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Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565 2022

The Medical Device Control Division, Thai FDA of the Ministry of Public Health has issued Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565, effective 03 December 2022, repealing The Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) B.E. 2563 dated 31 January 2020.

With this new regulation, all physical therapy products will be classified as Class B or C medical devices, requiring Notification from the Thai FDA. Existing physical therapy products with valid Listing certificate will still be allowed to be manufactured, imported, and sold until the expiry date of the Listing certificate. However, it is advisable to secure the Notification certificate of these products before the Listing certificate expires, to ensure the continuity of the supply chain.

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