ADMINISTRATIVE ORDER  
No. 2018 _____________  
 
 
 
SUBJECT:  Rules and Regulations  Governing  the Issuance  of an 
Authorization  for an In-Vitro Diagnostic  (IVD) M edical Device  
Based  on the  ASEAN H armonized  Technical Requirements  
 
 
I. RATIONALE  / BACKGROUND  
  
Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act 
of 2009”, and its Implementing Rules and Regulations, declare that it is the policy of the 
state to insure the safety, efficacy and quality of IVD medical devices in the country s o 
as to protect the health of the Filipino people.  
 
The signing of the ASEAN Agreement on Medical Device Directive (AMDD) in 
2014, mandated the Philippines to implement the following provisions to  a) “require the 
person responsible for placing the IVD med ical devices in that Member State or the 
authorized representative to register the IVD medical devices with the regulatory 
authority of that Member State”, b) “shall undertake all necessary measures to ensure 
that only IVD medical devices which conform to the AMDD  may be placed on markets 
of that Member State” and c) “put in place an appropriate system for the registration of 
IVD medical devices with the Regulatory Authority of that Member State”.  
 
The Department of Health through the Food and Drug Administ ration – Center for 
Device Regulation, Radiation Health and Research (CDRRHR) hereby adopt, issues and 
implement the AMDD guidelines on the registration of IVD medical devices and to 
provide the regulatory requirement and registration 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 authorizations fo r IVD 
medical devices adapting the provisions of ASEAN AMDD.  
 
III. SCOPE  OF APPLICATION  
 
This Administ rative Order shall cover all IVD medical devices and apply to all 
manufacturers, traders and distributors (e.g. importers, exporters and wholesalers) of 
IVD medical devices in the Philippines.  
 
IV. DEFINITION OF TERMS  
 
For purposes of this Administrative Order , the following terms shall be defined  as 
follows:  Republic of the Philippines  
Department  of Health 
OFFI CE OF THE SECRETARY  
  
 Applicant  - refers to any individual, partnership, c orporation, association, and/or 
organization either a manufacturer, trader, distributor, importer, exporter applying for an 
authorization.  
 
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 certificate of 
registration of accreditation, of compliance, or of exemption or any similar document.  
 
ASEAN Medical  Device Directive (AMDD)  - refers to the agreement of ASEAN 
Member States harmonizing the regulation of medical device.  
 
Calibrator  - refer to any substance, material or article intended by its product owner to 
be used in the calibration of a measuring ins trument or measuring system.  
 
Certificate of IVD Medical Device Listing (CIVDL)  - refers to the authorization issued 
to all IVD medical device intended for clinical evidence study and clinical research.  
 
Certificate of IVD Medical Device Notification (CIV DN) - refers to the authorization 
issued to all class A IVD medical device that complies with all the requirements for 
notification.  
 
Certificate of IVD Medical Device Registration (CIVDR)  - refers to the authorization 
issued to all class B, C and D IVD me dical device that complies with all the 
requirements for registration.   
 
Clinical Performance Study  - a study undertaken to establish or confirm performance 
of an IVD medical device.  
 
Common Submission Dossier Template (CSDT)  - is a set of technical requir ements 
agreed upon by the ten member countries of the ASEAN which shall govern the 
regulation of medical devices in the ASEAN.  
 
Control Materials  - refer to any substance, material or article intended by its product 
owner to verify the performance of an IV D medical device.  
 
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 
distribution to other establishments or outlets.  
 
Distributor/who lesaler  - means any establishment that procures raw materials, active 
ingredients and/or finished products from local establishments for local distribution on 
wholesale basis.  
 
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, 
advertising, or sponsorship of IVD medical devices, including the facilit ies and 
installation needed for its activities.   
 In-Vitro Diagnostic (IVD) Medical Device  - 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 blood 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 donations, including blood and    
tissue donations, with potential recipients; or  
d. to monitor therapeutic measures,  
 
and includes a specimen receptacle but not a product for g eneral laboratory use, unless 
that product, in view of its characteristics, is specifically intended by its product owner to 
be used for in vitro diagnostic examination.  
 
