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ADMINISTRATIVE ORDER  
No. _____________   
 
 
SUBJECT:  Rules and Regulations Governing the Issuance of an 
Authorization for an In -Vitro Diagnostic Medical Device (IVD)   
 
 
I. RATIONALE / BACKGROUND  
  
Republic Act No. 9711  and its Implementing Rules and Regulations, declare that 
it is the policy of the state to insure the safety, efficacy and quality of health products 
including IVDs in the country so as to protect the health of the Filipino people.  
 
The signing of the AMDD  in 2014, mandated the Philippines to implement the 
following provisions to  a) require the person responsible for placing the IVD in that 
Member State or the authorized representative to register the IVD with the regulatory 
authority of that Member State, b) undertake all necessary measures to ensure that only 
IVD which conform to the AMDD may be placed on markets of that Member State a nd 
c) put in place an appropriate system for the registration of IVD with the Regulatory 
Authority of that Member State.  
 
The Department of Health through the Food and Drug Administration (FDA) – 
Center for Device Regulation, Radiation Health and Research (CDRRHR) hereby adopts, 
issues and implement the AMDD guidelines on the issuance of an authorization for IVD 
and to provide the regulatory requirements and authorization process.  
 
 
II. OBJECTIVE  
 
This Administrative Order aims to specify the rules, guidelines,  procedures and 
requirements of the FDA -CDRRHR relative to the issuance of an authorization for IVD.  
  
 
III. SCOPE  
 
This Administrative Order shall cover all IVDs and apply to all manufacturers, 
traders and distributors (e.g. importers, exporters and wholesale rs) of IVD in the 
Philippines.  
 
 
 
 
 
 
 
 
Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila ● Trunk Line 651 -7800 local 1108, 1111 to 13  
  Direct Line: 711 -9502 to 03 Fax: 743 -1829 ● URL: http://www.doh.gov.ph ; e-mail: ftduque@doh.gov.ph  
Republic of the Philippines  
Department of Health  
OFFICE OF THE SECRETARY  
  
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 IV. DEFINITION OF TERMS  
 
For purposes of this Administrative Order, the following terms shall be defined as 
follows:  
 
1. Applicant  - refers to any individual, partnership, corporation, association, and/or 
organization either a manufacturer, trader, distributor, importer, exporter applying 
for an authorization.  
 
2. ASEAN Medical Device Directive (AMDD)  - refers to the agreement of ASEAN 
Member States harmonizing the regulation of medical device.  
 
3. Authorization  - means a permission embodied in a document granted by the FDA 
to a natural or juridical person who has submitted an application to implement the  
manufacture, importation, exportation, sale, offer for sale, distribution transfer, 
and/or where appropriate, the use, testing, promotion, advertising, or sponsorship of 
health products. The authorization can take the form of a permit, a license, a 
certif icate of registration, of accreditation, of compliance, or of exemption or any 
similar document.  
 
4. Calibrator  - refer to any substance, material or article intended by its product owner 
to be used in the calibration of a measuring instrument or measuring sy stem.  
 
5. Certificate of IVD Listing (CIVDL)  - refers to the authorization issued to all IVD 
intended for clinical evidence study, clinical research, educational purposes, samples 
for performance evaluation, donation, exhibit, personal use and that is not int ended 
for sale.  
 
6. Certificate of IVD Notification (CIVDN)  - refers to the authorization issued to all 
class A IVD that complies with all the requirements for notification.  
 
7. Certificate of IVD Registration (CIVDR)  - refers to the authorization issued to all 
class B, C and D IVD that complies with all the requirements for registration.   
 
8. Distributor/importer/exporter  - means any establishment that imports or exports 
raw materials, active ingredients and/or finished products for its own use or for 
wholesale dis tribution to other establishments or outlets.  
 
9. Distributor/wholesaler  - means any establishment that procures raw materials, 
active ingredients and/or finished products from local establishments for local 
distribution on a wholesale basis.  
 
10. Establishments  - means a sole proprietorship, a partnership, a corporation, an 
institution, an association, or an organization engaged in the manufacture, 
importation, exportation, sale, offer for sale, distribution, donation, transfer, use, 
testing, promotion, advertisi ng, or sponsorship of IVD including the facilities and 
installation needed for its activities.  
 
11. Instruction for use  – refers to the all necessary information from the product owner 
including the procedures, methods, frequency, duration, quantity and prepar ation to 
be followed for sale use of the IVD, instructions needed to use the IVD in a safe 
manner shall, to the extent possible, be included on the IVD itself and/or its 
packaging by other formats/forms.  This is the detailed instruction for use for the  
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 users of the medical device.  The instruction should be clear enough to guide its 
users.  
 
12. Instrument - refers to any equipment or apparatus intended by the product owner to 
be used as IVD.  
 
13. Intended use  - this refers to the use for which the IVD is intended , for which it is 
suited according to the data supplied by the product owner in the instructions as well 
as the functional capability of the IVD.  
 
14. In-Vitro Diagnostic Medical Device  (IVD)  - refers to any reagent, reagent product, 
calibrator, control material, kit, instrument, apparatus, equipment or system, whether 
used alone or in combination, intended by the manufacturer to be used in vitro for 
the examination of specimens, including blo od and tissue donation, derived from the 
human body, solely or principally for the purpose of providing information:  
 
a. concerning a physiological or pathological state;  
b. concerning a congenital abnormality;  
c. to determine the safety and compatibility of donati ons, including blood and    
tissue donations, with potential recipients; or  
d. to monitor therapeutic measures,  
 
and includes a specimen receptacle but not a product for general laboratory use, 
unless that product, in view of its characteristics, is specifica lly intended by its 
product owner to be used for in vitro diagnostic examination.  
 
15. Label – a written, printed or graphic information provided upon the IVD itself. It 
includes information provided on the packaging of each unit or on the packaging of 
multiple medical devices.   
 
16. Labelling  - the label , instructions for use, and/or any other informati on that is related 
to identification, technical description, intended purpose and proper use of the 
medical device, but excluding shipping documents.  
 
17. License to Operate (LTO)  - refers to the authorization issued by the FDA to a person 
or establishment to operate as a manufacturer, trader, distributor/ importer/ exporter/ 
wholesaler of IVD.  
 
18. Listing - refers to the process  of informing the FDA that such IVD are being 
manufactured and imported solely for  clinical evidence study, clinical research, 
educationa l purposes, samples for performance evaluation, donation, exhibit, 
personal use and that is not intended for sale.  
 
19. Manufacturer  - means an establishment engaged in any and all operations involved 
in the production of IVD including preparation, processing,  compounding, 
formulating, filling, packing, re -packing, altering, ornamenting, finishing, and 
labeling with the end view of its storage, sale or distribution.  
 
