Whether The Documents Of Comparable Medical Device(s) Must Be Authorized By Its Administrative Counterpart?

According to the “Guidance for Clinical Evaluation of Medical Devices” (General Notice No. 14 of 2015), the requirements for conducting clinical evaluation by the method of using comparable device(s) is clear that the relevant data should be acquired legally. The “Notice of NMPA on Issuing Implementation of Provisions for Medical Devices and In Vitro Diagnostic Reagents Registration” (Food and Drug Administration [2015] No. 247) mentions that, if a device which belongs to another administrative counterpart is chosen as a comparable device, and the manufacturing technique information, clinical data and other information of comparable device(s) are used, the administrative counterpart need to submit an authorization when conducting clinical evaluation accordance with Article 6 of the “Guidance for Clinical Evaluation of Medical Device”. The “Interpretation Provisions for Medical Devices Registration No. 5”further interprets the medical device clinical evaluation data authorization requirements, which is, the authorization is required to ensure the legality of the data source when non-public data of comparable medical device(s) is used; The use of public publication data, such as published literature, public data and information, etc., authorization is not required. Therefore, when conducting clinical evaluation by the method of using comparable device(s), if the device(s) of other administrative counterpart is chosen as comparable medical device, and the data sources from public data, test measurement, industry consensus, etc., the authorization of using such data is not required.