Generally speaking, the exemption report can be made in the following ways:
When applying for the registration of Class II medical device products listed in the catalogue, the applicant enterprise may apply in writing for exemption from submitting the application for clinical trials, and at the same time submit a comparative description of the declared varieties and similar products that have been listed. The contents of the comparison manual shall at least include the working principle, product material, structural composition, main technical performance indicators, disinfection/sterilization method (if any), expected use, whether it is for home use, etc.
Application report for exemption from clinical trials: explain the similarities and differences between the products applying for exemption from clinical trials and similar products that have been approved for marketing by the drug supervision and administration department (that is, obtained the registration certificate of medical device products) in terms of main performance indicators, structural composition, clinical application scope, etc.
Mainly explain the similarities and differences between the products applying for exemption from clinical trials and similar products registered by this enterprise in the main performance indicators, structural composition, clinical application scope and so on; Explain whether there have been any quality accidents or adverse events caused by any reason during the listing of similar products;
In addition, the requirements of provincial bureaus for clinical exemption are not necessarily the same. The specific reports and forms should be inquired on the website of the local provincial bureau.