20. Marketing Authorization Holder (MAH)  - refers to the medical device company, 
corporate or legal entity in whose name the CIVDR or CIVDN for an IVD has been 
granted. The MAH is responsible for all aspects of the product, including quality and 
compliance with the conditions of the issued CIVDR or CIVDN . The MAH may be 
a manufacturer, trader, or distributor (exporter, importer or wholesaler) of IVDs .    
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21. National Reference Laboratory (NRL)  - refers to agency/laboratories in the 
Philippines mandated to conduct performance evaluation of the IVD. Please see 
Anne x G - List of host hospitals and testing laboratories with their designated 
National Reference Laboratories based on technical expertise . The NRLs and their 
corresponding technical capabilities may be added which will be indicated in a 
separate Department Order.  
 
22. Notification  - means the process of approval of an application to notify class A IVD s 
prior to engaging in the manufacture, importation, exportation, sale, offer for sale, 
distribution, transfer, and where applicable, the use, testing, promotion, 
advertisement, and/or sponsorship of class A IVD s. 
 
23. Performance evaluation  - refers to the tests being done by the appropriate NRL to 
IVD to verify compliance to the test criteria set by the NRL or the data submitted by 
the applicant for the purpose of FDA registration.  
 
24. Person  - refers to any individual, partnership, corporatio n, association and/or 
organization.  
 
25. Product owner - refers to any person who:  
 
a. supplies the IVD under his own name, or under any trade mark, design, trade 
name or other name or mark owned or controlled by him; and  
b. is responsible for designing, manufacturing, assembling, processing, labelling, 
packaging, refurbishing or modifying the IVD, or for assigning to it a purpose, 
whether those tasks are performed by him or on his behalf.  
 
26. Product standard  - refers to in -vitro standard set, formulated, and or/established by 
the following:  
 
a. Department of Trade and Industry - Bureau of Philippine Standards (Philippine 
National Standard)  
b. International Standardization Organization (ISO)  
c. International Electrochemical Commission (I EC) 
d. Other International Standard Body or any person standards which may be 
accepted by FDA for the purpose of authorization.  
 
27. Reagent  - refers to any chemical, biological or immunological components, 
solutions or preparations intended by the product owner to be used as IVD.  
 
28. Registration  - means the process of approval of an application to register class B, 
C and D IVD prior to engaging in the manufacture, importation, exportation, sale, 
offer for sale, distribution, transfer, and where applicable, the use, testing, 
promotion, advertiseme nt, and/or sponsorship of class B, C, and D IVD.  
 
29. Safety  - means that the product will not impose any danger, injury, damage or 
undesirable effect to a person.  
 
30. Self-testing  – testing/monitoring performed by lay persons.  
  
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 31. Trader  - means any establishment which is registered owner of a health product and 
procures the raw materials and packing components, and provides the production 
monographs, quality control standards and procedures, but subcontracts the 
manufacture of such produ ct to a licensed manufacturer. In addition, a trader may 
also engage in the distribution and/or marketing of its products.  
 
32. Warning  – refers to the s pecific hazard alert information that a user needs to know 
before using the IVD.   
 
 
V. POLICIES AND GUIDELINE S  
 
A. General Guidelines  
 
1. All establishments that intend to place IVDs in the Philippine market are required 
to secure a n LTO as Medical Device Importer/ Distributor/ Manufacturer/ Trader 
(whichever is applicable) prior to securing a CIVDN and/or CIVDR. Donors, 
organizations or person involved in donations, medical missions and other 
humanitarian activities are exempted from LTO requirements . 
 
2. The establishment shall apply for CIVDN or CIVDR based on the following 
classification of IVD. The establishment shall apply for CIVDN for Class A IVD 
and/or CIVDR for Class B, C or D IVD.  
 
     Class                                       Level  
A Low Individual Risk and Low Public Health Risk  
B Moderate Individual Risk and/or Low Public Health Risk  
           C High Individual Risk and/or Moderate Public Health Risk  
 D  High Individual Risk and High Public Health Risk  
 
3. Approval of application for CIVDR shall be based on compliance with the FDA 
legal and technical requirements and results of performance evaluation for those 
IVDs that require performance evaluation by NRLs.  
 
4. The certificate of IVD notification  or registra tion shall be issued by the FDA 
through the CDRRHR  if the application is found to be meritorious; otherwise, 
the application shall be considered disapproved.   
 
5. The Notification Number or Registration Number shall be issued to the IVD with 
approved CIVDN or CIVDR.  
 
6. Reagents, reagent product, calibrator, control material, kit, instruments, 
apparatus, equipment or systems or software manufactured, sold or represented 
by manufacturers not for use in in -vitro diagnostic application and general 
laboratory use purposes are not classified as IVD.  
 
 
 
  
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 7. The applicant shall classify the IVD based on the risk classification rules for IVD 
medical devices  in Annex 3 of  the AMDD. The CDRRHR shall verify the 
classification made by the applicant and shall reclassify the device as deemed 
appropriate or when the level of risk is changed by a certain incident in the 
manufacture, distribution or use of the IVD upon proper cons ultation with the 
advisory committee set forth by the Philippine FDA and/or the ASEAN.  
 
8. IVD strictly for research, clinical trial, exhibit and/or donated brand new IVD 
equipment except for the reagents are exempted from notification and 
registration. Howev er, the researcher, institution and/or user of such devices 
shall apply for a CIVDL.  All applicants seeking for CIVDL shall submit the 
necessary documentary requirements specified in Annex F. 
 
9. Application for registration of IVD for class B, C and D shall be endorsed to the 
FDA Common Services Laboratory, NRL or other FDA accredited/recognized 
laboratory for performance evaluation, regardless if deficiencies were  found 
during the document and technical review. Guidelines on  the endorsement of 
application , responsibilit ies of the applicant and of the NRL regarding the  
performance evaluation of IVDs shall be covered by a separate FDA Circular.  
                    
10. Validity of CIVDR  
 
a. The validity of CIVDN shall be as specified in Section VII (1) of this Order . 
 
b. The C IVDR shall be valid for five (5) years and shall be renewed every five 
(5) years after initial approval.  
 
c. The CIVDN or CIVDR shall remain valid as long as there is no change in 
the composition, packaging, intended use, process and components of th e 
IVD.  
 
d. The validity of the CIVDR is independent of the validity of the performance 
evaluation set by the concerned NRL.  
 
