Regulatory Authority

Thailand Food and Drug Administration


Classification

Medical devices are classified as follows:

Class I (high risk)

Class II (moderate risk)

Class III (low risk)


Quality System

ISO 13485:2016


Applicant

A Thailand Authorized Representative is required.


Procedure

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.


Timeframes

Once the documentation is submitted, the approval process takes 8 to 10 months for Class I devices, from 6 to 8 months for Class II devices and up to 10 days for Class III devices.


Validity

As regards Class I and II medical devices, the certification is valid for 5 years.

As regards Class III devices, it depends on the validity of the free sale certificate.


Labeling and documentation language

Documentation and labeling 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.