Which risk class is your medical device?
Answer questions based on the Thai Ministry of Public Health rules to see the class (1–4) and the Thai FDA route: listing, detailed notification or licence.
Sources
- MOPH Notification on classification of medical devices by risk, B.E. 2562 (Royal Gazette, 18 Dec 2019)
- MOPH Notification on labels and instructions for medical devices, B.E. 2563 (Royal Gazette, 5 Nov 2020)
A preliminary assessment for planning. Final classification rests with the Thai FDA.