The Philippines Department of Health has issued Administrative Order (AO) 2025-0030, formally adopting the Post-Marketing Alert System (PMAS) requirements under Annex 5 of the ASEAN Medical Device Directive (AMDD).
This AO establishes the mandatory post-market surveillance framework for medical devices in the Philippines, ensuring continued safety, performance, and quality following market authorization.
Purpose of the Administrative Order
To formally adopt the Post-Marketing Alert System (PMAS) requirements under Annex 5 of the ASEAN Medical Device Directive (AMDD).
To establish a mandatory post-market surveillance framework for medical devices in the Philippines.
Scope of Application
This Administrative Order applies to medical device stakeholders in the Philippines, including:
- Manufacturers
- Importers
- Distributors
- Traders
- Retailers
Publication and Filing Details
- Newspaper Publication: Philippine Star, April 21, 2026.
- Filing with ONAR: Office of the National Administration Register (ONAR), University of the Philippine Law Center, February 10, 2026
Effectivity and Transition
Effectivity Date
Pursuant to Section IX of the AO, the regulation takes effect 15 days after publication.
Based on the April 21, 2026 publication date, the AO becomes effective on May 6, 2026.
Transition Period
In accordance with Section VI, Transitory Provision, the one-year transition period begins on May 6, 2026.
Key PMAS Compliance Areas
Stakeholders shall strengthen their post-market surveillance systems, including:
- Traceability mechanism
- Complaint handling procedures
- Adverse event reporting systems
- Field Safety Corrective Actions (FSCA) protocols
These measures will minimize risks and ensure smooth alignment with the new framework.
Implications to Clients
Medical device stakeholders, including manufacturers, importers, distributors, traders, and retailers, are advised to take note of the above timelines and begin the necessary review and preparations to ensure compliance with PMAS within the prescribed transition period.
Stakeholders should review existing post-market surveillance procedures and update internal systems where necessary to align with the new PMAS framework
Effective Date
May 6, 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in the Philippines, please contact sales@andamanmed.com.