After consulting on the draft in May, China National Medical Products Administration (NMPA) announced the Administrative Classifications of Medical Sodium Hyaluronate Products with immediate effect on Nov. 14, 2022.1
As new sodium hyaluronate products enter the market, the old version of classification rules issued in 2009 cannot accurately categorize the products, especially those with functions between drugs, medical devices, and cosmetics.
The new classification rules clarify the registration classifications based on the products' intended use (indication) and mechanism of action.
New Classifications
1. Products for treating arthritis and dry eyes should be administered as drugs;
2. Products should be administered as medical devices if they meet the following conditions and contain no medical ingredients that have pharmacological, metabolic, or immune functions. Such products' administrative classifications should be NO lower than Class II.
*Learn more about medical device classifications at Medical Device Registration and Filing in China.
Medical Devices Containing Sodium Hyaluronate | Classification | |
2.1. Used as contact lens care products | Class III medical device | |
2.2. Used as absorbable anti-adhesion products in surgery | Class III medical device | |
2.3. Used as ophthalmic viscosurgical devices (OVDs) | Class III medical device | |
2.4. Used as injectable fillers for augmenting tissue volume | Class III medical device | |
2.5. Used as products injected into dermis to improve skin condition by sodium hyaluronate's hydrating and moisturizing functions | Class III medical device | |
2.6. Used for healing glycosaminoglycans (GAGs) in bladder epithelium | Class III medical device | |
2.7. Used as medical dressings | Products can be partly or entirely absorbed by human body, or products used for chronic wounds | Class III medical device |
Products cannot be absorbed by human body and are used for non-chronic wounds | Class II medical device | |
2.8. Used as scar dressings for assisting the prevention and reduction of pathological skin scars | Class II medical device | |
2.9. Used as adjuvants in the healing treatments for mouth ulcers and oral tissue wounds | Class II medical device | |
2.10. Used as lubricant for putting a device (except condoms) into body cavity | Class II medical device | |
2.11. Condon with sodium hyaluronate as lubricant | Class II medical device | |
3. For drug-device combination products containing sodium hyaluronate, the classifications depend on the products' primary functions. NMPA does NOT recommend adding antibiotics to drug-device combination products.
For medical dressings with antibiotic ingredients, or injectable fillers with pharmaceutical ingredients for medical aesthetics, the classifications are as follows:
Drug-device Combination Products Containing Sodium Hyaluronate | Classification | ||
3.1. Medical dressings with antibiotic ingredients (*Applicants should provide non-clinical efficacy study or clinical study results to show if the dressing has antibiotic effects) | With antibiotic effects | Intended use is realized via antibiotic effects | Drug-led combination product |
Intended use is realized via physical coverage for wounds, osmosis, absorption, etc. | Device-led combination product | ||
Without antibiotic effects | Medical device | ||
3.2. Injectable fillers containing local anesthetics (e.g., lidocaine hydrochloride, amino acids, and vitamins), which can augment tissue volume for plastic surgery | Device-led combination product | ||
3.3. Injectable fillers containing local anesthetics (e.g., lidocaine hydrochloride, amino acids and vitamins), which can improve skin condition via sodium hyaluronate's hydrating and moisturizing functions | Device-led combination product | ||
3.4. Drug containing lubricants for putting devices (except condoms) into body cavity | Device-led combination product | ||
4. The following products do not belong to drugs or medical devices.
Products Not Classified as Drugs or Medical Devices |
4.1 Products that are sprayed on, applied to, or be used in other methods on skin, hair, nail, lip, or other human body surface for cleansing, protection, and/or beautification |
4.2 Products (not including vagina wound care products) alleviating colpoxerosis |
4.3 Washing lotion, sanitizer, and disinfecting cotton pad only used for disinfecting broken skin and wound |
5. Modified sodium hyaluronate products are subject to the new classifications after proved to be consistent with sodium hyaluronate in physical, chemical, and biological attributes.
Deadline for Changing Classifications
Registration applications of sodium hyaluronate products submitted after Nov. 14, 2022 shall obey the new classification rules.
For products under review or have been approved, and their classifications in the original applications not aligning with the new rules, China sets a transition period of about two years until December 31, 2024.
Related: How China Regulates Aesthetic Medicines—Thermage, Hyaluronic Acid, and Collagen
