How to write clinical information in the catalog of exemption from clinical trials

For inclusion in the "Catalogue of Medical Devices Exempted from Clinical Trials" (hereinafter referred to as the "Catalog" products, the applicant for registration is required to submit information on the comparison between the relevant information of the declared product and the content described in the "Catalog" and the comparison between the declared product and the "Catalog" medical devices that have been approved for registration in the territory of the comparative description. Specific requirements for the submission of clinical evaluation information are as follows:

(a) the submission of information related to the declared product and the content of the catalog described in the comparative information;

(b) the submission of the "declared product and the catalog has been approved for registration of medical devices in the territory of the comparative description" comparative description should include the "declared product and the catalog has been approved for registration of medical devices in the territory of the comparative description" should include the "declared product and the catalog has been approved for registration of medical devices". Comparison Table" and the corresponding supporting information (see Table 1 below).

The above information submitted should be able to prove that the declared product is equivalent to the product described in the Catalog. Regarding the equivalence, it can be summarized as follows:

1) the product name is the same or similar to the product in the Catalog as far as possible;

2) the scope of application is the same as, or less than, the scope of application in the Catalog;

Note: If the Catalog product is applicable to image data acquisition, transmission, processing, analysis, and diagnosis; the comparison of the product use may be "applicable to image data acquisition, transmission, processing, analysis";

3) the product structure composition, performance indicators, the implementation of the standard is basically equivalent;

Note: the product knot needs to be equal to or less than the structure of the product in the catalog, the performance indicators need to be in the range of indicators in the catalog, the implementation of the same standards;

4) the basic principle (working principle / mechanism) is basically the same;

5) sterilization / disinfection methods, methods of use are basically the same;

6) the use of key components, materials in contact with the human body is basically the same;

If it is not possible to prove that the product declared and the "directory" of products with the same nature, then it should be in accordance with:

Through clinical trials or clinical use of the same species of medical devices. Species of medical devices clinical trials or clinical use of data obtained by analyzing and evaluating, through clinical trials.

Note: The above mentioned "Catalog" refers to the latest CFDA's "Circular of the State Food and Drug Administration on the Release of the Catalog of Class II Medical Devices Exempted from Clinical Trials" and "Circular of the State Food and Drug Administration on the Release of the Catalog of Class III Medical Devices Exempted from Clinical Trials".

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