State Food and drug administration plans to carry out the action of "clearing the network" of medical devices

On April 15, the State Food and Drug Administration printed and distributed the "clearing the network" action plan for medical devices, and carried out the "clearing the network" action for medical devices nationwide The action of "clearing the Internet" is problem-oriented, focusing on illegal behaviors such as using the Internet to sell medical devices without certificates and selling unregistered medical devices, severely investigating and punishing illegal and illegal enterprises, clearing up a number of illegal websites, exposing a number of typical cases, and purifying the marketing environment of medical devices according to law; through urging the online transaction of medical devices to serve the third-party platform and online marketing of medical devices In accordance with the regulations and rules such as the regulations on the supervision and administration of medical devices and the measures for the supervision and administration of the network sale of medical devices, the selling enterprises carry out self inspection and rectification in an all-round way to further consolidate the main responsibility of the enterprise The action of "clearing the network" is divided into three stages, from late April to June is the stage of enterprise self inspection, from July to October is the stage of supervision department inspection, and from October to December is the stage of summary and evaluation According to the action plan, the third party platform shall carry out comprehensive self inspection and rectification in terms of office conditions, staffing, platform filing and information display, establishment and implementation of management system, and submit a report to the provincial drug administration Medical device network sales enterprises shall carry out comprehensive self inspection and rectification in terms of qualification, information release, sales records, storage and transportation conditions of medical device products sold online, and submit a report to the municipal department in charge of medical device supervision The action plan points out that the provincial drug regulatory authorities focus on checking whether the third-party platform provides medical device trading services for the settled enterprises without filing, directly participates in the online sales of medical devices, and fails to equip corresponding technical conditions, quality management organizations or personnel according to the regulations; whether the verification, registration, blocking and reporting of the settled enterprises are performed according to the regulations The company has the obligations of illegal sales of medical devices on the Internet The municipal and county departments in charge of the supervision of medical devices shall focus on checking whether there are any "offline" illegal medical device products such as medical device production license, business license or the second type of medical device business record voucher, and "online" illegal medical device products such as registration license or record voucher, and behaviors such as displaying false enterprises and product information, etc in the medical device network sales enterprises, so as to check whether there are "offline" illegal medical device production license, business license or the second type of medical device business record voucher Take "online" illegal product information as the clue, carry out "offline" investigation, expose "black websites", ban "black dens", and crack down on the use of Internet for illegal activities According to the action plan, drug regulatory authorities at all levels should strengthen legal knowledge training for third-party platforms and medical device network sales enterprises, improve their awareness of law-abiding integrity, strictly perform their legal obligations, and effectively implement their corporate responsibilities; for third-party platforms and medical device network sales enterprises that fail to carry out self inspection and rectification as required and do not participate in legal knowledge training, they should increase Monitor, supervise and inspect the strength, interview the legal representative or main person in charge of the enterprise, strictly investigate and punish the illegal behaviors found according to law; the third-party platform, medical device network sales enterprise and its legal representative or main responsible person with serious illegal behaviors shall be listed in the list of dishonest enterprises and dishonest personnel, and be made public to the society, and joint punishment shall be implemented The State Bureau will supervise and inspect the implementation of "clearing the network" operations in various regions.