11. All IVDs shall follow the existing labelling requirements of the FDA on      
medical devices . 
 
12. This Order shall be reviewed by the FDA within five (5) years of 
implementation.  
   
B. Specific Guidelines  
 
1. The applicant shall follow the latest  FDA policy/guidelines on the submission of 
application.   
 
2. Receiving, processing and evaluation of application fo r initial and renewal of 
CIVDN/CIVDR  shall be covered by a separate FDA Circular.   
 
3. All applicants shall submit the following requirements specified in the following 
Annex es:  
 
a. Annex A - Legal Requirements for Application for the Notification of IVD 
under Class A and Registration of IVD under Class B, C and D   
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 b. Annex B - Technical Requirements for Application for the Notification of 
IVD under Class A  
 
c. Annex C - Technical Requirements for the Initial Registration of C lass B, C, 
and D IVD  
The summary list of requirements for the initial registration of Class B, C and 
D IVD can be found in Annex D. 
d. Annex E - Requirements for the Renewal of Notiﬁcation/Registration of IVD 
for All Classiﬁcations  
e. Annex F - Requirements for Application for the Certiﬁcate of IVD Listing  
 
4. An application shall be filed separately per specific IVD whether for CIVDN or  
CIVDR.  The CDRRHR reserves the right to ask for additional documents not 
indicated in this Order that may arise based on the submitted compliance    
documents.  All documents shall be submitted in English language. Documents     
submitted in any other foreign langu age not accompanied with English 
translation shall b e disapproved.  
 
5. IVDs that passed the World Health Organization (WHO) pre -qualification shall 
not undergo performance evaluation but will undergo document review by the 
FDA. However, the IVD shall conform to the standard criteria on parameters set 
by the NRL.  
 
6. Renewal of CIVDR/CIVDN  
 
a. There shall be automatic renewal of CMDR or CMDN when the following 
conditions are satisfied:  
i. The application is filed before the expiration date of registration or 
notificatio n; 
ii. The prescribed renewal fee is paid upon filing of the application; and  
iii. A sworn statement indicating no change or variation whatsoever in the 
product is attached to the application  
 
b. Selected IVDs  that require post approval commitments to ensure their 
quality, safety and performance  shall not be qualified for automatic renewal . 
Post approval commitments are indicated in the issued CIVDR or CIVDN . 
These PAC shall be submitted to FDA during applicati on for renewal of 
CIVDR or CIVDN in addition to the regular requirements specified in 
Annex E. 
 
7. IVD Listings  
 
 The filing of application for IVD Listing shall be made prior to the importation                        
of the IVD by the concerned entity (donor, sponsor, research institution,                        
company, individual, etc.)  
 
 
VI.   FEES AND CHARGES  
 
Payment of initial and renewal application fees and other charges (surcharges, 
penalties, legal research fund fees etc.) shall be collected as may be allowed subject to 
the existing rules and regulations of the FDA on fees and charges  such as Department of   
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 Health Administrative Order No. 50 s. 2001 entitled “Revised 2001 Schedule of Fees and 
Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs” ,  
FDA Circular No. 2011 -003 or the “Collection of Legal Research Fee Imposed by 
Republi c Act No. 3870, as amended by PD 200 and further Amended by PD 1856”  and/or 
their subsequent amendment s.  
 
Performance evaluation fee is separately collected and paid to NRL.  
 
 
VII.   PHASES OF IMPLEMENTATION  
 
This A dministrative Order shall be implemented in phases  as specified below : 
 
1. Phase 1 : Registration of IVDs based on the latest FDA list of registrable IVDs, 
Notiﬁcation of all Class A IVDs ,  notiﬁcation  of Class B, C and D IVDs that are 
not included in the latest FDA list of registrable IVDs, and IVD listing.  
 
The legal and technical requirements for the notification of Class B, C and D under 
this Phase shall be the same as in Annex A and Annex C, respe ctively,  of this 
Order.  
 
The validity of CIVDN for Class A IVDs shall be five (5) years  and shall be 
renewed every five (5) years after initial approval.  
 
The CIVDN for Class B, C and D IVDs issued under Phase 1 shall be valid for two 
(2) years after whic h the MAH shall apply for registration certificate for these IVDs.  
 
2.     Phase 2: Registration of all Class B, C and D IVDs (Notiﬁcation of Class B, C and 
D IVDs shall cease during this phase)  
 
 
VIII. GROUNDS FOR DISAPPROVAL OF APPLICATION, CANCELLATI ON, 
REVOCATION AND/OR NON -RENEWAL OF CIVDN AND CIVDR  
 
In addition to the provisions of R.A. 9711 and its Implementing Rules and             
Regulations the following are the grounds for disapproval of application, cancellation,  
revocation and/or non-renewal of CIVDN and CIVDR:  
 
1. Failure to pass/meet the performance evaluation conducted by NRL for Class B, C 
and D IVDs;  
2. Non - coordination with the NRL after product endorsement ; 
3. The manufacture, sale, offering for sale or transfer of IVD that does no t meet all 
the requirements of safety, quality and efficacy;  
4. Misrepresentation or concealment of significant data or information about the        
product sought to be registered;  
5. Alteration, mutilation, destruction, obliteration or removal of any part of th e IVD 
and labeling;  
6. IVD that has a biological, chemical or physical property that may cause an       
unacceptable health risk;  
7. Submission of falsified document(s);  and/or  
8. Alteration or falsification of issued CIVDN or CIVDR.  
 
  
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    IX.   PENALTY CLAUSE  
 
Any violation of this Administrative Order consistent with Republic Act No. 3720 
and Republic Act No. 9711 and its implementing rules and regulations shall be a ground 
for filing appropriate administrative charges and/or imposition of administrative 
sanctions such as, but not limited to, imposition of fines, suspension, cancellation or 
revocation of any license, permit or registration issued by FDA.  
 
 
    XI.   SEPARABILITY CLAUSE  
 
In the event that any provision or portion of this Order is declared unauthorize d 
or rendered invalid by any court of law, those provisions not affected by such 
declaration shall remain valid and effective.  
 
 
  XII.   REPEALING CLAUSE  
 
Section B of FDA Memorandum Circular No. 2014 -005 entitled “Updated List of 
Medical Devices required to be registered prior to sale, distribution and use”, relevant 
provisions of FDA Memorandum No. 2020 -006 entitled “Issuance of Special 
Certification for Imported Test Kits of COVID -19” and FDA Memorandum No. 2021 -
009 entitled “Minimum Performance Requirements for COVID -19 Test Kits Used for 
SARS -CoV -2 Infection”,  administrative orders, rules and regulations and 
administrative issuances or parts thereof inconsistent with  the provisions of this Order 
are hereby repealed or modified accordingly.  
 
