SODIUM HYALURONATE PRODUCTS AS DRUG IN CHINA
SODIUM HYALURONATE should be classified as drug when used to treat arthritis, dry eye among other applications.
SODIUM HYALURONATE AS MEDICAL DEVICES IN CHINA
SODIUM HYALURONATE should be classified as a medical device when it doesn’t contain any ingredient with pharmacological, metabolic, or immunological activity. Based on its risk it can be classified as Class I, Class II or Class III medical device.
CLASS III DEVICES WHEN USED AS:
- Contact lens care products
- Absorbable surgical anti-block material,
- Ophthalmic viscoelastic agent,
- Injection filler to increase tissue volume
- Injections to improve skin condition via moisturizing and hydrating
- Used to repair the bladder epithelial glucosamine protective layer,
- When used as a medical dressing, the product can be partially or completely absorbed by the human body or used for chronic wounds.
CLASS II DEVICES WHEN USED AS:
- Medical dressing that is not absorbed by the human body and is used for non-chronic wounds.
- Scar repair dressings to help improve pathological scars of the skin and prevent their initial formation.
- Auxiliary material for the healing of mouth ulcers and oral tissue wounds.
CLASS I DEVICES WHEN USED AS:
- Cold gels
- photon cold gels
- liquid dressings
- paste dressings.
SODIUM HYALURONATE AS COMBINATION PRODUCTS IN CHINA
For combination products containing sodium hyaluronate, they will be classified as medical device or drug based on their primary mode of action. The following uses of sodium hyaluronate are considered drug-device combinations:
- If a product achieves its intended use through the antibacterial therapeutic effect, it is classified as a drug-device combination product that functions primarily as a drug.
- A product that mainly achieves its intended use through physical coverage (of wounds) is classified as a drug-device combination product that acts primarily as a medical device.
- If the product does not have an antibacterial therapeutic effect, the product is classified as a medical device.
- Injection fillers for plastic surgery which contain local anesthetic drugs (such as lidocaine hydrochloride, amino acids, and vitamins) and increase tissue volume by filling are classified as drug-device products that function primarily as a medical device.
- Medical beauty injection materials containing local anesthetic drugs that improve skin condition mainly through the moisturizing and hydrating effects of sodium hyaluronate are classified as drug-device combination products that mainly act as a medical device.
- When applied as lubricant for the introduction of a body cavity device (excluding condoms) it is classified as a drug-device combination product that functions primarily as a medical device.
- The following uses of sodium hyaluronate are considered drugs: Products used for the treatment of arthritis, xerophthalmia, etc.
MISCELLANEOUS SODIUM HYALURONATE USES
Cleaning and Disinfectant Usages
Products applied to the skin, hair, nails, lips or other human surfaces that are utilized for cleaning, protecting, and beautifying via rubbing, spraying or other similar methods are not classified either as drugs or medical devices. Cleaning solutions, disinfectants, antiseptic swabs, etc. that contain disinfectant ingredients and are only used for broken skin and wound disinfection are not considered drugs or medical devices. Products used to relieve vaginal dryness (excluding products used for vaginal wound care) are not classified as drugs or medical devices either.
For medical dressing products that have antibacterial ingredients, non-clinical pharmacodynamic studies or clinical studies should be provided to confirm whether the product has antibacterial therapeutic effects.
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