics , especially  in its 
articles  6, 7, 13, 14, 16 , and 35, the Authority  has issued  Guidelines  No 
DFAR/HMDAR/GDL/012  on submission  of documentation  for registration  of In Vitro 
Diagnostics Devices.  
 
These  guidelines  were  developed  in reference  to the East African Medicines Regulatory 
Harmonization,  World Health  Organization  (WHO) and  the International Medical Devices 
Regulators Forum (IMDRF) .  
 
The purpo se of these  guidelines  is to provide  guidance  to In Vitro Diagnostics Devices  (IVDDs) 
importers,  manufacturers , and distributors  intending  to market  their products  in Rwanda  on the 
documentation  requirements  by the Authority  to assess  the conformity  of such products  to the 
essential  principles  of safety  and performance before  market  authorization  can be issued.  
These  guidelines  are hereby  promulgated  for information, guidance  and strict compliance  by all 
concerned.  
 
Adherence  to the  guidelines  by the manufa cturers/applicants  will facilitate  timely  assessments  
and approvals  of medical  device  dossiers  by the Authority  for pre-market,  marketing 
authorization,  registration , and post-marketing  review.  
 
We wish  to express  our gratitude  to all individuals  who activ ely participated  in the 
development  of the  guidelines.  
 
The Authority  acknowledges  all the efforts  of key stakeholders  who participated  in the 
development  and validation of  these guidelines.  
 
 
 
 
 
 
  
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
Revision No.:0  Approval date: 24/10/2022  Effective Date: 31/10 /2022  
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GUIDELINES  DEVELOPMENT HIS TORY  
 
DRAFT  ZERO    01/12/2020  
ADOPTION  BY RWANDA  FDA   05/05/2022  
STAKEHOLDERS  CONSULTATION   27/05/2022  
ADOPTION  OF STAKEHOLDERS ' COMMENTS   09/06/2022  
DATE  FOR  COMING  INTO EFFECT   31/10/2022  
 
Document Revision History  
 
Date of revision  Revision number  Changes made and/or reasons for revision  
17/10/2022  0 First Issue  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
Revision No.:0  Approval date: 24/10/2022  Effective Date: 31/10 /2022  
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  TABLE OF C ONTENTS   
 
FOREWORD  ................................ ................................ ................................ .........................  2 
ACRONYMS AND ABBREVIATIONS  ................................ ................................ ..............  5 
GLOSSARY/DEFINITIONS  ................................ ................................ ................................  6 
INTRODUCTION  ................................ ................................ ................................ .................  9 
3.1. B ackground  ................................ ................................ ................................ .....................  9 
3.2. Scope  ................................ ................................ ................................ ...............................  9 
3.3. General  principles  ................................ ................................ ................................ ...........  9 
3.4. Submissi on of application ................................ ................................ .............................  10 
3.5. Types of  IVDDs registration  Applications  ................................ ................................ ... 10 
3.6. Application  Requirements  ................................ ................................ ............................  11 
3.6.1. Application requirements  for notification  ................................ ................................ . 11 
3.6.2. Application requirement  for registration  ................................ ................................ ... 11 
3.7. Receiving new  applications for IVDD registration  ................................ ......................  12 
3.8. Rwanda FDA Dossier  Notification  Procedure  ................................ .............................  12 
3.9. Rw anda FDA Dossier  Registration  Procedure  ................................ .............................  12 
3.10.  Compliance with the Quality Management System (QMS)  ................................ ....... 13 
3.11. Authority’s  Peer R eview  Committee for  In Vitro Diagnostics Devices Registration/ 
notification  ................................ ................................ ................................ .......................  14 
3.12. Timelines for In Vitro Diagnostics registration/notification  ................................ ...... 14 
3.13.  Classification  of In Vitro Diagnostics Devices  ................................ ..........................  14 
3.14. Technical Documentation  Requirements  ................................ ................................ .... 15 
3.14. 1. Format and data presentation of the dossier  ................................ ............................  15 
3.14.2. Device details  ................................ ................................ ................................ ...........  16 
3.14.3. Summary of Technical Documentation (STED)  ................................ .....................  17 
3.14.4. Labelling Requirements  ................................ ................................ ...........................  27 
REFERENCES  ................................ ................................ ................................ ....................  30 
ENDORSEMENT OF THE GUIDELINES  ................................ ................................ ........  31 
APPENDICES  ................................ ................................ ................................ .....................  32 
Annex I:  cover letter  ................................ ................................ ................................ ...........  32 
Annex II: Application form  ................................ ................................ ................................ . 34 
Annex III: Notification Form  ................................ ................................ ...............................  40 
Annex IV : Classification rules of Invitro Diagnostics Devices (IVDDs)  ..........................  43 
Annex V: Essential Principle checklist of Medical Devices including IVDDs  ...................  47 
 
  
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
Revision No.:0  Approval date: 24/10/2022  Effective Date: 31/10 /2022  
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  ACRONYMS AND ABBREVIATIONS  
 
PRC                             Peer Review Commit tee 
Rwanda FDA           Rwanda Food  and Drugs  Authority   
EP                                Essential  Principles  
FIFO                      First In First Out 
STED                           Summary  of Technical  Documentation   
IVDD                           In Vitro Diagnostic  Device  
QMS                            Quality  Management  Systems   
LTR                             Local  Technical  Representative   
EEC                             European  Economic  Community   
CAB                             Conformity  Asse ssment  Body  
IMDRF                        International Medical Devices Regulators Forum  
WHO                            World Health Organisation  
EAC                             East African Community  
EAC -MRH                   East African Medicines Regulato ry Harmonization  
QCL                              Quality Control Laboratory  
SRA                              Stringent Regulatory Authority  
GMP                            Good Manufacturing Practices  
NRA                              National Regulatory Au thority  
HIV                                Human Immunodeficiency Virus  
HCV                               Hepatitis C Virus  
HBV                               Hepatitis B Virus  
HTLV                             Human T -lymphotropic virus  
 
 
  
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  GLOSSARY/ DEFINITI ONS  
For the purpose  of these  guidelines,  the following definitions  shall apply:  
1. “Authority ” means  the Rwanda  Food  and Drugs  Authority  or its acronym  “Rwanda  
FDA”,  established  under  Law N0. 003/2018 of 09/02/2018.  
2. “Abridged assessment” , a limited independen t assessment of specific parts of the 
dossier, or regulatory submission of data for suitability of use under local conditions 
and regulatory requirements, taking into account prior assessment (including dossier 
review  and/or independent performance evaluat ion) and inspection outcomes from 
WHO prequalification or any Stringent Regulatory Authority ( SRA ) to inform the 
Authority’s decision.  
3. “Applicant”  means  the person  by, or on whose  behalf,  an application  for, an 
update  or amendment  to an existing  registrati on, is made.  After  the product  is 
registered,  the applicant  shall be  the “Marketing Authorisation  Holder”.  
4. “Collaborative procedure”  a procedure for collaboration between the Authority 
and WHO or any regulatory authority in the assessment and accelerated n ational 
registration of IVDDs.  
5. “Conformity  Assessment  Body  (CAB)”  means  A body,  other  than a regulatory  
authority,  engaged  in determining  whether  the relevant  requirements  in technical  
regulations  or standards are fulfilled.  
6. “Law” means  Law N0 003/2018 of 09/02/2018  establishing  the Rwanda  FDA  and 
determining its mission, organization and fu nction  
7. “Local  Technical  Representative  (LTR)”  means any corporate body registered in 
Rwanda and authorized by Rwanda FDA to deal with Medical Devices and In Vitro 
Diagn ostics that has received a mandate from the Applicant to act on his/her behalf 
with regard to matters pertaining to the registration of medical devices including 
IVDDs. 
8. “In vitro  diagnostic  device  (IVD D)” A device, whether used alone or in combination, 
intended by the manufacturer for the in vitro examination of specimens derived from 
the human body solely or principally to provide information for diagnostic, monitoring 
or compatibility purposes. This includes reagents, calibrators, control materials, 
speci men receptacles, software, and related instruments or apparatus or other articles  
Note: IVD devices include reagents, calibrators, control materials, specimen 
receptacles, software, and related instruments or apparatus or other articles and are 
used, for example, for the following test purposes: diagnosis, aid to diagnosis, 
screening, monitoring, predisposition, prognosis, prediction, determination of 
physiological status.  
9. “Accessory  to an IVDD” means  an article  intended  specifically  by its 
manufacturer  to be used together  with a particular  IVD device  to enable  or assist  
that device  to be used in accordance with its intended  use.  
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  10. “Label ” means any tag, brand, mark, pictorial or other descriptive matter, written, 
printed stenciled, marked, embossed or impres sed on or attached to a container of any 
In Vitro Diagnostics Devices;  
11. “Labeling ” is all labels and other written, printed, or graphic matter (l) upon any 
article or any of its containers or wrappers, or (2) accompanying such article" at any 
time while a d evice is held for sale after shipment or delivery for shipment in 
interstate commerce.  
The term "accompanying" is interpreted liberally to mean more than physical 
association with the product. It extends to posters, tags, pamphlets, circulars, 
booklets, br ochures, instruction books, direction sheets, and fillers (where 
applicable).  
12. “Manufacture ” means  all operations  that involve  preparation,  processing, 
filling  transforming,  packaging,  repackaging  and labelling  of  an IVDD ; 
13. “Manufacturer ” means  a person  or a firm that is engaged  in the manufacture  of 
an IVDD:  
14. “Medical device ” means any instrument, apparatus, implement, machine, appliance, 
implant, software, material or other similar or related article, intended by the 
manufacturer to be used, alone or in com bination, for human beings or animals, for 
one or more of the specific medical purpose(s) of diagnosis, prevention, monitoring, 
treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or 
compensation for an injury; investigati on, repl acement, modification or support of the 
anatomy or a physiological process; supporting or sustaining life; control of 
conception; disinfection of medical devices; providing information by means of in 
vitro examination of specimens derived from the human or animal bodies, and which 
does not achieve its primary intended action by pharmacological, immunological or 
metabolic means, in or on the human or animal body, but which may be assisted in its 
intended function by such means.  
15. “Fee”  means  the fee prescribed  in Regulation  CBD/TRG/004  related  to regulatory  
services  Tariff/Fees  and fines.  
16. “Intended use/purpose” The objective intent of the manufacturer regarding the use 
of a product, process or service as reflected in the specifications, instructions and  
information provided by the manufacturer  
17.   “Batch  number  (or lot number)”  a distinctive  combination  of numbers  and/or  
letters  which  specifically  identifies  a batch  on the  labels,  the batch  records,    etc. 
18. “Packaging”  means  all operations,  including  fillin g and labelling,  that a medical  
device  has to undergo.  
19. “Packaging  material”  means  any material,  including  printed  material,  employed  
in the packaging  of a medical  device,  excluding  any outer  packaging  used for 
transportation  or shipment.  
20. “IVD test kit” an IVD test kit is an in vitro diagnostic  Device  (IVD D) that consists of  
reagents or articles that are from the same manufacturer ; intended to be used in  
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  combination to complete a specific intended purpose; sold under a single test kit name 
or the labeling, i nstructions for u se (IFU), brochures or catalog s for each reagents or 
article states that the component is intended for use with the IVD test kit; and 
compatible when used as a test kit.   
Note : An IVD test kit does not include the instruments, such as anal yzers needed to 
perform the test.   
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  INTRODUCTION  
 
1.1. Background  
Rwanda  Food  and Drugs  Authority  (Rwanda  FDA)  is established  by Law N° 003/2018  of 
09/02/2018,  especially  in its article s 8 and 9; 
 
Considering  the provisions  of the technical  regulations  No DFAR/H MDAR/TRG/002 
Rev_2 Governing Registration of Medical Devices including In Vitro Diagnostics , 
especially  in its articles  6, 7, 13, 14, 16 and 35, the authority  has issued  Guidelines  No 
DFAR/HMDAR/GDL/012  on Submission  of documentation  For Registration  Of In  Vitro 
Diagnostics Devices .  
Manufacturers  of all classes  of IVDDs are  expected  to demonstrate  conformity  to the 
Essential  Principles  of Safety  and Performance,  through  the preparation  and holding  of 
technical  documentation  that shows  how each In Vitro Dia gnostic  device  was developed,  
designed  and manufactured  together  with the descriptions  and explanations  necessary  to 
understand  the manufacture r’s determination  with respect  to such conformity.  The technical  
documentation  should  be revised  to reflect  the current  status  of IVDDs through  normal  
application  of the manufacture r’s QMS.  
1.2. Scope  
These  guidelines  shall  apply  to all In Vitro Diagnostics devices  intended  to be marketed  in 
Rwanda.  They  provide  guidance  on the summary  technical  documentation  to be submit ted 
to the Authority  for assessment  and registration.  
1.3. General  principles  
For the purpose  of conformity  assessment,  the manufacturer  should  assemble  information  
from  existing  technical  documentation to provide  evidence  that the  subject  In Vitro 
Diagnostic d evice is in conformity  with the Essential  Principles.  The information  
submitted  shall  reflect  the status  of the IVDD  at a particular  moment  in time (e.g. at 
the moment  of pre- market  submission  or when  requested)  and is prepared  in order  to 
meet  regulatory  requirements.  
The submission  may contain  summary  information  on selected  topics  and may contain  
detailed  information  on certain  specific  topics  including  the Essential  Principles  checklist  - 
EP checklist.  All information  should  be submitted  in the officia l language (s) and may 
also include,  for example , abstracts,  high-level  summaries,  or existing  controlled  
documents  sufficient  to communicate  key relevant  information  and allow  a reviewer  to 
understand  the subject  and assess  the validity  of that information . 
The EP checklist  is created  as part of the manufacture r’s technical  documentation  and is 
controlled  by the manufacture r’s QMS.  It provides  a tabular  overview  of the Essential  
Principles  and identifies  those  that are applicable  to the IVDD , the chosen  method of 
demonstrating  that the device  conforms  to each relevant  Essential  Principle  and the 
reference  of the controlled  document  that is relevant  to a specific  Essential  Principle.  While   
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  many  controlled  documents  are referenced  in the EP checklist,  only some may be contained  
within  this submission.  The cited  references  to the controlled  documents  also allow  easy 
identification  of additional  relevant  documents and data.  
1.4. Submission  of application  
An application  for In Vitro Diagnostics  Devices  registration  for either  a locally  
manufactured  or imported  IVVD  shall  be made  in writing  via a cover  letter  and 
application  form  dated  and signed  by the applicant.  If the applicant  is a foreign  company,  
the applicant  shall  appoint  a local  technical  representative  through  whom  an application  
shall  be submitted.  The local  technical  representative  shall  be any corporate body 
registered in Rwanda and authorized by Rwanda FDA to deal with Medical Devices 
including In Vitro Diagnostics  Devices  that has received a mandate from th e Applicant to 
act on his/her behalf with regard to matters  in the relevant area . 
The application  should  be submitted  to Rwanda  FDA  through  the authorized  local  technical  
Representative  to the  following  address:  
 