Instrument - refers to any equipment or apparatus intended by the product owner to be  
used as IVD medical device.  
 
Label - written, printed or graphic information provided upon the IVD medical device 
itself. Where physical constraints prevent, this happening, this term includes information 
provided on the packaging of each unit or on the p ackaging of multiple medical devices.   
 
Labelling  - the label , instructions for use, and/or any other information that is related to 
identification, technical description, intended purpose and proper use of the medical 
device, but excluding shipping docum ents. 
 
License to Operate (LTO)  - refers to the authorization issued by FDA to a person or 
establishment to operate as a manufacturer, distributor/importer/exporter/wholesaler of 
medical devices.  
 
Listing - refers to the process  of informing the FDA that s uch IVD medical device are 
being manufactured and imported solely for  clinical evidence study and research.  
 
Manufacturer  - means an establishment engaged in any and all operations involved in 
the production of IVD medical devices including preparation, pr ocessing, compounding, 
formulating, filling, packing, re -packing, altering, ornamenting, finishing, and labeling 
with the end view of its storage, sale or distribution.  
 
National Reference Laboratory  (NRL)  - refers to agency/laboratories mandated to 
conduc t performance evaluation of the IVD medical devices.  
 
Notification  - means the process of approval of an application to notify class A IVD 
medical devices 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 medical device.  
 
Performance Testing/Evaluation  - refers to the tests being done  by the appropriate 
NRL to IVD medical device  to verify compliance  to the test criteria set by the NRL or 
the data submitted by the applicant  for the purpose of FDA registration . 
 
Person  - refers to any individual, partnership, corporation, association and/or 
organization.  
  
 Post market surveillance performance testing/ev aluation  - refers to the test being 
done by the appropriate NRL to IVD medical device after the issuance of CPR to verify 
its continuous compliance to the test criteria set by the NRL or the data submitted by the 
applicant.  
 
Product Standards  - refers to in-vitro medical devices standards set, formulated, and 
or/established by the following:  
 
a. Bureau of Philippine Standards (Philippine National Standard)  
b. International Standardization Organization (ISO)  
c. International Electrochemical Commission (IEC)  
d. Other In ternational Standard Body or any person standards which may be 
accepted by FDA for the purpose of registration.  
 
Product Owner – refers to any person who:  
 
a. supplies the IVD me dical device under his own name, or  under any trade mark, 
design, trade name or o ther name or mark owned or controlled by him; and  
b. is responsible for designing, manufacturing, assembling, processing, labelling, 
packaging, refurbishing or modifying the IVD medical device, or for assigning to 
it a purpose, whether those tasks are perform ed by him or on his behalf.  
 
Quality Management System (QMS) Certification  - refers to a document issued by an 
accredited certifying body to an establishment that conforms to the requirements of 
quality management system for IVD medical devices.  
 
Reagent  - refers to any chemical, biological or immunological components, solutions or 
preparations intended by the product owner to be used as IVD medical devices.  
 
Registration  - means the process of approval of an application to register class B, C and 
D IVD me dical devices 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 B, C, and D IVD  medical device.  
 
Safet y - means that the product will not impose any danger, injury, damage or 
undesirable effect to a person.  
 
Self-Testing  – testing/monitoring performed by lay persons.  
 
Scientific Research  – is the systematic investigation of scientific theories and 
hypothes is.  
 
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 product to a licensed manufacturer. In addition, a trader may also engage in the 
distribution and/or marketing of its products.  
 
 
 
 
V. POLICIES AND GUIDELINES  
 
A. General Guidelines   
  
1. All establishments that intend to place IVD medical devices in the Phil ippine 
market shall apply first for a License to Operate  consistent with the current rules 
and regulations on unified licensing of FDA  before applying for registration  or 
notification  of their IVD medical devices.  
 
2. The certificate of IVD medical device not ification and registration shall be 
issued by the CDRRHR upon the approval of the Center Director or his/her 
authorized representative if the application is found to be meritorious; 
otherwise, the application shall be disapproved.  
 
