Medical Sodium Hyaluronate Management Regulations issued by NMPA China(2022 No. 103)

The index numberFGWJ-2022-256
titleAnnouncement of the NMPA on the management category of medical sodium hyaluronate products (2022 No. 103)
release date2022-11-14

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.

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