Director  General   
Rwanda Food and Drugs  Authority  
P. O. Box 1948  Kigali -
Rwanda  
 
1.5.  Types of  IVDDs registration  Applications  
For the  purposes  of  submission  of  an IVDD  Dossier  to Rwanda   FDA,   applications   
are classified  into three  categories  as follows:  
1. New  applications  for registration /notifi cation : an application  for 
registration /notification  of In Vitro Diagnostics  Devices  that is intended  to be placed  
on the Rwandan  market  for the first time or a device  which  was on the market  
without a certificate  of registration or notification . 
2. Renewal  of product  registration /notification : Applications  for renewal  of a 
registered  or notified In Vitro Diagnostic  Device . The application  shall be made  at 
least 3 months before the expiry  of the existing  registration /notification . 
3. Variation  of a registered /notified IVDD : an application  for any change  in the 
registered /notified  In Vitro Diagnostic  Device . All applications  for variation  to a 
registered /notified  device  shall  be made  according  to requirements  as stipulated  in 
the Rwanda  FDA Guidelines for  Variation  of Registered /notified  In Vitro 
Diagnostics  Devices .  
  
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  1.6. Application  Requirements  
1.6.1.  Application requirements  for notification  
a) In Vitro Diagnostics Devices falling under class A which are in  a non-sterile state, a non-
activ e and non-measuring function shal l apply for notification  to the Authority. Applicants 
shall  
submit the following:  
1. Signed  and dated original  hard copy  of a cover letter  (Annex I)  
2. Signed  and dated and duly filled in notification form ( Annex I II) 
3. Proof  of payment  of notification  fee at the time of submission   
4. One commercial pack sample of the device or artwork (where applicable)  
1.6.2.  Application requirement  for registration  
a) An application  for In Vitro Diagnostics  Devices  registration  in Rwanda shall include  the 
following:  
1. Signed  and dated origin al hard-copy  of the cover letter  (annex  I) 
2. Signed  and dated application form  for the In Vitro Diagnostic  Device  
registration  (annex II) 
3. Proof  of payment  of registration  fee at  the time of submission  as per 
regulations N0 CBD/TRG/004  related to regulatory service tariff/fees and 
fines.  
4. Two CD-Rom  or any  other external  driver containing STED  in a selectable  
PDF.  
5. Two commercial  samples  of the IVDD and certificate  of conformity  (where  
applicable),  however , additional samples  might  be required.  
 
b) An application  for a prequalified In Vitro Diagnostics Devices  registration  in Rwanda 
shall also  include  the following:  
1. Consent of WHO prequalification holder for WHO to confidentially share 
information with Rwanda FDA under Abridged registration Procedure. Refer to 
WHO  Appendix 2. Consent of WHO prequalification holder for WHO to 
confidentially share information with the NRA under the Procedure  
 
2. Expression of interest to be provided to the Authority along with the application. 
Refer to WHO Appendix 3, Part A Expression of interest to the national 
regulatory authorities (NRAs) in the assessment and accelerated national 
registration of a World Health Organization (WHO) -prequalified in vitro 
diagnostic  
  
 
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  1.7. Receiving new  applications for IVDD  registration  
An application  consist s of soft and  hard copies  submission. The  application  for registration  
of In Vitro Diagnostic s Devices  is only received  by the Authority  when  the payment  
of prescribed  registration /notification  fees is effected.  After  receiving  a device  
registration  applic ation,  a reference  number  is assigned  to the application  and it will be 
used in all subsequent  correspondences  relating  to the  application.  An acknowledged  
receipt will be  issued.  
1.8. Rwanda FDA Dossier  Notification  Procedure  
After  receiving an  application req uesting notification, the Authority shall proceed with the 
screening of the dossier for completeness  based on the First in First out (FIFO) rules .  
An IVDD  dossier  is reviewed  by one assessor  to verify the completeness of requirements . 
During  the review , additional  data and/or  samples  may be requested  through  an official  
communication  letter.  Once  a query  has been  issued  to the applicant,  the notification 
process  stops  until the Authority  receives  a written  response  to the raised  queries.  Further  
processing  of the application  may only be undertaken  if responses  to queries  issued  in 
the official  communication  letter  contain s all outstanding  information  requested  in one 
submission.  Failure  to comply  with this condition  or if the queries  have  been  reissued  for 
a second  time and the applicant  provides  unsatisfactory  responses,  the application  will be  
rejected.  
In the event  that the responses  to the queries  are not submitted  within  thirty  (30) calendar  
days from  the date they were  issued,  it will be considered  that the applicant  has withdrawn  
the application  unless  the applicant  has requested  an extension  of the deadline  to the 
Authority.  
Thereafter,  registration  of In Vitro Diagnostics Devices  may only be considered  upon  
submission  of a new application.  
In case th e dossier is complete, the application will be scheduled  for peer review. The 
applicant shall receive a certificate of notification within thirty (30) working days.  
 
1.9. Rwanda FDA Dossier  Registration  Procedure  
After  receiving  an application  requesting regist ration , the Authority  shall  proceed  with the   
screening  of the dossier  for completeness.  In the event  that the dossier  is incomplete,  it will 
not be scheduled  for assessment  and the applicant  will be notified  within  thirty  (30) 
working  days and requested  to comply  with requirements  in writing.  Devices under abridged 
assessment shall no t undergo the screening process.  
In case of a positive  outcome  during  the screening,  the application  will be scheduled  for 
assessment  according  to the First in First out (FIFO ) rules.  Priority  assessment  may be 
granted  where  the device  is intended  for diagnosis  of rare disease  conditions  or in the  case 
of an emergency  situation.  
An IVDD  dossier  is reviewed  by two assessors  to provide  scientific  and regulatory   
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
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  oversight  regardin g the quality,  safety  and performance of the IVDD under assessment.  
The Authority  reserves  the right  to request  any additional  information  to establish  the 
quality,  safety  and performance  of In Vitro Diagnostics  Devices . During  the assessment,  
additional  data and/or  samples  may be requested  through  an official  communication  
letter.   
Samples may be analyzed in the Quality Control Laborato ry in order to guide the 
Authority’s final decision . Once a query has been  raised and  issued to the applicant, the 
assessm ent process stops until  the Authority  receives  a written  response  to the raised  
queries.  Further  processing  of the application  may only be undertaken  if responses  to 
queries  issued  in the official  communication  letter  contain  all outstanding  information  
requested  in one submission.  Failure  to comply  with this condition  or if the queries  have  
been  reissued  for the fourth  time and the applicant  provides  unsatisfactory  responses,  the 
application  will be  rejected.  
In the event  that the responses  to the queries  are not submitted  within  ninety  (90) calendar  
days/thirty (30) calendar days  for IVVDs  undergoing  abridged assessment procedure from  
the date they were  issued,  it will be considered  that the applicant  has withdrawn  the 
application  unless  the applicant  has requested  for extension  of the deadline  to the Authority.  
Thereafter,  registration  of In Vitro Diagnostics  Devices  may only be considered  upon  
submission  of a new application.  
In case the dossier is complete, the application will be scheduled for peer  review.  
 
Note : The  Authority  may rely on assessments  and audits  conducted  by other  recognized  
regulatory  authorities  or conformity  assessment  bodies  (CABs) ; An abridged assessment  
procedure might  then be conducted . 
 
1.10. Compliance with  the Quality Management Syst em (QMS)  
The QMS audit is part of the In Vitro Diagnostics Device registration process. The 
Authority should conduct an inspection of the facility or use other means to verify whether 
the manufacturing site complies with QMS before an IVD is registered. All devices under 
classes C and D shall undergo  a QMS audit. During the assessment, assessors may highlight 
QMS’s issues and communicate to the department that has the mandate of inspection and 
compliance.  
QMS audit compliance  of the manufacturing site of  devices under the abridged assessment 
procedure shall be confirmed through desk review ; however , if deemed necessary  the 
Authority may conduct an onsite inspection .   
More information on QMS requirements and application for QMS  audit /GMP inspection  is 
detai led in relevant guidelines.  
  
 
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  1.11. Authority’s  Peer Review  Committee for  In Vitro Diagnostics Devices Registration / 
notification  
After  a thorough  dossier assessment, a final dossier assessment report shall be presented to 
the Authority ’s Peer Review Committee (PRC) before making final decisions for granting or 
rejecting market authorization of the IVD D. 
In the event, that there are safety, quality or performance issues to be resolved as per the 
decision of the PRC, the application shall remain pending until the  resolution of the raised 
issues. If the applicant fails to provide the required data within ninety  (90) calendar days, the 
product application shall be considered as withdrawn.  
The Authority will register / notify  the IVD D in the event that data on safety,  quality and 
performance  or other requirements  are considered satisfactory and a certificate of 
registration / certificate of notification of IVD D will be granted. The registration shall be 
valid for a period of five (5) years , whereas the certificate of no tification  validity shall be 
three (3) years . In the event that the Authority suspends or cancels the 
registration /notification  validity, a written official communication shall be issued to  the 
applicant.  
1.12. Timelines for In Vitro Diagnostics registration /notification  
In Vitro Diagnostics Device  dossiers shall be scheduled for assessment according to the First 
in First out (FIFO) basis upon compliance with the requirements.  
A new application  for registration  shall be processed within : 
 Thirty (30) calendar da ys for the notification  procedure  
 Ninety (90) calendar days for the abridged assessment  procedure  
 Nine (9) months  for the full assessment procedure  
 
Any additional  data shall be submitted  within :  
 Thirty (30) calendar days for IV DDs undergoing notificatio n procedure  
 Thirty (30) calendar days for IV DDs undergoing abridged assessment 
procedure  
 Ninety  (90) calendar  days undergoing the full assessment procedure   
 
1.13. Classification  of In Vitro Diagnostics  Devices  
In Vitro Diagnostics  Devices  are classified  into four classes  based on risk levels  (Class  A 
represents  the class  with the lowest  risk and Class  D represents  the class  with the highest  
risk to the individual and/or to public health ) Table 1. The classification of risks is  based  on 
the intended use and indic ations for use as specified by the manufacturer , the 
technical/scientific/medical expertise of the intended user (lay person or healthcare 
professional) , the importance of the information to the diagnosis (sole determinant or one of 
several), taking into c onsideration the natural history of the disease or disorder including 
presenting signs and symptoms which may guide a physician and the impact of the result 
(true or false) to the individual and/or to public health .   
 
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  Table 1: Classi fication examples for IVDDs  
CLASS  RISK  LEVELS   
A Low ( reagents, specimen receptacles, urine cups)  
B Low-Moderate (Pregnancy self -test, urine test) strips.  
C Moderate -High  (Cardiac markers, Prothrombin time testing.)  
 
 
 
 
 D High  (tests to identify HIV,  HCV, HBV, HTLV  
 
Where an In Vitro Diagnostic  Device  falls into more than one class, the class representing the 
higher class shall apply .  
Where  one IVD is intended  to be used together  with a different  IVDD, that may or may 
not be from  the same  manufactur er, a separate  submission  should  be made  and the 
conformity  assessments  of the IVDD shall  be applied  separately  to each of the devices.  
Whilst  the manufacturer  has the primary  responsibility  to classify  its devices,  the Authority  
may challenge  the classifi cation  and will have  the final say in deciding  the class  of the 
IVDDs. 
1.14. Technical Documentation  Requirements  
All IVDDs in classes  A, B,  C &  D require  pre-market  submission  of technical  
documentation demonstrating conformity  with Essential  Principles , excep t for those requiring 
notification.  
1.14.1.  Format and data presentation  of the dossier  
The information must be organized in the Summary of Technical Documentation ( STED ) 
such that it incorporates the sections described in these guidelines.  
1.14.1.1.  Preparation , content  and compilation of the dossier   
Applicants are required to arrange the application dossier in the format described below: - 
 
i. Application form  
 
ii. Device Details  
 
iii. Registration status in different countries along with supporting documents (marketing 
authoriza tion approval, free sale certificate, etc)  
iv. Summary technical documentation (where applicable ) 
 
v. Labelling information  
 
vi. Essential requirement checklist (where applicable)  
 
Note : Failure to arrange the application dossier accordingly will lead to the rejecti on of the 
application.   
 