3. The Notification Number or Registration Number shall be issued to the IVD 
medical devices with approved CIVDN or CIVDR.  
 
4. The initial CIVDR shall be valid for three (3) years  as long there is no change in 
the composition, packaging, intended use, process and components of the IVD 
medical devices and shall be renewed every five (5) years .   
 
5. The CIVDN shall be valid for one (1) year as long there is no change in the 
composition, packaging, intended use, process and components of the IVD 
medical devices and shall be renewed every one  (1) year .  
 
6. The validity of the CIVDR is independent with the validity of the performance 
testing/ evaluation set by the concerned NRL . The validity  of performance 
testing/evaluation shall be reflected at the back of the CIVDR.  
 
7. All registered IVD  medical devices that has its performance  tested/evaluated  by 
appropriate NRL prior to its registration  shall undergo  post market surveillance  
performance  testing/evaluation within 2 to 3 years after the issuance of the 
CIVDR.  
 
8. The FDA through CDRRHR in coordinatio n with NRL shall issue guidelines on 
the conduct of post market surveillance  of all registered IVD medical devices.  
 
9. Reagents, reagent product, calibrator, control, material, kit, instruments, 
apparatus, equipment or systems manufactured, sold or represen ted by 
manufacturers not for  use in in -vitro diagnostic application  purposes  are not 
classified as IVD medical device.   
 
B. Specific Guidelines  
 
1. The applicant shall classify the IVD medical devices based on the ruling in the 
ASEAN Medical Device Directive.  The classification of IVD medical devices  
as follows:  
 
       Class                  Risk 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  
 
The FDA shall issue guidelines on the classification of IVD medical devices.  
  
 2. The CDRRHR shall verify the classification an d shall reclassify certain IVD 
medical devices when the level of risk is changed by a certain incident in the 
manufacture, distribution or use of the IVD medical devices upon proper 
consultation with the advisory committee set forth by the Philippine FDA a nd/or 
the ASEAN.  
 
3. The applicant shall follow the current FDA policy/guidelines on the submission 
of application.  
 
4. All IVD medical devices under class A shall apply for notification, while all 
under class B , C and D shall apply for registration.  
 
5. IVD medica l devices intended solely for clinical performance study  and 
scientific research  are exempted from notification and registration. However, 
the researcher, institution and/user of such devices shall apply for CIVDL . 
 
6. An application shall be made separately per specific IVD medical devices. 
Single applicati on can be filed for IVD medical devices;  however,  a separate 
authorization shall be issued provided that such IVD medical devices meet the 
following conditions:   
 
a. with accessories that are intended to be so ld separately;  
b. manufactured in multiple manufacturing sites and shall co -exist in the 
market;  
c. system where the use of one part of the system is needed to be used 
together with all or any part of the system;  
d. with the same intended use and the same manufactu ring process but 
differ in one or more raw materials;  
e. with the same intended use and the same manufacturing process but 
differ in the design;  
f. with the same raw materials but differ in types or shapes resulting in 
different specific intended use.  
 
The fee f or this type of application shall be equivalent to the total fees for all 
the individual authorization issued.  
 
7. All applicants shall submit the legal requirements (see annex A)  and appropriate 
CSDT of IVD medical devices. FDA shall issue guideline on the s ubmission of 
CSDT.  
 
8. All IVD medical devices shall follow the labeling requirements of FDA e xisting 
rules on labelling of medical device and IVD medical device . 
 
9. All appropriate  requirements shall b e submitted in Filipino and/or American 
Standard English v ersion . 
 
10. The CDRRHR shall have the right to ask for additional documents not indicated 
in this Order that may arise based on the submitted compliance documents.  
 
