Bryan Gilburg - China

“The NMPA has issued new guidance outlining common uses of Sodium Hyaluronate to help manufacturers better understand their regulatory requirements earlier in the decision making process.”

Bryan Gilburg

Managing Director

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China NMPA Updates Classification of Sodium Hyaluronate Products

Published on: November 21st, 2022

On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products. Depending on their intended use and working principles, these products are categorized as one of three options: either a medical device, drug, or combination drug-device. Common examples of products using sodium hyaluronate include dermal fillers, eye drops, and arthritis treatments. 

Given its various uses and gel-like form, sodium hyaluronate has been difficult for international manufacturers to classify, as competent authorities around the world often have varying opinions on how these products are regulated. The NMPA’s specific guidance on this product is welcomed by the industry and the different uses and distinctions are outlined in this notice, as well as described below. 

If you have further questions about sodium hyaluronate products, please contact us here.  

What is Sodium Hyaluronate? 

Sodium hyaluronate, also sometimes used interchangeably with Hyaluronic acid (HA), is a substance naturally produced by the human body as a lubricant found in the eyes, joints, and skin. The only difference between sodium hyaluronate and hyaluronic acid is that sodium hyaluronate has a lower molecular weight, allowing it to permeate surfaces further. Additionally, sodium hyaluronate is more stable than HA, allowing it to maintain a longer shelf-life. 

Sodium Hyaluronate Products Considered Medical Devices in China 

Medical devices are classified into 3 categories in China. Class I is the lowest risk products,  Class II is medium risk and Class III is the highest risk medical devices. If any of the following conditions are met and there is no pharmacological, metabolic, or immunological drug ingredient, the product will be categorized as a Class II or Class III medical device. 

Examples of Class III Hyaluronate Products 

Below are examples of Class III (highest risk) medical devices that use sodium hyaluronate: 

  • 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. 

Examples of Class II Hyaluronate Products 

Below are examples of Class II (medium risk) medical devices that use sodium hyaluronate: 

  • When used as a medical dressing, the product cannot be absorbed by the human body and is used for non-chronic wounds.  
  • Used for scar repair dressings to help improve pathological scars of the skin and prevent their initial formation,  
  • Used as an auxiliary material for the healing of mouth ulcers and oral tissue wounds,  
  • Condoms containing sodium hyaluronate lubricant. 

Example of Drug and Combination Devices 

For pharmaceutical and device combination products containing sodium hyaluronate, it will be classified as a drug-device combination product, acting mainly as a drug or mainly as a medical device, in accordance with the primary mode of action of the product. It is not recommended to add antibacterial components to the drug-device combination products.  

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. 

Antibacterial Uses 

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. 

If you have continued questions/concerns as to whether your product will be classified as a drug or medical device after this NMPA notice, please contact us here. 

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Whatever the scenario, Asia Actual has regulatory experts throughout Asia ready to help your device expeditiously achieve market access and begin, or continue, growing your sales in the region.   

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services. 

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