Announcement of the State Food and Drug Administration on the Management Category of Medical Sodium Hyaluronate Products (No. 103 in 2022)

In order to strengthen the supervision and management of medical sodium hyaluronate (sodium hyaluronate) products, further standardize the registration (filing) of related products, and ensure the safety and effectiveness of public medical devices, in accordance with the relevant provisions of the Drug Administration Law and the Regulations on the Supervision and Administration of Medical Devices, we hereby announce the following matters concerning the management of such products:

One、According to different intended uses (indications), working principles, etc., medical sodium hyaluronate (sodium hyaluronate) products are managed according to the following situations:

（1） Products used for the treatment of arthritis, dry eye, etc. shall be managed according to drugs.

（2） If the following conditions are met and the pharmaceutical ingredients that play pharmacological, metabolic or immunological roles are not included, they shall be managed as medical devices, and their management category shall not be lower than Category II.

1. When used as a contact lens care product, it shall be managed according to the third category of medical devices.

2. When used as an absorbable surgical anti adhesion material, it shall be managed according to Category III medical devices.

3. When it is used as an eye viscoelastic agent, it shall be managed according to Category III medical devices.

4. When the product is used as injection filling to increase tissue volume, it shall be managed according to Category III medical devices.

5. When it is injected into the dermis, it is mainly used to improve the skin condition through the moisturizing, moisturizing and other functions of sodium hyaluronate, and it is managed according to the third class medical devices.

6. When it is used to repair the glucosamine protective layer of bladder epithelium, it shall be managed according to Class III medical devices.

7. 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 Category III medical devices; If the product cannot be absorbed by the human body and is used for non chronic wounds, it shall be managed according to Class II medical devices.

8. When the scar repair dressing is used to help improve and prevent the formation of skin pathological scars, it shall be managed according to Class II medical devices.

9. When used as an auxiliary material for the treatment of oral ulcer and oral tissue wound healing, it shall be managed according to Class II medical devices.

10. When lubricant is used as body cavity instrument (excluding condom), it shall be managed as Class II medical instrument.

11. Condoms containing sodium hyaluronate lubricant shall be managed as Class II medical devices.

（3） For pharmaceutical and mechanical combination products containing sodium hyaluronate (sodium hyaluronate), it shall be determined as pharmaceutical or medical device based combination products according to the primary action mode of the product. It is not recommended to add antibacterial ingredients to pharmaceutical and mechanical combination products.

Medical dressing products containing antibacterial ingredients and plastic injection fillers containing drugs shall be judged according to the following principles:

1.For medical dressing products containing antibacterial ingredients, non clinical pharmacodynamic studies and/or clinical studies shall be provided to verify whether the products have antibacterial effects. Non clinical pharmacodynamic studies and/or clinical studies and evaluation criteria used to determine whether the product has antibacterial effects can refer to the non clinical and clinical technical guidelines related to drug research and development.

 (1) If the non clinical pharmacodynamic study and/or clinical study confirm that the product has a clear antibacterial effect, among which, the product that achieves its intended use mainly through the antibacterial effect is determined to be a combination product of medicine and machinery dominated by drugs; The products that achieve their intended use mainly through wound physical coverage, exudation absorption and other functions are judged to be medical device based combination products. 

(2) If the non clinical pharmacodynamics study and/or clinical study do not show that the product has antibacterial effect, the product shall be managed as a medical device.

2. Plastic injection fillings containing local anesthetics (such as lidocaine hydrochloride, amino acids, vitamins) and other drugs (mainly through filling to increase the tissue volume) are judged to be combination products of medicine and machinery dominated by medical devices.

3. The medical cosmetic injection materials containing local anesthetics (such as lidocaine hydrochloride, amino acids, vitamins, etc.), which mainly improve the skin condition through the moisturizing, moisturizing and other functions of sodium hyaluronate, are judged to be the combination products of medicine and equipment mainly based on medical devices.

4. The body cavity devices containing drugs (excluding condoms) are imported with lubricant, which is judged as a combination of medical devices.

Two、Products that are applied to skin, hair, nails, lips and other human surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, decorating and beautifying are not managed as drugs or medical devices.

Products used to alleviate vaginal dryness (excluding products used for vaginal wound care) are not managed according to drugs or medical devices.

Lotions, disinfectants, and cotton pads containing disinfectant ingredients that are only used to disinfect damaged skin and wound surfaces are not managed as drugs or medical devices.

Three、If the physical, chemical and biological characteristics of the modified sodium hyaluronate (sodium hyaluronate) are consistent with that of sodium hyaluronate after verification, the management attributes and management categories can refer to this bulletin.

Four、 From the date of announcement, the registration application of medical sodium hyaluronate (sodium hyaluronate) products shall be accepted according to the above management categories.

Five、The registration application that has been accepted according to the drugs or medical devices, and the varieties that are being reviewed and approved continue to be reviewed and approved according to the drugs or medical devices. If the requirements are met, the drug approval number or medical device registration certificate will be issued. Where the management attribute or category needs to be changed, the expiry date of the approval number or registration certificate shall be December 31, 2024.

Six、For the products that have obtained the drug approval number or medical device registration certificate and need to change the management attribute and management category, the original drug approval number or medical device registration certificate will continue to be valid within the validity period of the certificate; The enterprises involved shall actively carry out the conversion according to the relevant requirements of the corresponding management attributes and categories, and complete the conversion before December 31, 2024. If the original drug approval number or medical device registration certificate expires during the conversion, the enterprise can apply to the original approval department for extension according to the original management attribute and category, provided that the product is safe and effective and no serious adverse event or quality accident has occurred after marketing. If the extension is granted, the validity of the original drug approval number or medical device registration certificate shall not exceed December 31, 2024.

Seven、Cold compress gel, photon cold gel, liquid dressing, paste dressing and other products that have been filed as Class I medical devices shall be implemented in accordance with the relevant requirements of the Notice on Relevant Matters of Implementing the Catalog of Class I Medical Devices (SFDA Notice No. 107 in 2021) and the Notice on Adjusting Part of the Catalog of Medical Devices (SFDA Notice No. 25 in 2022).

Eight、 All relevant enterprises shall earnestly implement the main responsibility of product quality and safety to ensure the safety and effectiveness of listed products. Drug regulatory departments at all levels should strengthen publicity, implementation and training, and earnestly do a good job in the review, approval and post marketing supervision of related products.

Nine、 This announcement shall come into force as of the date of promulgation, and the Announcement on the Management Category of Medical Sodium Hyaluronate (the original Announcement of the State Food and Drug Administration (2009) No. 81) shall be repealed at the same time.

State Food and Drug Administration

November 10, 2022