 
X.   TRANSITORY PROVISIONS  
 
Phase 1 shall be implemented six (6) months after the effectivity of this Order. The 
schedule of implementation of phase 2 shall be issued in a separat e FDA Circular.  
 
NRL shall inform and update FDA regarding its capability to conduct 
performance evaluation of IVD. FDA shall issue updated list of IVDs that need to 
undergo performance testing/verification of NRLs prior to registration.  
 
 
XIII.   EFFECTIVITY  
 
        This Administrative Order shall take effect fifteen (15) days following its 
publication in one (1) newspaper of general  circulation or upon filing of the same to the 
Office of the National Administrative Regi ster, University of the Philippines .  
 
 
 
FRANCISCO T. DUQUE III, MD, MSc  
                                                                                                      Secretary of Health  
 
 
 
 
  
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ANNEX A 
 
Legal Requirements for Application for the Notification of IVD under Class A and                
Registration of IVD under Class B, C and D  
 
1. Notarized Application Form  
● Shall  be completely filled -out 
● Model / reference number / sizes / codes must be properly identified  
● Refrain from indicating the brand name (if applicable) on  the name of the product and 
vice versa  
● For kits/sets, identify the complete contents/inclusions on the space provided for IVD  
              name  
●   For multiple models / reference number / size / codes, an annex page may be attached  
●   For multiple model s / reference number / size / codes; a Word copy must be submitted    
●   Shall  be signed by the proper authority as indicated on the form  
●   Re-used/ Altered  forms is not acceptable since this is a legal document  
2. Payment  
3. Copy of Letter of Authorization. For imported IVD, the copy of the Letter of Authorization 
shall be accompanied by an original copy of a notarized declaration from the legal 
manufacturer or product owner attesting that the authorization is true and correct .  
● Shall be valid  
● Shall be authenticated/apostilled by the territorial Philippine Consulate  
● The product being applied shall  be indicated.  
● For imported IVD but the agreements are signed by both the principal and importer in the 
Philippines, it shall be notarized locally, with passport and record of arrival and departure 
of the principal to and from the Philippines.  
● For open -dated agreements/authorizations, if the certificate is beyond the 5 -year period, 
a re-issued agreement/authorization shall  be submit ted or a notarized attestation by the 
Principal that the agreement/authorization is still in effect.  
● For locally manufactured IVD with exclusive distributors, the agreement shall  be duly 
notarized.  
● For locally manufactured medical devices with toll manuf acturer, agreement between the 
trader and the manufacturer shall  be duly notarized.  
4. A government issued certificate attesting to the status of the manufacturer with regard to the 
competence and reliability of the personnel and facilities, a Quality System s Certificate of 
approval, or a compliance certificate for ISO 13485. For imported IVD, the copy of the 
certificate shall be accompanied by an original copy of a notarized declaration from the legal 
manufacturer or product owner attesting that the certific ate is true and correct.  
5. For imported IVD, the CIVDN or CIVDR or any equivalent document attesting to the safety, 
quality and effectiveness of the IVD issued by the National Regulatory Agency or accredited 
notified body in the country of origin. The copy o f the certificate shall be accompanied by 
an original copy of a notarized declaration from the legal manufacturer or product owner 
attesting that the certificate is true and correct.  
● Shall be valid  
● Shall be authenticated/apostilled by the territorial Phi lippine Consulate  
● For products that are manufactured in multiple sites or toll manufacturers,  identify or 
highlight where the product will be sourced from.  
● The product being applied shall  be indicated in the scope.  
6. Colored picture of the device from all  sides. However, the CDRRHR can require a 
representative sample or commercial presentation for verification purposes.  
 
 
 
ANNEX B   
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Technical Requirements for Application for the Notification of IVD under Class A  
 
1. Device description consisting of the following:  
1.2 Intended use  
1.3 Instruction for use  
1.4 List of all raw materials  
1.5 Technical specification of the finished product  
1.6 List of references codes, sizes, colors, models and variance, whichever is applicable.  
2. Certificate of Conformity (issued by government ag ency dealing with metrology) on the 
aspect of manufacture relating to metrology for devices with measuring functions, if 
applicable  
3.  Declaration of Conformity (self declaration by the manufacturer) with product     
standards, if applicable  
4. Clear and complete colored pictures of label from all sides of the packaging) loose label  
        or artworks of all layers of packaging)  
5.     Declaration of shelf life  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX C 
   
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Technical Requirements for the Initial Registration of CLASS B, C, and D IVD  
 
1. EXECUTIVE SUMMARY  
1.1. Overview  
1.1.1.  Introductory descriptive information on the medical device, the intended use 
and indications for use of the device.  
1.1.2.  Information on the use of the device, if any, such as targeted patient population, 
user profile (e.g. specific trained users), specific disease status or clinical 
condition (e.g. monitoring of a disease), assay principle (e.g. immunoassay) etc.  
1.1.3.  If the medical device has any unique or novel feature or characteristic (e .g. 
nanotechnology), a description must be provided.  
1.1.4.  Any high -level background information or details that the product owner 
wishes to highlight in relation to the device, its history or relation to other 
approved devices (e.g. predicate devices) or previo us submissions (provides 
context to submission).  
1.1.5.  Risk classification of the device and the rule it is based on as listed in Annex 3 
of the AMDD  
1.2. Commercial Marketing History  
1.2.1.  List of countries where the medical device is marketed.  
1.2.2.  Date and country where the  device was first introduced for commercial 
distribution, globally.  
1.3. List of Regulatory Approval  
1.3.1.  Registration status (i.e. submitted, not submitted, pending approval, rejected or 
withdrawn), registration certificate number  and approved intended use and 
indications of the medical device, in a tabular format. If device is withdrawn/ 
rejected by any reference agencies, reason for rejection or withdrawal shall be 
provided.  
1.4. Important Safety and Performance Related Information  
1.4.1.  To include a summary of reportable adverse events (AEs) and field safety 
corrective actions (FSCAs) for the medical device since its first introduction on 
the global market, in a tabular format.  
 
2. ESSENTIAL PRINCIPLES CHECKLIST  
2.1. Include in the dossier an Essential Principles checklist in the form of a table that lists:  
2.1.1.  The Essential Principles of Safety and Performance of Medical Devices 
applicable to IVDs ( See Annex 1 of ASEAN Medical Device Directive).  
2.1.2.  Whether each Essential P rinciple applies to the IVD and if not, provide a 
justification as to why not.  
2.1.3.  The method used to demonstrate conformity with each Essential Principle that 
applies, as well as the reference for the method used.  
2.1.4.  A reference for the manufacturer’s actual t echnical documentation that provides 
evidence of conformity with each method used.  
2.1.5.  Where that technical documentation is located, both within the full technical 
documentation held by the manufacturer (e.g., the names of documents) and 
within the dossier (w hen such documentation is specifically required for 
inclusion in the dossier as outlined in this instructions).  
 
