What Clinical Evaluation Data Should Be Submitted For Polyurethane Foam Dressings?


Based on whether it is covered by the “Catalogue of Medical Devices Exempted from Clinical Trials (Revised),, (hereinafter referred to as the Catalogue), polyurethane foam dressings can be subjected to clinical evaluation in the following two aspects:

  1. For polyurethane foam dressings that meet the requirements of the Catalogue, the administrative counterpart should submit the comparison data of the product under application related information and the content described in the Catalogue, and a comparison description of the product under application and the medical devices that have been approved for registration in China in the Catalogue and the corresponding supporting documents.
  2. For polyurethane foam dressings that are not within the scope of the Catalogue, on the premise of meeting the requirements of registration regulations, the clinical data of appropriate predicate products should be selected for clinical evaluation in accordance with the “‘Technical Guidelines for Clinical Evaluation of Medical Devices” and a clinical evaluation report should be issued in accordance with the Guidelines. The administrative counterpart can also confirm the safety and effectiveness of the product in clinical application through clinical trials. If a clinical trial is conducted, consideration should be given to the purpose of the clinical trial, the study population, the choice of the control group (if needed), sample size estimation, evaluation indicator assessment methods and quantification methods, and statistical analysis methods, etc.

In general, before clinical evaluation, the clinical mechanism of polyurethane foam dressing, the expected effect on the wound, the possible risks and potential adverse events should be clarified, and fully considered in the clinical evaluation.