Changes in regulations for clinical evaluation of medical devices and their impact on the industry

For medical device products that require clinical evaluation, it is necessary to proceed from the company's own situation, fully consider the availability of resources, and select a reasonable clinical evaluation path according to product characteristics, clinical risks, existing clinical data, etc. Generally there are the following situations:

1) The safety and effectiveness of the product can be proved through the evaluation of the clinical literature and clinical data of the same variety of medical devices, and the clinical evaluation can be carried out by simply comparing the same variety;

2) The declared product or the predecessor product of the declared product has some clinical literature and clinical data, which includes clinical trials conducted in China, clinical trials conducted outside China, multi-regional clinical trials, and clinical trials reported in clinical literature. , or if the existing clinical data of similar devices are insufficient to confirm the safety and effectiveness of the product, clinical trials should be carried out for the unconfirmed parts. If the existing clinical data are overseas clinical data and clinical experience data of the declared product, supplementary clinical trials based on the original clinical trial protocol can be carried out. If the existing clinical data are the data of the same variety of products, clinical trials for differences can be carried out.

3) If the enterprise is unable to grasp the clinical data of any declared product or the predecessor product of the declared product, and cannot grasp the clinical data of similar products, it should conduct clinical trials.