3. DEVICE DESCRIPTION  
1  
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 3.1. The intended use of the diagnostic.  
3.1.1.  What the product detects.  
3.1.2.  The function of the product (e.g., screening, monitoring, diagnostic or aid to 
diagnosis, staging or aid to staging of disease).  
3.1.3.  The specific disorder, condition or risk factor of interest that the product is 
intended to detect, define or differentiate.  
3.1.4.  Whether the product is automated or manually operated.  
3.1.5.  Whether the test is qualitative or quantitative.  
3.1.6.  The type of specimen(s) required (e.g. serum, plasma, whole blood, sputum, 
urine, etc.).  
3.2. The intended testing population (e.g. neonates, antenatal women, symptomatic 
individuals, etc.).  
3.3. The intended user (laboratory professional and/or health care worker at point -of-care).  
3.4. The intended setting of use (laboratory, point -of-care).  
3.5. A general d escription of the principle of the assay method or instrument principles of 
operation.  
3.6. A description of the components of the assay (e.g., reagents, assay controls and 
calibrators), and, where appropriate, a description of the reactive ingredients of 
relevant components (e.g., antibodies, antigens, nucleic acid primers).  
3.7. A description of the specimen collection and transport materials are provided with the 
product or descriptions of specifications recommended for use.  
3.8. For instruments of automated assays:  a description of the appropriate assay 
characteristics or dedicated assays.  
3.9. For automated assays: a description of the appropriate instrumentation characteristics 
or dedicated instrumentation.  
3.10. If applicable, a description of any software to be used with  the product.  
3.11. If applicable, a description or complete list of the various configurations/variants of 
product that will be made available.  
3.12. If applicable, a description of the accessories, and other products that are intended to 
be used in combination wit h the diagnostic.  
3.13. Where safety and effectiveness data of similar or previous generation devices are 
used in the current submission, the following information is to be provided:  
3.13.1.  A list of such devices and specific information on the registration status of 
these devices are to be included (e.g. Registration number).  
3.13.2.  A comparison, preferably in a table, of the design, specifications and 
intended use/indications for use between the subject device in the current 
submission and the comparator devices (similar an d/or previous generation). 
To include labelled pictorial representation (diagrams, photos, drawings) 
where necessary  
 
3.14. Materials  
3.14.1.  For each of the ingredients, provide formulation/composition information. 
For example, include information such as nucleic acid sequences for primers, 
ingredient lists for buffers, amino acid sequence details for recombinant 
proteins, etc.  
3.14.2.  Identify the sources of the materials from which the IVD components are 
constructed.  
3.14.3.  Provide a table or list of all biological components included in the product 
under assessment. This should include material of bacterial, viral, parasitic, 2  
14 
 animal, or human origin, such as plasma, cells, tissues, or their derivatives. 
The table or list sho uld include:  
3.14.3.1.  the name of the biological component  
3.14.3.2.  details of the use of the biological component in the product  
3.14.3.3.  a description of steps taken for the reduction of transmission or 
infection risk  
3.15. Declaration from the legal manufacturer and/or importer and/o r distributor for the 
following:  
3.15.1.  Storage conditions  
3.15.2.  Shelf life  
3.15.3.  Packaging material  
3.15.4.  Commercial presentation (i.e. kit contents, No. of tests/package)  
3.15.5.  Suggested retail price  
 
