On November 14, the website of the China Food and Drug Administration released the "Announcement on the Management Category of Medical Sodium Hyaluronate Products" (hereinafter referred to as the "Announcement"). Among them, it is clear that sodium hyaluronate has been used in cosmetics as a moisturizing and hydrating ingredient. Products containing sodium hyaluronate that is applied to skin, hair, nails, lips, and other human surfaces by rubbing, spraying, or other similar methods for cleaning, protection, modification, and beautification are not managed as drugs or medical devices. Such products should not claim medical use.

According to the "Announcement", the medical sodium hyaluronate product for the treatment of bladder epithelial glucosamine protective layer defects has been approved for marketing as a third-class medical device. This type of product is currently not approved for marketing as a drug. To maintain the continuity of management, the original management attributes will continue to be maintained.

When the medical sodium hyaluronate product is used for injection into the dermis layer of the skin and below, as an injection filling product to increase tissue volume, if the product does not contain pharmaceutical ingredients that exert pharmacological, metabolic, or immunological effects, according to the third category Medical device management; if the product contains local anesthetics and other drugs (such as lidocaine hydrochloride, amino acids, vitamins), it is judged as a drug-device combination product dominated by medical devices.

When the medical sodium hyaluronate product is injected into the dermis, it is mainly used to improve the skin condition through the moisturizing and hydrating functions of the sodium hyaluronate contained in the product, if the product does not contain drugs that exert pharmacological, metabolic or immunological effects If the product contains local anesthetics and other drugs (such as lidocaine hydrochloride, amino acids, vitamins, etc.), it is determined to be a drug-device combination product dominated by medical devices.

Medical dressings containing sodium hyaluronate, if they do not contain pharmaceutical ingredients that exert pharmacological, metabolic, or immunological effects, are managed as medical devices; if they can be partially or completely absorbed by the human body, or used for chronic wounds, they are managed as Class III medical devices are managed; if they cannot be absorbed by the human body and are used for non-chronic wounds, they are managed as Class II medical devices.

Given the auxiliary improvement of skin pathological scars, the scar repair materials that help to prevent the formation of skin pathological scars have been included in the "Medical Device Classification Catalog" 14-12-02 Scar repair materials and are managed according to the second category of medical devices. When such products contain sodium hyaluronate, their regulatory attributes and regulatory categories remain unchanged.

The management category of medical sodium hyaluronate products is not lower than the second category

The "Announcement" pointed out that sodium hyaluronate (sodium hyaluronate) is generally extracted from animal tissues or produced by microbial fermentation, and there are certain potential risks. It is difficult for first-class medical device supervision measures to ensure its safety and effectiveness. Therefore, according to the medical device, The management category of the managed medical sodium hyaluronate (sodium hyaluronate) products should not be lower than the second category.

In addition, the "Announcement" also clarifies that lotions, disinfectants, and cotton pads containing disinfectants that are only used for the disinfection of damaged skin and wound surfaces are not managed as drugs or medical devices; modified sodium hyaluronate has been verified If the relevant physical, chemical, and biological properties are consistent with sodium hyaluronate, the management attributes and management categories can be implemented concerning this announcement.