11. All initial applications  that do not comply with the requirements of FDA shall 
be notified thr ough a letter and shall be given a one -time chance to correct the 
deficiencies within ninety (90) calendar days  for registration and thirty (30) 
calendar days for notification . If the applicant still fails to comply with the  
 requirements, he/she will be gi ven a chance  to re -apply, with a corresponding 
fee, and to submit the complete compliance documents within sixty (60) 
calendar days  for registration and thirty (30) calendar days for notification . 
Failure to comply with the required documentation within th e given period shall 
be a ground for disapproval of the application.  
 
12. All application for renewal of the certificates of product registration or 
notification shall be filed 90 calendar days prior to its expiration.  
 
13. Application for renewal of certificates of product registration or notification 
filed after the validity date shall be imposed with corresponding penalty in 
accordance with the existing rules and re gulations on fees and charges.  
 
14. An application for renewal filed after one hundred twenty (120) ca lendar days 
shall be considered as initial application. IVD medical devices with expired 
validity and whose application was turned into an initial application shall cease 
the selling of such device until such time that the certification of pro duct 
registra tion is approved. The applicant can, however, opt to request the retention 
of the product registration/notification number.   
 
15. An application for renewal filed from within 120 calendar days from its original 
expiry the CPR shall be consider valid and existi ng until FDA decision or 
resolution rendered on the renewal application.  
 
16. All renewal applications that do not comply with the requirements of FDA shall 
be notified through a letter and shall be given a one -time chance to correct the 
deficiencies within t hirty (30) calendar days.  
 
17. All IVD medical devices  that need to undergo  performance testing /evaluation  
prior to its initial and renewal registration shall be endorsed to the appropriate 
NRL  (see annex B). The CDRRHR shall inform the applicant regarding the  
endorsement.  
 
18. Applicants shall follow rules and guidelines of the appropriate NRL during the 
conduct of performance testing /evaluation . 
 
19. The applicant shall coordinate with the NRL for the submission of samples, 
laboratory testing fee and other documentar y requirements within two (2) 
months after the endorsement. Non -coordination and Non-compliance within 
the prescribed period shall make the application disapproved.  
 
20. NRL ’s shall  give feedback report to FDA regarding the status of the endorsed 
applications .  
 
21. NRL’s shall submit the report of performance testing and/or evaluation to the 
FDA . 
 
22. Approval and/or disapproval of the  application  shall be based on the applicant ’s 
compliance with the requirements of the CDRRHR and the results of the 
performance testin g/evaluation  conducted by the appropriate NRL.  
 
23. The list of all approved CIVDRs and CIVDNs shall be posted in the FDA 
website.   
  
24. All applicants  seeking for CIVDL  shall submit all necessary documentary 
requirements (see Annex C).  
 
C. Fees and Charges  
 
1. Payment o f 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.  
 
2. NRL shall collect p ayment for the fees and other  charges on the conduct of 
performance and interval performance testing/evaluation as may be allowed 
subject to the existing rules and regulations of the appropriate NRL .  
 
D. Grounds for Disapproval  of Application , Cancellation, 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, r evocation and/or non-renewal of CIVDN and CIVDR : 
  
1. The manufacture, sale , offering for sale or transfer of IVD medical device that 
does not meet  all the requirements of safety, quality and eff icacy ; 
 
2. Misrepresentation or concealment of significant data or information about the 
product sought to be registered;  
 
3. Alteration, muti lation, destruction, obliteration or removal of any part of the 
IVD and labeling;  
 
4. IVD medical device that has a biological, chemical or physical property that 
may ca use an unacceptable health risk;  
 
5. Submission of falsified document(s);  
 
6. Alteration or fals ification of issued CIVDN or CIVDR.  
 
VI. SANCTIONS  
 
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 ch arges 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.  
 
VII. TRANSITORY PROVISIONS  
 
The implementation of the registratio n and notification of IVD medical devices 
following the new set of regulatory requirements shall be one (1) year upon the 
effectivity of this Administrative Order. However, IVD medical devices establishments 
may voluntarily comply with the new sets of requ irements  within the said 1 year period of 
transition.  
  