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  1.14.1.2.  Evidence of Compliance with QMS  
For the I n Vitro Diagnostics D evices with higher risks the pre -registration GMP inspection or 
Quality Manag ement System audit will be conducted to verify their compliance. The audit 
will be conducted o n a risk basis, however , in most cases , evidence of compliance with GMP 
or the Quality Management System for IVD D provided by the manufacturer will be adequate.  
For IVD Ds that require evidence of compliance with the Quality Management System, a CE 
certific ate issued by a Notified Body designated in Europe for the purposes of the In Vitro 
Diagnostic Medical Devices Directive (98/79/EC) (IVDD) will be accepted. (May also be 
referred to as an EU Certificate, an EC certificate or an EEC Certificate) ISO 13485 
certificates issued by recognized Notified Bodies for the purposes of the IVDD will also be 
accepted.  
 
CE and ISO 13485 certificates will only be accepted if they include acceptable evidence of 
good manufacturing practice (GMP) for IVD Ds:   
 Full legal name of the manufacturer of the goods, including trading names if 
appropriate.  
 Street address of the manufacturing site (PO box is not acceptable)  
 Date of the last audit/inspection.  
 Standard of manufacture with which the manufacturer of the product(s) complies.  
 Product(s) or type(s) of the product(s) in sufficient detail to determine if the scope of 
the certificate is relevant to the IVD D to be supplied  
 Date of issue  
 Period of validity or expiry date (must be current)  
 Notified Body number  
 Notified Body name  
1.14.2.  Devi ce details  
1.14.2.1.  Name(s)  
State the generic and brand name (where applicable) of the IVDD . 
1.14.2.2.  Description  
Provide a general description on the design, characteristics and performance of the IVD D. 
The description should also include information on the device packagin g. 
1.14.2.3.   Category/classification  
State the class of the IVD D and the applicable classification rule as appended in Annex I V of 
these guidelines.  
1.14.2.4.  Intended Use/Indication  
State the intended use of the IVD D and/or provide a general description of the disease or 
condition that the device will help diagnose , treat, prevent, or mitigate. The description of the  
 
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  target patient population for which the device is intended should also be included, whether it 
is automated or not, whether it is qualitative or quantitative; the type of specimen it requires 
(serum, plasma, urine) and what the assay type is e.g. immunoassay, chemistry, 
cytochemistry, image analysis should be stated.  
1.14.2.5.   Instruction of Use  
Give a concise summary of information for the safe use of the device includi ng procedures, 
methods, frequency, duration, quantity and preparation to be followed.  
1.14.2.6.   Contraindications  
State conditions under which the IVD D should not be used. For example, a limitation of an 
assay using specimens from patients who have received prepara tions of mouse monoclonal 
antibodies for therapy when tested with assay kits which employed mouse monoclonal 
antibodies. It may show either false elevated or depressed values.  
1.14.2.7.  Warnings  
State the specific hazard alert information that a user needs to know b efore using the IVD D. 
E.g. for products containing biological material, radioactive material, explosive material and 
any other hazardous material, safety warnings must be included.  
1.14.2.8.   Precautions  
State briefly the precautions to be taken and any special care  necessary for the safe and 
effective use of the IVD D. 
1.14.2.9.   Adverse  effects /events  
Describe all adverse and side effects associated with IVD D under normal conditions of use.  
1.14.2.10.  Alternative Use  
Describe any alternative practices or procedures for helping in the diagnosi s, treat ment , or 
mitigati on of  the disease or condition for which the IVD D is intended.  
1.14.2.11.  Storage conditions  
State the storage conditions for the IVD D. 
1.14.2.12.  Recommended shelf -life (where applicable)  
State the recommended shelf -life of the IVD D. 
1.14.3.  Summary of T echnical Documentation (STED)  
1.14.3.1.  Device description and features  
Provide a detailed description of the device attributes that are necessary to explain how the 
device functions. These details should include:   
 
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(a) Intended use of the In Vitro D iagnostic  Device . Thi s may include:  
 
(i) What is detected  
 
(ii) The function of the IVD D (e.g. screening, monitoring, diagnostic or aid to 
diagnosis, staging or aid to staging of disease);  
(iii) The specific disorder, condition or risk factor of interest that is intended to detect, 
define or  differentiate;  
 
(iv) Whether the product is automated or not;  
 
(v) Whether the test is qualitative or quantitative.  
 
(vi) The type of specimen(s) required (e.g. serum, plasma, whole blood, sputum, 
urine)  
 
(vii) The intended testing population (e.g. neonates, antenatal women)  
 
(b) The intended user (laboratory professional and/or at point -of-care);  
 
(c) A general description of the principle of the assay method or instrument principles of 
operation.  
 
(d) A description of the components of the assay (e.g. reagents, assay controls and 
calib rators), and where appropriate, a description of the reactive ingredients of relevant 
components (such as antibodies, antigens, nucleic acid primers).  
 
(e) A description of the specimen collection and transport materials provided with the 
product or a descript ion of specifications recommended for use.  
 
(f) For instruments of automated assays: a description of the appropriate assay characteristics 
or dedicated assays.  
(g) For automated assays: a description of the appropriate instrumentation characteristics or 
dedicated  instrumentation.  
 
(h) If applicable, a description of any software to be used with the product.  
 
(i) If applicable, a description or complete list of the various configuration s/variants of the 
product that will be made available. For example , a family of pregnanc y rapid test s can 
consist of device s available in different configurations, such as test strip s or in a cassette.  
 
(j) If applicable, a description of the accessories, and other non IVD products that are 
intended to be used in combination with the  IVDD .  
 
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(k) Risk class and the applicable classification rule for the IVD D according to the 
classification rules in annex  IV below  
 
The instruction for use may be used to provide some of this information on the condition that 
a cross -reference to the different requirements  is supplied in conjunction with the 
instructions -for-use.  
1.14.3.2.   Evidence of Conformity to Essential Principles  
Provide evidence of conformity to Essential Principles of Safety and Performance (EPSP) by 
completing the checklist appended as Annex V. 
 
Note:  
(i) Manu facturer should identify the essential principles of safety and performance that 
are applicable to the device and the general methods used to demonstrate conformity 
to each applicable Essential Principle. The methods that may be used include: - 
 
(a) Conformity with a recognized or another /other standard  (s) 
 
(b) Conformity with a commonly accepted industry test method (reference method)  
 
(c) Conformity with appropriate in -house test methods that have been validated and 
verified;  
 
(d) Comparison to a n IVDD  already available on the market.  
 
(ii) When the manufacturer uses national, international or other standards to demonstrate 
conformity with the Essential Principles, the full title of the standard, identifying 
numbers, the date of the standard and the organization that created t he standard should 
be provided. (Essential Principles of Safety and  Performance of Medical Devices.  
 
The IVD D, to which the Essential Principles (EP) conformity checklist is applicable, should 
be identified by the brand name, common name and risk class on  the checklist itself. The 
columns of the checklist should be completed as follows:  
 
a) Applicable to the IVD D? 
Either a “Yes” or “No” answer is required. If the answer is “No” there should be a brief 
explanation.  
 
b) Method of conformity  
State the title and re ference of the standard(s), industry or in -house test method(s), 
comparison study(ies) or other methods to demonstrate compliance. For standards, this 
should include the date of the standard and where a standard is referred to more than once in 
the checkli st, the reference number and date can be repeated.   
 
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c) Identity of specific documents  
The column should contain the reference to the actual technical documentation that 
demonstrates compliance to the EP, i.e. the certificate number(s), test reports, study rep orts or 
other documents that resulted from the method used to demonstrate compliance , and its 
location within the technical documentation or dossier.  
1.14.3.3.   Risk Analysis  
Provide a summary of the risks identified during the risk analysis process and how such ris ks 
have been controlled to an acceptable level. Preferably, the risk analysis should be based on 
recognized standards and be part of the manufacturer’s risk management plan.  
 
The summary should address possible hazards for the IVD D such as the risk from fa lse 
positive or false negative results, indirect risks which may lead to erroneous results, or from 
user-related hazards, such as reagents containing infectious agents.  
 
The results of the risk analysis should provide a conclusion with evidence that the remaining 
risks are acceptable when compared to the benefits.   
1.14.3.4.   Design and Manufacturing Information  
1.14.3.4.1.   Product design  
Provide information such as to give a general understanding of the design applied to the 
IVDD.  It should include a description of the critic al ingredients of an assay such as 
antibodies, antigens, enzymes and nucleic acid primers provided or recommended for use 
with the IVD D. 
i. For instruments , include a description of major subsystems, analytical technology 
(e.g. operating principles, control m echanisms), dedicated computer hardware and 
software.   
ii. For instruments and software , give an overview of the entire system, including an 
Architecture Design Chart which is typically a flowchart of the relationships among 
the major functional units in the software, including relationships to hardware and to 
data flows such as networking.  
iii. For standalone software , include a description of the data interpretation 
methodology (i.e. algorithms).   
iv. For self -testing IVDDs the design should include a description of  the design aspects 
that make it suitable for lay person use.  
v. If design takes place at multiple sites, a controlling site must be identified.  
1.14.3.4.1.1.  Formulation and composition  
 
Provide formulation/composition for each of the ingredients;   
 
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(a) Materials  
 
Provide complete details of material specifications, including raw materials;  
 
(i) All components of the IVD D should be listed , chemically and biologically 
characterized, including antibodies, antigens, and assay controls, substrates used 
to detect antigen -antibody c omplexes, and test reagents. Appropriate references 
should be cited.  
 
(ii) If synthetic peptides are used, the peptide sequence should be provided.  
 
(iii) If components are of biological origin or recombinant, the source must be 
indicated and details on production mu st be provided. These details would include 
the strain of the virus, the cell line for the cultivation of the virus, sequences of 
relevant nucleic acids and amino acids, etc., used in the manufacturing process of 
viral lysate, purified proteins, recombinan t and synthetic proteins.  
 
(iv) If applicable, process validation results to be provided to substantiate that 
manufacturing procedures are in place to minimize biological risks, in particular, 
with regard to viruses and other transmissible agents. This also inc ludes the 
inactivation of infectious organisms in reagents and the production of reagents.  
 
(v) If applicable, information to be provided on irradiating components, non -ionising 
or ionizing (e.g. Iodide - 131 in the Radioimmunoassay kit, radio -labelled 
Phosphor us-32 DNA probes in Southern blots)  
 
(vi) If applicable, information to be provided on the poison or controlled substance ( 
e.g Buprenorphine in drug assay kit)  
 
(vii) Give the nature and specification of the packaging material(s) including complete 
chemical and phys ical characterization of the packaging material making either 
direct or indirect contact with the IVD D. 
 
Identify the sources of the materials from which the components are constructed.  
 
(a) Biological Safety  
 
List all biological components included in the IV DD to include material of bacterial, viral, 
parasitic, animal, or human origin or their derivatives where applicable. Indicate the name of 
the biological component, details of its use in the product and description of steps taken for 
the reduction of trans mission or infection risk.  
 
(b)  Documentation of design change   
 
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Provide records of each design change, if any, with reasons for these changes along with 
associated validation/,  data. Include evidence that the change achieves the desired effect, and 
that t he product continues to comply with the Essential Principles of Safety and Performance.  
 
1.14.3.4.2.  Manufacturing Processes  
1.14.3.4.2.1.   Overview of Manufacturing Process  
Provide information on the manufacturing process, which may be in form of a process flow 
chart, showing an o verview of production including technologies used, assembly and 
packaging as well as details on each major step in the manufacturing process of the finished 
IVDD and Verification and validation for all stages of design and manufacturing process.  
Include d etails of any in -process and final device  testing (e.g. the manufacturer’s QC release 
program  such as batch release criteria for the device, etc ).   
1.14.3.4.2.2.   Sites of Manufacture  
Provide the following information;  
 
i. Name of site,  
 
ii. Physical address of the site,  
 
iii. Description of the component manufacture/stage of manufacturing process carried out 
at the site,  
 
iv. A simple sight plan highlighting production areas and the number of employees at the 
site, 
 
v. A description of any other manufacturing that occurs at the site;  
 
vi. A certified QMS certificate  equivalent  for all sites  
 
For all the critical manufacturing sites that are involved in the manufacture of this device  (i.e. 
including design, warehousing and quality control stages of manufacture).  
1.14.3.4.2.3.   Key Suppliers  
Provide a list o f key suppliers of ingredients/products/services for the manufacture of the 
IVDD, indicating the;  
 
i. Name of the supplier,  
 
ii. Supplier’s manufacturing site physical address   
 
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  iii. A description of the ingredient/product/service supplied  
 
iv. Evidence of purchasing and ve rification procedures for the 
ingredients/products/services sourced from these suppliers  
1.14.3.5.   Device Specifications  
Describe functional characteristics and technical performance specifications for the device 
including accuracy, sensitivity, specificity of meas uring and other specifications including 
chemical, physical, mechanical, electrical and biological.  
 
A list of the features, dimensions and performance characteristics of the IVD D its variants 
and accessories should be provided in the dossier and also made  available to the end user.  
1.14.3.5.1.   Device Verification and Validation  
Summarize the results of verification and validation studies undertaken to demonstrate 
compliance of the IVD D with the Essential Principles that apply to it. Whenever applicable 
the informatio n should cover:  
 
i. The complete study protocol,  
 
ii. The method of data analysis,  
 
iii. Complete the study report,  
 
iv. The study 's conclusion,  
 
v. Any published literature regarding the device or substantially similar devices.  
 
vi. Summaries or reports of tests and evaluations  based on other standards, manufacturer 
methods and tests or alternative ways of demonstrating compliance. 
Declarations/certificate s of compliance to a recognized standard as applied by the 
manufacturer should be provided.  
 
