Medical device manufacturers must appoint, and grant Authorization to a local, registered company in Thailand to submit registration applications and act as License Holder. The Thai License Holder is responsible for post market vigilance reporting, annual importing records reporting, the proactive traceability of devices on the market and retention of device history documents. License Holder responsibilities are non-transferable, but manufacturers may have an unlimited number of Import Licenses for the same device at the same time. Appointing a trustworthy Independent License Holder is the foundation of a successful business strategy in Thailand.