 NRL’s shall inform and update FDA its capability to conduct performance 
testing/evaluation of IVD medical devices . FDA shall issue updated list of IVD medical 
devices  that need to undergo  performance te sting /verification  of NRL’ s prior to 
registration .  
 
VIII.  REPEALING AND SEPARABILITY CLAUSE  
 
All administrative orders, rules and regulations and administrative issuances or 
parts thereof inconsistent with the provision of this order are hereby repealed or modi fied 
accordingly.  
 
If any provision in this Administrative Order, or application of such provision to 
any circumstances, is held invalid, the remainder of the provisions in this Administrative 
Order shall not be affected.  
 
IX. EFFECTIVITY  
 
This Administrative  Order shall take effect fifteen (15) days following its 
publication in two (2) newspaper of national circulation and upon filing to the University 
of the Philippines Law Center Office of the National Administrative Register.  
 
 
 
 
 
 
FRANCISCO T. DUQUE III, MD, MSc  
                                                                                                              Secretary of Health  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 ANNEX A  
Legal Documentary Requirements for the Application of Initial/Renewal Notification and 
Registrati on of IVD Medical Devices  
 
1. Notarized Application Form  
2. Copy of the valid License to Operate (LTO)  issued by FDA  
3. Copy of Letter of Authorization. (indicating the duration of agreement). For imported IVD 
medical devices, the copy of the Letter of Authorizati on 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.  
4. A government – issued certificate attesting to the status of the Manufacturer with re gard 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 medical 
devices, 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. For imported IVD medical devices, the Certificate of Product Notification or Registration 
or any equivalent d ocument attesting to t he safety, quality and effectiveness of the IVD 
medical device 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.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
ANNEX B  
National Reference Laboratories  
 
I. East Avenue Medical Center:  
a. Environmental and Occupational Health  
b. Toxicology  
c. Micronutrie nt Assay  
d. Industrial and Chemical Emergencies  
 
II. Lung Center of the Philippines : 
a. General Clinical Chemistry  
b. Anatomic Pathology for Pulmonary Diseases  
 
III. National Kidney and Transplant Institute:  
a. Hematology and Immunohematology  
b. Urinalysis  
c. Anatomic Pathology for Renal Diseases (to include unassigned organ systems)  
d. Cellular -Based Product Testing  
 
IV. Philippine Heart Center:  
a. Anatomic Pathology for Cardiac Diseases  
b. Cardiac Markers  
 
V. Research Institute for Tropical Medicine : 
a. Antimicrobial Resistance  
b. National Tuberculosis  
c. Malaria and Other Parasites  
d. Schistosomiasis  
e. Dengue and Arboviruses  
f. Influenza and Other Respiratory Viruses  
g. Polio and Other Enteroviruses  
h. Rotavirus and Other Enteric Viruses  
i. Measles and Other Exanthems  
j. Bacterial Enteric Diseases  
k. Emerging and Re -Emerging Ba cterial Diseases  
l. Invasive Bacterial Vaccine Preventable Diseases  
m. Leptospirosis  
n. Mycology  
o. Transfusion -Transmissible Infections  
p. Rabies and Other Lyssaviruses  
q. Special Pathogens  
r. Public Health Entomology  
 
VI. STD AIDS Cooperative Central Laboratory (SACCL) – San Laz aro Hospital:  
a. HIV/AIDS  
b. Hepatitis B  
c. Hepatitis C  
d. Syphilis  
e. Other Sexually Transmitted Infections  
 
  
  
ANNEX C  
IVD Medical Device Listing Documentary Requirements  
 
 
I. Notarized l etter addressed to the Director, CDRRHR , stating that the IVD medical 
device will be used solely for clinical performance study  and scientific research and is 
not intended for sale. The letter should contain the following information:  
a. Complete list of the IVD medical device indicating the quantity, brand and the 
name of the manufacturer o f the product  
b. Declaration that the organization shall be the sole entity responsible for the IVD 
medical devices and that the DOH, FDA -CDRRHR will not be held liable for 
any safety issue concerning the product  
II. Study Design/Protocol  
III. Sample of IVD medical de vice if applicable