{"id":14559,"date":"2016-08-24T21:16:17","date_gmt":"2016-08-24T21:16:17","guid":{"rendered":"https:\/\/www.china-certification.com\/en\/?page_id=705"},"modified":"2023-02-09T11:44:50","modified_gmt":"2023-02-09T10:44:50","slug":"cfda-priority-review-procedure-for-medical-devices","status":"publish","type":"post","link":"https:\/\/www.china-certification.com\/en\/cfda-priority-review-procedure-for-medical-devices\/","title":{"rendered":"CFDA: Priority Review Procedure for Medical Devices"},"content":{"rendered":"
The China Food and Drug Administration<\/strong> (CFDA) issued a draft of regulation for priority review<\/strong> for medical device manufacturers. The circular proposes the qualifying criteria, process and features of the priority review. The public was able to comment the draft until July 20th 2016.<\/div>\n

In China it is necessary that manufacturers of class II and class III medical devices follow a strict technical review. This technical review is done by the Centre for Medical Device Evaluation<\/strong> (CMDE). This is necessary before the devices can be shipped to China.<\/p>\n

The priority review should give the applicants shorter review time in the registration process. According to the circular, applicants with class II medical devices (only foreign applicants) or class III medical device manufacturers (both domestic and foreign applicants) can request a priority review in some cases. First of all, a priority review is possible if the device is part of the National Science and Technology Major Project or the National Key Research and Development Plan. Priority review is also possible if a medical device can:<\/p>\n