| Regulatory Authority | Philippines Food and Drug Administration |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | A,B,C,D |
| Medical Device Regulations | Center for Device Regulation, Radiation, Health and Research | Click Here |
| IVD Classification | A,B,C,D |
| Registration Process | Certificate of Medical Device Registration (CMDR) | Click Here |
| Registration Timeline | 6 to 8 months |
| Technical Documentation Format |
1. Annex A — Legal Requirements for Application for the Notification of Medical Devices under Class A and Registration of Medical Devices under Classes B, C and D. 2. Annex B — Technical Requirements for Application for the Notification of Medical Devices under Class A 3. Annex C — Technical Requirements for the Initial Registration of Medical Devices under Class B in accordance with the CSDT Template 4. Annex D — Technical Requirements for the Initial Registration of Medical Devices under Class C in accordance with the CSDT Template 5. Annex E — Technical Requirements for the Initial Registration of Medical Devices under Class D in accordance with the CSDT Template | Click Here |
| Requirement of Authorized Representative | YES |
| Language Requirement | Labels must be in English or Filipino Language |
| Clinical Trials Information |
Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines | Click Here |
| Certificate of Free Sale |
Application or Certificate of Free Sale (CFS) | Click Here |
| Advertising and Promotions |
Implementing Guidelines on the Promotion and Marketinq of Prescription Pharmaceutical Products and Medical Devices | Click Here |
| Additional Information | The application shall be evaluated within one hundred eighty (180) days upon filing ofthe applications. All applications that do not comply with the technical requirements shall be notified through a letter and shall be given a one-time chance to correct the deficiencies within ninety (90) days. If the applicant still fails to comply with the requirements, he/she will be given a chance to re-apply, with a corresponding fee, and to submit the complete compliance documents within sixty (60) days. Failure to comply with the required documentation within the given period shall be a ground |