On the 2nd of July 2024, the Centre for Medical Device Evaluation (CMDE) announced the clarification by the National Medical Products Administration (NMPA) on the requirements for radiofrequency therapy devices.
Effectively from 1 April 2026, NMPA obligates radio frequency therapy devices and radio frequency skin therapy devices in the 09-07-02 radiofrequency therapy (non-ablation) equipment as stated in the appendix of the “Announcement on Adjusting Part of the Contents of the Medical Device Classification Catalogue (No.30 of 2022)” to obtain a medical device registration certificate before being produced, imported, or sold in the market.
Class II medical device registration certificate holder with the original registration certification will remain valid during its validity period. However, the registrant may apply for an extension that shall not exceed 31 March 2026, if, the original registration certificate expires before 1 April 2026. The application can be submitted to the original registration certificate's original approver.
NMPA aims to streamline product research and development work related to radiofrequency therapy devices while maintaining prioritized public safety that uses medical devices.
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