The Philippine Food and Drug Administration (FDA) has released a draft circular introducing clearer and more detailed post-market surveillance (PMS) requirements for medical devices. The proposal aims to strengthen traceability and improve how medical device safety issues are monitored and addressed.
The draft is based on existing laws and aligns with the ASEAN Medical Device Directive. This reflects ongoing efforts to harmonize with regional PMS standards. It introduces four main areas of focus – record-keeping for traceability, product complaint handling, adverse event reporting, and field safety corrective actions. Marketing Authorization Holders must maintain detailed distribution records and keep them for five years.
The draft also sets clearer timelines. Serious public health threats must be reported within 48 hours, while deaths or serious injuries must be reported within 10 days. Other potentially serious events must be reported within 30 days.
Field safety corrective actions are more structured, with defined reporting and closure requirements. The rules apply to all registered medical devices and in vitro diagnostics. A six-month transition period is proposed. Overall, the draft signals a move toward a more structured and proactive PMS system for medical devices, which requires companies and their local third-party agents to strengthen internal processes and compliance systems.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.