NMPA Notice On Medical Sodium Hyaluronate Product Category
2022-11-23
With the rapid development of science and technology and industry, new products continue to emerge. The NMPA issued the Notice On Medical Sodium Hyaluronate Product Category on November 14, 2022 (No.103, 2022, hereinafter referred to as Notice No. 103).
The main content of the revision consists of 11 articles:
At present, sodium hyaluronate products are used at the edge of drugs, medical devices and cosmetics. Notice No. 103 has identified the classification of edge products and drug-device combination products involving sodium hyaluronate.
A medical sodium hyaluronate product for the treatment of urinary bladder epithelial glucosamine protective layer defects has been approved for marketing as a Class III medical device. This kind of product is not approved in accordance with the situation of drug marketing.
When the medical sodium hyaluronate product is used for injection into the dermis and below, as an injection filling product to increase tissue volume, if the product does not contain pharmaceutical ingredients to play pharmacological, metabolic or immunological effects, it shall be regulated as Class III medical device; If the product contains local anesthetics and other drugs, it is judged to be a drug-device combination product mainly based on medical devices.
When the medical sodium hyaluronate products are injected into the dermis to improve the skin condition mainly through the moisturizing and hydrating effects of sodium hyaluronate, if the products do not contain pharmaceutical ingredients that play pharmacological, metabolic or immunological effects, they shall be regulated as Class III medical devices; If the product contains local anesthetics and other drugs, it is judged to be a drug-device combination product mainly based on medical devices.
Medical dressings that clearly contain sodium hyaluronate in Notice No. 103 are regulated as medical devices if they do not contain pharmaceutical ingredients that have pharmacological, metabolic or immunological effects; If it can be partially or completely absorbed by the body or used for chronic wounds, it should be regulated as Class Ⅲ medical device. If it can not be absorbed by the body and is used for non-chronic wounds, it should be regulated as Class II medical device.
In view of the fact that scar repair materials assisting in improving and preventing the formation of dermatologic rational scars have been listed in the Classification Catalogue of Medical Devices (14-12-02), scar repair materials shall be regulated according to Class II medical devices. When such products contain sodium hyaluronate, their regulation properties and categories do not change.
Sodium hyaluronate is generally extracted from animal tissues or produced by microbial fermentation, which has certain potential risks. The safety and effectiveness of Class I medical devices cannot be guaranteed by regulatory measures. Therefore, the regulation category of medical sodium hyaluronate products under the regulation of medical devices should not be lower than Class II.
Sodium hyaluronate has been used in cosmetics. Products containing sodium hyaluronate for the purpose of cleaning, protection, modification and beautification shall not be administered as drugs or medical devices. Such products should not be claimed for medical use.
Lotion, disinfectant solution and antiseptic swab that are only used to disinfect damaged skin and wounds shall not be administered as drugs or medical devices.
If the modified sodium hyaluronate is verified to be consistent with the relevant physical, chemical and biological properties of sodium hyaluronate, the regulation attributes and categories may be implemented by reference to this notice.
In order to clarify the implementation requirements, the relevant matters of registration application under different circumstances are stipulated. For the situation involving the transformation of product regulation attributes or categories, the implementation transition period of about 2 years is given to ensure a smooth transition.
If you have any questions on Medical Sodium Hyaluronate Products, please contact info@bradyknowsmedical.com.
