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China to Renew Medical Sodium Hyaluronate's Administrative Classifications

As more sodium hyaluronate products emerge on the market, China is going to update its regulations to better guide the registration and supervision of the products.

On May 20, China National Medical Products Administration (NMPA) released the revised draft of the Announcement on the Administrative Classifications of Sodium Hyaluronate Products for Medical Use (hereafter referred to as the draft and the Announcement, respectively) for public comments. The draft renews the classification system of medical sodium hyaluronate products according to their intended uses and mechanisms of action.1

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Current Classifications of Medical Sodium Hyaluronate

The current classifications are based on the 2009 version of the Announcement. Medical sodium hyaluronate products are generally classified into two categories: administered as drugs and as medical devices.2

Medical Sodium Hyaluronate

Classification

Products that have clear pharmacological effects, e.g., treating arthritis, dry eyes, skin ulcer, etc.

Drug

Adjuvant products in eye surgery;

Anti-adhesion products in surgery;

Tissue filler and tissue volume-augmenting products, etc.

Medical Device

Classifications for Consultation

If following the current classification rules, some sodium hyaluronate products are difficult to classify because in terms of functions, they are on the boundaries between drugs, medical devices, and cosmetics. To address the difficulty, the draft defines the classifications of such "boundary" products, drug-device combination products, and relevant medical devices:

1. Products for treating arthritis or 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 lubricant for putting a device (except condoms) into body cavity

Class II medical device

2.2. Used as adjuvants in the healing treatments for mouth ulcers and oral tissue wounds

Class II medical device

2.3. Used as contact lens care products

Class III medical device

2.4. Used as absorbable anti-adhesion products in surgery

Class III medical device

2.5. Used as ophthalmic viscosurgical devices (OVDs)

Class III medical device

2.6. Used as injectable fillers for augmenting tissue volume

Class III medical device

2.7. Used as products injected into dermis to improve skin condition by sodium hyaluronate's hydrating and moisturizing functions

Class III medical device

2.8. Used for healing glycosaminoglycans (GAGs) of bladder epithelium

Class III medical device

2.9. 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

2.10. Used as scar dressings for assisting the prevention and reduction of pathological skin scars

Class II medical device

2.11. Used as lubricants in the same package of condom

Class II medical device (should be registered together with the condom)

3. For drug-device combination products containing sodium hyaluronate, the classifications depend on the products' primary functions. For combination products that are medical dressings with antibiotic ingredients, or are 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 (*Product sponsors should provide nonclinical 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. Medical aesthetic injectable fillers containing local anesthetics (e.g., lidocaine hydrochloride, amino acids and vitamins) for augmenting tissue volume

Device-led combination product

3.3. Medical aesthetic injectable fillers containing local anesthetics (e.g., lidocaine hydrochloride, amino acids and vitamins) and for improving 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. Daily chemical products should be administered as cosmetics if they are sprayed on, applied to, or be used in other methods on human body surface for cleansing, protection, and beautification.

5. Products (not including vagina wound care products) alleviating colpoxerosis are not administered as drugs, medical devices, or cosmetics.

Deadline for Changing Classifications

China sets a transition period of about two years for applicants to adjust to the new classification rules once the draft takes effect. The interim deadline is December 31, 2024, for all sodium hyaluronate products to obey the new classifications, whether the products are under review or have been approved.

Submit your Comments

The above is how China plans to revise its regulations on medical sodium hyaluronate's classifications. As the regulations are still in consultation, stakeholders can send comments to mdct@nmpa.gov.cn. You are welcomed to send relevant enquires to contact@chemlinked.com and we are willing to help with answers and solutions.

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