China Food and Drug Administration (CFDA) pays high attention to the innovation and development of medical device industry. In order to better implement the “Fast Review and Approval Track for the Innovative Medical Devices (Trial)” (hereinafter referred to as “Innovation Track”), centralize the power, improve the efficiency, accomplish the special approval work for innovative medical devices successfully, and encourage the applicants to focus on research and development innovation, some of the issues are interpreted as follows:
A. About the application time of the special approval for innovative medical device
In accordance with the “Innovation Tracl”, China Food and Drug Administration will handle the special review and approval applications for innovative medical device which has been applied before the registration application of medical device in accordance with the corresponding requirements of “innovative track”.
B. If the application of class I medical device can be handled in accordance with the “Innovation Procedures”?
In accordance with the “Regulations on the Supervision and Administration of Medical Devices “(State Council Decree No. 680), class I medical device are subject to filing management instead of administrative licensing management, so the “innovation track” are not applied to the class I medical device.
China Food and Drug Administration will not accept the special approval for innovative medical device applied by class I medical device. If the applications of special approval for innovative medical device which has been accepted by China Food and Drug Administration are defined as the class I medical device after reviewing, they will not be reviewed and approved in accordance with the “innovative track”.
C. If the “innovative track” can be applied to the renewal application/ licensing items changing application
In accordance with Article 12, 14 and 17 of the “Innovation Track”, the special review and approval for innovative medical devices can only be applied to the first time registration applications which are defined clearly by “Medical Device Registration Management Measures” (No. 4 Decree of China Food and Drug Administration) and ” Registration and Management Measures of in Vitro Diagnostic Reagents “( No. 5 Decree of China Food and Drug Administration) instead of the renewal application or licensing items changing application.
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