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?
- In order 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. A Product License is issued for Class 4 Licensed Medical Devices, a Notification Certificate is issued for Class 2&3 Notified Medical Devices and a Listing Certificate is issued for Class 1 Listing Medical Devices.
- 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 in order 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.
- Certain medical devices may require additional licenses such as for wifi/bluetooth connections prior to import.
Are there any exemptions or exclusions?
- Certain products may be imported using Special Access Routes (see below).
- Products that are re-exported from customs area before proceeding through import customs clearance do not require product licenses.
- Products that are re-imported after exported for repairs abroad.
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.
Special registration routes are also allowed for Emergency use such as during the COVID-19 pandemic:
- SARS-CoV-2 Test Kit for diagnosis of Covid-19 is a Licensed Medical Device which is allowed to register via specific registration
- Specific medical devices for Covid-19 use can be submitted via the Fast Track.
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to Thailand to:
- maintain a valid Importer’s Licence To Operate
- maintain a record of all imports (and exports)
- maintain the scientific document of the registered product regarding quality, standard, performance and safety assurance to show the document to the Thai FDA officer during inspection at the place of import
- provide appropriate storage conditions to maintain the safety and quality of imported products
- maintain importation and distribution records (which is required as part of the FDA audit)
- maintain records of any complaints
- report any Adverse Effects (AE) or Field Safety Corrective Actions (FSCA) to the Thai FDA.
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:
- register and import your medical device
- ensure your product is correctly labelled
- 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.
We also offer additional support services such as:
- Online regulatory training
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market.