According to the official website of the State Food and drug administration, the State Food and Drug Administration recently issued an announcement to adjust the contents of the catalogue of medical devices involved in 27 categories of medical devices. Some medical beauty products are managed according to class III medical devices Among them, RF therapeutic instrument and RF skin therapeutic instrument are used to treat skin relaxation, reduce skin wrinkles, shrink pores, tighten and improve skin tissue, or treat acne and scar, or reduce fat (fat softening or decomposition), which are managed according to class III medical devices. Sodium hyaluronate solution for injection is used to inject into the dermis. It mainly improves the skin state through the moisturizing and hydrating effects of sodium hyaluronate and other materials. It is managed according to class III medical devices. Facial implant line, facial lifting line and facial cone lifting line are used to implant facial tissue to improve loose and sagging tissue and correct wrinkles. They are managed according to class III medical devices. According to the announcement, for medical devices that have been accepted but have not completed registration approval (including initial registration and continuous registration), the drug regulatory department shall continue to review and approve according to the original acceptance category. If registration is approved, the medical device registration certificate shall be issued, and the adjusted product management category shall be indicated in the remarks column of the registration certificate. If the management category of registered medical devices is adjusted from category III to category II, the medical device registration certificate will continue to be valid within the period of validity. In case of renewal, the registrant shall apply to the corresponding drug regulatory department for renewal registration according to the changed category 6 months before the expiration of the validity of the medical device registration certificate. If the renewal registration is allowed, the medical device registration certificate shall be issued according to the adjusted product management category. In addition, the announcement pointed out that since April 1, 2024, RF therapeutic instruments and RF skin therapeutic instruments shall not be produced, imported and sold without obtaining the medical device registration certificate according to law. Other products with adjusted contents shall be implemented as of the date of promulgation of this announcement. Classification standards and methods of medical devices According to the official website of the State Food and drug administration, China classifies and manages medical devices according to the product safety of medical devices. The classification catalogue is formulated by the State Food and drug administration according to the classification rules of medical devices: The first category is the medical devices with low risk, and the implementation of routine management can ensure their safety and effectiveness. Such as surgical instruments (knives, scissors, forceps, tweezers, hooks), scraping board, medical X-ray film, surgical clothes, surgical caps, inspection gloves, gauze, bandages, drainage bags, etc. The second category is medical devices with moderate risk and need to be strictly controlled and managed to ensure their safety and effectiveness. Such as medical suture needle, sphygmomanometer, thermometer, ECG machine, EEG machine, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, non absorbable suture, etc. The third category is medical devices with high risk and need to take special measures to strictly control and manage to ensure their safety and effectiveness. Such as implantable cardiac pacemaker, corneal contact lens, intraocular lens, ultrasonic tumor focusing knife, hemodialysis device, implantation equipment, vascular stent, comprehensive anesthesia machine, dental implant materials, medical absorbable suture, intravascular catheter, etc. (outlook new era)