CFDA: 156 special audits of medical devices have been completed

Source: Innovation on June 26, 2015 is an important driving force for economic growth under the new normal, and is also the strategic deployment of several opinions of the CPC Central Committee and the State Council on deepening institutional reform and accelerating the implementation of innovation driven development strategy In order to encourage the innovation and development of medical device industry, in March 2014, the State Food and Drug Administration issued the special approval procedure for innovative medical devices (Trial) (hereinafter referred to as the special approval procedure) So, how many applications have entered or passed the review of the special approval process, and how can relevant departments ensure that the approval process is scientific, rigorous and fair? For more than a year, these problems have been highly concerned by the society The reporter recently learned from the technical evaluation center of medical devices of the State Administration of industry and Commerce (hereinafter referred to as the "evaluation center") that as of April this year, the evaluation center had received 196 special approval applications for innovative medical devices and completed 156 application reviews, 23 of which passed the review, with an overall pass rate of 14.7%; 6 Three applications for registration have entered the technical review process, and the review center has given priority to review, three of which have been completed After the release of the special approval procedure, according to its requirements, the evaluation center established an innovative medical device Review Office The review office is led by a deputy director of the review center, and its members include the head of the registration office of the Department of medical device registration and management of the State Administration, the heads of each department of the review center, the head of the Chinese society of Biomedical Engineering and the head of the Secretariat It conducts collective research and decision-making on the expert review opinions and related issues in the form of a member work meeting to ensure the scientific review work Justice The review center has drafted the operation specification for special approval application review of innovative medical devices (Trial), established the working system of expert review and confirmation by the review office, formed a clear working system in the aspects of expert selection principle, expert determination procedure, review working procedure and review opinion determination procedure, and formulated scientific and rigorous working specifications for the review work According to reports, in terms of the selection of review experts, the review center entrusts relevant societies to recommend review experts according to the specified conditions, and finally selects the most authoritative experts and scholars in the relevant research fields to participate in the review The leader responsibility system is implemented in the expert review meeting At the same time, the evaluation center also formulated the operation specification for communication, exchange and technical evaluation of innovative medical devices (Trial), which defines the responsibilities, processes and exit conditions for communication, exchange and technical evaluation of innovative medical devices entering the special approval process, and provides the legal basis for the communication, exchange and priority evaluation of innovative medical devices within the center In addition, for the case problems in the actual operation process and the weak links in the review process and mechanism, the Review Office timely held a working meeting of the members, studied the handling of relevant matters, collectively formed handling opinions, and strengthened the communication and coordination with the acceptance center of the State Administration and the innovation medical device Review Department of the local provincial Bureau by holding a working forum According to the person in charge of the evaluation center with the largest number of applications for class III devices, up to April this year, there were 4 applications for imported innovative medical devices, 17 provinces and cities involved in domestic applications for innovative medical devices, and 3 provinces and cities with relatively more applications were Beijing, Jiangsu and Guangdong In terms of product categories, there are 188 applications for the management of the third category of medical devices, accounting for 96%; in terms of product types, the proportion from high to low is respectively passive implant products, in vitro diagnostic reagents, active products and passive non implant products, accounting for 35.6%, 30.9%, 22.3% and 11.2% respectively.