Regulatory Authority
Thailand Food and Drug Administration
Classification
Medical Devices are classified as follows: Class I (high risk), Class II (moderate risk) e Class III (low risk).
Quality system
ISO 13485:2016
Medical Device Registration in Thailand
Class I devices must be registered with the Regulatory Authority, therefore it is necessary to submit the required documentation in the Common Submission Dossier Template (CSDT) format which will be subject to an in-depth revision. If successful, the Regulatory Authority will issue the Licence for Sale.
Class II devices must be notified to the Regulatory Authority, therefore it is necessary to submit the required documentation in the Common Submission Dossier Template (CSDT) format for the revision that will be less detailed compared to Class I devices one. If successful, the Regulatory Authority will issue the Notification.
Class III devices, on the other hand, must be validated by the Regulatory Authority which will issue the Certificate for Custom Process after the revision. As regards sterile Medical Devices it is necessary to submit the ISO 13485:2016 certification.
Applicant
A Thailand Authorized Representative is required.
Timeframe and fees
Once the documentation is submitted, the approval process takes eight to ten months for Class I devices, from six to eight months for Class II devices and up to ten days for Class III devices.
Validity
As regards Class I and II Medical Devices, the certification is valid for five years.
As regards Class III devices, it depends on the validity of the free sale certificate.
Labelling and documentation language
Documentation and labelling must be submitted in English and Thai.
Useful information
Thailand FDA intends to reclassify Medical Devices based on the associated risk level to comply with the ASEAN Medical Device Directive.
