Thailand: Thai FDA released a draft Ministerial Announcement on the Quality Management System for Importing or Selling Medical Devices, B.E.

In the interest of consumer protection and to ensure the standardized quality, efficiency, and safety of importing or selling medical devices, the Thai FDA released a draft announcement and guideline on the Quality Management Systems for Importing and Selling Medical Devices on 19 July 2023. Should the final announcement/guideline be approved and released, effectivity would be after 360 days from the date of publication in the Royal Gazette. 


The timeline for implementation of the requirements is as follows:

Categories 2, 3 shall begin to comply after 360 days from the date of publication.

Categories 2, 3, and 4 shall begin to comply after January 1, 2027.

Categories 1, 2, 3, and 4 shall begin to comply after January 1, 2029.


Guideline and best practices for importing or selling medical devices:

Category 1: Organizational structure, management systems, and assignment of responsibilities

Category 2: Resource management

Category 3: Supply chain and device-specific requirements

Category 4: Monitoring and surveillance


The application of these criteria and good practices for distributing medical devices allows manufacturers to exempt certain requirements that have not been implemented, such as calibration, special requirements for active medical devices, outsourcing, etc. Manufacturers must provide sufficient and appropriate justification for not applying those specific requirements.

For further information on this announcement, click here

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