The Thai FDA regulates and monitors manufactured and imported medical devices to meet international quality and efficacy standards. It works under the supervision of the Ministry of Health and is in charge of the Deputies Secretary General. 

Thai FDA categorizes medical devices and IVDs into three classes. It is important to notice that the classes are in reverse order as compared to the USFDA. In other words, the Thai Class III, for example, is the least stringent class.

The Thai FDA requires a local legal entity for handling the registration process. Our country specific (*) regulatory services in Thailand include:



Medical Device specific regulation strategy reports, Medical Device Registration with Thai FDA, Thai Representative and certification holder for Medical Device manufacturers, Thai FDA Technical documents preparation and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill the following form, submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Thailand!

(*) Thailand Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat service