Medical device importation to Thailand
Only registered medical devices may be imported into Thailand, that means they must be registered with the Thai Food and Drug Administration and has been issued with a Listing Certificate, Notification Certificate or License prior to importation unless exempted from registration (see below).
What are the requirements for importing medical devices into Thailand?
Are there any exemptions or exclusions?
Special Access Routes for importing medical devices into Thailand
Special cases where special permits/certifications/exemption are issued for unregistered medical devices:
Special registration routes are also allowed for Emergency use such as during the COVID-19 pandemic:
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to Thailand to:
How Andaman Medical can help with importing medical devices to Thailand:
Andaman Medical holds a License To Operate as an Importer of medical devices 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: