NMPA: Radiofrequency therapy apparatus and radiofrequency skin therapy apparatus

To steadily and orderly advance the work related to Radiofrequency Therapy Apparatus and Radiofrequency Skin Therapy Apparatus medical devices, considering the practicalities of product development and balancing the needs of public medical device safety and orderly industry development, the National Medical Products Administration (NMPA) has decided that:

As of April 1, 2026, for the products classified as Radiofrequency Therapy Apparatus and Radiofrequency Skin Therapy Apparatus under 09-07-02 Radiofrequency Therapy (Non-Ablation) Equipment in the annex of the Announcement on Adjusting Part of the Content of the Medical Device Classification Catalog (No. 30, 2022), those that have not obtained a medical device registration certificate in accordance with the law shall not be produced, imported, or sold.

For those that have already obtained a Class II medical device registration certificate, the original certificate remains valid within its validity period. If the original registration certificate expires before April 1, 2026, the registration holder may apply to the original approving department for an extension of the original certificate. The maximum extension period shall not exceed March 31, 2026.

Registration holders and manufacturers of Radiofrequency Therapy Apparatus and Radiofrequency Skin Therapy Apparatus products shall effectively fulfill their responsibility as the main entity for product quality and safety, comprehensively strengthen quality management throughout the product lifecycle, and ensure that marketed products are safe and effective.