May 9, 2018

Thai FDA announces that they will modify the Medical Device Act and will be adopting the international risk classification method (Class I-IV) in order to comply with the ASEAN Agreement on Medical Device Directive.

Since the ASEAN Agreement on Medical Device Directive (AMDD) was signed, Thailand has been drafting the amendments necessary to fulfill the conditions stated in the agreement. The draft of anticipated changes in the original Medical Device Act B.E.2551 (2008) along with its clarification statement were published recently; however, the effective date of the revised Act was not stated.

The major change to the Act is that Thailand shall adopt risk classification method and risk control measures in line with the international agreement in order to facilitate international trade (as stated in Annex 2: Risk Classification Rules for Medical Devices other than IVD Medical Devices and

Annex 3: Risk Classification Rules for IVD Medical Devices of the AMDD agreement.)



1.     Clarification:

2.     Draft: