The State Council issued a document to reform the free trade zone | Implementing a medical device registrant system

According to the medical website of the Ministry of Health of the People's Republic of China, on May 6, 2018, the State Council issued the document "Further Deepening the Reform and Opening-up Program of China's Free Trade Pilot Zone", which proposed allowing medical device registration applicants in the Pilot Free Trade Zone to entrust Guangdong medical device manufacturers to produce products. "The further deepening of the China (Tianjin) Free Trade Pilot Zone reform and opening up program" proposed to allow medical device registration applicants in the Pilot Free Trade Zone to entrust Tianjin medical device manufacturers to produce products. Up till now, there have been included Shanghai Free Trade Zones. Pilot area.

drug The system of holders of marketable licenses refers to the drug R&D institutions or scientific research personnel within the pilot administrative area that can serve as drug registration applicants (hereinafter referred to as applicants) to submit drug clinical trial applications, drug market applications, and the applicants to obtain drug marketing permits and drugs. The approval number may become a holder of drug marketing licenses. Starting May 26, 2016 in Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, Sichuan and other 10 provinces (cities) pilot projects Implementation. Corresponding, medical instruments The registrant system means that a qualified medical device registration applicant can apply for a medical device registration certificate and then entrust it to a qualified and productive production. enterprise Production, to enable the product to achieve OEM production. The scope of the pilot includes domestic medical equipment of the second and third category. Article 8 of the Measures for the Supervision and Administration of the Production of Medical Devices, which came into effect on October 1, 2014, sets out the second category. In the case of three kinds of medical device manufacturing enterprises, they shall produce licenses to the food and drug supervision and administration departments of the provinces, autonomous regions, and municipalities directly under the central government, and one of the materials that must be submitted shall be the registration certificate and product technical requirements of the medical devices produced by the applicant enterprise. That is, the production license and the medical device registration must be completed by the same subject.

The medical device registrant system broke through this Regulation Restrictions: Eligible applicants can apply for a medical device registration certificate, and then entrust them to a qualified and productive enterprise. This policy allows the registrant to entrust more production, that is, the registrant can re-commission Produced by other manufacturers. The trustee is also allowed to submit a medical device registration certificate issued by the entrusting party to apply for a production license. On February 27, 2018, the single-channel ECG recorder developed by Shanghai Yuanxin Medical Technology Co., Ltd. was awarded Shanghai Food and Drug Administration. The supervisory authority approved the registration certificate. On the same day, Shanghai MicroPort Electrophysiology Medical Technology Co., Ltd. obtained the production license for this product. This product became the first product for the registration of medical device registrant system, and the product was only used from acceptance to certification. 26 working days, less than one-third of the legal workday.

Shanghai Yuanxin Medical Technology Co., Ltd. is a research and development company with a single-channel ECG recorder technology, but it does not have its own production capacity. Shanghai Weichuang Electrophysiology Medical Technology Co., Ltd. consists of Shanghai Minimally Invasive Medical Devices (Group) Co., Ltd. On August 31st, 2010, the company was established in Shanghai Medical Park, Medical Park. The main business is R&D, production, and operation of various types of medical devices and equipment related to cardiac electrophysiological interventions, including ablation catheters and diagnostic catheters. Cardiac electrophysiological mapping systems and other products have mature medical device production capabilities. The medical device registrant system enables the two companies to achieve division of labor and collaboration, complementing each other.

The China Free Trade Zone belongs to the Free Trade Zone (FTZ). It refers to one or more areas within a country that eliminate tariffs and trade quotas, and implement special economic management systems in areas such as cargo supervision, foreign exchange management, and establishment of enterprises. The Free Trade Zone has the mission of comprehensively deepening reforms and expanding development, exploring new approaches, and accumulating new experiences. It carries the positive role of demonstrations and serves the country. It is responsible for enhancing the activity of foreign trade, stimulating regional economic growth, and improving China’s supervision. System, promote the status of the country, and promote the responsibility of investment. The most important feature of the free trade zone is the institutional innovation as the core, and it can be replicated and promoted as the basic requirement.

This reform initiative of medical device registrants will help strengthen the registrant's life cycle responsibilities, encourage innovation and R&D, and continuously improve the quality. It will help scientific research personnel, R&D institutions and innovative companies gather, optimize the market allocation of innovative resources, and help to break through the land. Resources and environmental resources constraints, promote cooperation in the upstream and downstream division of labor in the medical device industry chain, enhance industrial energy levels, and create advanced manufacturing advantages; Help align with international medical device manufacturing access rules, promote local production of high-end medical devices; Improve registration of medical devices The supervisory system promotes the standardization of reviewing standards and reviews, establishes an effective cross-regional supervision method afterwards, facilitates the speeding up of the listing of medical devices, and satisfies the increasingly pressing high quality of the public. health service requirements.