For medical device products that are exempt from clinical evaluation, the relevant information submitted should be classified as "other information" in the non clinical data.
The specific requirements are as follows: For Class II and Class III medical devices that are exempt from clinical evaluation, the applicant shall demonstrate the safety and effectiveness of the products in accordance with the "Technical Guidelines for Comparing and Explaining Products Listed in the Catalogue of Medical Devices Exempted from Clinical Evaluation" from the aspects of basic principles, structural composition, performance, safety, and applicability.
For disposable medical devices, supporting materials proving that they cannot be reused should also be provided.