Medical Device Registration in
Thailand
Ministry of Health
Ministry of Public Health – Thailand Food & Drug Administration (Thai FDA)
Regulatory Authority
Medical Devices Control Division (MDCD)
Medical Device Regulation
- Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2)
- Medical Device Act B.E 2551 (2008)
Official Language
Thai
Classification
Class I, II, III and IV
Registration Process
- There are two processes involved – Product Registration (Listing/ Notification/ Licensing) & Dealer’s License
- Product registration is to obtain marketing clearance for its import & supply in Thailand
- Medical device dealers license can engage in the manufacture, import or wholesale of medical device in Thailand.
- For Class I – Device Listing ; Class II & III – Notification ; Class IV – Licensing
- Common Submission Dossier Template (CDST) format is needed for Class II, III and IV device registration
Documents Required
- QMS certification
- Application Form
- Technical Document preparation
- IFU, Label or User Manual
- Letter of Authorization
- Import License or Manufacturing license
Applicable QMS
ISO 13485
Registration Timeline
- Class I – 200 days
- Class II and III – 250 days
- Class IV – 300 days
Authorized Representative
Yes
License Validity
5 years
Special Notes
Labels and IFUs should be in Thai and English.