CFDA: Some medical devices with significant clinical advantages will be approved as a priority

In order to ensure the clinical use of medical devices, the State Administration of Food and Drug Administration issued the "Priority Approval Procedure for Medical Devices" on the 26th, from January 1, 2017, will diagnose or treat rare diseases, malignant tumors and medical devices with obvious clinical advantages.
According to the procedures, the medical devices approved by the General Administration of Food and Drug Administration include: diagnosis or treatment of rare diseases, malignant tumors and obvious clinical advantages; diagnosis or treatment of endearing and multiple diseases in the elderly, and there is currently no effective diagnosis or treatment means;
The General Administration of Food and Drug Administration said that for the projects to be identified for priority approval, the whole link will speed up the efficiency of review and approval, give priority to technical review, prioritize the verification of the quality management system for medical device registration, give priority to administrative approval, shorten the time to market, and ensure that the corresponding results and products can be applied to clinical use as soon as possible. (Xinhua News Agency)