State Food and Drug Administration: radiofrequency therapy instrument, “water light needle” and other medical products are regulated as class III devices

2022-06-05 0 By

On March 30, China financial and economic dispatch (reporter dutin) today, the state food and drug administration issued “about to adjust the catalog of medical device classification part of the announcement, announcement, since April 1, 2024, the radio frequency therapy apparatus, rf skin therapeutic products not in accordance with the law in medical device registration certificate may not be the production, import and sales.The announcement is to adjust the 27 categories of medical devices involved in the “Medical Device Classification Catalog” content, the announcement said, for the adjustment of the 09-07-02 radiofrequency therapy (non-ablation) equipment in the radiofrequency therapy device, radiofrequency skin therapy device products, since the announcement of the date,Registration can be applied for in accordance with the Measures for the Administration of Registration and Archival Filing of Medical Devices (Order 47 of the State Administration for Market Regulation).Reporter noticed that the adjustment is to adjust part of the medical beauty products regulatory category, among them, the radio frequency therapy apparatus, rf skin therapeutic apparatus, used in the treatment of skin is flabby, reduce the skin wrinkles, shrink pores, tighten, enhance skin tissue, or the treatment of acne, scarring, or reducing fat (fat softening or decomposition), etc., according to the regulation of class III devices;Sodium hyaluronate solution for injection, used for injection into dermis, mainly through the sodium hyaluronate and other materials contained in the moisturizing, hydrating and other functions, improve the skin state, clearly according to the class III device supervision;Plastic implant wire is used to implant facial tissue to lift sagging tissue and correct wrinkles. It is supervised by class III devices.(Editor: An Di)