4. SUMMARY OF DESIGN VERIFICATION AND VALIDATION DOCUMENTS  
For each study to be submitted, the following must be provided:  
4.1 Study description, study identifier, product identifier (for example, lot numbers), IFU 
version used, the date of initiation and the date of completion  
4.2 A summary of the study findings including a conclusion that clarifies how the study 
objectives have been met  
4.3 The study protocol and full report, which incorporates at a minimum, the following 
information:  
4.3.1 study objectives, study design, the methodology used and data collected  
4.3.2 the site where the study was performed (for example, Manufacturers R&D 
laboratory, hospital laboratory, health care clinic)  
4.3.3 operator of the assay  
4.3.4 the reference standard, if applicable  
4.3.5 specimen acceptance criteria, specimen characterization  
4.3.6 specimen type (serum,  plasma, finger stick whole blood, venous whole 
blood) and numbers of each type  
4.3.7 actual test result summaries with their acceptance criteria and not just 
pass/fail statements  
4.3.8 all data is clearly labeled, and clearly linked to the study report  
4.3.9 details of statistical methods, estimations and calculations applied  
4.3.10  the study conclusion  
4.3.11  when performed by a party other than the manufacturer, details of this party 
and the relationship to the manufacturer  
4.4  If using other brand name  
4.4.1 Analytical studies  
4.4.1.1  Specimen type 
4.4.1.1.1  Detailed information for each matrix and anticoagulant, 
when applicable  
4.4.1.1.2  Provide studies and information supporting the use of each 
specimen type (and where applicable, anticoagulant).  
4.4.1.1.3  Provide studies and information in support of stability 
claims , storage claims and, where applicable, claims for 
transport conditions for each applicable specimen type, 
including:  
4.4.1.1.3.1  Duration  3  
15 
 4.4.1.1.3.2  Temperatures  
4.4.1.1.3.3  Number of allowable freeze/thaw cycles  
4.4.1.1.3.4  Specimen stability claims  
4.4.1.2  Analytical performance characteristics  
4.4.1.2.1  Accuracy of measurement  
4.4.1.2.1.1  Trueness of measurement  
4.4.1.2.1.2  Precision of measurement  
4.4.1.2.1.2.1  Repeatability  
For products to be used at 
point -of-care, where the testing 
may be undertaken by non -
laboratory trained personnel 
(for example, clinic nurses), 
repeatability should be 
established in two steps, first, 
with professional laboratory 
personnel to establish the  
optimal repeatability of the IVD 
under controlled laboratory 
conditions then followed by a 
consumer field evaluation to 
determine the product’s 
performance when used by non -
laboratory trained personnel, 
unassisted, following 
instructions provided with the  
product.  
4.4.1.2.1.2.2  Reproducibility  
For products to be used at 
point -of-care, where the testing 
may be undertaken by non -
laboratory trained personnel 
(for example, clinic nurses), 
repeatability should be 
established in two steps, first, 
with professional laboratory 
personnel to establish the 
optimal repeatability of the IVD 
under controlled laboratory 
conditions then followed by a 
consumer field evaluation to 
determine the product’s 
performance when used by non -
laboratory trained personnel, 
unassisted,  following 
instructions provided with the 
product.  
4.4.1.2.2  Analytical sensitivity  4  
16 
 4.4.1.2.2.1  For a quantitative assay, identify the following 
parameters and provide details on how they 
were derived:  
4.4.1.2.2.1.1  Limit of blank (LoB)  
4.4.1.2.2.1.2  Limit of detection (LoD)  
4.4.1.2.2.1.3  Limit of quantitation (LoQ)  
4.4.1.2.3  Analytical specificity  
4.4.1.2.3.1  Interference studies  
4.4.1.2.3.2  Cross reactivity studies  
4.4.1.2.4  Traceability of calibrators and control material values  
4.4.1.2.5  Measuring range of the assay  
4.4.1.2.6  Validation of assay cut -off  
4.4.1.2.7  Validation of assay procedure – reading time  
4.5 Stability (excluding specimen stability)  
4.5.1 Claimed shelf life  
4.5.1.1  Testing is done on at least three different lots manufactured under 
conditions that are equivalent to routine production conditions  
4.5.1.2  Accelerated studies or extrapolated data from real time data are 
acceptable for initial shelf life claim but need to be followed up with 
real time stability studies. Results derived from testing three different 
lots is required.  
4.5.1.3  The conclusions must clear ly identify claimed shelf life stability.  
4.5.2 In-use stability  
4.5.2.1  Studies should be submitted for each assay component (for example, 
test cartridge, buffer, conjugate, substrate, acid).  
4.5.2.2  For each component, testing is required on a minimum of one lot.  
4.5.2.3  Open vial stability and/or on -board stability.  
4.5.2.4  If calibration stability is claimed, then supporting data should be 
included.  
4.5.2.5  The conclusions must clearly identify the claimed in -use stability.  
4.5.3 Shipping stability  
4.5.4 For IVDs that does not have expiry dates, provide the  projected useful life of 
the device.  
4.6 Robustness Studies  
4.7 Clinical evidence (clinical or diagnostic sensitivity and specificity)  
4.7.1 Clinical evaluation – Manufacturer  
4.7.2 Clinical evaluation - Independent study  
4.7.3 Additional requirements for self -testing and near -patient testing, if applicable  
4.8 Declaration of Conformity  to the recognized product standards issued by the legal 
manufacturer/product owner . 
4.9 Software Verification and Validation  
4.9.1 Specify the version of the software to be supplied.  
4.9.2 An overview of all verification, validation and testing performed for the software 
both in -house and in a simulated or actual user environment prior to final release. 
Where the software has been validated together with the IVD instruments (e.g. 
IVD analyse rs), reports of such validation addressing the safety and performance 
considerations for the software is to be provided.  5  
17 
 4.9.3 All unresolved anomalies in the release version of the software should be 
summarized, along with a justification for acceptability (i.e . the problem, impact 
on safety and effectiveness, and any plans for correction of the problems).  
4.10 Electrical Safety and Electromagnetic Compatibility  
4.10.1  For example, if a device is claimed to meet the requirements of IEC 60601 -1 
and IEC 60601 -1-2, summary test reports and/or certificates are to be submitted 
for verification of conformance to these standards.  
4.11 Other Evidences  
4.11.1  Evidence to support the cybersecurity of connected medical devices such as 
wireless enabled, internet -connected and network -connected devices. For 
example, but not limited to:  
4.11.1.1  Cybersecurity vulnerabilities and risks analysis  
4.11.1.2  Cybersecurity control measures  
4.11.1.3  On-going plans, processes or mechanisms for surveillance, timely 
detection and management of the cybersecurity related threats 
during the useful life of the device, especially when a breach has 
been detected.  
4.11.2  For non -IVD medical device accessories to be registered with the IVD medical 
device e.g. a lancet that is provided in the package to the user to perform a test, 
information on precl inical studies necessary to establish the safety and 
performance of these medical devices shall be provided e.g. biocompatibility 
and sterilisation validation studies.  
 
5. CLEAR AND COMPLETE COLORED PICTURES OF LABEL IN ALL ANGLES 
OF THE PACKAGING  
5.1. Photographs  of all kit components (packaged and individually).  
5.2. Immediate label, secondary packaging, box label and package insert/brochure, 
whichever is applicable.  
5.3. For any additional product claims on the label, submit studies or tests supporting the 
claims.  
5.4. For imported products, if the brand name is the product’s local brand, declaration 
from the manufacturer allowing use of the brand name and Intellectual Property 
Office ( IPO) approval of the said brand name.  
5.5. For local manufactured products, IPO approval of  the said brand name  
5.6. If the CE marking is reflected on the label, submit a valid certificate supporting the 
placement of the CE mark.  
5.7. Pictures and text of the label should be clear and not be pixelated when the view is 
increased in size.  
5.8. Lot No., Batch No. , Serial No., whichever is applicable, should be reflected.  
5.9. Expiration date, reference codes/sizes/variants/model whichever is applicable should 
be reflected.  
5.10. Storage condition, sterilization method should be reflected if applicable.  
5.11. Importer and distribut or’s name and address should be reflected in the label of the 
product together with the Registration Number.  
5.12. Suggested Retail Price (SRP) in Philippine peso.  
 
 
6. RISK ANALYSIS/RISK ASSESSMENT  6  
18 
 6.1. A summary report of the risks identified during the risk analysis process, including, 
but not limited to:  
6.1.1.  Risk to the patient arising from false positive or false negative results  
6.1.2.  Indirect risks that may result from product -associated hazards, such as 
instability, which could lead to erroneous results  
6.1.3.  User -related hazards, such as reagents containing infectious agents  
6.1.4.  Production -related risks  
6.2. Failure Mode Effect Analysis / Risk Be nefit Analysis  
6.3. A description of how these risks have been controlled to an acceptable level.  
6.4. A conclusion with evidence that the remaining risks are acceptable when compared 
to the benefits. This should be signed by senior management.  
6.5. Identification of specific standards or guidelines (for example, ISO 14791:2007 (E) 
“Medical devices -- Application of risk management to medical devices”).  
 
