Legislation Overview
RA 9711 · DOH AOs · FDA Circulars · ASEAN AMDD
Primary Laws
RA 9711 — Food and Drug Administration Act of 2009
The foundational modern legislation for the Philippines FDA:
- Establishes FDA Philippines and its organizational structure
- Grants FDA Philippines authority over medical devices
- Provides for licensing (LTO) and registration (CMDN/CMDR)
- Sets penalties for violations — including criminal provisions for falsification of certificates
- Provides for Motion for Reconsideration and appeal process
- Protects confidentiality of technical data submitted for registration
- Grants FDA authority to issue emergency authorisations
RA 3720 — Food, Drugs, Devices and Cosmetics Act (1963)
The legacy legislation with the original definition of "drug" and "device." Still partially applicable — particularly for definitional provisions where RA 9711 cross-references.
RA 9502 — Universally Accessible Cheaper Medicines Act
Affects pricing provisions for health products. Relevant for manufacturers concerned about price regulation in the Philippines.
Administrative Orders
| AO | Content |
|---|---|
| DOH AO 2018-002 | Medical Device Registration — core operational rules for CMDN/CMDR applications, requirements, timelines |
| DOH AO 2015-0001 | Post-Market Surveillance — obligations for CMDN/CMDR holders |
| AO No. 2018-0002 | Labelling requirements for medical devices |
| DOH AO 50 s.2001 | FDA Philippines fee schedule — CMDN/CMDR, LTO, and other FDA fees |
FDA Circulars
| Circular | Content |
|---|---|
| FDA Circular 2022-008 | Abridged ASEAN NRA reliance pathway — 30 working-day CMDR |
Circulars are numbered and dated. Always confirm you have the current version — circulars may be updated or superseded.
ASEAN Instruments
| Instrument | Role |
|---|---|
| ASEAN Medical Device Directive (AMDD) | The harmonised framework underpinning Philippines' Class A–D classification |
| ASEAN Common Submission Dossier Template (CSDT) | Required format for Class B/C/D (CMDR) applications |
| ASEAN CSDT guidance documents | Section-by-section guidance on CSDT preparation |
How to Access Philippines Legislation
- FDA Philippines website: www.fda.gov.ph — Administrative Orders, FDA Circulars, forms
- Official Gazette: Official publication of Philippines Republic Acts and Presidential Decrees
- Chan Robles Virtual Law Library: Comprehensive repository of Philippines laws
- CDRRHR: www.fda.gov.ph/center-for-device-regulation-radiation-health-and-research/ — device-specific guidance
DOH Administrative Orders may be revised or replaced without formal notice in some cases. Always confirm you are referencing the current version before preparing an application by: • Checking the FDA Philippines official website (www.fda.gov.ph) • Contacting CDRRHR directly if the version date is unclear • Downloading fresh templates and documents for each new application