The first medical device production license was issued.

July 16, according to Xinhua News, recently, The Fujian Provincial Drug Administration for Belaisheng Electronics (Xiamen) Co., Ltd. issued the first medical device registration system in Fujian Province after the pilot, Xiamen Nalong Technology Co., Ltd. holds a registration certificate, Belleson Electronics commissioned to produce digital electrocardiogram machine, thus becoming Fujian Province's first medical device registrant system pilot products.
the pilot implementation of the medical device registrant system in Fujian Province for medical device product registration certificate and production license for the "untie" to promote the complementarity of the two enterprises.
in accordance with the relevant provisions, Nalong Technology as a registrant may entrust Belleson Electronics for product production, enterprises no longer need to put into production and construction, easy to focus on high-tech research and development;
it is understood that in August 2019, Fujian was included in the implementation of the medical device registry system pilot provinces, the provincial drug regulatory bureau immediately issued the "Fujian Province medical device registrant system pilot implementation plan" to explore new ways of medical device supervision.
the pilot scope of the registrant system to expand According to media reports, there are currently a number of provinces in the country in the application to join the medical device registrant system pilot, the degree of enthusiasm exceeded expectations. what has the medical registrar system been changed
? Previously, in October 2014, the implementation of the "Medical Device Production Supervision and Management Measures" clearly stipulates that the medical device registration certificate can apply for the second and third category of medical deviceproduction license, and obtain a production license to produce, entrusted to produce the corresponding medical devices.
that registration is tied to a production license and must be done by a principal.
now, the medical device registrant system has been reformed, allowing enterprises, institutions and personnel to apply for medical device registration certificates separately, and then in the capacity of the registrant to entrust other enterprises to produce the corresponding medical devices.
registration and production licenses can be done without a single entity.
"The registrant system has realized the unbundling of product registration and production licenses, and 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 department of the Shanghai Drug Administration.
these areas have been carried out from a national perspective, the registrant system ahead of Shanghai, Guangdong, Tianjin, the three free trade zones, and then Tianjin, Beijing and other places also "into the bureau."
the following time process for the implementation of the promotion: In March 2017, the State Council issued the "Comprehensive Deepening of China (Shanghai) Free Trade Pilot Zone Reform and Opening-up Program" proposed to optimize the market allocation mechanism of innovative elements, allowing the applicant for registration of medical devices in the FTA test zone to entrust Shanghai medical device manufacturers to produce products.
October 2017, the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Pharmaceutical Medical Devices, issued by the China Office and the State Office, made it clear that the system of listing permit holders should be fully implemented.
allow medical device research and development institutions and researchers to apply for medical device listing licenses.
December 2017, the former Shanghai Food and Drug Administration issued a notice on the implementation of the Pilot Program for the Registration of Medical Devices in the China (Shanghai) Free Trade Pilot Zone.
July 2018, the Shanghai Drug Administration will expand the pilot to the whole city of Shanghai.
May 2018, the State Council issued the "Further Deepening china (Guangdong), (Tianjin) and (Fujian) Free Trade Pilot Zone Reform and Opening-up Program" clearly, allowing the Guangdong FREE trade test area medical device registration applicant to entrust The Guangdong Province medical device manufacturing enterprises to produce products;
August 2018, the State Drug Administration issued the Approval of the Pilot Work on the Medical Device Registry System, agreeing to carry out the pilot work of the Registry System in the China (Guangdong) Free Trade Pilot Zone and the Guangzhou, Shenzhen, Zhuhai and China (Tianjin) Free Trade Pilot Zone.
August 2018, the Tianjin Municipal Market and Quality Supervision and Administration Commission issued a notice on the issuance of the "Pilot Implementation Program for medical device registrants in the China (Tianjin) Free Trade Pilot Zone", further extending the medical device registrer system to Tianjin.
February 2019, the State Council issued the approval of the Comprehensive Pilot Program on the Comprehensive Promotion of the Expansion of The Service Industry in Beijing, which clearly states that the medical device registrer system will be piloted to allow the Beijing Medical Device Registrant to entrust medical device manufacturers in Beijing,Tianjin-Hebei region to produce medical devices.
... In June 2020, the Guangxi Drug Administration issued the Application Requirements and Reporting Procedure for the Pilot Work of the Guangxi Medical Device Registry System in the form of a circular, promoted the pilot work of the Guangxi Medical Device Registrant System, strengthened service guidance, standardized the approval process, and promoted the innovation and development of the medical device industry in the jurisdiction.
a number of enterprises to taste sweetness in the concrete implementation, approved by the State Council, the industry change swayed by Shanghai.
February 8, 2018, Shanghai Yuanxin Medical Technology Co., Ltd.'s single electrocardiogram recorder was awarded the second class medical device product registration certificate issued by the Shanghai Drug Administration, becoming the first product in China to enjoy the new policy of medical device registrant system.
holding a registration certificate of the distant heart medical treatment and the commissioned production of minimally invasive electrophysiological are affiliated with Shanghai micro-invasive, which thus became China's medical device registrant system pilot the first winner. Li Yong, vice president of Shanghai Micro-Invention Medical Devices Co., Ltd.
, said that from the pilot practice of our enterprise, the New Deal has greatly saved the investment in research and development costs.
to our first product to obtain a pilot registration certificate, for example, saving more than 10 million yuan in research and development investment.
tasted the sweetness of Shanghai minimally invasive, more and more intense efforts.
up to now, the enterprise has a number of companies to apply for registrars, some of the products have been registered.
from the results of the current implementation of various places, the pilot work of the registrar system has achieved some results, but there are still some problems.
for example, some enterprises understand the registrant system simply as commissioning production, without realizing that the registrant is responsible for the quality management of medical devices throughout the life cycle, some enterprises deliberately split up the holder or trustee to enjoy the incentive policies during the pilot period (e.g. priority review, etc.;
need to see that, due to the limitations of the current pilot scope, the medical device registrant system, although the continuous release of dividends, but the rate needs to be strengthened.
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