Importing & Customs Clearance
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
The requirements for importing medical devices into Thailand
- To import a medical device into Thailand, a company must first obtain an Establishment License for the import of the medical device, otherwise known as a License To Operate (LTO) as a Medical Device Importer. Only people of Thai nationality or locally established companies in Thailand can apply for an LTO from the Thai FDA.
- The relevant product license or certificate issued by the Thai FDA is also required prior to importation. This is issued once the medical device has been registered.
- Please note that transfers of product licenses are not allowed in Thailand; therefore, it can prove judicious to appoint an independent local authorized representative to register and import your medical device giving you freedom in your distribution strategy; you may even appoint multiple distributors
- A License per Invoice (LPI) must also be obtained from the Thai FDA to import; this is required for each shipment. Once the Thai FDA has confirmed that all devices listed in the shipment (airway bill, invoice and packing list) correspond to valid product license(s) or certificate then the LPI will be issued for customs clearance.
Special Access Routes for importing medical devices into Thailand
Special cases where special permits/certifications/exemption are issued for unregistered medical devices:
- Personal Use
- Exhibition
- Sample
- Clinical Trial
- Research Use.
How LHM can help with importing medical devices to Thailand
LHM 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:
- register and import your medical device
- ensure your product is correctly labeled.
- facilitate customs clearance
- maintain post-market surveillance of your registered product
- liaise with your appointed distributors and the Thai FDA concerning the mandatory reporting of Adverse Effects and Field Safety Corrective Actions.