When a recognized standard exist s that contains the protocol and the method of data analysis, 
this information can be substituted by a declaration/certificate of conformity to the 
recognized standard. However, a summary of the data and conclusions should be provided. 
Where appropriate ac tual test results summaries with their acceptance criteria should be 
provided and not just pass/fail statements.  
1.14.3.5.2.  Specimen type  
This section should describe the different specimen types that can be used, including their 
stability (and storage) conditions an d is typically applicable to all systems and assay types.  
  
 
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  i. Stability includes storage and where applicable transport conditions. Storage includes 
elements such as duration, temperature limits and freeze/thaw cycles.  
 
ii. Summary information for each matrix and  anticoagulant when applicable, including a 
description of the measurement procedure for comparison or determination of 
measurement accuracy. This includes information such as specimen type tested, 
number of samples, sample range (using spiked samples as a ppropriate) or target 
concentrations tested, calculations and statistical methods, results and conclusions.  
1.14.3.6.   Analytical performance characteristics  
1.14.3.6.1.  Accuracy of measurement  
Provide information to describe both trueness and precision studies.  
1.14.3.6.2.  Trueness of mea surement  
Provide information on the trueness of the measurement procedure and summarize the data 
used to establish the trueness measures for both quantitative and qualitative assays.  
 
(a) Precision of measurement  
 
Provide information to describe repeatabi lity and reproducibility studies.  
 
(i) Repeatability  
Provide detail on repeatability estimation and information about the studies used to estimate, 
as appropriate, within -run variability. Repeatability data is obtained for instrumentation in 
conjunction with an appropriate assay.  
(ii) Reproducibility  
Provide information on reproducibility estimates and information about the studies used to 
estimate, as appropriate, variability between days, runs, sites, lots, operators and instruments. 
Such variability is also know n as “Intermediate Precision”.  
1.14.3.6.3.  Analytical sensitivity  
Provide information about the study design and results. Give a detailed description of 
specimen type and preparation including matrix, analyte (measured) levels, and how levels 
were established. The n umber of replicates tested at each concentration should also be 
provided as well as a description of the calculation used to determine assay sensitivity. For 
example:  
 
(i) Number of standard deviations above the mean value of the sample without 
analyte (measur and), commonly referred to as ‘limit of blank’ (LoB).  
(ii) Lowest concentration distinguishable from zero, based on measurements of 
samples containing the analyte (measurand), commonly referred to as ‘limit of 
detection, (LoD).   
 
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  (iii) Lowest concentration at which pre cision and/or trueness are within specified 
criteria , commonly referr ed to as the ‘limit of quantitation’ (LoQ).  
1.14.3.6.4.  Analytical specificity  
Give information to describe interference and cross -reactivity studies to determine the 
analytical specificity, defined  as the ability of a measurement procedure to detect or measure 
only the analyte (measurand) to be detected, in the presence of other substances/agents in the 
sample.  
 
Provide information on the evaluation  of potentially interfering and cross -reacting 
substances/agents on the assay. Information should be provided on the substance/agent type 
and concentration tested , sample type, analyte (measurand) test concentration, and results.  
 
Interferents and cross -reacting substances/agents, which vary greatly depend ing on the assay 
type and design, could derive from exogenous or endogenous sources such as:  
 
Substances used for patient treatment (e.g. therapeutic drugs,  alcohol, vitamins, foods, etc.), 
substances added during sample preparation (e.g. preservatives, s tabilizers), substances 
encountered in specific specimen types (e.g. haemoglobin, lipids, bilirubin, proteins), and; 
analytes of similar structure (e.g. precursors, metabolites) or medical conditions unrelated to 
the test condition including specimens nega tive for the assay but positive for a condition that 
may mimic the test condition (e.g. for a hepatitis A assay: test specimens negative for 
hepatitis A virus, but positive for hepatitis B virus)  
1.14.3.6.5.  Metrological traceability of calibrator and control material  values  
The applicant shall summarize the information about the metrological traceability of values 
assigned to calibrators and trueness control materials. Include, for reference materials and/or 
reference measurement procedures and a description of value assignment and validation.  
1.14.3.6.5.1.   Measuring the range of the assay  
Provide a summary of studies which define the measuring range (linear and non -linear 
measuring systems) including the limit of detection and describe information on how these 
were established. T he summary should include a description of specimen type, number of 
samples, number of replicates, and preparation including information on matrix, analyte 
(measurand) levels and how levels were established. If applicable, add a description of the 
high dos e hook effect and the data supporting the mitigation (e.g. dilution) steps.  
1.14.3.6.5.2.  Validation of assay cut -off  
Provide a summary of analytical data with a description of the study design including 
methods for determining the assay cut -off, including the populati on (s) studied, method or 
mode of characterization of specimens and statistical methods e.g. Receiver Operator 
Characteristic (ROC) to generate results and if applicable, define grey-zone/equivocal zone.   
 
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  1.14.3.7.   Stability (excluding specimen stability)   
Describe claimed shelf life, in-use stability and shipping studies.  
1.14.3.7.1.   Claimed shelf life  
Provide information on stability testing studies, to support the claimed shelf life, performed 
on at least three different lots manufactured under conditions that are essentiall y equivalent to 
routine production conditions (these lots do not need to be consecutive lots). The summary 
should include:  
 
i. The study report (i.e. protocol, number of lots, acceptance criteria and testing 
intervals),  
 
ii. When accelerated studies have been p erformed in anticipation of the real time studies, 
the method used for accelerated studies;  
 
iii. Conclusion and claimed shelf life.  
 
Note :  
Shelf life can be derived from the lot with the longest real time stability data as long as 
accelerated or extrapolated data from all three lots are comparable.  
1.14.3.7.2.     In use stability  
Provide information on in use stability studies for one lot reflecting actual routine use of the 
device (real or simulated). This may include open vial stability and/or, for automated 
instruments , on board stability.  
 
In case of automated instrumentation if calibration stability is claimed, supporting data 
should be included sufficient to describe: the study protocol (i.e. protocol, acceptance criteria 
and testing intervals), conclusions and claim ed in use stability.  
1.14.3.7.3.   Shipping stability  
Provide information on shipping stability studies for one lot to evaluate the tolerance of 
products to the anticipated shipping conditions, describing the study report ( i.e. protocol, 
acceptance criteria), a method  used for simulated conditions, conclusion and recommended 
shipping conditions.  
 
Shipping studies can be done under real and/or simulated conditions and should include 
variable shipping conditions such as extreme heat and/or cold.  
1.14.3.8.   Software Verification an d Validation  
Provide information on the software design and development process and evidence of the 
validation of the software, as used in the finished device. This information should typically 
include the summary results of all verification, validation pr otocol and report and testing  
 
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  performed both in -house and in a simulated or actual user environment prior to final release. 
It should also address all of the different hardware configurations and, where applicable, 
operating systems identified in the label ling. 
1.14.3.9.   Clinical Performance  
Provide evidence of assessment and analysis of data generated from the clinical use of the 
product sufficient enough to verify the clinical safety of the IVD D. Include claims for 
clinical/diagnostic sensitivity and specificity.  All claims should be supported by well -
designed performance evaluations which should include:  
 
(a) A detailed written plan and protocol for the evaluation study  
 
(b) Dates on which the study was performed and by which site  
 
(c) A written report on the outcome of the study; all anomalous results should be explained 
and justified. The report outline should contain,  
 
i. The technology on which the device is based, the intended use of the device and any 
claims made about the device’s clinical performance or safety.  
 
ii. The natu re and extent of the clinical data that has been evaluated; and,  
 
iii. How does the referenced information (recognized standards and/or clinical data) 
demonstrate the clinical performance and safety of the device in question.  
 
(d) Details of the IVD D lots/batches u sed for the evaluation including lot number , date of 
expiry, and storage conditions of the product prior to and during the study.  
(e) The clinical evaluation report should be signed and dated by the evaluator(s) and 
accompanied by the manufacturer’s justificat ion of the choice of an evaluator.  
 
The clinical evaluation report should be summarized as per the required information 
elaborated above.  
1.14.4.   Labelling Requirements  
Labelling information shall be in English , French  and/or  Kinyarwanda and shall be expressed 
in a legible, permanent and prominent manner that can be easily understood by the intended 
user.  
Provide a complete set of labeling associated with the IVD D including immediate and outer 
container labels on the IVD D, and instructions for use.  
The labeling s hould contain the final content as determined by the manufacturer.  
 
Depending on the type of device, the following minimum information should be provided on 
the label:  
  
 
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  (a) The name of the IVD D shall be indicated. If the name does not uniquely identify the 
IVDD, an additional means of identification shall also be provided.  
Examples: Catalogue number, commodity number  
 
(b) the name and address of the manufacturer  
 
(c) the identifier of the device, including the identifier of a device that is part of a system, 
test kit, or device class.  
(d) batch or lot number  
 
(e) Contents: if the contents are not readily apparent, an indication of what the package  
contains, expressed in terms appropriate to the device, such as size, net weight, length, 
volume or number of units, volume after  reconstitution shall be indicated  
 
(f) the words “Sterile” if the manufacturer intends to sell the IVD D in a sterile condition  
 
(g) the word “For Single Use Only” shall be included if the IVD D is intended for single 
use 
 
(h) In vitro diagnostics use: The In vitro diag nostics use of the device shall be indicated 
e.g. “For In vitro diagnostics use” or graphical symbol: “In vitro diagnostic device”.  
 
(i) The Expiry date: An expiry date based upon the storage instructions shall be indicated 
and shall follow the requirements of  ISO 8601. Expiry dates shall be expressed as the 
year, the month and where relevant, the day. E.g. “YYYY -MM-DD” or “YYYY -
MM”.  
 
(j) Unless self -evident to the intended user, the medical conditions, purposes and uses for 
which the device is manufactured, sold o r represented, including the performance 
specifications of the device if those specifications are necessary for proper use  
 
(k) the directions for use, unless directions are not required for the device to be used 
safely and effectively  
 
(l) Warning and precaution s: If an IVD D is considered hazardous, the outer container 
label shall include the appropriate danger wording or symbol(s) e.g. chemical, 
radioactive and biological hazards  
 
(m)  Storage and Handling conditions: The storage conditions necessary to maintain the  
stability of the reagents, calibrators, control materials in the unopened state and other 
IVDDs shall be indicated. If there are any other conditions that may affect the 
handling or storage of the reagents, calibrators, control materials and other IVD Ds 
shall be specified e.g. Fragile  
  
 
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  (n) Intended use: If the intended use is not indicated by the name of the IVD D, then an 
abbreviated intended use statement shall be given or included in the instruction for 
use. e.g. For measurement of plasma glucose concentrati on 
In case the device is intended to be sold to the general public, labeling information: - 
 
i. Shall be set out on the outside of the package that contains the device , and be 
visible under normal conditions of sale  
ii. where a package that contains a device is to o small to display all the 
information in accordance with (a -k) above, the directions for use shall 
accompany the device but need not be set out on the outside of the package or 
be visible under normal conditions of sale.  
 
Specimen label(s), promotional ma terial(s) and user manual(s) should be provided.  
 
Note:  
Requirements that have been described in a respective standard should also be followed when 
labelling a device.   
 
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  REFERENCES  
 
1. IMDRF/IVD WG/N64FINAL:2021 . Principles of In Vitro Diagnostic (IVD) Medical  
Devices Classification   
2. EAC/TF -MED/MER/FD/DEVICES/N2R0 . Requirements for Assessment and Market 
Authorization of In Vitro Diagnostic Medical Devices  
3. WHO Global Model Regulatory Framework for Medical Devices including In Vitro 
Diagnostic Medical Devices  
4. WHO /BS/2020.2397. Annex 4: Collaborative procedure between the World Health 
Organization and national regulatory authorities in the assessment and accelerated 
national registration of WHO -prequalified in vitro diagnostics   
 
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ENDORSEMENT OF THE GUIDELINES  
 
 
 
  
 
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  APPENDIC ES  
 
Annex I :  cover letter  
 
 
Cover Letter                                                                                                              
 
<App licant>  
<Address>  
<Postal Code><Town>  
<Date>  
 
<Applicant’s reference>  
<Rwanda FDA>  
<P.O.Box:1948><Kigali_Rwanda>  
 
 
Dear Sir/Madam,  
 
Subject : Submission of Application Dossier(s) for Marketing Authorization of < 
Medical device(s) >  
 
We are pleased to submit  our Application Dossier(s) for the registration of medical 
devices/In Vitro Diagnostics Devices (IVDDs) that details are as follows:  
 
Name of the Medical device(s) /IVDD(s): 
………………………………….……………………..  
 
Classification of the Medical Device(s)/IVDD(s): 
……………… …………………………….…..  
 
Intended use of the Medical Device(s)/IVDD(s): ……………………................................  
 
You will find enclosed the submission dossier as specified hereafter:  
 
 Two (2) CD rom/external driver that contains the summary of technical 
documenta tion (STED) in selectable PDF format  
 The proof of payment.  
 
 We confirm that the electronic submission has been checked with up -to-date and 
state-of-the-art antivirus software.  
 
 Type of Submission:  󠇯Full registration Application           󠇯Abridged Application        
󠇯notification              
 QMS No: DFAR/HMDAR/FMT/001  
Revision No: 1  
Effective Date: 16/06/2022   
 
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Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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 sample(s) submitted  
 
 Application for QMS audit/GMP inspection has been made to Rwanda FDA (as per 
relevant guidelines)  
 
 I confirm  that the Product Dossier information submitted is the same in all aspects as 
the product registered with the relevant SRA, WHO PQ and EAC (Only for Abridged 
Application s) 
I, the undersigned certify that all the information in this form and accompanying 
documentation is correct, complete and true to the best of my knowledge  
 
Yours sincerely,  
 
<Signature>  
 
<Name>  
 
<Title>  
 
<Phone number(s)>  
 
<Email address>   
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  Annex II : Application form  
 
   
 
 Department/Division/Office/Unit  DFAR Department/ HMDAR Division  
Document Type:  Form  Doc. No  :DFAR/HMDAR/FOM/022  
  
Title:  
Application Form for Medical 
Devices and In Vitro 
Diagnostics Devices (IVD Ds) 
for registration  
 Revision 
Number  : 2 
Revision 
Date:  : 17/10/2022  
Effective 
Date  : 31/10/2022  
Review 
Due Date  : 30/10/2025  
Ref Doc.  : 
Application 
Number  Rwanda FDA use only  
Date of 
submission of 
dossier  Rwanda FDA use only  
1.0 PARTICULARS OF THE MEDICAL DEVICE or IVDD ( Bold or Tick  the right type of 
application)  
1.1 Type of application  
 New              full registration       abridged registration   
 Renewal   
 Variation*  
* If variation has been made, information supporting the changes should be submitted.  
1.2 Name of the Medical Device or IVDD  
       
 
 
1.3 Classification of the Medical Device or I VDD  
         
 
 Form at: QMS/FMT/002  
Revision No: 1  
Effective Date: 20 June 2022   
 
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  1.4 Intended use of the Medical Device or IVDD  
             
 
1.5 Name and address (physical and postal) of Applicant  
Address:                     
Country:                       
Telephone:                 
Telefax:                       
E-Mail:         
1.6 Name and address ( physical and postal) of the manufacturer  
Address:                     
Country:                     
Telephone:                 
Telefax:                      
E-Mail        
1.7 Visual description of the Medical Device or I VDD  
         
 
1.8 Proposed shelf life (in months) (where applicable):  
        
 
 
1.9 Proposed storage conditions (where applicable):  
      
 
1.10 Other sister /variants of the  medical device (s) or IVD (s) registered or applied for 
registration   
 
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1.11 list all accessories that are manufactured/ sold with the devices  
 
1.12 Do you hold Marketing Authorization(s) for another/ other medical device(s) or In 
Vitro Diagnostics Devices (IVDDs) in any of the East African Community (EAC)?  
 Yes  
 No  
If yes stat e Medical Device(s) or IVDD(s) name:      
 
Regulatory Authority(ies) where the product is authorized:  
       
Marketing authorization number(s):        
 
Indication(s):      
 
1.13 Have you applied for Marketing Authorization(s) of medical device(s) or In Vi tro 
Diagnostics Devices (IVDs) in any of the countr ies of the East African Community 
(EAC)?  
 Yes  
 No  
If yes state  
Medical Device name or IVDD:      
Regulatory Authority(ies) where you have applied for registration:     
 
Indication(s):    
 
1.14 Country of origin (where the device was manufactured)   
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
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1.15 Device Marketing Authorization in the country of origin (Attach Marketing 
Authorization of the Medical Device or IVDD from the National Regulatory 
Authority). If not registered, state the reasons  
 Authorized Country:     
Date of authorization:      
Authorization number:       
 
 Refused Country:     
Date of refusal:      
Reason for refusal:      
  Withdrawn (by the applicant after 
authorization) Country:      
Date of withdrawal:      
Reason for withdrawal:      
 
 Suspended/revoked (by competent 
authority) Country:      
Date of suspension/revocation:      
Reason for suspension/revocation:      
 
 
1.16 Name(s) and physical address(es) of the manufacturing site(s) of the Medical Device 
or IVDD. Altern ative sites should be also declared here.  
All manufacturing sites involved in the manufacturing process of the device, stating 
the role of each including the quality control / in -process testing sites should be listed.  
Address:                      
Country :                     
Telephone:                  
Telefax:                       
E-Mail:         
 
1.17 Name and address (physical and postal) of the Agent/Local Technical Representative 
(LTR) (Attach a valid appointment letter notarized from the country o f origin):         
Address:                      
Country:                     
Telephone:                 
Telefax:                       
E-Mail:         
  
 
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  1.18 Name and address (physical and postal) of the person or company responsible for 
Pharmacovigilance  and Post Marketing Surveillance:         
Address:                        
Country:                      
Telephone:                   
Telefax:                       
E-Mail:         
 
1.19 Declaration of Conformity specifying all standards  used in the manufa cturing of the 
Medical Device or IVDD  
            
1.20 Qualitative and Quantitative composition of the Medical Device or IVDD (If 
applicable)  
 
1.21 Name and address (physical and postal) of the Contract Research Organisation(s) 
where the clinical studies  of the Medical Device or IVDD were conducted. (If 
applicable)  
Address:                      
Country:                     
Telephone:                  
Telefax:                       
E-Mail:          
2.0 DECLARATION BY THE APPLICANT  
 
I,                                                                                             , the undersigned certify that all 
the information in this form and accompanying documentation is correct, complete and true 
to the best of my knowledge.  
I further confirm that the i nformation referred to in my application dossier is available for 
verification during the Quality audit inspection. I also agree that I shall carry out 
pharmacovigilance and Post-marketing Surveillance to monitor the safety, quality and 
performance of the device on the market and provide safety, quality and performance update  
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  reports to Rwanda FDA.  
I further agree that I am obliged to follow the requirements of Rwanda 's Legislation and 
Regulations, which are applicable to Medical Devices and IVDDs. I also c onsent to the 
processing of information provided to Rwanda FDA. It is hereby confirmed that fees will be 
paid/have been paid according to the authority’s rules*  
Signature:  
 
Date:  
* Note : If fees have been paid, attach proof of payment   
 
Guidelines  on Submission  of Documentation  for Registration  of In Vitro Diagnostics Devices  
 
Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  Annex  III: Notifi cation F orm  
 
 
 
 Department/Division/Office/Unit  DFAR Department/HMDAR 
Division  
Document Type:  Form  Doc. No  :DFAR/HMDAR/FOM/023  
  
Title:  
Application Form for Medical 
Devices and In Vitro 
Diagnostics Devices (IVDDs) 
for notification  Revision 
Number  : 0 
Revision 
Date:  : 17/10/2022  
Effective 
Date  : 31/10/2022  
Review 
Due 
Date  : 30/10/2025  
Ref Doc.  : 
Application 
Number  Rwanda FDA use only  
Date of 
submission of 
dossier  Rwanda FDA use only  
1.0 PARTICULARS OF THE MEDICAL DEVICE or IVDD ( Bold or  Tick  the right type of 
application)  
1.1 Type of application  
 New  
 Renewal  
 Variation*  
* If variation has been made, information supporting the changes should be 
submitted.  
1.2 Name of the Medical Device or IVDD  
       
 
 
1.3 Classification of the  Medical Device or IVDD  
         
 
 
1.4 Intended use of the Medical Device or IVDD  
             
Intended user:  
 Professional    
  self user  
1.5 Name and address (physical and postal) of Applicant  
Address:                     
Country:                       
Telephone:                 
Telefax:                       Format: QMS/FMT/002  
Revision No: 1  
Effective Date: 20 June 2022   
 
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Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  E-Mail:         
1.6 Name and address ( physical and postal) of manufacturer  
Address:                     
Country:                     
Telephone:                 
Telefax:                      
E-Mail         
1.7 Visual description of the Medical Device or IVDD  
         
 
1.8 Proposed shelf life (in months) (where applicable):  
        
 
 
1.9 Proposed storage conditions (where applicable):  
      
 
1.10 Other regulatory authority(ies) approval(s) (i.e. E uropean conformity (CE) mark, 
United States Food and Drug Administration (USFDA) approval, etc)  
     
1.11 Country of origin (where the device was manufactured)  
    
 
1.12 Name(s) and physical address(es) of the manufacturing site(s) of the Medical 
Device or IVDD. Alternative sites should be also declared here.  
All manufacturing sites involved in the manufacturing process of the device, stating 
the role of each including quality control / in -process testing sites should be listed.  
Address:                      
Country:                     
Telephone:                  
Telefax:                       
E-Mail:         
 
1.13 Name and address (physical and postal) of the Agent/Local Technical 
Representative (LTR) (Attach a valid appointment letter notarized from th e country 
of origin):         
Address:                      
Country:                     
Telephone:                 
Telefax:                       
E-Mail:         
 
1.14 Declaration of Conformity specifying all standards  used in the manufacturing of the 
Medical Device or IVDD  
            
1.15 Global Medical Device 
Nomenclature ( GMDN)  Name   
GMDN  Code   
  
 
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  1.16 Version  of the product  insert  (attach a copy of relevant labeling including the 
Instruction For Use (IFU )) 
 
2.0 DECLARATION BY THE APPLICANT  
 
I,                                                                                             , the undersigned certify that all 
the information in this form and accompanying documentation is correct, complete and true 
to the best of my knowledge.  
I further c onfirm that the information referred to in my application dossier is available for 
verification during the Quality audit inspection. I also agree that I shall carry out 
pharmacovigilance and Post-marketing Surveillance to monitor the safety, quality and 
performance of the device on the market and provide safety, quality and performance update 
reports to Rwanda FDA.  
I further agree that I am obliged to follow the requirements of Rwanda 's Legislations and 
Regulations, which are applicable to Medical Devices a nd IVDDs. I also consent to the 
processing of information provided to Rwanda FDA. It is hereby confirmed that fees will be 
paid/have been paid according to the authority’s rules*  
 
Signature:  
 
Date:  
 
* Note : If fees have been paid, attach proof of payment  
  
 
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Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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  Annex I V : Classification rules of Invitro Diagnostics  Devices  (IVD Ds) 
 
  
Rule 1:  
 IVDDs intended for the following purposes are classified as Class D:  
● Devices intended to be used to detect the presence of, or exposure to, a 
transmissible  
agent in blood, blood components, cells, tissues or organs or any of their  
derivatives, in order to assess their suitability for transfusion, transplantation or 
cell 
administration.  
● Devices intended to be used to detect the presence of, or exposure to, a 
transmissible  
agent that causes a life -threatening, disease with a high or suspected risk of  
propagation;  
 
Rationale: The application of this rule as defined above s hould be in accordance 
with the  rationale that follows: Devices in this Class are intended to be used to 
ensure the  
safety of blood and blood components for transfusion and/or cells, tissues and  
organs for transplantation. In most cases, the result of the test is the major  
determinant as to whether the donation/product will be used. Serious diseases are  
those that result in death or long -term disability, that are often incurable or 
require  
major therapeutic interventions and where an accurate diagnosis is v ital to 
mitigate  
the public health impact of the condition.  
Examples: Tests to detect infection by HIV, HCV, HBV, HTLV; HIV blood 
donor screening  
and HIV blood diagnostics. This rule applies to first -line assays, confirmatory  
assays, and supplemental assay s. 
 
Rule 2:  
 IVDDs intended to be used for blood grouping , or to determine foetomaternal 
blood group incompatibility, or tissue typing to ensure the immunological 
compatibility of blood, blood grouping for cell administration, blood 
components, cells, tis sue, or organs that are intended for transfusion or 
transplantation, are classified as Class C, except when intended to determine the 
presence of the antigen or antibody for any of the following markers:  
ABO system [A (ABO1), B (ABO2), AB (ABO3)], Rhesus s ystem [RH1 (D), 
RH2 (C), RH3 (E), RH4 (c), RH5 (e), and weak or partial Rh(D)], Kell system 
[Kel1 (K)],  Kidd system [JK1 (Jka), JK2 (Jkb)]; or Duffy system [FY1 (Fya), 
FY2 (Fyb)], in which case they are classified as Class D.  
 
Rationale: The application o f this rule as defined above should be in accordance 
with the  rationale for this rule, which is as follows: A high individual risk, where 
an erroneous result would put the patient in an imminent life -threatening 
situation, places the device into Class D. T he rule divides blood -grouping 
devices into two subsets, Class C or D, depending on the nature of the blood 
group antigen the IVD medical device is designed to detect, and its importance 
in a transfusion setting. Examples: HLA, Rhesus system, Duffy system (other 
Duffy systems except those listed in the rule as Class D are in Class C).   
 
