echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical World News > Four provincial drug administration jointly issued the new medical equipment Alliance

    Four provincial drug administration jointly issued the new medical equipment Alliance

    • Last Update: 2019-10-30
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    ▍ source: Cypress blue equipment / China Medical Journal ▍ finishing: Mick Heavy progress, the Yangtze River Delta medical device registration system integration formed (details attached at the end) On October 29, according to Jiangsu drug administration, Shanghai, Jiangsu, Zhejiang and Anhui Drug Administration jointly issued the implementation plan for pilot work of medical device registrant system in the Yangtze River Delta region It is reported that the major move is to integrate the medical device industry in the Yangtze River Delta region in accordance with the requirements of the notice on expanding the pilot work of medical device registrants issued by the State Drug Administration It can be seen that the Yangtze River Delta medical device registrant system integration formed "Medical device registrant system", an innovative reform in the medical device industry, was first piloted in Shanghai and then expanded to Tianjin and Guangdong In August 2019, the relevant notice of the State Food and drug administration made it clear that 21 provinces, autonomous regions and municipalities directly under the central government, including Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong and Guangdong, participated in the pilot of medical device registrant system What is the medical registration system and what kind of change has it experienced? Previously, in the measures for supervision and management of medical device production implemented since October 2014, it was clearly stipulated that only when the medical device registration certificate was obtained, can the production license of class II and class III medical devices be applied for, and only when the production license was obtained, can the corresponding medical devices be produced and commissioned That is to say, the registration and production license are bound together, which must be completed by one entity Now, the system of medical device registrant has been reformed, allowing enterprises, institutions and personnel to apply for medical device registration certificate separately, and then entrust other enterprises to produce corresponding medical devices as registrant That is, registration and production license can not be completed by one entity Mode change: (image source: CFDA regulations online) "The registrant system realizes the deregulation of product registration and production license, which is more conducive to encouraging innovation, integrating social resources and accelerating the listing of medical device products," said Lin Senyong, director of the medical device regulatory office of Shanghai pharmaceutical regulatory bureau In terms of specific implementation, with the approval of the State Council, the industrial transformation will be initiated in Shanghai On February 8, 2018, the single channel ECG recorder of Shanghai Yuanxin Medical Technology Co., Ltd obtained the second type of medical device product registration certificate issued by Shanghai pharmaceutical regulatory department, becoming the first product in China to enjoy the new policy of medical device registration system Both Yuanxin medical with registration certificate and minimally invasive electrophysiology of entrusted production belong to Shanghai minimally invasive, which has become the first winner of the pilot system of medical device registrant in China Li Yong, vice president of Shanghai minimally invasive medical devices Co., Ltd., said that from the perspective of the pilot practice of our enterprise, the new policy has greatly reduced the investment in research and development costs Taking our first product with pilot registration certificate as an example, more than 10 million yuan of R & D investment has been saved Taste the sweetness of Shanghai minimally invasive, try more and more Up to now, the company has 7 companies and 12 product registrants, of which 2 products have obtained registration certificates It is reported that in addition to the two products of Shanghai minimally invasive technology Co., Ltd., six products of four enterprises in Shanghai were approved in the pilot process The pilot forms also include expanding production sites, multi-point entrustment, the registrant being a scientific research-oriented enterprise, interaction between medical workers, cross regional entrustment of non related subjects, and localization of imported products The advantages of medical device registrant system, which can shorten the product listing cycle and improve efficiency, have emerged, and can be confirmed by the practice in Shanghai The system reform has brought changes to the industry, and the leading domestic medical device enterprises have set sail one after another As far as Medtronic is concerned, it is different from Shanghai minimally invasive technology Co., Ltd., which is a professional third-party OEM company Taking its approved surgical power system as an example, it took only 45 days for the product to be approved for marketing after commission Lin Feng, director of the medical device registration office of Shanghai food and drug administration, said in this regard that the product should have been registered as an imported product, but it was locally registered and manufactured in the pilot process, making it possible for localization transfer The launch of this product also means that in the future, more advanced medical devices in our Congress will not be imported, but through local registration and production to achieve rapid listing According to the results of the implementation in different regions, the pilot work of the registrant system has achieved some results, but there are still some problems For example, some enterprises simply understand the registrant system as entrusted production and fail to realize that the registrant has to bear the main responsibility for the quality management of the whole life cycle of medical devices; some enterprises deliberately split out the holder or trustee to enjoy the incentive policies during the pilot period (such as priority review); some holders and clients have intellectual property disputes.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.