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.

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.

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)

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