Thai FDA Updates Medical Device Application Fees

On September 30, 2021 the Thai FDA published (reference Gazette Volume 138, Special Section 239N) a revised fee schedule covering medical and diagnostic device registration applications, license establishments, quality systems, and other review processes. In most cases the TFDA medical device application fees have been lowered from the levels established in February of this year. For example, Specialist Review fees for Class 3 and 4 applications have decreased by about 33%. This announcement provides manufacturers with updated guidance on various costs associated with the newly implemented medical device regulations.

Updated Specialist Review Fees

Specialist Reviews are optional for all Class 2, 3, and 4 applications the TFDA reserves the right to select any application for a Specialist Review. Most applications selected for this process have novel technology or indications for use in Thailand. Manufacturers trying to determine how likely one of their applications is to being selected for a Specialist Review fee should consider identifying predicate devices already on the market and submit a product comparison as part of the submitted documentation.