On October 18th, 2023, the Thai Food and Drugs Administration (FDA) provided more explanation to the registration of medical devices scheme, by issuing a pamphlet that can be accessed here (in Thai language). The pamphlet emphasizes more on the registration process based on the risk classification of the medical devices, in which registration of accessories will also be based on the risk classification as well.
Exemption to register accessories based on risk classification is allowed under Special Access Under Section 27, with cases as below:
- In the case where the main medical devices have been approved under Certification of importation Bor.Nor.Tor.1 (license under old regulation).
- In the case where the Certificate of Importation (Bor.Nor.Tor.1) becomes invalid but the accessories are required to be imported continuously, the Thai FDA allows submission under the special access under section 27 to import accessories with additional documents of evidence from the owner of the main medical devices, to show the purpose of using accessories together with the main medical devices or its maintenance.
This route of submission will not be applicable for medical devices with license under the new regulation. Those licensed under the new regulation will have a 12 digits registration number, and will be referred as follows:
- Listing Medical Devices – for Class A;
- Notified Medical Devices – for Class B & C;
- License – for Class D
There will be no implications on importation process for medical devices registered under the new regulation.
If you have any queries regarding this announcement, please contact us or click the button below.