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 .
Asia Actual is a full-service provider of medical device license-holder services in Thailand. Contracting with us as your Thai License Holder allows you to:
Sell directly to multiple regional distributors (avoiding mark-up by a national importer)
Increase transfer pricing (as distributors are not investing in registration costs)
Improve leverage in distributor negotiations/responses
Secure intellectual property from local commercial agents
Assure expert handling of post market vigilance and license maintenance
Contact Asia Actual to see if our Thailand Independent License Holding service is right for your business.