Medical device distribution in Thailand
Only registered medical devices may be distributed in Thailand, that means they must be registered with the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health and been issued with a Product License (Listing Certificate/Notification Certificate/License).
Importation depending upon their class, and unless exempted from registration. Registered medical devices can only be distributed by companies who have a license as medical device importers or manufacturers in Thailand, known locally as an Establishment License.
Who can distribute medical devices Thailand?
What are the requirements for distributing medical devices in Thailand?
Advertising, communication and promotion of medical device is a common part of a distribution contract, either falling to the manufacturer or the local distributor to undertake. In Thailand, advertisements, promotion and marketing of medical devices should comply with Medical Device Act BE2551. Prior to advertising in any platform (radio, TV, digital media) medical devices, an advertisement permit must first be obtained from the Thai FDA.
Distributor’s duties and obligations
It is mandatory for distributors of medical devices and IVDs in Thailand to:
How Andaman Medical can help with distributing medical devices in Thailand:
Andaman Medical holds an Establishment License to operate as an Importer of medical devices, IVDS, medical equipment and Software as a Medical Device (SaMD) in Thailand. We remain independent from any final distribution channel partner you choose to appoint, giving you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists will help you to: