🇵🇭Philippines Medical Device Regulations

Reference List of Class A Medical Devices

FDA Circular No. 2021-017 establishing reference list of 1,242 Class A medical device categories. ASEAN-harmonized classification: Class A (low), B (low-moderate), C (moderate-high), D (high risk).

Center for Medical Device Regulation (CMDR) Registration Guidelines

Official guidelines for Certificate of Medical Device Registration (CMDR) initial applications. Covers documentation requirements, standards, and submission procedures.

Food and Drug Administration Philippines - Medical Devices

FDA Philippines under Department of Health regulates medical devices. Responsible for device registration, establishment licensing, and post-market surveillance.

Administrative Order No. 2018-0002 - Medical Devices Regulation (Full Text PDF)

Primary administrative order governing medical device regulation in the Philippines. Establishes ASEAN-harmonized classification, registration requirements, and establishment licensing.

License to Operate (LTO) Guidelines for Medical Device Establishments

Official guidelines for initial License to Operate (LTO) application for medical device traders via eServices portal. Covers requirements and procedures.

Medical Device Vigilance and Post-Market Surveillance

Post-market surveillance requirements including adverse event reporting, field safety corrective actions, and medical device advisories.

Republic Act No. 9711 - FDA Act of 2009

Foundational law establishing FDA Philippines with authority to regulate food, drugs, cosmetics, and medical devices. Strengthened regulatory framework.