Upcoming changes to medical device registrations in Thailand
All medical devices to enter Thailand, whether manufactured domestically or imported, are regulated by the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health.
Currently, the registration of medical devices is classified according to the level of control, which lists 3 levels:
- Licensed Medical Devices
- Notified Medical Devices
- General Medical Devices.
Registrations of Licensed and Notified Medical Devices must be submitted using the Common Submission Dossier Template (CSDT), however, the CSDT file is not required for General Medical Devices. Verification of the Certificate of Free Sale (CFS) by the Thai FDA is applicable for General Medical Devices. And all medical device registrations must be submitted via the online medical device registration system called the “E-submission system”.
Upcoming changes to the above medical device regulations
The new regulations will be promulgated in the near future (expected publication date in mid-February 2021) in order to align with the ASEAN Medical Device Directive (AMDD). The registration of medical devices shall be in accordance with a risk-based classification, which list 4 types:
- Class 4 or Licensed Medical Devices
- Class 2 and 3 or Notified Medical Devices
- Class 1 or Listing Medical Devices.
Registrations of Licensed and Notified Medical Devices shall require the CSDT file for registration, however, the CSDT will not be required for Listing Medical Devices. Self-declarations and test reports for sterile medical devices or those which have a measuring function will be required for Listing Medical Devices. And all medical device registrations must be submitted via E-submission system.
The medical device class will determine the necessary documentary requirements for registration. Licensed and Notified Medical Devices shall require more documentary information for submission in order to register. A fee is payable for each medical device registration, which is a non-tax fee. The fee and timeline for Licensed, Notified and Listing Medical Devices will be published in the Government Gazette. The regulations shall be enforced on the date of publication for Licensed and Notified Medical Devices, however, the regulations shall enter into force 30 days following the date of publication for Listing Medical Devices.
Implications for medical device registrations currently being prepared
Once the new regulation is in force, which is expected to be around mid-March 2021, the new registration procedure must be followed, which means a longer registration lead time, more documents will be required, as well as increased fees.
If you would like more information or are interested in registering your medical device in Thailand please send us an email to [email protected]