Thailand
Thailand is an emerging market for medical devices, with a high demand for advanced healthcare technologies. The government is encouraging foreign investment in the healthcare sector.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The regulatory authority is the Thai Food and Drug Administration (Thai FDA), responsible for approval and post-market surveillance.
Device Classification:
- Class 1: Low risk
- Class 2: Moderate risk
- Class 3: High risk
- Class 4: Very high risk
Specific Local Requirements
| Language | Documentation must be in English or Thai. |
| Local Representative | Mandatory for foreign companies. |
| Certifications | Certificate of Free Sale, compliance with ISO standards, and registration with the Thai FDA are required. |
Challenges and Operational Advice
- Complex Procedures: Ensure that all documentation complies with Thai FDA requirements.
- Variable Timelines: For high-risk devices, the process may exceed 18 months.
- Regulatory Updates: Monitor local regulations to avoid delays.
Why Choose ISEMED
- LOCAL EXPERTISE
Experience with the Thai FDA and local regulations. - COMPREHENSIVE SUPPORT
Assistance with documentation preparation and handling regulatory authority requests. - DIRECT CONTACTS
Collaboration with local partners to facilitate market access.
FAQ
- Is a local representative required? Yes.
- Documentation language? English or Thai.
- License duration? For Class I and II medical devices, the certification is valid for five years. For Class III devices, it depends on the validity of the Certificate of Free Sale.