RF Beauty Instrument Officially Incorporated into the Management of Medical Devices, with A Transition Period of Two Years

Recently, NMPA have adjusted the classification catalogue of medical devices, adjusted the product description and expected use of 09-07-02 radio frequency (non ablation) treatment equipment, and officially included the radio frequency skin treatment instrument in the classification catalogue of medical devices. In the future, enterprises should obtain the registration certificate of medical devices before producing, importing and selling RF Beauty Instruments.

I. Product of radiofrequency beauty instrument describes radiofrequency beauty instrument or radiofrequency skin therapeutic instrument. The classification code of medical devices is 09-07-02. It belongs to radiofrequency treatment equipment and is managed according to class III medical devices. RF skin therapeutic instrument is usually composed of RF generator, temperature measuring device, therapeutic electrode, cable, neutral electrode (if any), etc. RF energy (usually in the form of current) is applied to human skin and subcutaneous tissue through therapeutic electrodes, resulting in pathological / physiological changes in human tissues and cells. It is used to treat skin relaxation, reduce skin wrinkles, shrink pores, tighten and improve skin tissue, or treat acne and scars, or reduce fat (fat softening or decomposition).

II. The registration transition period of RF beauty instrument is two years, that is, before April 1, 2024, the enterprise shall complete the corresponding registration declaration, fulfill the main responsibility for the quality and safety of medical devices according to the requirements of the production quality management specifications of medical devices, and actively report to the provincial drug supervision and administration department where the manufacturer is located (where the imported products are the agent), the commitment of RF beauty instrument according to the development and registration plan and safety standards of medical devices Production quality management system and operation, customer complaint handling and adverse event system and implementation, etc.

III.The clinical evaluation of radio frequency beauty instruments requires radio frequency beauty instruments to be managed as a Class III medical device. Because it is newly adjusted to the management of medical devices and has not been included in the list of medical devices exempt from clinical evaluation, the radio frequency beauty instrument should complete clinical evaluation before registration, and clinical evaluation can use overseas clinical trial data or conduct clinical trials in China.

IV. Registration process of RF Beauty Instrument: RF beauty instrument shall complete R & D and sample production under the production quality management specification of medical devices. After qualified samples are produced, they shall first complete testing (including safety regulations, EMC, performance, etc.) and animal test (when necessary) in a qualified organization, Then, the medical device clinical trial institutions (2-3) on record carry out clinical trials in accordance with the clinical trial quality management specification (also known as medical device GCP), and submit the registration application to the State Food and Drug Administration Based on the recently sorted registration application materials.

As a medical device management, RF beauty instruments will be regulated throughout the life cycle. Enterprises should reasonably standardize product registration and clinical trial plans to ensure that medical device registration is completed during the transition period and the registration and production license approval are successfully obtained.

BradyKnows has seasoned staff in registration and can help manufacturers on legal compliance. If you have any questions, please feel free to contact us  info@bradyknowsmedical.com for more information.