7. PHYSICAL MANUFACTURER INFORMATION  
7.1. Manufacturing process, including quality assurance measures. This should include 
the manufacturing methods and procedures, manufacturing environment or 
conditions, facilities and controls. The information may be presented in the form of 
a process flow chart showing an overview of production, controls, assembly, final 
product testing, a nd packaging of finished medical device.  
7.2. A brief summary of the sterilization method should be included.  
7.3. Include sterilization standard parameters, sterilization procedures, validation 
protocol and results of latest sterilization revalidation.  
7.4. If the steri lization of the device is contracted out, submit a copy of valid ISO 
Certificate of the contracted sterilizing company.  
7.5. For non -sterile devices:  
7.5.1.  Submit Non -sterile declaration from the manufacturer  
7.5.2.  If the device is required to be sterilized prior to use, submit recommended 
sterilization guidelines from the manufacturer  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX D  7  
19 
  
Summary List of Requirements for the Initial Registration of Class B, C and D IVD  
 
Requirements  CLASS  
B CLASS  
  C CLASS  
 D 
Legal Documents     
1.  Notarized application form  √ √ √ 
2.  Copy of Letter of Authorization. For 
imported IVD, the copy of the Letter of 
Authorization shall be accompanied by an 
original copy of a notarized declaration from 
the legal manufacturer or product owner 
attesting that the authorization is true and 
correc t. √ √ √ 
3. A government issued certificate attesting to 
the status of the manufacturer with regard to 
the competence and reliability of the 
personnel and facilities, a Quality Systems 
Certificate of approval, or a compliance 
certificate for ISO 13485. For  imported IVD, 
the copy of the certificate shall be 
accompanied by an original copy of a 
notarized declaration from the legal 
manufacturer or product owner attesting that 
the certificate is true and correct.  √ √ √ 
4. For imported IVD, the CIVDN or CIVDR or  
any equivalent document attesting to the 
safety, quality and effectiveness of the IVD 
issued by the National Regulatory Agency or 
accredited notified body in the country of 
origin. The copy of the certificate shall be 
accompanied by an original copy of a 
notarized declaration from the legal 
manufacturer or product owner attesting that 
the certificate is true and correct.  √ √ √ 
5. Colored picture of the device from all sides. 
However, the CDRRHR can require a 
representative sample or commercial 
presentation  for verification purposes.  √ √ √ 
Technical Requirements     
6.  Executive Summary  √ √ √ 
7. Essential Principle Checklist  √ √ √ 
8. Device Description  √ √ √ 
Detailed 
information on 
the material 
specification 
would be 
provided  
 
 
 
 
 
 
9. Summary of Design Verification  and 
Validation Documents (whichever is 
applicable)     
1  
20 
 9.1 Declaration of Conformity  √ √ √ 
9.2 Summary of each study conducted  √ √ √ 
9.3 Analytical Studies  √ √ √ 
9.3.1  Specimen type  Summary 
information  Summary 
information  Detailed 
information 
including 
formatted raw 
data must be 
submitted  
9.3.2 Analytical performance 
characteristics  √ √ √ 
● Accuracy measurement  Summary 
information  Detailed 
information  Detailed 
information  
● Analytical Sensitivity  Summary 
information  Detailed 
information  Detailed 
information  
● Analytical Specificity  Summary 
information  Detailed 
information  Detailed 
information  
● Traceability of calibrators and 
control material values  Summary 
report  Summary 
report  Detailed report  
● Measuring range of the assay  Summary 
information  Detailed 
information  Detailed 
information  
● Validation of assay cut -off Summary 
information  Detailed 
information  Detailed 
information  
● Validation of assay procedure -
reading time  Summary 
information  Detailed 
information  Detailed 
information  
9.4 Stability  Studies  √ √ √ 
9.4.1 Claimed shelf life     Summary 
information  Detailed 
information  Detailed 
information  
9.4.2 In-use stability  Summary 
information  Detailed 
information  Detailed 
information  
9.4.3  Shipping stability  Summary 
information  Detailed 
information  Detailed 
information  
9.5 Robustness Studies  √ 
Summary 
information  √ 
Summary 
information  √ 
Detailed 
information  
9.6 Clinical Evidence  √  
Summary 
information  √  
Summary 
information  √ 
Detailed 
information 
including 
formatted raw 
data must be 
submitted  
9.7 Software Verification and Validation  √ 
Summary 
information  √  
Summary 
information  √ 
Detailed 
information  
9.8 Electrical Safety and Electromagnetic  
Compatibility  √ √ √ 
9.9 Other Evidences  
● Evidence to support the 
cybersecurity  √ 
Summary 
information  √  
Summary 
information  √ 
Detailed 
information  
 
 
 
 
10. Clear and complete colored pictures of labels 
in all angles of the packaging  √  √  √ 
11. Risk Analysis/ Risk Assessment  √  
Summary 
information  √  
Summary 
information  √ 
Detailed 
information  2  
21 
 12. Physical Manufacturer Information  √ √ √ 
 
NOTES:   
 
1. Summary information -refers to the brief description of the study protocols, results with  acceptance/ standard 
criteria used and conclusion  
2. Detailed information - refers to the complete study protocol, method of analysis, study report, and  study 
conclusion  
3. The specific  details of each technical requirements are in ANNEX C 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX E 
 
Requirements for the Renewal of Notiﬁcation/Registration of IVD for All Classiﬁcations  
 3  
22 
 1.   For Automatic Renewal  
1.1 Notarized Application Form  
1.2 Payment  
1.3 A sworn statement indicating no change or variation whatsoever in the product is 
attached to the application  
 
2. For Regular Renewal  
2.1 Notarized Application Form  
2.2 Payment  
2.3 Copy of Letter of Authorization. For imported IVD, the copy of the Letter of 
Authorization shall be accompanied by an original copy of a notarized declaration 
from the legal manufacturer or product owner attesting that the authorization is true 
and correct .  
2.4 A government - issued certiﬁcate attesting to the status of the Manufacturer with regard 
to the competence and reliability of the personnel and facilities, a Quality Systems 
Certiﬁcate of approval, or a compliance certiﬁcate for ISO 13485. For imported IVD, 
the copy of the certiﬁcate shall be accompanied by an original copy of a notarized 
declaration from the legal manufacturer or product owner attesting that the certiﬁcate 
is true and correct.  
2.5 Colored picture of the IVD from all sides. However, the CDR RHR can require a      
representative sample or commercial presentation for veriﬁcation purposes.  
2.6 Clear and complete colored pictures of commercial label from all sides of the 
packaging.  
2.7 Real-time aging stability test data and results which shall include:  
● shelf life  
● in-use stability  
● shipping stability studies to justify claimed shelf life  
● shall be performed on at least three (3) different product lots manufactured under 
conditions that are essentially equivalent to routine production conditions.  
2.8   Documents to comply the Post Approval Commitments  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX F 
 
