According to the announcement of the State Food and Drug Administration on adjusting part of the content of the "Classification Catalogue of Medical Devices" (No. 30 of 2022), the radio frequency therapy device and radio frequency skin treatment device in the "09-07-02 radio frequency therapy (non-ablation) equipment" in the "medical device classification catalog" have been adjusted, and they will be managed in accordance with the third class of medical devices since the announcement was issued. From April 1, 2024, radiofrequency therapy devices and radiofrequency skin therapy devices will not be produced, imported and sold without obtaining a medical device registration certificate in accordance with the law. The following are the management attributes and management categories of RF products for cosmetic use:
1. Not all RF products are medical devices. Whether the product is managed as a medical device shall be comprehensively determined in accordance with the definition of medical device in Article 103 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council), and the management category of the product shall be determined according to the Classification Rules for Medical Devices and the Classification Catalogue of Medical Devices.
2. According to Announcement No. 30, the working principle of radiofrequency therapy devices and radiofrequency skin therapy devices managed in accordance with medical devices is generally "to act radiofrequency energy on human skin and subcutaneous tissues through therapeutic electrodes, so as to cause pathological/physiological changes in human tissues and cells", and it is expected to be "used to treat skin laxity, reduce skin wrinkles, shrink pores, tighten and lift skin tissues, or treat acne and scars, or reduce fat (fat softening or decomposition)". Products that comply with the provisions of Announcement 30 shall be managed as Class III medical devices.
For example, radiofrequency beauty products that are expected to be used to "lighten wrinkles (such as forehead lines, crow's feet, etc.), reduce fine lines, remove wrinkles around the eyes, improve sagging and sagging, lift apple muscles, lift facial contours, tighten contours, tighten skin, lift and shape, and shrink pores" should be managed as Class III medical devices.
For radiofrequency therapy devices and radiofrequency skin therapy devices managed as medical devices, if the products also have other functions (such as microcurrent stimulation, ultrasound therapy, intense pulsed light therapy, cold compresses, etc.), according to Article 6 (1) of the "Medical Device Classification Rules", "if two or more classifications are applicable to the same medical device, the classification with the highest degree of risk shall be adopted", and the product shall be managed as a Class III medical device.
For example, if a product with two working mechanisms, radiofrequency skin therapy and IPL hair removal, the function of RF skin treatment is the function of Class III medical device, and the function of IPL hair removal is the function of Class II medical device, then the product as a whole should be managed as a Class III medical device.
3. Radio frequency products that do not meet the definition of medical devices are not managed as medical devices. For example, radiofrequency products whose intended use does not involve the circumstances specified in Announcement 30 but are only used for "non-invasive skin penetration promotion of essence (not used for drugs and medical device permeation), essence absorption, skin surface cleansing, warm massage, physical massage, skin relaxation, exfoliation" or similar purposes do not meet the definition of medical devices and are not regulated as medical devices.
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