Administrative Order (AO) 2025-0030 was issued by the Philippines Department of Health to formally adopt and implement the Post-Marketing Alert System (PMAS) requirements under Annex 5 of the ASEAN Medical Device Directive (AMDD). The AO establishes the mandatory post-market surveillance framework for medical devices in the Philippines to ensure continued safety, performance and quality following market authorization.
The PMAS Requirements outlined in Annex 5 of the AMDD, along with its supplements and updates, will be accessible on the FDA website at the following link: https://www.fda.gov.ph
Purpose of the Administrative Order
To formally adopt and implement the Post-Marketing Alert System (PMAS) requirements under Annex 5 of the ASEAN Medical Device Directive (AMDD).
To establish the mandatory post-market surveillance framework for medical devices in the Philippines to ensure continued safety, performance and quality following market authorization.
Scope of Application
This Administrative Order applies to:
- All medical devices, including in vitro diagnostic (IVD) medical devices
- Medical device manufacturers
- Marketing Authorization Holders (MAHs)
- Importers
- Distributors
- Traders
Key Highlights
Adoption of AMDD Annex 5
Adopts AMDD Annex 5 (PMAS Requirements) as the mandatory regulatory guidance for post market obligations of medical device stakeholders in the Philippines.
Core PMAS Elements
Covers core PMAS elements, including:
- Importation and distribution record-keeping (traceability)
- Complaint handling and documentation
- Adverse event (AE) reporting criteria, timelines and formats
- Field Safety Corrective Action (FSCA) reporting and implementation
Regulatory Authority
Designates the FDA – Center for Device Regulation, Radiation Health and Research (CDRRHR) as the lead center for PMAS implementation, monitoring, and enforcement.
FDA Evaluation Timelines
Establishes defined timelines for FDA evaluation of post marketing alerts in line with the Ease of Doing Business Act.
- Initial assessment within seven (7) working days from receipt of the post-marketing alert. The submitter will be notified if additional information or clarification is required.
- Comprehensive risk assessment within twenty (20) working days, considering factors such as device type, intended use, patient population, and available scientific evidence. Regulatory actions may include recall, market suspension, issuance of safety advisories, labeling changes, or further investigation.
Transition Period
Provides a one-year transition period for Marketing Authorization Holders (MAHs) to fully comply with the PMAS requirements.
Implications to Clients
Medical device manufacturers, MAHs, importers, distributors, and traders must:
- Strengthen post-market surveillance systems, including traceability, complaint handling, and adverse event reporting
- Implement documented procedures for AE reporting and FSCA execution in accordance with AMDD standards
Failure to comply with PMAS obligations may result in regulatory actions, such as recalls, market suspension, or other enforcement measures.
Companies operating across ASEAN markets will benefit from greater regulatory alignment with regional post-market surveillance requirements.
Effective Date
The Administrative Order shall take effect fifteen (15) days after its publication in the Official Gazette.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in the Philippines, please contact sales@andamanmed.com.