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Doc. No: DFAR/HMDAR/GDL/012  Revision Date: 17/10/ 2022  Review Due Date: 30 /10/2025  
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Rule 3:  
 IVDDs are classified as Class C if they are intended for use:  
● in detecting the presence of, or exposure to, a sexually transmitted agent.  
Examples: Sexually tran smitted diseases, such as Chlamydia trachomatis, and 
Neisseria gonorrhoeae.  
● in detecting the presence in cerebrospinal fluid or blood of an infectious agent 
with a risk of limited propagation.  
Examples: Neisseria meningitidis or Cryptococcus neoformans.  
● in detecting the presence of an infectious agent, if there is a significant risk 
that an erroneous result would cause death or severe disability to the individual, 
foetus or embryo being tested or to the individual`s offspring.  
Examples: diagnostic assay  for CMV, Chlamydia pneumonia, Methicillin 
Resistant Staphylococcus aureus.  
● in a pre-natal screening of women in order to determine their immune status 
towards transmissible agents.  
Examples: Immune status tests for Rubella or Toxoplasmosis.  
● in determi ning infective disease status or immune status, and where there is a 
risk that an erroneous result will lead to a patient management decision resulting 
in an imminent life -threatening situation or severe disability for the patient or for 
the patient`s offs pring.  
Examples: Enteroviruses, CMV and HSV in transplant patients.  
● in screening for selection of patients for selective therapy and management as 
companion diagnostics  
● in screening, diagnosis or staging of cancer;  
Examples: PSA, CEA, and CA 125.  
Note: those IVDDs where the therapy decision would usually be made only a fter 
further investigation and those used for monitoring would fall into class B under 
rule 6.  
● in human genetic testing  
Examples: Huntington’s Disease, Cystic Fibrosis.  
● to monitor levels of medicines, substances or biological components, when 
there is  a risk that an erroneous result will lead to a patient management decision 
resulting in an immediate life -threatening situation for the patient or for the 
patient`s offspring. Examples: Troponin, Cyclosporin, and Prothrombin time 
testing.  
● in the managem ent of patients suffering from a life -threatening disease or 
condition. Examples: HBV monitoring marker, HCV viral load, HIV Viral Load 
and HIV and HCV geno - and subtyping  
● in screening for congenital disorders in the foetus or embryo.  
Examples: Spina Bif ida, Down Syndrome, Glucose -6-Phosphate Dehydrogenase 
Deficiency, and Tay -Sachs disease.  
● in screening for congenital disorders in new  born babies where failure to detect 
and treat such disorders could lead to life -threatening situations or severe 
disabil ities.  
 
Rationale: The application of this rule as defined above should be in accordance 
with the rationale for this rule, which is as follows: devices in this Class present 
a moderate public health risk, or a high individual risk, where an erroneous resul t 
would put the patient in an imminent life -threatening situation , or would have a 
major negative impact on the outcome. The devices provide the critical, or sole, 
determinant for the correct diagnosis and monitoring. They may also present a  
 
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  high individua l risk because of the stress and anxiety resulting from the 
information and the nature of the possible follow -up measures.  
 
Rule 4:  
 IVDDs intended for use by lay users (such as for self -testing or near  patient 
testing) are classified as Class C, except those devices from which the result is 
not determining a critical situation, in which case they are classified under Class 
B, and those devices which are classified under Class D by Rule 1 and/or Rule 2.  
 
Rationale: The application of this rule as defined above s hould be in accordance 
with the rationale for this rule, which is as follows: in general, these devices may 
be used by  the lay user.  
Example for self -testing class C: Blood glucose monitoring.  
Example s of self-testing class B: Pregnancy self -test, f ertility testing, and urine 
test strips.  
 
Rule 5:  
 The following IVDDs are classified as Class A:  
● Reagents or other articles, which possess no critical characteristics intended by 
the 
manufacturer to make them suitable for in vitro diagnostic procedures related to 
a specific examination;  
● Instruments intended by the manufacturer specifically to be u sed for in vitro  
diagnostic procedures.  
● Specimen receptacles.  
 
Note 1: Any product for general laboratory use which is not specifically intended 
by the  
manufacturer to be used in in vitro diagnostic applications is not deemed to be an 
IVDD, as defined in  this document.  
 
Rationale: The application of this rule as defined above should be in accordance 
with the  rationale for this rule which is as follows: these devices present a low 
individual risk and no or minimal public health risk.  
Examples: General cult ure media (excluding the dehydrated powders which are 
considered not  to be a finished IVDD), wash solutions, plain urine cup s, , and 
microbiological specimen collection devices.  
 
Note 2: The performance of the software or an instrument that is specifically  
required to  perform a particular test will be assessed at the same time as the 
respective reagent(s).  
 
Rule 6:  
 IVDDs not covered in Rules 1 through 5 are classified as Class B.  
Rationale: The application of this rule as defined above should be in accor dance 
with the rationale for this rule which is as follows: These devices present a 
moderate individual risk as they are not likely to lead to an erroneous result that 
would cause death or severe disability, have a major negative impact on the 
patient outc ome or put the individual in immediate danger. The devices give 
results that are usually one of several determinants. If the test result is the sole 
determinant, but other information is available, such as presenting signs and 
symptoms or other clinical in formation, which may guide a physician, 
classification into Class B may be justified. Other appropriate controls may also 
be in place to validate the results. This Class also includes those devices that  
 
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  present a low public health risk because they detect infectious agents that are not 
easily propagated in a population.  
Examples: Blood gases, H. pylori test, physiological markers such as hormones, 
vitamins, and  
enzymes, metabolic markers, specific IgE assays and celiac disease markers, and 
tests for anti -nuclear antibody, sex hormone -binding globulin (SHBG), blood 
urea nitrogen (BUN), aspartate aminotransferase (AST), alkaline phosphatase 
(ALP), creatinine and HbA1c.  
 
Rule 7:  
 IVDDs that are controls without a quantitative or qualitative assigned value wi ll 
be classi fied as Class B.  
 
Rationale: For such controls, the qualitative or quantitative value is assigned by 
the user and  
not the manufacturer.  
Examples: Urinalysis controls and chemistry controls.  
  
 
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  Annex V: Essential Principle  checklist of Medical D evices including IVDDs  
 
   
 
 Department/Division/Office/Unit  DFAR Department/HMDAR 
Division  
Document Type:  Checklist  Doc. No  :DFAR/HMDAR/CKL/004  
  
Title:  
Essential Principle checklist of 
Medical Devices including 
IVDDs  
 Revision 
Number  :1 
Revision 
Date:  :17/10/2022  
Effective 
Date  :31/10/2022  
Review 
Due 
Date  :30/10/2025  
Ref Doc.  : 
Clause  Essential Princip al Applicable 
to the 
device?  Method of 
Conformity  Identity of 
specific  
Documents  
1. GENERAL REQUIREMENTS  
 
Medical devices should be 
designed and manufactured in 
such a way that, when used under 
the conditions and for the 
purposes intended and, where 
applicable, by virtue of the 
technical knowledge, experience, 
education or training, and the 
medical and physical conditions 
of intended users, they will 
perform as intended by the 
manufacturer and not compromise 
the clinical condition or the safety 
of patient s, or the safety and 
health of users or, where 
applicable, other persons, 
provided that any risks which may 
be associated with their use 
constitute acceptable risks when 
weighed against the benefits to the 
patient and are compatible with a 
high level of pr otection of health     
ESSENTIAL REQUIREMENTS CHECK LIST  
 
 
Brand name : 
__________________   
Generic name: __________________   
RISK CLASS: 
______________  
 Format: QMS/FMT/002  
Revision No: 1  
Effective Date: 20 June 2022   
 
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  and safety . 
 
2. The solutions adopted by the 
manufacturer for the design and 
manufacture of the devices should 
conform to safety principles, 
taking account of the generally 
acknowledged state of the art.  
When risk reduction is requi red, 
the manufacturer should control 
the risk(s) so that the residual 
risk(s) associated with each 
hazard is judged acceptable.  The 
manufacturer should apply the 
following principles in the priority 
order listed:  
identify known or foreseeable 
hazards and estimate the 
associated risks arising from the 
intended use and foreseeable 
misuse;  
eliminate risks as far as 
reasonably practicable through 
inherently safe design and 
manufacture;  
reduce as far as is reasonably 
practicable the remaining risks by 
taking ad equate protection 
measures, including alarms; and  
inform users of any residual risks.     
3. Medical devices should achieve 
the performance intended by the 
manufacturer and be designed and 
manufactured in such a way that 
they are suitable for their intende d 
purpose.  
    
4. The characteristics and 
performances referred to in 
Clauses 1, 2 and 3 should not be 
adversely affected to such a 
degree that the health or safety of 
the patient or the user and, where 
applicable, of other persons are 
compromised during the lifetime 
of the device, as indicated by the 
manufacturer , when the device is 
subjected to the stresses which can 
occur during normal conditions of 
use and has been properly 
maintained in accordance with the 
manufacturer’s instructions.  
     
 
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  5. Medical devices should be 
designed, manufactured and 
packaged in such a way that their 
characteristics and performances 
during their intended use will not 
be adversely affected by transport 
and storage conditions (for 
example, fluctuations of 
temperature and humid ity) taking 
account of the instructions and 
information provided by the 
manufacturer.  
    
6. Medical d evices should achieve 
their intended performance during 
normal conditions of use.  All 
known, and foreseeable risks, and 
any undesirable effects, should be 
minimized and be acceptable 
when weighed against the benefits 
of the intended performance.  
    
 
 
 
7. 
 
7.1 ESSENTIAL PRINCIPLES 
APPLICABLE TO MEDICAL 
DEVICES OTHER THAN IVD 
DEVICES  
 
DESIGN AND  
MANUFACTURING 
REQUIREMENTS  
 
Chemical, physical & biologica l 
properties  
The devices should be designed 
and manufactured in such a way 
as to ensure the characteristics and 
performance referred to in clause 
6.  Particular attention should be 
paid to:  
the choice of materials used, 
particularly as regards toxicity 
and, where appropriate, 
flammability,  
the compatibility between the 
materials used and biological 
tissues, cells, and body fluids 
taking into account the intended 
purpose of the device.  
the choice of materials used 
should reflect, where appropriate, 
matters s uch as hardness, wear 
and fatigue strength.;  
     
 
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  7.2 The devices should be designed, 
manufactured and packaged in 
such a way as to minimize the risk 
posed by contaminants and 
residues to the persons involved in 
the transport, storage and use of 
the device s and to patients, taking 
account of the intended purpose of 
the product.  Particu lar attention 
should be paid to tissues exposed 
and to the duration and frequency 
of exposure.     
7.3 The devices should be designed 
and manufactured in such a way 
that they  can be used safely with 
the materials, substances and 
gases with which they enter into 
contact during their normal use or 
during routine procedures; if the 
devices are intended to administer 
medicinal products they should be 
designed and manufactured in 
such a way as to be compatible 
with the medicinal products 
concerned according to the 
provisions and restrictions 
governing these products and that 
their performance is maintained in 
accordance with the intended use.  
    
7.4 The devices should be designed 
and manufactured in such a way 
as to reduce as far as reasonably 
practicable and appropriate the 
risks posed by substances that 
may leach or leak from the device.  
Special attention shall be given to 
substances which are 
carcinogenic, mutagenic or toxic 
to reproduction.  
    
7.5 Devices should be designed and 
manufactured in such a way as to 
reduce as far as reasonably 
practicable and appropriate risks 
posed by the unintentional ingress 
or egress of substances into or 
from the device taking into 
account the  device and the nature 
of the environment in which it is 
intended to be used.  
 
     
 
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  8. 
 
8.1 Infection & microbial 
contamination  
The devices and manufacturing 
processes should be designed in 
such a way as to eliminate or to 
reduce as far as reasonably 
pract icable and appropriate the 
risk of infection to patients, users 
and, where applicable, other 
persons.  The design should:  
allow easy handling, and, where 
necessary:  
reduce as far as reasonably 
practicable and appropriate any 
microbial leakage from the devi ce 
and/or microbial exposure during 
use, 
prevent microbial contamination 
of the device or specimen, where 
applicable, by the patient, user or  
another person  / other  people . 
    
8.2 Devices labelled as having a 
special microbiological state 
should be desig ned, manufactured 
and packaged to ensure they 
remain so when placed on the 
market and remain so under the 
transport and storage conditions 
specified by the manufacturer.  
    
8.3 Devices delivered in a sterile state 
should be designed, manufactured 
and pac kaged in a non -reusable 
pack, and/or according to 
appropriate procedures, to ensure 
that they are sterile when placed 
on the market and remain sterile, 
under the transport and storage 
conditions indicated by the 
manufacturer, until the protective 
packaging  is damaged or opened.  
    
8.4 Devices labelled either as sterile 
or as having a special 
microbiological state should have 
been processed, manufactured 
and, if applicable, sterilized by 
appropriate, validated methods.  
    
8.5 Devices intended to be steri lized 
should be manufactured in 
appropriately controlled (e.g.     
 
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  environmental) conditions.  
 
8.6 Packaging systems for non  sterile 
devices should maintain the 
integrity and cleanliness of the 
product and, if the devices are to 
be sterilized prior to use,  
minimize the risk of microbial 
contamination; the packaging 
system should be suitable taking 
account of the method of 
sterilization indicated by the 
manufacturer.  
    
8.7 The labelling of the device should 
distinguish between identical or 
similar product s placed on the 
market in both sterile and non -
sterile condition s. 
    
9. 
 
9.1 Medical devices incorporating a 
substance considered to be a 
medicinal product/drug  
Where a device incorporates, as 
an integral part, a substance 
which, if used separately, may  be 
considered to be a medicinal 
product/drug as defined in the 
relevant legislation that applies 
within that jurisdiction and which 
is liable to act upon the body with 
action ancillary to that of the 
device, the safety, quality and 
performance of the devi ce as a 
whole should be verified, as well 
as the safety, quality and efficacy 
of the substance in the specific 
application,     
10. 
 
