Pay attention! China Radio Frequency Beauty Devices Regulation Now Updated!

China’s NMPA issued the Guidelines for the Registration of Radio Frequency Beauty Devices, the radio frequency beauty devices should be given a clear application part and purpose in the scope of application.

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On April 12, the Center for Medical Device Evaluation, National Medical Products Administration (NMPA) issued a notice on the guidelines for the registration review of radio frequency beauty devices, pointing out that in order to further standardize the management of radio frequency beauty devices, the Center for Device Evaluation of NMPA organized the formulation of the Guidelines for the Registration of Radio frequency Beauty Devices (hereinafter referred to as the guidelines).

According to the guidelines, the radio frequency beauty devices should be given a clear application part and purpose in the scope of application. Depending on the intended use of the product, the following normative expressions are recommended as "for the reduction of (body, face) skin wrinkles", "for the treatment of acne", "for the treatment of (body, face) atrophic scars", "for the treatment of Reduce (abdomen, flanks) subcutaneous fat", etc. For special areas such as the eyes, cheeks, and neck, the available areas and forbidden areas should be clearly shown in the form of diagrams.

For imported radio frequency beauty devices products, if they are not managed as medical devices in the country of origin, they should provide the corresponding regulatory basis and certification documents that allow the product to be marketed in the country of origin.

The guidelines pointed out that the radio frequency beauty devices are mainly aimed at improving the appearance and aesthetics of the human body, rather than treating diseases. The applicable target is mostly healthy people, and the main benefits from the devices come more from psychological or social needs rather than physical health needs.

Therefore, compared with traditional medical devices, the risk-benefit analysis of radio frequency beauty devices should focus more on safety requirements, and have a sufficient risk-benefit ratio under the premise of relatively sufficient safety. When necessary, a comprehensive evaluation should be made in combination with factors such as patient preference and alternative methods (such as sound, light and other cosmetic devices or cosmetics, etc.).

The product manual of radio frequency beauty devices should specify the indications, contraindications and use restrictions of the product, and specify the applicable target and applicable parts. A schematic diagram of areas that can and cannot be used (e.g. specific areas such as eyes, cheeks, neck) should be given.

From April 1 next year, radio frequency beauty devices will also be officially included in the management of third tier medical devices, and home-used radio frequency therapeutic devices (beauty devices) will also need to carry out human clinical trials as third tier medical devices.