Due to a number of queries received from manufacturers concerning which category (drug, medical device, or a combination) would their products fall under, NMPA has released the draft entitled "Principles for the Determining the Category of Medical Products Containing Antibacterial Components " in the end of January. NMPA shall determine the category of products with antimicrobial ingredients in accordance with the following basic principles:
1. If the product is mainly understood physically by virtue of its intended use, and the antibacterial component is incorporated on the medical device for the sole purpose of disinfecting it and does not have anything to do with ameliorating the patient’s disease status, then this kind of “Product” is managed as a combination medical device.
2. If the intended use of the “Product” is mainly to kill or inhibit pathogenic microorganisms thereby reducing the incidence of infection, then the primary mode of action is based upon the product’s pharmacology, immunogenicity or metabolism. The function of medical device determines the product’s classification: a) If the medical device only serves as a carrier, then the “Product” is a Drug; b) Otherwise, it should be treated as a combination medical device.
3. If the “Product” exerts its intended action by means of both its physical and pharmacological, immunological or metabolic properties, then there is no definitive way to determine its primary mode of working principle. In such cases, the “Product” is then defined as a combination medical device.
4. The abovementioned principles do not apply to:
- Some medical products containing antimicrobial substances that were mentioned in other relevant regulatory guidance and does not satisfy any of the conditions given above
- Products which have gained approval by the CFDA