Republic of the Philippines  
Department of Health  
OFFICE OF THE SECRETARY  
 
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  
1 
 
 
 
ADMINISTRATIVE  ORDER  
No. _________ ______  
 
 
SUBJECT:  Adoption of the Post Marketing Alert System (PMAS) Requirements, 
Annex 5 of the ASEAN Medical Device Directive (AMDD)  
 
 
 
I. BACKGROUND / RATIONALE  
 
Republic Act No. 3720, otherwise known as the “Food, Drug, Device, and 
Cosmetic Act” as amended, and Republic Act No. 9711, otherwise known as the “Food 
and Drug Administration (FDA) Act of 2009”, and its Implementing Rules and 
Regu lations, were enacted to protect and promote the right to health of the Filipino 
people by ensuring the safety, efficacy, and quality of health products, including 
medical devices.  
 
Under Sections 4 (i), (k), and (l) of RA No. 3720 as amended by RA No. 971 1, 
the FDA is mandated to: (i) to require all manufacturers, traders, distributors, importers, 
exporters, wholesalers, retailers, consumers, and non -consumer users of health products 
to report to the FDA any incident that reasonably indicates that said pro duct has caused 
or contributed to the death, serious illness or serious injury to a consumer, a patient, or 
any person; (k) after due process, to order the ban, recall, and/or withdrawal of any 
health product found to have caused the death, serious illness  or serious injury to a 
consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or 
grossly deceptive, and to require all concerned to implement the risk management plan 
which is a requirement for the issuance of the appropriate auth orization; and (l) to 
strengthen the post market surveillance system in monitoring health products as defined 
in this Act and incidents of adverse events involving such products.  
  
The Philippines as a signatory to the AMDD in 2014 adheres and commits to i ts 
provisions and its Annexes on the regulation of medical devices. With this, the 
government signed the Instrument of Ratification of the AMDD on 18 November 2020. 
The ASEAN Agreement on Medical Device Directive entered into force for the 
Philippines on 4  March 2021, in accordance with Article 22 of the said Agreement.  
 
In order to implement this mandate, the FDA hereby adopts, issues and 
implements Annex 5 of the AMDD as a regulatory guidance on the post market 
surveillance system of medical devices. Anne x 5 of the AMDD provides guidelines on 
the post marketing alerting system requirements concerning medical devices such as (1) 
importation  and/or  distribution  records, (2) complaint  records, (3) adverse  event  (AE)  
reporting  criteria  and reporting  format, and (4) field  safety  corrective  action  (FSCA)  
reporting  format.  
 
 
 
  
2 II. OBJECTIVE  
 
The objective of this Administrative Order is to officially adopt and incorporate 
the provisions of Annex 5 of the AMDD “Post Marketing Alert System (PMAS) 
Requirements” hereto attached as Annex A into the national regulations of medical 
devices in the cou ntry.   
 
 
III. SCOPE  
 
This Administrative Order shall cover all medical devices including in -vitro 
diagnostic (IVD)  medical devices  and apply to all manufacturers, traders, retailers and 
distributors (e.g. importers, exporters and wholesalers) of medical device s in the 
Philippines.  
 
 
IV. DEFINITION OF TERMS  
 
Other t erms, words and phrase shall follow the definitions provided for by the 
AMDD as long as these definitions are consistent with the current national laws, rules 
and regulations of the Philippines otherwise  the latter shall prevail .  
 
Marketing Authorization Holder (MAH) refers to the owner of the permission 
embodied in a document granted by the FDA to a natural or juridical person who has 
submitted application to implement the manufacture, importation, expo rtation, 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 com pliance, or of 
exemption, or any similar document. The MAH is responsible and accountable for the 
safety, efficacy and quality of the health products approved by the FDA to be in the 
market.  
 
Trader means any establishment which is a 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 subcontract the manufacture 
of such product to a licensed manufacturer. In addition, a trader may als o engage in the 
distribution and/or marketing of its products.  
 
 
V. GENERAL GUIDELINES  
 
The Department of Health (DOH) through the FDA  – Center for Device 
Regulation, Radiation Health and Research (FDA -CDRRHR) shall establish and 
maintain the post marketing s urveillance system in monitoring medical devices and 
incidents of adverse events involving such products. The FDA -CDRRHR shall have the 
full authority to enforce the law on medical devices in the country.   
 
The DOH -FDA hereby adopts the current version of  AMDD Annex 5 Post 
Marketing Alert System (PMAS) Requirements insofar as it is not in conflict with the 
national laws to provide guidance on the post -market obligations of MAH and dealers 
including retailers of medical devices in the Philippines.  
 
 
  
3 VI. SPECIFIC GUIDELINES  
 
1. The FDA -CDRRHR shall issue specific guidelines on the following PMAS 
requirements of medical devices:  
a. Importation  and/or  distribution  records  
b. Complaint  records  
c. Adverse  event  (AE)  reporting  criteria  and reporting  format  
d. Field  Safety  Corrective  Action  (FSCA)  reporting  format  
 
2. All supplements and revisions related to the AMDD Annex 5 shall be adopted 
automatically insofar as the provisions or requirements are consistent with the 
national laws.  
 
3. The adopted Annex 5, its supplements and r evisions shall be made accessible at the 
FDA Website.  
 
 
VII. TRANSITORY PROVISION  
 
All medical device MAH shall be given a one (1) year transition period to 
comply with the AMDD Annex 5 starting from the effectivity date of this Order.  
 
 
VIII.  REPEALING CLAUSE  
 
All administrative orders, rules and regulations and administrative issuances or 
parts thereof inconsistent with the provision of this order are hereby repealed or 
modified accordingly.  
 
 
IX. SEPARABILITY CLAUSE  
 
If any provision in this Administrative Order, or a pplication of such provision to 
any circumstances, is held invalid, the remainder of the provisions in this Administrative 
Order shall not be affected.  
 
 
X. EFFECTIVITY  
 
This Order shall take effect fifteen (15) days following its publication in  a 
newspaper o f general circulation  and upon filing  three (3) certified copies  to the 
University of the Philippines Law Center . 
 
  
                                                                                                                    
FRANCISCO T. DUQUE III,  MD, MSc  
                                                                                                            Secretary of Health