10.1 Medical devices incorporating 
materials of biological origin  
In some jurisdictions products 
incorporating tissues, ce lls and 
substances of animal origin may 
be considered medical devices.  In 
this case, such tissues, cells and 
substances should originate from 
animals that have been subjected 
to veterinary controls and 
surveillance adapted to the 
intended use of the tissu es.  
National regulations may require 
that the manufacturer and/or the 
Regulatory Authority retain     
 
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  information on the geographical 
origin of the animals.  Processing, 
preservation, testing and handling 
of tissues, cells and substances of 
animal origin shou ld be carried 
out so as to provide optimal safety 
for patients, users and, where 
applicable, other persons.  In 
particular, safety with regard to 
viruses and other transmissible 
agents should be addressed by the 
implementation of validated 
methods of elimi nation or 
inactivation in the course of the 
manufacturing process.   
10.2 In some jurisdictions products 
incorporating human tissues, cells 
and substances may be considered 
medical devices.  In this case, the 
selection of sources, donors and/or 
substan ces of human origin, the 
processing, preservation, testing 
and handling of tissues, cells and 
substances of such origin should 
be carried out so as to provide 
optimal safety for patients, users 
and, where applicable, other 
persons.  In particular, safety w ith 
regard to viruses and other 
transmissible agents should be 
addressed by the implementation 
of validated methods of 
elimination or inactivation in the 
course of the manufacturing 
process.     
10.3 In some jurisdictions products 
incorporating cells and s ubstances 
of microbial origin may be 
considered medical devices.  In 
this case, processing, preservation, 
testing and handling of cells and 
substances should be carried out 
so as to provide optimal safety for 
patients, users and, where 
applicable, other pe rsons.  In 
particular, safety with regard to 
viruses and other transmissible 
agents should be addressed by the 
implementation of validated 
methods of elimination or 
inactivation in the course of the 
manufacturing process.  
     
 
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  11. 
 
11.1 Manufacturing and e nvironmental 
properties  
 
If the device is intended for use in 
combination with other devices or 
equipment, the whole 
combination, including the 
connection system should be safe 
and should not impair the 
specified performance of the 
devices.  Any restrictio ns on use 
applying to such combinations 
should be indicated on the 
labelling and/or in the instructions 
for use. Connections which the 
user has to handle, such as fluid, 
gas transfer or mechanical 
coupling,  should be designed and 
constructed in such a way  as to 
minimize all possible risks from 
an incorrect connection.     
11.2 Devices should be designed and 
manufactured in such a way as to 
remove or reduce as far as 
reasonably practicable and 
appropriate:  
the risk of injury to the patient, 
user or other pe rsons in 
connection with their physical and 
ergonomic features,  
the risk of use error due to the 
ergonomic features, human factors 
and the environment in which the 
device is intended to be used;  
risks connected with reasonably 
foreseeable external influen ces or 
environmental conditions, such as 
magnetic fields, external electrical 
and electromagnetic effects, 
electrostatic discharge, radiation 
associated with diagnostic or 
therapeutic procedures, pressure, 
humidity, temperature or 
variations in pressure an d 
acceleration;  
the risks associated with the use of 
the device when it comes into 
contact with materials, liquids, 
and gases to which it is exposed 
during normal conditions of use;  
the risk associated with the 
possible negative interaction 
between softwar e and the     
 
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  environment within which it 
operates and interacts;  
the risks of accidental penetration 
of substances into the device;  
the risk of incorrect identification 
of specimens;  
the risks of reciprocal interference 
with other devices normally used 
in the  investigations or for the 
treatment given;  
risks arising where maintenance 
or calibration is not possible (as 
with implants), from ageing of 
materials used or loss of accuracy 
of any measuring or control 
mechanism.  
 
11.3 Devices should be designed and  
manufactured in such a way as to 
minimize the risks of fire or 
explosion during normal use and 
in single -fault condition.  
Particular attention should be paid 
to devices whose intended use 
includes exposure to or use in 
association with flammable 
substanc es or substances which 
could cause combustion.  
    
11.4 Devices must be designed and 
manufactured in such a way as to 
facilitate the safe disposal of any 
waste substances.  
    
12. 
 
12.1 Devices with a diagnostic or 
measuring function.  
Devices with a meas uring 
function , should be designed and 
manufactured in such a way as to 
provide sufficient accuracy, 
precision and stability for their 
intended purpose of the device, 
based on appropriate scientific 
and technical methods.  The limits 
of accuracy should be indicated by 
the manufacturer.     
12.2 Diagnostic devices should be 
designed and manufactured in 
such a way as to provide sufficient 
accuracy, precision and stability 
for their intended use, based on 
appropriate scientific and 
technical methods.      
 
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12.3 Any measurement, monitoring or 
display scale should be designed 
in line with ergonomic principles, 
taking into account the intended 
purpose of the device.  
    
12.4 Wherever possible values 
expressed numerically should be 
in commonly accepted, 
standardize d units, and understood 
by the users of the device.  
    
13. 
 
13.1 
 
13.1.1  Protection against radiation  
 
General  
 
Devices should be designed and 
manufactured and packaged in 
such a way that exposure of 
patients, users and other persons 
to any emitted radia tion should be 
reduced as far as practicable and 
appropriate, compatible with the 
intended purpose, whilst not 
restricting the application of 
appropriate specified levels for 
therapeutic and diagnostic 
purposes.  
    
13.2 
 
13.2.1  Intended radiation  
 
Where devices are designed to 
emit hazardous, or potentially 
hazardous, levels of visible and/or 
invisible radiation necessary for a 
specific medical purpose the 
benefit of which is considered to 
outweigh the risks inherent in the 
emission, it should be possible  for 
the user to control the emissions.  
Such devices should be designed 
and manufactured to ensure the 
reproducibility of relevant 
variable parameters within an 
acceptable tolerance.  
    
13.2.2  Where devices are intended to 
emit potentially hazardous, vi sible 
and/or invisible radiation, they 
should be fitted, where 
practicable, with visual displays 
and/or audible warnings of such     
 
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  emissions.  
 
13.3 
 
13.3.1  Unintended radiation  
Devices should be designed and 
manufactured in such a way that 
exposure of pa tients, users and 
other persons to the emission of 
unintended, stray or scattered 
radiation is reduced as far as 
practicable and appropriate.  
    
13.4 
 
13.4.1  Instructions  
 
The operating instructions for 
devices emitting radiation must 
give detailed infor mation as to the 
nature of the emitted radiation, 
means of protecting the patient 
and the user and on ways of 
avoiding misuse & of eliminating 
the risks inherent in installation.     
 
13.5 
 
13.5.1   
Ionising radiation  
Devices intended to emit ionizing 
radiation should be designed and 
manufactured in such a way as to 
ensure that, where practicable, the 
quantity, geometry and energy 
distribution (or quality) of 
radiation emitted can be varied 
and controlled taking into account 
the intended use.     
13.5.2  Devices emitting ionizing 
radiation intended for diagnostic 
radiology should be designed and 
manufactured in such a way as to 
achieve the appropriate image 
and/or output quality for the 
intended medical purpose whilst 
minimizing radiation exposure to 
the pati ent and user.  
    
13.5.3  Devices emitting ionizing 
radiation, intended for therapeutic 
radiology should be designed and 
manufactured in such a way as to 
enable reliable monitoring and 
control of the delivered dose, the 
beam type and energy and where 
appro priate the energy distribution 
of the radiation beam.  
    
14. Medical devices that incorporate     
 
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14.1 software and standalone medical 
device software  
Devices incorporating electronic 
programmable systems, including 
software, or standalone software 
that ar e devices in themselves, 
should be designed to ensure 
repeatability, reliability and 
performance according to the 
intended use.  In the event of a 
single fault condition, appropriate 
means should be adopted to 
eliminate or reduce as far as 
practicable and appropriate 
consequent risks.  
 
14.2 For devices which incorporate 
software or for standalone 
software that are  devices in 
themselves, the software must be 
validated according to the state of 
the art taking into account the 
principles of the development  
lifecycle, risk management, 
validation and verification.  
    
15. 
 
 
15.1 Active medical devices and 
devices connected to them  
 
For active medical devices, in the 
event of a single fault condition, 
appropriate means should be 
adopted to eliminate or reduc e as 
far as practicable and appropriate 
consequent risks.  
    
15.2 Devices , where the safety of the 
patients depends on an internal 
power supply,  should be equipped 
with a means of determining the 
state of the power supply.  
    
15.3 Devices , where the sa fety of the 
patients depends on an external 
power supply,  should include an 
alarm system to signal any power 
failure.  
    
15.4 Devices intended to monitor one 
or more clinical parameters of a 
patient should be equipped with 
appropriate alarm systems to al ert     
 
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  the user of situations which could 
lead to death or severe 
deterioration of the patient's state 
of health  
 
15.5 Devices should be designed and 
manufactured in such a way as to 
reduce as far as practicable and 
appropriate the risks of creating 
elect romagnetic interference 
which  could impair the operation 
of this or  other devices or 
equipment in the usual 
environment.  
    
15.6 Devices should be designed and 
manufactured in such a way as to 
provide an adequate level of 
intrinsic immunity to 
electromag netic disturbance to 
enable them to operate as 
intended.  
    
15.7 Devices should be designed and 
manufactured in such a way as to 
avoid, as far as reasonably 
practicable, the risk of accidental 
electric shocks to the patient, user 
or any other person, bot h during 
normal use of the device and in 
the event of a single fault 
condition in the device, provided 
the device is installed and 
maintained as indicated by the 
manufacturer     
16.0 
 
16.1 Protection against mechanical 
risks  
 
Devices should be designed an d 
manufactured in such a way as to 
protect the patient and user against 
mechanical risks connected with, 
for example, resistance to 
movement , instability and moving 
parts.  
    
16.2 Devices should be designed and 
manufactured in such a way as to 
reduce to the lowest practicable 
level the risks arising from 
vibration generated by the 
devices, taking account of 
technical progress and of the     
 
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  means available for limiting 
vibrations, particularly at source, 
unless the vibrations are part of 
the specified perform ance.  
 
16.3 Devices should be designed and 
manufactured in such a way as to 
reduce to the lowest practicable 
level the risks arising from the 
noise emitted, taking account of 
technical progress and of the 
means available to reduce noise, 
particularly a t source, unless the 
noise emitted is part of the 
specified performance  
    
16.4 Terminals and connectors to the 
electricity, gas or hydraulic and 
pneumatic energy supplies which 
the user has to handle should be 
designed and constructed in such a 
way as t o minimize all possible 
risks.  
    
16.5 Accessible parts of the devices 
(excluding the parts or areas 
intended to supply heat or reach 
given temperatures) and their 
surroundings should not attain 
potentially dangerous 
temperatures under normal use.  
    
17.0 
 
 
17.1 Protection against the risks posed 
to the patient or user by supplied 
energy or substances  
Devices for supplying the patient 
with energy or substances should 
be designed and constructed in 
such a way that the delivered 
amount can be set and main tained 
accurately enough to guarantee 
the safety of the patient and of the 
user 
    
17.2 Devices should be fitted with the 
means of preventing and/or 
indicating any inadequacies in the 
delivered amount which could 
pose a danger.  Devices should 
incorporat e suitable means to 
prevent, as far as possible, the 
accidental release of dangerous 
levels of energy or substances     
 
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  from an energy and/or substance 
source.  
 
17.3 The function of the controls and 
indicators should be clearly 
specified on the devices.  W here a 
device bears instructions required 
for its operation or indicates 
operating or adjustment 
parameters by means of a visual 
system, such information should 
be understandable to the user and, 
as appropriate, the patient.  
    
18.0 
 
 
18.1 Protection aga inst the risks posed 
by medical devices intended by 
the manufacturer for use by lay 
persons  
 
Devices for use by lay persons 
should be designed and 
manufactured in such a way that 
they perform appropriately for 
their intended purpose taking into 
account th e skills and the means 
available to lay persons and the 
influence resulting from variation 
that can reasonably be anticipated 
in the lay person’s technique and 
environment.  The information 
and instructions provided by the 
manufacturer should be easy for 
the lay person to understand and 
apply.  
    
18.2 Devices for use by lay persons 
should be designed and 
manufactured in such a way as to 
reduce as far as practicable the 
risk of error during use by the lay 
person in the handling of the 
device and also in th e 
interpretation of results.  
    
18.3 Devices for use by lay persons 
should, where reasonably 
possible, include a procedure by 
which the lay person can verify 
that, at the time of use, the product 
will perform a s intended by the 
manufacturer.     
19.0 
 Label and Instructions for Use  
     
 
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  19.1 Users should be provided with the 
information needed to identify the 
manufacturer, use the device 
safely and ensure the intended 
performance, taking account of 
their training  and knowledge.  
This information should be ea sily 
understood  
20.0 
 
20.1 Clinical evaluation  
 
For all medical devices, the 
demonstration of conformity with 
essential principles includes a 
clinical evaluation in accordance 
with GHTF guidance.  The 
clinical evaluation should review 
clinical data in the form of any:  
clinical investigation reports,  
literature reports/reviews, and  
clinical experience to establish 
that a favourable benefit -risk ratio 
exists for the device.   
Note : Further information is 
provided in 
GHTF/SG5/N2R8:2007  Clinical 
Evaluation.     
20.2 Clinical investigations1 on human 
subjects should be carried out in 
accordance with the spirit of the 
Helsinki Declaration.  This 
includes every step in the clinical 
investigation from first 
consideration of the need and 
justification of the stud y to 
publication of the results. In 
addition, some countries may have 
specific regulatory requirements 
for pre -study protocol review or 
informed consent.  
    
 
 
21.0 
 
21.1 Essential Principles applicable to 
IVD Devices  
 
Chemical, physical and biological 
properties  
 
The IVD devices should be 
designed and manufactured in 
such a way as to ensure the 
characteristics and performance 
referred to in Section 6.  Particular    
                                                 
1  See GHTF/SG5/N3:2010 Clinical Investigations   
 
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  attention should be paid to the 
possibility of impairment of 
analytical performance due to 
incompatibility between the 
materials used and the specimens 
and/or analyte (measurand) to be 
detected (such as biological 
tissues, cells, body fluids and 
micro -organisms) intended to be 
used with the device, taking 
account of its intended purpose.  
21.2 The IVD devices should be 
designed, manufactured and 
packaged in such a way as to 
minimize the risk posed by 
contaminants and residues to the 
persons involved in the transport, 
storage and use of the devices and 
to patients, taking account of the 
intended purpose of the product.   
    
