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 commercial implications of that choice.
Key Questions
• What is a License Holder and why is one mandatory for selling medical devices in Thailand?
• Which Thai regulations govern the role of an in-country representative?
• What are the primary legal duties of a Local Authorized Representative, from pre-market to post-market?
• Should you appoint your distributor as your official License Holder?
• What are the commercial risks of tying your product registration to a single distribution partner?
• How can an independent representative provide greater control and market flexibility?
• What is an Establishment License and how does it relate to product registration?
• Who is responsible for vigilance and adverse event reporting to the Thai FDA?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
