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The Shanghai Food and Drug Safety Commission issued the “Fifteenth Five-Year Plan” for Ensuring Drug Safety and Promoting High-Quality Development of the Pharmaceutical Industry in Shanghai. Among them, it is mentioned that reforms in the field of medical devices will continue to be promoted. Encourage medical institutions to speed up pilot work to develop and use their own in vitro diagnostic reagents, and promote the conversion and registration of registered self-developed reagents as in vitro diagnostic reagents. Encourage the transfer of medical devices produced overseas that have already been marketed domestically to domestic production. Pre-registration communication services are provided for innovative medical devices that meet the national priority review policy. Optimize the site change process and support enterprises that have obtained domestic medical device registration certificates to produce Class II and Class III medical devices in Shanghai. Actively explore and carry out pilot medical device registration certificate transfers. Explore medical devices that have been marketed abroad and are not registered domestically, that are urgently needed for clinical trials in Shanghai. Promote the sharing of facilities and equipment such as inspection and testing, process water and gas use among eligible medical device manufacturers in the city's industrial parks. Support eligible medical device logistics service companies to set up warehouses across provinces in accordance with regulations.
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The Shanghai Food and Drug Safety Commission issued the “Fifteenth Five-Year Plan” for Ensuring Drug Safety and Promoting High-Quality Development of the Pharmaceutical Industry in Shanghai. Among them, it is mentioned that reforms in the field of medical devices will continue to be promoted. Encourage medical institutions to speed up pilot work to develop and use their own in vitro diagnostic reagents, and promote the conversion and registration of registered self-developed reagents as in vitro diagnostic reagents. Encourage the transfer of medical devices produced overseas that have already been marketed domestically to domestic production. Pre-registration communication services are provided for innovative medical devices that meet the national priority review policy. Optimize the site change process and support enterprises that have obtained domestic medical device registration certificates to produce Class II and Class III medical devices in Shanghai. Actively explore and carry out pilot medical device registration certificate transfers. Explore medical devices that have been marketed abroad and are not registered domestically, that are urgently needed for clinical trials in Shanghai. Promote the sharing of facilities and equipment such as inspection and testing, process water and gas use among eligible medical device manufacturers in the city's industrial parks. Support eligible medical device logistics service companies to set up warehouses across provinces in accordance with regulations.
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