Thailand's MedTech Gatekeeper: Navigating the Local Representative Role

Medical Device Global Market Access · Oct 19, 2025 · 3m

This episode delves into the essential role of the License Holder (ผู้รับใบอนุญาต) for foreign medical device manufacturers entering the Thai market. We explain why appointing a local representative is mandatory under the Medical Devices Act, detailing their key responsibilities which include obtaining an Establishment License, managing product registration with the Thai FDA, and overseeing all post-market surveillance and vigilance activities. We also analyze the critical strategic decision between appointing a distributor versus an independent third-party representative and the long-term…