Philippines Medical Device Post-Market Surveillance: Vigilance and ASEAN Alignment

Philippines Medical Device Post-Market Surveillance (PMS)

The Philippines Food and Drug Administration (FDA) is enhancing its Post-Market Surveillance (PMS) requirements for medical devices, with a clear direction toward mandatory reporting and alignment with the ASEAN Medical Device Directive (AMDD) Annex 5 on Post-Market Vigilance. While PMS reporting has historically been voluntary, adherence to the new, more structured requirements is expected to become compulsory.

Key Components of PMS Compliance

Medical device dealers (importers, distributors) in the Philippines must establish and maintain systems that support traceability and respond to potential safety issues.

1. Importation and Distribution Records

Maintaining proper and appropriate importation and/or distribution records is critical. These records ensure the traceability of medical devices in the market, allowing the Regulatory Authority to track devices in case of a safety issue or recall.

2. Complaint Records

A documented and effective complaint handling system is required as part of the Quality Management System. Local dealers must:

• Maintain records of all complaint reports and the corresponding actions taken.
• Establish procedures to conduct effective and timely investigations of reported problems.
• Analyze results to determine the complaint's validity, causes, and necessary corrective actions to prevent recurrence.

3. Adverse Event (AE) Reporting

Mandatory reporting of Adverse Events (AEs) by medical device dealers is an essential part of the PMS system, focusing on vigilance.

• Objective: The goal of AE reporting is to improve patient and user safety by disseminating information that can reduce the likelihood of, or prevent the repetition of, adverse events.
• Measures: PMS includes mandatory reporting from dealers, reports from healthcare professionals, and the exchange of regulatory information with other international agencies.

4. Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action (FSCA) is necessary when a product owner needs to take action to eliminate or reduce the risk of identified hazards. This may include a recall of the medical device.

• Applicability: FSCA only applies to a medical device that has already been distributed. It may still be necessary even if the device is no longer actively on the market but could still be in use (e.g., implants).
• Responsibility: The product owner, physical manufacturer, authorized representative(s), importer, and/or authorized distributor(s) in the Philippines are jointly responsible for performing and completing the FSCA within the Member State. FSCA does not apply to upgrades or commercial removals unrelated to safety risks.