Are Adhesive-backed Polyurethane Foam Dressings Covered By The “Polyurethane Foam Dressings” In The Catalogue Of Class III Medical Devices Exempted From Clinical Trials?


Such products belong to the scope of the Catalog, but it should be noted that the exemption of clinical trials does not include the following 4 conditions:

  1. Products claimed to promote epithelialization, guide tissue regeneration, facilitate wound healing, reduce pain, stop bleeding, reduce scars, and prevent adhesions;
  2. Products claimed for use in internal wound, third-degree burns, infected wounds, wounds with significant necrotic tissue, patients with wound sepsis, etc.;
  3. Products containing active ingredients: such as pharmaceuticals/active pharmaceutical ingredients, biological products/bioactive ingredients, silver, disinfectants, etc.;
  4. Other new products.