In order to strengthen the supervision and management of medical sodium hyaluronate (sodium hyaluronate) products, to further standardize the registration of related products ( filing), to ensure that the public use of medicines and equipment safety and effectiveness, according to the “Drug Administration Law,” “Medical Devices Supervision and Administration Regulations,” the relevant provisions of the management of such products are now announced in the following matters related to the management of the product:

1. According to different intended use (indications), working principle, etc., medical sodium hyaluronate (sodium hyaluronate) products are managed in accordance with the following situation:

(i) Products used for the treatment of arthritis, dry eyes, etc. are managed as pharmaceuticals.

(ii) According to the following situations, if it does not contain drug components that play a role in pharmacology, metabolism or immunology, it shall be managed in accordance with the management of medical devices, and its management category shall not be lower than Class II.

  1. When used as contact lens care products, it is managed as Class III medical device.
  2. When used as absorbable surgical anti-adhesion material, it is managed as Class III medical device.
  3. When used as ocular viscoelastic, it is managed as Class III medical device.
  4.  When used as injectable fillers to increase tissue volume, it is managed as Class III medical device.
  5. When used as injection into the dermis, mainly through the sodium hyaluronate contained in the moisturizing, hydration and other effects, to improve the skin condition application, it is managed as Class III medical device.
  6. When used as repairing the bladder epithelial glucosamine protective layer, it is managed as Class III medical devices.
  7. When used as medical dressing, if the product can be partially or completely absorbed by the human body or used for chronic wounds, it is managed as Class III medical device; if the product cannot be absorbed by the human body and used for non-chronic wounds, it is managed as Class II medical device.
  8. When used as a scar repair dressing to assist in the improvement of dermatopathic scars and to assist in the prevention of dermatopathic scar formation, it is managed as a Class II medical device.
  9.  When used as oral ulcers, oral tissue wound healing treatment aids, it is managed as Class II medical devices.
  10. When used as lubricant for introduction of body cavity instruments (excluding condoms), it is managed as Class II medical devices.
  11. When used as a lubricant for the introduction of body cavity devices (excluding condoms), it is managed as a Class II medical device.

 

(iii) For containing sodium hyaluronate (sodium hyaluronate) combination of medicines and devices products, should be based on the product’s primary mode of action to determine whether the main role of drugs or the main role of medical devices combination of drug and device products. Do not advocate the addition of antimicrobial ingredients to the combination of drug and device products.

Medical dressing products containing antimicrobial ingredients and injectable fillers for orthopedic use containing drugs are judged according to the following principles:

  1. For medical dressing products containing antimicrobial ingredients, non-clinical pharmacodynamic studies and/or clinical studies should be provided to confirm whether the products have antimicrobial therapeutic effects. The non-clinical pharmacodynamic studies and/or clinical studies used to determine whether the product has antimicrobial therapeutic effects and the evaluation criteria can be referred to the non-clinical and clinical technical guidelines related to drug development.(A) If non-clinical pharmacodynamic studies and/or clinical studies confirm that the product has a clear antimicrobial therapeutic effect, in which case, the product that realizes its intended use mainly through the antimicrobial therapeutic effect is judged to be a pharmaceutical-based drug-device combination product; and the product that realizes its intended use mainly through the effects of physical coverage of wounds, exudate absorption and so on, is judged to be a medical-device-based drug-device combination product.   (B)If non-clinical pharmacodynamic studies and/or clinical studies do not show that the product has an antimicrobial therapeutic effect, the product is managed as medical device.
  2. Injectable fillers for orthopaedic use containing drugs such as local anaesthetics (e.g. lidocaine hydrochloride, amino acids, vitamins) and increasing the volume of tissues mainly by filling are judged to be drug-device combination products that are mainly medical devices.
  3.  Injectable materials for medical cosmetology that contain local anesthetics and other drugs (e.g. lidocaine hydrochloride, amino acids, vitamins, etc.), and that improve the state of the skin mainly through the moisturizing and hydrating effects of the sodium hyaluronate contained therein, are judged to be drug-device combination products that are mainly medical devices.
  4. The introduction of lubricants into body cavity devices (excluding condoms) that contain drugs is judged to be drug-device combination products that are mainly medical devices.

 

  1. Products used for cleaning, protecting, modifying or beautifying the skin, hair, nails, lips and other surfaces of the human body by rubbing, spraying or other similar methods are not managed as drugs or medical devices.

Products used to relieve vaginal dryness (excluding products used for vaginal wound care) are not managed as drugs or medical devices.

Products such as lotions, disinfectant solutions, disinfectant pads, etc. containing disinfectant ingredients, which are only used for disinfecting broken skin and wounds, are not managed as drugs or medical devices.

 

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