Philippines: Adoption of the Post-Marketing Alert System (PMAS) Requirements for medical devices

The Philippines is a signatory to ASEAN Medical Device Directive (AMDD) since 2014 and it adheres and commits to its provisions and its Annexes. The government of Philippines signed the Instrument of Ratification of the AMDD on 18 November 2020 and the AMDD entered into force for the Philippines on 4 March 2021, in accordance with Article 22 of the said Agreement.

Now, Philippines published an Administrative Order to officially adopt and incorporate the provisions of Annex 5 of the AMDD “Post Marketing Alert System (PMAS) Requirements”. 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.

This Administrative Order covers 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.

(1) Importation and/or Distribution records

Traceability is not only a requirement of an effective quality system but also the requirement of regulatory bodies around the world. Keeping proper and appropriate importation and/or distribution records is an important component of ensuring traceability of medical devices in the market.

(2) Complaint records

An effective complaint handling system is an important part of any quality system. Any complaint received on a medical device should be evaluated and if necessary, thoroughly investigated and analyzed, and corrective actions should be taken. The results of the evaluation should lead to a conclusion regarding whether the complaint was valid, the causes of the complaint, and what actions were necessary to prevent further occurrences.

Dealers of medical devices in the Member State shall be required to:

maintain records of complaint reports and of actions taken in response to these reports, and produce such records for inspection by the Regulatory Authority in that Member State as and when requested; and
establish and implement documented procedures to conduct effective and timely investigations of reported problems.

(3) Adverse events

A number of post-marketing risk assessment measures to ensure the continued safe use of medical devices may be undertaken. These measures include reporting from healthcare professionals, mandatory reporting from medical device dealers, and exchange of regulatory information with other medical device regulatory agencies.

The mandatory reporting of AEs by medical device dealers is an important part of the post-market surveillance system. The objective of AE reporting and subsequent evaluations is to improve protection of the health and safety of patients, users and others by disseminating information that may reduce the likelihood of, or prevent repetition of AEs, or alleviate consequences of such repetition.

(4) Field Safety Corrective Action (FSCA)

A FSCA is required when it becomes necessary for the product owner of the medical device to take action (including recall of the medical device) to eliminate, or reduce the risk of, the hazards identified.

A FSCA may still be necessary even when the medical device is no longer on the market or has been withdrawn but could still possibly be in use (e.g. implants).

A FSCA only applies to a medical device that has already been distributed by the product owner.

It does not arise when a product owner is exchanging or upgrading medical devices in the absence of a safety risk or when removals from the market are for purely commercial reasons.

The product owner, physical manufacturer, authorized representative(s), importer and/or authorized distributor(s) in the Member State shall be responsible for performing and completing the FSCA in that Member State

The ASEAN Medical Device Directive (AMDD) is a harmonized medical device regulation applicable across the ASEAN countries.

The ASEAN Medical Device Directive (AMDD) is adapted by the group of ten (10) countries of Southeast Asia including Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. These countries are at different stages of adapting and implementing the Directives.