Thai FDA GSDP Requirements for Medical Device Distribution in Thailand The Thai Food and Drug Administration (Thai FDA) has formally strengthened regulatory oversight over the distribution of medical devices by introducing Good Supply-chain Distribution Practices (GSDP) requirements. These obligations form part of a broader regulatory plan aimed at ensuring product integrity, traceability, and patient safety […]

Medical Device Importer of Record in Thailand In Thailand, the role of Importer of Record (IOR) for medical devices is often misunderstood or intentionally simplified.In reality, it is a non-delegable legal function that must be aligned with both regulatory authorization and fiscal responsibility. Any structure in which the Importer of Record: is different from the […]

Authorized Representative for Medical Devices in Thailand The Legal Role of the Authorized Representative Under Thai FDA Rules In the Thai medical device regulatory framework, the Authorized Representative (AR) is not a formal placeholder.It is the legal and fiscal cornerstone of market access. Any structure where the Authorized Representative: does not hold the licenses, does […]