Important: China’s NMPA Further Clarifies the Requirements for Radio Frequency Therapy Devices

China's National Medical Products Administration (NMPA) has decided that starting from April 1, 2026, radio-frequency therapeutic (non-ablative) equipment that has not obtained a medical device registration certificate in accordance with the law cannot be manufactured, imported, or sold.

This decision aims to ensure the smooth and orderly advancement of work related to radio frequency therapeutic devices and radio frequency skin treatment devices, and takes into account the actual conditions of product development as well as the need to balance public safety and the orderly development of the industry. This refers to products classified under 09-07-02 radio frequency therapeutic (non-ablative) equipment in the annex of the "Announcement on Adjusting Parts of the Medical Device Classification Catalog" (No. 30, 2022).

For those who have obtained a Class II medical device registration certificate, the original certificate will remain valid within its validity period. If the original certificate expires before April 1, 2026, the registrant may apply for an extension from the original approval department, with the maximum extension period not exceeding March 31, 2026.

Registrants and manufacturers of radio-frequency therapeutic devices and radio-frequency skin treatment devices must earnestly fulfill their primary responsibility for product quality and safety, comprehensively strengthen quality management throughout the entire product lifecycle, and ensure the safety and effectiveness of products on the market.

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