Requirements for Application for the Certiﬁcate of IVD Listing  
 
1. Notarized Application Form    
23 
 2. Notarized letter addressed to the Director, Center for Device Regulation, Radiation Health, 
and Research, stating that the IVD will be used solely for research, analysis, or is being 
donated by a certain organization and is not intended for sale. The lette r should contain the 
following information:  
2.1 Complete list of the IVD indicating the quantity, brand and the name of the 
manufacturer of the product  
2.2 Declaration that the organization shall be the sole entity responsible for the IVD and 
that the CDRRHR - FDA, DOH will not be held liable for any safety issue concerning 
the product.  
3.  Certiﬁcate of In -Vitro Diagnostic Notiﬁcation or Certiﬁcate of In -Vitro Diagnostic 
Registration or any equivalent document attesting to the safety and effectiveness of the 
device issued by the regulatory agency in the country where the device will come from.  
4.   For a donated IVD (brand new), a certiﬁed true copy of the deed of donation, the deed of  
      acceptance, and the packing list or any document that will show the quantity of the 
product.  
5.   Copy of SEC or DTI registration, when applicable  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX G 
 
List of Host Hospitals and Testing Laboratories with their Designated National 
Reference Laboratories Based on Technical Expertise  
 1  
24 
 1. East Avenue Medical Center  
1.1 National Reference Laboratory for Environment and Occupational Health  
1.2 National Reference Laboratory for Toxicology  
1.3 National Reference Laboratory for Micronutrient Assay  
1.4 National Reference Laboratory for Industrial and Chemical Emergencies  
 
2. Lung Center of the Philippines  
2.1 National Reference Laboratory for General Clinical Chemistry  
2.2 National Reference Laboratory for Anat omic Pathology for Pulmonary and Pleural 
Diseases  
 
3. National Kidney and Transplant Institute  
3.1 National Reference Laboratory for Hematology  
3.2 National Reference Laboratory for Immunohematology  
3.3 National Reference Laboratory for Urinalysis  
3.4 National Reference Labo ratory for Anatomic Pathology for Renal Diseases and other 
Unassigned Organ Systems  
3.5 National Reference Laboratory for Cellular -Based Product Testing  
 
  4.     Philippine Heart Center  
4.1  National Reference Laboratory for Anatomic Pathology for Cardiac Disease s 
4.2  National Reference Laboratory for Cardiac Makers  
 
  5.     Research Institute for Tropical Medicine  
5.1  National Reference Laboratory for Antimicrobial Resistance  
5.2  National Tuberculosis Reference Laboratory  
5.3  National Reference Laboratory for Transfusion -Transmissible Infections  
5.4  National Reference Laboratory for Dengue and Other Arboviruses  
5.5  National Reference Laboratory for Influenza and Other Respiratory Viruses  
5.6  National Reference Laboratory for Emerging a nd Re -Emerging Bacterial Diseases  
5.7  National Reference Laboratory for Leptospirosis  
5.8  National Reference Laboratory for Special Pathogens  
5.9  National Reference Laboratory for Mosquito Vectors of Human Diseases  
5.10  National Reference Laboratory for Malaria and Oth er Parasites  
5.11  National Reference Laboratory for Schistosomiasis  
5.12  National Reference Laboratory for Rabies and Other Lyssaviruses  
5.13  National Reference Laboratory for Polio and Other Enteroviruses  
5.14  National Reference Laboratory for Measles and Other Exanthems  
5.15 National Reference Laboratory for Invasive Bacterial Vaccine Preventable Diseases  
5.16  National Reference Laboratory for Rotavirus and Other Enteric Viruses  
5.17  National Reference Laboratory for Bacterial Enteric Diseases  
5.18  National Reference Laboratory for Mycol ogy 
         
6.      San Lazaro Hospital - STD AIDS Cooperative Central Laboratory (SACCL)  
  6.1   National Reference Laboratory for HIV/AIDS  
            6.2   National Reference Laboratory for Hepatitis B and Hepatitis C  
6.3  National  Reference Laboratory for Syphilis and Other Sexually -Transmitted  
       Infections  
 
  7.      Food and Drug Administration – Common Services Laboratory  
7.1 Testing Laboratory for Pregnancy Test Kit  
 
 
ANNEX H 
 
References  
 
 1  
25 
 Food and Drug Administration Act (FDA) of 2009. Republic Act No. 9711. Retrieved from  
https://www.fda.gov.ph/wp -content/uploads/2021/04/Republic -Act-No.-9711.pdf  
 
ASEAN Agreement  on Medical Device Directive (AMDD). (2014). Retrieved from  
http://agreement.asean.org/media/download/20141204115621.pdf  
 
Department of Health. (2018). Guidelines Governing the Issuance of an Authorization for a 
Medical Device based on the ASEAN Harmonized Technical Requirements. 
Administrative Order No. 2018 -0002. Retrieved from 
https://dmas.doh.gov.ph:8083/Rest/GetFile?id=605689  
 
Department of Health. Food and Drug Administration. Citizen’s Charter. (2021). (1st Edition). 
Retrieved from https://www.fda.gov.ph/wp -content/uploads/2021/03/09 -Feb-2021 -
FDA -Citizen_s -Charter -CDRRHR_CPR_02 -February -2021.pdf  
 
Departmen t of Health. ( 2001 ). Revised 2001 Schedule of Fees and Charges for the 
Corresponding Services Rendered by the Bureau of Food and Drugs . Administrative 
Order No. 50 s. 2001 . Retrieved from 
https://dmas.doh.gov.ph:8083/Rest/GetFile?id=336397   
 
Department of Health. (2020). Institutionalizing and Strengthening the National Reference 
Laboratories in the Philippines. Department Order No. 2020 -0820.   
 
Global Harmonization Task Force. (2011). Summary Technical Documentation (STED) for 
Demonstrating Conformity to the Essential Principles of Safety and Performance of In 
Vitro Medical Devices . GHTF/SG1/N063:201 1. Retrieved from 
http://www.imdrf.org/docs/ghtf/archived/sg1/technical -docs/ghtf -sg1-n063 -2011 -
summary -technical -documentation -ivd-safety -conformity -110317.pdf   
 
World Health Organizat ion. (2014). WHO Instruction for Compilation of a Product Dossier – 
Prequalification of IVD Programme . PQDx_018  v3. Geneva: WHO. Retrieved from 
https://www.who.int/diagnostics_laboratory/evaluations/141015_pqdx_018_dossier_ins
tructions_v4.pdf  
 
Health Sciences Authority. (2021) . GN-18: Guidance on Preparation of a Product Registration 
Submission for In -vitro Diagnostic Medical Device using the A SEAN CSDT . Singapore. 
Retrieved from https://www.hsa.gov.sg/docs/default -source/hprg -mdb/gn -18-r1-1-
guidance -on-preparation -of-a-product -registration -submission -for-in-vitro -diagnostic -
medical -devices -using -the-asean -csdt-(aug21 -pub).pdf  
 
 
 
 
 
 
1