State Food and Drug Administration: It is clarified that some medical beauty products are managed as medical devices
On March 30, the State Drug Administration issued the "Announcement on Adjusting Some Contents of the <Medical Device Classification Catalog>" to dynamically adjust the content of the classification catalogues involved in 27 medical devices.
Among them, the adjusted content of the "Medical Device Classification Catalog" announced this time includes some medical beauty products. The "Announcement" clarifies that the following medical beauty products are managed as medical devices.
From the date of implementation, according to the "Regulations on the Supervision and Administration of Medical Devices", products that have not obtained a medical device registration certificate according to law shall not be produced, imported or sold.
details as follows:
1. Radio frequency therapeutic apparatus and radio frequency skin therapeutic apparatus are used to treat sagging skin, reduce skin wrinkles, shrink pores, tighten and enhance skin tissue, or treat acne, scars, or reduce fat (fat softening or decomposition), etc. Class III medical device supervision.
2. Facial implant lines, facial lifting lines, and facial cone lifting lines are used to implant facial tissues to lift sagging and sagging tissues and correct wrinkles, all of which are regulated in accordance with Class III medical devices.
3. Sodium hyaluronate solution for injection is used for injection into the dermis layer, mainly through the moisturizing and hydrating functions of the contained sodium hyaluronate and other materials to improve the skin condition. These are clearly regulated in accordance with Class III medical devices.
The "Announcement" pointed out that, except for the radio frequency therapeutic apparatus and radio frequency skin therapeutic apparatus, other products are implemented from the date of the "Announcement".
(Headquarters CCTV reporter Yu Jingying)