Chongqing introduced 12 measures to help the medical device industry

full tracking service, approval time limit reduced by 1/3, simplify foreign enterprises into the product registration, set up a service consulting platform ... On January 17, the Chongqing Municipal Drug Administration held a press conference and issued 12 key measures to optimize the development of the medical device industry for services, to help the development of the medical device industry in Chongqing to raise the growth rate.Li Xiaoping, deputy director of the
Municipal Drug Administration, said that in recent years, the number of medical device product registrations in Chongqing has maintained an annual growth rate of more than 20%, the product chain is becoming more complete, the innovation ability of enterprises is constantly enhanced, with global competitiveness of high-tech products are also emerging.
The 12 new measures issued this time are aimed at helping enterprises to innovate their products, smooth the green channel for rapid approval, streamline licensing links, approve time limits, set up a service consulting platform, etc., to support the development of the city's medical device industry;
widely solicited the opinions and suggestions of the city's medical device manufacturers, the Municipal Drug Administration issued 12 key measures to optimize services. In terms of technological innovation of enterprise products, we will strive for the authorization of the National Medical Device Technology Review Center to set up Chongqing Innovation Service Station, as the National Medical Device Technology Review Center is located in Chongqing's pre-service platform, to help build Chongqing medical device innovation industry highland.
In the smooth and rapid approval of green channels, deepen the implementation of the Chongqing Medical Device Product Registration Priority Review and Approval Regulations, the possession of national and municipal related scientific research projects, core technology invention patents;
In the licensing link, registration information, administrative examination and approval time limit has been streamlined, the change of medical device registration license matters that will not increase product safety and effective risk can be combined with the renewal of registration;
, speed up the construction of inspection and testing platform. In accordance with the approval plan of the municipal government, Chongqing Medical Device Quality Inspection Center purchased 19,000 square meters of ordinary experimental room, customized electromagnetic compatibility laboratory 2000 square meters, and the second phase of the purchase of 18,000 square meters. Of these, the total investment in infrastructure hardware will exceed 200 million yuan. At present, has purchased a phase of the laboratory and entered the decoration design stage, and strive to put into use in the second half of this year. At that time, the scope of inspection and testing qualification will be further expanded, real estate product registration and inspection coverage will reach more than 95%, the annual inspection and testing volume of more than 2500 batches, for the development of the medical device industry in Chongqing to provide efficient and adequate testing technology support services.
If a foreign enterprise is transferred to a newly established enterprise in Chongqing, its original registered listed products need to be re-registered in Chongqing, if no adverse events occur after listing, the original enterprise is authorized to endorse clinical trials and related registration data and data in principle under the condition of ensuring product consistency.
In addition, the introduction of the wisdom Henghui, Huaguang certification and other developed regions of the third-party high-quality platform for enterprises to provide product research and development design, clinical programs, product registration and other advisory services, so that enterprises take fewer detours. (Chongqing Daily)