All comments can be sent at [email protected] Deadline of submission of comments shall
be by 07 August 2021
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 Regulations, 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. 9711, 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 product 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 authorization; 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 its 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. Annex 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.
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 country.
III. SCOPE OF APPLICATION
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 devices in the Philippines.
IV. DEFINITION OF TERMS
Other terms, 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, 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 compliance, 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 also 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 surveillance 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.
VI. SPECIFIC GUIDELINES
- 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
- 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.
- The adopted Annex 5, its supplements and revisions shall be made accessible at the FDA Website.
VII. TRANSITORY PROVISIONS
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 application of such provision to any circumstances, is held invalid, the remainder of the provisions in this Administrative Order shall not be affected.
This Order shall take effect fifteen (15) days following its publication in a newspaper of general circulation and upon filing three (3) certified copies to the University of the Philippines Law Center.