21.3 The IVD devices should be 
designed and manufactured in 
such a way as to reduce as far as 
reasonably practicable and 
appropriate the risks posed by 
substances that may leach or leak 
from the IVD device.  Special 
attention  should be given to 
substances which are 
carcinogenic, mutagenic or toxic 
to reproduction.  
    
21.4 IVD devices should be designed 
and manufactured in such a way 
as to reduce as far as reasonably 
practicable and appropriate risks 
posed by the unintentiona l ingress 
or egress of substances into or 
from the IVD  device taking into 
account the device and the nature 
of the environment in which it is 
intended to be used.  
    
22.0 
 
22.1 Infection and microbial 
contamination  
 
The IVD devices and 
manufacturing proc esses should 
be designed in such a way as to 
eliminate or to reduce as far as 
reasonably practicable and 
appropriate the risk of infection to     
 
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  a user, professional or lay, or, 
where applicable, another person 
or other people .  The design 
should:  
allow easy and safe handling; and, 
where necessary:  
reduce as far as reasonably 
practicable and appropriate any 
microbial leakage from the IVD 
device and/or microbial exposure 
during use; and prevent microbial 
contamination of the IVD device 
or specimen where applica ble, by 
the user, professional or lay, or 
another person  or other people . 
 
22.2 IVD devices labeled either as 
sterile or as having a special 
microbiological state should be 
designed, manufactured and 
packaged to ensure they remain so 
when placed on the  market and 
remain so under the transport and 
storage conditions specified by the 
manufacturer , until the protective 
packaging is damaged or opened.  
    
22.3 IVD devices labeled either as 
sterile or as having a special 
microbiological state should have 
been processed, manufactured 
and, if applicable, sterilized by 
appropriate, validated methods.  
    
22.4 IVD devices intended to be 
sterilized should be manufactured 
in appropriately controlled (e.g. 
environmental) conditions.  
    
22.5 Packaging systems for  non sterile 
IVD devices should maintain the 
integrity and cleanliness of the 
product.  
    
23.0 
 
23.1 IVD devices incorporating 
materials of biological origin  
Where IVD devices include 
tissues, cells and substances 
originating from animals, 
processing, p reservation, testing 
and handling of tissues, cells and 
substances of animal origin should 
be carried out so as to provide     
 
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  optimal safety for user, 
professional or lay, or other 
person.  
In particular safety with regard to 
viruses and other transmissible 
agents should be addressed by 
implementation of validated 
methods of elimination or 
inactivation in the course of the 
manufacturing process.  This may 
not apply to certain IVD devices if 
the activity of the virus and other 
transmissible agent s are integral t o 
the intended purpose of the IVD 
device or when such an 
elimination or inactivation process 
would compromise the 
performance of the IVD device.  
National regulations may require 
that the manufacturer and/or the 
Regulatory Authority retain 
information on t he geographical 
origin of the animals.  
23.2 Where IVD devices include 
human tissues, cells and 
substances, the selection of 
sources, donors and/or substances 
of human origin, the processing, 
preservation, testing and handling 
of tissues, cells and subs tances of 
such origin should be carried out 
so as to provide optimal safety for 
the user, professional or lay, or 
other person.  
In particular safety with regard to 
viruses and other transmissible 
agents should be addressed by the 
implementation of validate d 
methods of elimination or 
inactivation in the course of the 
manufacturing process.  This may 
not apply to certain IVD devices if 
the activity of the virus and other 
transmissible agent s are integral to 
the intended purpose of the IVD 
device or when such elimination 
or inactivation process would 
compromise the  performance of 
the IVD device.     
23.3 Where IVD devices include cells 
and substances of microbial 
origin, processing, preservation, 
testing and handling of cells and     
 
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  substances should be carried ou t 
so as to provide optimal safety for 
user, professional or lay, or other 
person.   In particular, safety with 
regard to viruses and other 
transmissible agents should be 
addressed by implementation of 
validated methods of elimination 
or inactivation in the  course of the 
manufacturing process.  This may 
not apply to certain IVD devices if 
the activity of the virus and other 
transmissible agent are integral to 
the intended purpose of the IVD 
medical device or when such 
elimination or inactivation process 
woul d compromise the 
performance of the IVD device.  
24.0 
 
24.1 Manufacturing and environmental 
properties  
If the IVD device is intended for 
use in combination with other 
devices or equipment, the whole 
combination, including the 
connection system should no t 
impair the specified performance 
of the devices.  Any restrictions 
on use applying to such 
combinations should be indicated 
on the label and/or in the 
instructions for use.     
24.2 IVD devices should be designed 
and manufactured in such a way 
as to remo ve or reduce as far as 
reasonably practicable and 
appropriate:  
the risk of injury to user, 
professional or lay, or other 
person in connection with their 
physical and ergonomic features,  
the risk of use error due to the 
ergonomic features, human factors 
and the environment in which the 
IVD device is intended to be used;  
risks connected with reasonably 
foreseeable external influences or 
environmental conditions, such as 
magnetic fields, external electrical 
and electromagnetic effects, 
electrostatic discharge , pressure, 
humidity, temperature or 
variations thereof;  
     
 
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  the risks associated with the use of 
the IVD device when it comes 
into contact with materials, 
liquids, and gases to which it is 
exposed during normal conditions 
of use;  
the risk associated with the 
possible negative interaction 
between software and the 
environment within which it 
operates and interacts;  
the risks of accidental penetration 
of substances into the IVD device;  
the risk of incorrect identification 
of specimens; and  
the risks of reasonably  foreseeable 
interference with other devices 
such as carry over between IVD 
devices  
 
24.3 IVD devices should be designed 
and manufactured in such a way 
as to minimize the risks of fire or 
explosion during normal use and 
in single fault condition.  
Parti cular attention should be paid 
to IVD devices whose intended 
use includes exposure to or use in 
association with flammable 
substances or substances which 
could cause combustion.  
    
24.4 IVD devices must be designed and 
manufactured in such a way as to 
facilitate the safe disposal of any 
waste substances.  
    
25.0 
 
25.1 Performance characteristics  
IVD devices should be designed 
and manufactured in such a way 
that the performance 
characteristics support the 
intended use, based on appropriate 
scientific and t echnical methods.  
In particular, where appropriate, 
the design should address 
sensitivity, specificity, accuracy 
which is trueness and precision 
(repeatability and reproducibility), 
control of known relevant 
interference and limits of 
detection.  
     
 
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  These per formance characteristics 
need to be maintained during the 
lifetime of the IVD device as 
indicated by the manufacturer.  
 
25.2 Where the performance of devices 
depends on the use of calibrators 
and/or control materials, the 
traceability of values assigne d to 
such calibrators and/or control 
materials should be assured 
through available reference 
measurement procedures and/or 
available reference materials of a 
higher order.  
    
25.3 Wherever possible values 
expressed numerically should be 
in commonly accept ed, 
standardized units, and understood 
by the users of the device.  
Note :  While SG1 generally 
supports convergence on the 
global use of internationally 
standardized measurement units, 
considerations of safety, user 
familiarity, and established 
clinical pra ctice may justify the 
use of other recognized 
measurement units.  
    
26.0 
 
26.1 Protection against radiation  
 
IVD devices should be designed, 
manufactured and packaged in 
such a way that exposure of user, 
professional or lay, or other 
person to the emitte d radiation 
(intended, unintended, stray or 
scattered) is reduced as far as 
practicable and appropriate  
    
26.2 When IVD devices are intended to 
emit potentially hazardous, visible 
and/or invisible radiation, they 
should as far as practicable and 
appropr iate be:  
designed and manufactured in 
such a way as to ensure that the 
characteristics and the quantity of 
radiation emitted can be 
controlled and/or adjusted; and  
fitted with visual displays and/or     
 
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  audible warnings of such 
emissions  
 
27.0 
 
 
27.1 IVD d evices that incorporate 
software and standalone IVD 
device software  
For IVD devices which 
incorporate software or for 
standalone software that are IVD 
devices in themselves, the 
software must be validated 
according to the state of the art 
taking into accou nt the principles 
of development lifecycle, risk 
management, verification and 
validation.  
    
28.0 
 
 
28.1 IVD devices connected to, or 
equipped with, an energy source  
 
IVD devices where the safety of 
the patient depends on an internal 
power supply in the  IVD device , 
should be equipped with a means 
of determining the state of the 
power supply.  
    
28.2 IVD devices should be designed 
and manufactured in such a way 
as to reduce as far as practicable 
and appropriate the risks of 
creating electromagnetic 
interference which could impair 
the operation of this or other 
devices or equipment in the usual 
environment.  
    
28.3 IVD devices should be designed 
and manufactured in such a way 
as to provide an adequate level of 
intrinsic immunity to 
electromagnetic distu rbance to 
enable them to operate as 
intended.  
    
28.4 IVD devices should be designed 
and manufactured in such a way 
as to avoid, as far as reasonably 
practicable, the risk of accidental 
electric shocks to the user, 
professional or lay, or other 
person bo th during normal use of 
the device and in the event of a     
 
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   Page 70 of 73 
  single fault condition in the 
device, provided the IVD device 
is installed and maintained as 
indicated by the manufacturer.  
29.0 
 
 
29.1 Protection against mechanical and 
thermal risks  
 
IVD device s should be designed 
and manufactured in such a way 
as to protect the user, professional 
or lay, or other person against 
mechanical risks connected with, 
for example, resistance to 
movement, instability and moving 
parts.  
Where there are risks due to the 
presence of moving parts, risks 
due to break -up or detachment, or 
leakage of substances, then 
appropriate protection means must 
be incorporated.     
29.2 IVD devices should be designed 
and manufactured in such a way 
as to reduce to the lowest 
practicable lev el the risks arising 
from vibration generated by the 
devices, taking account of 
technical progress and of the 
means available for limiting 
vibrations, particularly at source, 
unless the vibrations are part of 
the specified performance.  
    
29.3 IVD device s should be designed 
and manufactured in such a way 
as to reduce to the lowest 
practicable level the risks arising 
from the noise emitted, taking 
account of technical progress and 
of the means available to reduce 
noise, particularly at source.  
    
29.4 Terminals and connectors to the 
electricity, gas or hydraulic and 
pneumatic energy supplies which 
the user, professional or lay, or 
other person has to handle should 
be designed and constructed in 
such a way as to minimize all 
possible risks.  
    
29.5 Acce ssible parts of the IVD  
devices (excluding the parts or     
 
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  areas intended to supply heat or 
reach given temperatures) and 
their surroundings should not 
attain potentially dangerous 
temperatures under normal use.  
30.0 
 
 
 
30.1 Protection against the risks posed 
by IVD devices intended by the 
manufacturer for self -testing  
 
IVD devices intended for self -
testing should be designed and 
manufactured in such a way that 
they perform appropriately for 
their intended purpose taking into  
account the skills and the means 
available to lay persons and the 
influence resulting from variation 
that can reasonably be anticipated 
in the lay person’s technique and 
environment.  The information 
and instructions provided by the 
manufacturer should be  easy for 
the lay person to understand and 
apply.      
30.2 IVD devices intended for self -
testing should be designed and 
manufactured in such a way as to 
reduce as far as practicable the 
risk of error by the lay person in 
the handling of the device and, if  
applicable, the specimen, and also 
in the interpretation of results.     
30.3 IVD devices intended for self -
testing should, where reasonably 
possible, include a procedure by 
which the lay person can verify 
that, at the time of use, the product 
will perfor m as intended by the 
manufacturer.     
31.0 
 
31.1 Label and Instructions for Use  
 
Users should be provided with the 
information needed to identify the 
manufacturer, use the device 
safely and ensure the intended 
performance, taking account of 
their trainin g and knowledge.  
This information should be easily 
understood.  
Note : Further information is 
provided in GHTF/ SG1/N43:2005  
Labelling for Medical Devices     
32.0      
 
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32.1 Performance evaluation including 
analytical performance and, where 
appropriate, clinic al performance  
 
For an IVD device , a performance 
evaluation should be conducted in 
accordance with GHTF guidance.  
The performance evaluation 
should review analytical 
performance data and, where 
appropriate, clinical performance 
data in the form of any:  
literature;  
performance study reports; and  
experience gained by routine 
diagnostic testing.  
to establish that the IVD device 
achieves its intended performance 
during normal conditions of use 
and that the known, and 
foreseeable risks, and any 
undesirable eff ects, are minimised 
and acceptable when weighed 
against the benefits of the 
intended performance.  
The depth and extent of a 
performance evaluation should be 
appropriate to the nature, intended 
use and risks of the IVD device,  
and in accordance with GHTF 
guidance . 
Note : Further information is 
provided in GHTF/SG1/N46:2008  
Principles of Conformity 
Assessment for IVD Medical 
Devices . 
 
32.2 Clinical performance studies using 
specimens from human subjects 
should be carried out in 
accordance with the spirit of  the 
Declaration of Helsinki.  This 
includes every step in the clinical 
performance study from the first 
consideration of the need and 
justification of the study to the 
publication of the results.  
    
I declare that the information provided in this form i s accurate and correct and the device 
conforms to all applicable requirements stipulated above.  
 
Name:   ___________________________________________________  
  
 
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  Signature:  ____________________________________________________  
 
Position:  ________________________ ____________________________  
 
Date:   ________________________________________  
 
 
End of document