Thailand: Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565 2022
On 09 December 2022, the Thai FDA issued a clarification on the Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565, that has become effective on 03 December 2022.
With this new regulation, all physical therapy products will be classified as either Class A, 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.
In addition, Thai FDA also announced that the product classification of massager, vibrator, air mattress for pressure sore prevention is Class 1 (Rule12 in Thailand). Other physical therapy products will be classification as Class B or C depending on their intended use.
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