Regulatory Framework Overview
FDA Philippines · CDRRHR · RA 9711 · ASEAN AMDD
FDA Philippines and CDRRHR
FDA Philippines (officially: Food and Drug Administration) operates under the Department of Health (DoH). Within the FDA, the Center for Device Regulation, Radiation Health and Research (CDRRHR) handles all medical device regulation.
| Function | Body |
|---|---|
| CMDN / CMDR applications | CDRRHR |
| LTO issuance for device operators | CDRRHR |
| Post-market surveillance | CDRRHR |
| Recall and enforcement | CDRRHR |
| Regional compliance monitoring | CDRRHR + Regional Field Offices |
| Emergency authorisations | CDRRHR / FDA Crisis Management Committee |
Other FDA Centers — Scope Boundaries
FDA Philippines has multiple centers covering different product categories:
| Center | Products |
|---|---|
| CDRRHR | Medical devices, radiation-emitting products |
| CDRR (Center for Drug Regulation and Research) | Pharmaceuticals |
| CFRR (Center for Food Regulation and Research) | Food products |
| CCSR (Center for Cosmetics Safety and Regulation) | Cosmetics |
Borderline products (e.g., drug-device combinations) are assessed by the appropriate center based on principal intended action.
Primary Legislation
| Law | Role |
|---|---|
| RA 9711 — FDA Act of 2009 | Establishes FDA Philippines, grants authority over medical devices, sets penalties |
| RA 3720 — Food, Drugs, Devices and Cosmetics Act (1963) | Legacy legislation still partially applicable; definition of "device" |
| RA 9502 — Universally Accessible Cheaper Medicines Act | Relevant to pricing of health products |
| DOH AO 2018-002 | Medical Device Registration — operational rules for CMDN/CMDR |
| DOH AO 2015-0001 | Post-Market Surveillance |
| DOH AO 50 s.2001 | Fee schedule for FDA Philippines |
| FDA Circular 2022-008 | Abridged ASEAN NRA pathway (30 working days) |
| AO 2018-0002 | Labelling requirements |
ASEAN AMDD Alignment
The Philippines is a full ASEAN AMDD participant:
- Class A–D risk classification follows ASEAN principles
- ASEAN CSDT (Common Submission Dossier Template) is required for Class B/C/D (CMDR)
- ASEAN NRA reliance pathway available via FDA Circular 2022-008
- Philippines participated in ASEAN harmonisation process
CMDN and CMDR — The Dual-Certificate System
The Philippines uses a dual-certificate model based on device risk class:
| Class | Certificate | Type |
|---|---|---|
| A (low risk) | CMDN — Certificate of Medical Device Notification | Notification — streamlined |
| B, C, D (higher risk) | CMDR — Certificate of Medical Device Registration | Registration — comprehensive review |
See CMDN (Class A) and CMDR (Class B/C/D).