State Food and Drug Administration: exempting 1400 kinds of medical equipment from clinical experiments and influencing a large number of equipment enterprises

On August 1, the equipment examination center of the State Food and Drug Administration issued the catalogue of medical devices exempt from clinical trials (Draft for comments on the revised version in 2019) (hereinafter referred to as the "2019 version of the catalogue of exemption (Draft)"), a total of 996 medical devices and 420 in vitro diagnostic reagents were exempt from clinical trials According to the statistics of cerberyl devices, compared with 2018 edition, there are 142 new medical devices and 27 in vitro diagnostic reagents in 2019 edition of exemption catalogue (opinion draft), 19 new medical devices have expanded the scope of exemption or revised the description, and 142 new medical devices include 102 class II and 40 class III medical devices In fact, this is the fifth batch of medical devices exempt from clinical trials The 2018 edition of the exemption catalogue includes the first four batches, totaling 1248 kinds, including 855 kinds of medical devices and 393 kinds of in vitro diagnostic reagents, with an increase of 84 kinds of medical devices and 277 kinds of in vitro diagnostic reagents compared with the previous three batches Continuously expanding the catalogue and adding medical devices that are exempt from clinical trials can effectively reduce the requirements of clinical trials for products with high maturity and low risk, reduce the burden of enterprises, and enable enterprises to devote more energy to product research and development and quality improvement At the same time, it is also conducive to optimize clinical trials and review and approval resources, put valuable resources into clinical urgent need and innovation of medical device products, and promote the safe, effective and risk controllable products to market as soon as possible Attachment: new medical devices and in vitro diagnostic reagents exempted from clinical trials