In order to optimize the procedures for medical device review and improve the efficiency of review and approval, CFDA has recently issued Decision of the China Food and Drug Administration on the Adjustment of Administrative Review and Approval for Medical Devices (hereinafter referred to as Decision), which calls for an adjustment of the administrative review and approval matters on medical devices that are subject to CFDA including clinical trial approvals, re-registration and extension matters of registration review and approval and registration changes.
According to Decision, from July, 1, 2017 on, the approval decision on the third category of high-risk medical device clinical trials, the approval decision on the third category of domestic and imported medical device permission changes and the approval decision on the third category of domestic and imported medical device registration renewal will be made by the Center for Medical Device Evaluation of CFDA in the name of CFDA.
CFDA pointed out that in 2014, CFDA actively carried out the newly-revised Regulation on the Supervision and Administration of Medical Devices, issued Provisions for Medical Device Registration, Measures for the Administration of Registration of In-Vitro Diagnostic Reagents, Registration, Review and Operation Specifications for The Third Domestic Category of and Imported Medical Devices and defined 4 links, including acceptance, technical review, administrative review and approval document preparation. Among them, the technical review is in the charge of Center for Medical Device Evaluation of CFDA while administrative review is in the charge of CFDA. After the completion of technical review for medical devices, CFDA will make decisions within 20 working days from the date of receiving the technical review opinions. The decisions on technical and administrative reviews of some review and approval matters were made by CFDA Center for Medical Device Evaluation. For adjusted review and approval matters, the review and approval procedures were optimized, including 3 links of reception, technical review. administrative review and approval documents preparation. For adjusted review and approval matters, CFDA Center for Medical Device Evaluation made decisions that require related departments to prepare approval documents within 10 working days, including Registration Certificate for medical Device, Medical Device Registration Change and Not Granting Administrative Licensing.
CFDA said that the adjustment of some administrative reviews and approvals for medical devices is an important measure in implementing the reform on medical device review and approval system, which combines the technical review and administrative review resources optimize the procedures and will further improve the working efficacy.