Thailand
- Regulatory Authority:
Medical Device Control Division (MDCD) of Thai Food and Drug Administration (TFDA), Ministry of Public Health
- Legislation:
Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2)
- Registration period:
Class I: 6 months
Class II & III: 8 months
Class IV: 10 months
- Language of labeling and documentation:
Labels for professional use devices are not required to have a Thai version. Home use devices should be labelled both in Thai and English
- Notes::
Site inspection is required for new medical devices requiring technology assessment
Local testing is only required for HIV test kits
Local clinical evaluation is not required
- Certificate validity period:
5 years
- Authorized Representative:
country resident
A brief algorithm for registration of medical devices in Thailand:
Document preparation:
All necessary documents should be collected, including technical documentation, data on the safety and effectiveness of the product, and certificates of compliance with international standards.
Submission of the application:
The application must be submitted to the Thai Food and Drug Administration (Thai FDA). The application must include all details of the manufacturer and the product.
Examination and Testing:
Thai FDA examines the submitted documents and may require additional testing of the product to confirm its safety and efficacy
Registration and authorization:
after successfully passing all stages of examination and testing, the product is registered, and authorization is granted for its sale and use in Thailand.
Labelling and Monitoring
Registered products must be properly labelled in accordance with Thai FDA requirements. Post marketing monitoring is also required to track the safety and efficacy of the product under actual conditions of use.