Thailand Regulatory Approval Process for Medical and IVD Devices

The Medical Devices Control Division (MDCD) under the Thai Food and Drug Administration (Thai FDA) regulates medical devices and in vitro diagnostic (IVD) devices in Thailand. All medical devices and IVDs require marketing authorization.

The Thai FDA medical device approval process explained  

Step 1
Determine the classification of your device according to the Thai FDA’s classification rules.  

Step 2
Appoint an in-country representative to manage your device registration and interact with the Thai FDA on your behalf.  

Step 3
Prepare the application dossier with the necessary documents and formatting associated with your device’s registration route (depending on device classification).   

Step 4
Your in-country representative submits the application via the Thai FDA’s online system. The MDCD screens the application for completeness and refers it to the next stage of review. 

Step 5
The applicant pays the fees due at this stage of the process (depending on device classification and registration route). 

Step 6
The Thai FDA reviews the submission and may request additional information or require an expert/specialist reviewer at their discretion. 

Step 7
The Thai FDA notifies the applicant of their submission outcome. If approved, the applicant pays any additional fees due at this stage of the process (depending on device classification and registration route).  

Step 8
The Thai FDA issues the marketing authorization for your device.