| The index number | FGWJ-2022-256 | ||
| title | Announcement of the NMPA on the management category of medical sodium hyaluronate products (2022 No. 103) | ||
| release date | 2022-11-14 |
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 medical devices used by the public, according to the relevant provisions of the “Drug Administration Law” and “Regulations on the Supervision and Administration of Medical Devices”, The relevant matters related to the management of such products are hereby announced as follows:
1. 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 to treat arthritis, dry eye, etc. shall be managed as drugs.
(2) If the following conditions are met, and it does not contain pharmaceutical ingredients that exert pharmacological, metabolic or immunological effects, it shall be managed as a medical device, and its management category shall not be lower than the second category.
1. When used as a contact lens care product, it shall be managed in accordance with Class III medical devices.
2. When used as an absorbable surgical anti-adhesion material, it shall be managed in accordance with the third category of medical devices.
3. When it is used as ophthalmic viscoelastic agent, it shall be managed according to the third category of medical devices.
4. When used as an injection filler to increase tissue volume, it shall be managed according to the third category of medical devices.
5. As an injection into the dermis, mainly through the moisturizing and hydrating effects of sodium hyaluronate to improve the skin condition, it should be managed as a third-class medical device.
6. When it is used to repair the glucosamine protective layer of bladder epithelium, it shall be managed according to the third category of medical devices.
7. When used as a medical dressing, if the product can be partially or fully absorbed by the human body, or used for chronic wounds, it shall be managed according to the third category of 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 the second category of medical devices. Device management.
8. When applied as a scar repair dressing to assist in the improvement of pathological skin scars and to prevent the formation of pathological skin scars, it shall be managed as a second-class medical device.
9. When used as an auxiliary material for oral ulcer and oral tissue wound healing treatment, it shall be managed as a second-class medical device.
10. When used as a body cavity device (excluding condoms) to introduce lubricants, it shall be managed as a second-class medical device.
11. Condoms containing sodium hyaluronate lubricants shall be managed as Class II medical devices.
(3) For a drug-device combination product containing sodium hyaluronate (sodium hyaluronate), it should be judged as a drug-device combination product with the main action of a drug or a medical device based on the primary mode of action of the product. It is not recommended to add antibacterial ingredients to drug-device combination products.
For medical dressing products containing antibacterial ingredients, injection fillers for plastic surgery containing drugs, etc., the following principles shall be used to judge:
1. For medical dressing products containing antibacterial ingredients, non-clinical pharmacodynamic studies and/or clinical studies should be provided to confirm whether the products have antibacterial therapeutic effects. Non-clinical pharmacodynamic studies and/or clinical studies and evaluation criteria used to determine whether a product has an antibacterial therapeutic effect can refer to non-clinical and clinical technical guidelines related to drug development. (1) If non-clinical pharmacodynamic studies and/or clinical studies confirm that the product has a clear antibacterial therapeutic effect, among them, the product that mainly achieves its intended use through antibacterial therapeutic effect is determined to be a drug-based drug-device combination product; mainly through Products whose functions such as wound surface coverage and exudate absorption achieve their intended purpose are determined as medical device-based drug-device combination products. (2) If non-clinical pharmacodynamic studies and/or clinical studies do not show that the product has an antibacterial therapeutic effect, the product shall be managed as a medical device.
2. Injectable fillers for plastic surgery that contain local anesthetics and other drugs (such as lidocaine hydrochloride, amino acids, vitamins), and mainly increase tissue volume through filling, are determined to be medical device-based drug-device combination products.
3. Injectable materials for medical cosmetology that contain local anesthetics and other drugs (such as lidocaine hydrochloride, amino acids, vitamins, etc.), mainly through the moisturizing and hydrating effects of sodium hyaluronate to improve skin conditions, are determined to be medical devices The main drug-device combination product.
4. Lubricants introduced into body cavity devices (excluding condoms) containing drugs are determined to be medical device-based drug-device combination products.
2. Products that are applied to skin, hair, nails, lips and other human body surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, modifying and beautifying are not managed as drugs or medical devices.
Products used to relieve vaginal dryness (excluding products used for vaginal wound care) are not managed as drugs or medical devices.
Lotions, disinfectants, disinfectant pads, etc. containing disinfectant ingredients that are only used for the disinfection of damaged skin and wounds shall not be managed as drugs or medical devices.
3. If the modified sodium hyaluronate (sodium hyaluronate) is verified to have the same physical, chemical, and biological properties as sodium hyaluronate, the management attributes and management categories can be implemented with reference to this announcement.
4. From the date of publication of the announcement, the application for registration of medical sodium hyaluronate (sodium hyaluronate) products will be accepted according to the above-mentioned management category.
5. The registration application that has been accepted as a drug or medical device, and the variety that is being reviewed and approved will continue to be reviewed and approved as a drug or medical device. If the requirements are met, a drug approval number or a medical device registration certificate will be issued. Among them, if it is necessary to change the management attribute or category, the deadline for the validity period of its approval number or registration certificate is limited to December 31, 2024.
6. For products that have obtained drug approval numbers or medical device registration certificates, if the management attributes and management categories need to be changed, the original drug approval number or medical device registration certificates shall continue to be valid within the validity period of the certificates; the enterprises involved shall follow the corresponding management attributes According to the relevant requirements of the category and category, the transformation work should be carried out actively, and the transformation should be completed before December 31, 2024. If the original drug approval number or medical device registration certificate expires during the conversion work, on the premise that the product is safe and effective and no serious adverse events or quality accidents have occurred after listing, the company can apply for an extension to the original approval department according to the original management attributes and categories If the application is extended, the validity period of the original drug approval number or medical device registration certificate shall not exceed December 31, 2024.
7. Products such as cold compress gels, photon cold gels, liquid dressings, and ointment dressings that have been filed as Class I medical devices shall comply with the “Notice on Matters Concerning the Implementation of the Catalog of Class I Medical Devices” (National Pharmaceutical Circular No. 107 of 2021) and the Announcement on Adjusting Part of the Contents of the Medical Device Classification Catalog (National Food and Drug Administration Announcement No. 25 of 2022).
8. All relevant enterprises should effectively implement the main responsibility for product quality and safety to ensure the safety and effectiveness of marketed products. Drug supervision and management departments at all levels should strengthen publicity and implementation training, and do a good job in relevant product review and approval and post-market supervision.
9. This Announcement will come into effect on the date of its release, and the Announcement on the Management Category of Medical Sodium Hyaluronate Products (former State Food and Drug Administration Announcement No. 81 in 2009) will be abolished at the same time.
National Medical Products Management
November 10, 2022
