Philippines
The Philippines is one of the emerging markets in Southeast Asia, with growing demand for medical devices driven by the development of healthcare infrastructure.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Food and Drug Administration Philippines (FDA Philippines).
Device Classification:
- Class A: Low risk
- Class B: Moderate risk
- Class C: High risk
- Class D: Very high risk
Specific Local Requirements
| Language | Documentation in English. |
| Local Representative | Required for foreign manufacturers. |
| Certifications | ISO 13485. CE Certificate, FDA, and Certificate of Free Sale facilitate the process. |
Challenges and Operational Advice
- Online system: Use of the eServices portal is mandatory.
- Possible delays: Timelines vary depending on the risk class.
Why Choose ISEMED
- ASEAN Experience
Support in Southeast Asian markets. - Digital Management
Assistance with portal use and communication with FDA Philippines.
FAQ
- Is a local representative required? Yes.
- Documentation language? English.
- License duration? 5 years.