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Thailand: Announcement of the Timelines for the Implementation Quality System for Importing or Selling of Medical Devices B.E.2566 (2023) in Thailand

To ensure the standardized quality, efficiency, and safety of importing or selling medical devices, which is in the interest of consumer protection, it is appropriate to establish a Quality Management System for Importing or Selling Medical Devices. This announcement shall become effective after 1 year from the date of publication in the Royal Gazette.

The timelines for implementation of the requirements for new establishment registrant of importer and seller are as follows:

  • Chapters 2, 3 shall comply from the effective date of this announcement.
  • Chapters 2, 3, and 4 shall comply from January 1, 2027.
  • Chapters 1, 2, 3, and 4 shall comply from January 1, 2029.

The timeline for implementation of the requirements for current establishment registrant of importer and seller as follows:

  • Chapters 2, 3 shall comply after 1 year from the effective date of this announcement.
  • Chapters 2, 3, and 4 shall comply from January 1, 2027.
  • Chapters 1, 2, 3, and 4 shall comply from January 1, 2029.

Criteria and best practices for importing or selling medical devices:

  • Chapter 1: Organization, Management System, and Allocation of Duties and Responsibilities
  • Chapter 2: Resource management
  • Chapter 3: Supply chain and device-specific requirements
  • Chapter 4: Monitoring and surveillance

To apply criteria and good practices for distributing medical devices, registrants can exempt any requirements if there is no activity to comply that requirements such as calibration, special requirements for active medical devices, outsourcing, etc. Registrants must provide sufficient and appropriate justification for not applying those specific requirements.

Further information on the implementation of the quality system for importing or selling of medical devices can be accessed here.

If you have any queries about this announcement, please do not hesitate to contact us at sales@andamanmed.com or click the button below.

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