The State Council issued a text plus code free trade zone reform to implement the medical device registrar system

On May 4, 2018, the State Council issued a "Further Deepening china (Guangdong) Free Trade Pilot Zone Reform and Opening-up Program", which proposed to allow applicants for medical device registration in the FTZ to entrust medical device manufacturers in Guangdong Province to produce products. The Reform and Opening-up Plan for the Free Trade Pilot Zone of China (Tianjin) proposes to allow applicants for medical device registration in the FTZ to entrust Tianjin medical device manufacturers to produce products. Up to now, there are three pilot zones, including the Shanghai Free Trade Zone.
The drug listing license holder system means that drug research and development institutions or researchers in the pilot administrative area may, as drug registration applicants (hereinafter referred to as applicants), submit applications for drug clinical trials and drug market applications, and applicants who have obtained drug listing licenses and drug approval numbers may become drug market license holders. It has been piloted in 10 provinces (cities) including Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan since May 26, 2016. Correspondingly, the medical device registrant system means that eligible medical device registration applicants can apply for a medical device registration certificate separately and then entrust it to a qualified and productive production enterprise for production, so that the product can be manufactured as a substitute. The scope of the pilot includes domestic second- and third-class medical devices. Article 8 of the Measures for the Supervision and Administration of Medical Device Production, which has been in effect since October 1, 2014, stipulates that any medical device manufacturer in the second and third categories shall submit a production license to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government, in which one of the information must be the registration certificate and product technical requirements of the medical device produced by the applicant enterprise, that is, the production license and the medical device registration certificate must be completed by the same subject.
medical device registrant system breaks through this regulatory restriction, eligible applicants can apply for a medical device registration certificate separately, and then entrusted to qualified and productive enterprises to produce. This policy allows the registrar to entrust production by multiple points, i.e. after the registrar has been approved for the first production, he may then entrust the production of other production enterprises. It also allows the trustee to submit a medical device registration certificate held by the entrusting party to apply for a production license. On February 27, 2018, a single electrostartical recorder developed by Shanghai Yuanscope Medical Technology Co., Ltd. was approved by the Shanghai Food and Drug Administration to obtain a registration certificate, and on the same day, Shanghai Minimally Invasive Electrophysiological Medical Technology Co., Ltd. obtained a production license for the product. The product became the first product of the medical device registrar system, which took only 26 working days from acceptance to certification, less than one-third of the statutory working days.
, Shanghai Yuanscopic Medical Technology Co., Ltd. is a research and development-oriented company, with a single electrostartic recorder technology, but it does not have the production capacity. Shanghai Minimally Invasive Electrophysiological Medical Technology Co., Ltd. was established by Shanghai Minimally Invasive Medical Devices (Group) Co., Ltd. on August 31, 2010 at the Medical Valley Park of Shanghai International Medical Park. Main business for research and development, production, operation and cardiac electrophysiological interventional diagnosis and treatment related to various types of medical equipment and equipment, including ablation catheters, diagnostic catheters, three-dimensional cardiac electrophysiological measurement system and other products, with mature medical device production capacity. The medical device registrar system allows the two enterprises to realize the division of labor and cooperation, complement each other and win-win situation.
China Free Trade Zone (FTZ) is a specific area in a country where one or more tariffs and trade quotas have been eliminated and special economic management systems have been implemented in areas such as cargo regulation, foreign exchange management and enterprise establishment. The FTZ is shouldering the mission of comprehensively deepening reform and expanding development, exploring new ways and accumulating new experience, and bearing the positive role of model-driven and serving the whole country. It is responsible for enhancing the activity of foreign trade, stimulating regional economic growth, perfecting China's regulatory system, enhancing the status of the country and promoting investment. The biggest feature of the FTZ is that it is based on institutional innovation and replicable and replicable as the basic requirement.
The reform of medical device registrars is conducive to strengthening the full life cycle responsibility of registrars, encouraging innovative research and development and continuous improvement of quality, gathering scientific research personnel, research and development institutions and innovative enterprises, optimizing the market allocation of innovative resources, breaking through the constraints of land resources and environmental resources, promoting the division of labor and cooperation in the medical device industry chain, and enhancing industrial energy level. , the formation of advanced manufacturing advantages, is conducive to connecting the international medical device manufacturing rules, promote the local production of high-end medical devices, is conducive to perfecting the medical device registration and production supervision system, promote the evaluation standards and review unity, establish an effective cross-regional after-the-fact supervision mode, is conducive to speeding up the listing of medical devices to meet the increasingly urgent needs of the public for high-quality health services. (Arterial network)