Recently, National Medical Products Administration of China issued the “Announcement on the Management Category of Medical Hyaluronate Acid Products” (Draft for Comments) and revised opinions. It clarifies that when medical hyaluronate acid is used as a medical dressing, if the product cannot be absorbed by the human body and is used for non-chronic wounds, it shall be managed as a Class II medical device. Therefore, many people believe that this is the relaxation of the supervision of the Class II hyaluronate acid dressing.
On May 20, BST (all times in this article are Beijing time), National Medical Products Administration of China solicited public opinions on the announcement on the management category of medical hyaluronate acid products (Draft for comments on the revised draft) (hereinafter referred to as the “draft “). The draft is a revision and supplement to the Announcement on the Management Category of Medical Hyaluronate Acid Products issued in 2009.
At present, hyaluronate acid products are not only used in drugs and medical devices, but also used in cosmetics, food and other fields. Some products are used at the edge of drugs, medical devices and cosmetics. Therefore, the opinion draft adds the definition principles of management attributes of edge products and pharmaceutical machinery combination products involving hyaluronate acid and the classification principles of relevant medical device products, and defines the management attributes and management categories of relevant products.
According to different intended uses (indications) and working principles, the draft defines the management attributes of medical hyaluronate acid products respectively. The combined products of drugs and instruments containing hyaluronate acid shall be determined as the combined products of drugs or medical devices according to the primary mode of action of the products; by rubbing, spraying or other similar methods, daily chemical industrial products that are applied to the skin and other human surfaces for the purpose of cleaning, protecting, modifying and beautifying should not claim medical use in accordance with cosmetics management.
In addition, the draft lists in detail 11 cases of medical device management, and stipulates that its management category shall not be lower than the second category. Among them, as an injection into the dermis, it mainly improves the skin state through the moisturizing and hydrating effects of hyaluronate acid, which is managed according to the third category of medical devices. When used as a medical dressing, if the product can be partially or completely absorbed by the human body or used for chronic wounds, it shall be managed according to Class III medical devices. If the product cannot be absorbed by the human body and used for nonchronic wounds, it shall be managed according to Class II medical devices.
As is known to all, in recent years, “medical beauty masks” and “medical mechanical masks” have been rampant on the Internet, confusing consumers and causing considerable harm to the Chinese cosmetics industry. For a long time, the National Medical Products Administration(NMPA) of China has been rectifying medical cold compresses, and the industry should realize that this edge behavior is not desirable. NMPA once issued an article stating that there is no medical mask product, cosmetics are cosmetics, medicines are medicines, they cannot be confused, and no edge behavior is allowed.
With “hyaluronic acid” as the keyword, only 6 records are displayed in the medical devices (filing history system) within the territory of NMPA. The query with “hyaluronic acid” as the keyword in the medical devices (Registration) within the territory of NMPA shows that there are 180 records, including nearly 50 Class III of products and products such as “hyaluronic acid test kits”. There are only about 30 products of Class II hyaluronic acid dressing (including repair patch).
Although few products have obtained the registration certificate of Class II hyaluronic acid dressing at present, the market of hyaluronic acid dressing is relatively prosperous. A search on Tmall, China’s mainstream e-commerce platform, with “hyaluronic acid dressing” as the keyword, showed a total of 1223 related goods, and the monthly sales of the top three products exceeded 10,000.
It is worth noting that, due to the subtle “education” of merchants and KOLs, consumers have confused dressings with masks. Therefore, with the opening of the Class II hyaluronic acid dressing, it is also necessary for consumers to be alert to those medical beauty masks that are fishing in troubled waters in the market.