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[Shanghai: Encourage the transfer of overseas-produced medical devices that have been marketed in China to domestic production] On November 9, the Shanghai Food and Drug Safety Commission issued the "Shanghai City's 15th Five-Year Plan to Ensure Drug Safety and Promote High-Quality Development of the Pharmaceutical Industry." It is mentioned that we will continue to promote reforms in the field of medical devices. Medical institutions are encouraged to accelerate the pilot work of self-developed and used in vitro diagnostic reagents, and promote the conversion and registration of registered self-developed reagents into in vitro diagnostic reagents. Encourage the transfer of overseas-produced medical devices that have been marketed domestically to domestic production. Provide registration application pre-communication services for innovative medical devices that comply with the national priority review policy. Optimize the site change process and support companies that have obtained domestic medical device registration certificates to produce Class II and III medical devices in Shanghai. Actively explore and carry out pilot projects for the transfer of medical device registration certificates. Explore the clinically urgent medical devices that have been marketed overseas and have not been registered in China for trial use in Shanghai. Promote the sharing of inspection and testing, process water and gas and other facilities and equipment among qualified medical device manufacturers in the city's industrial parks. Support qualified medical device logistics service companies to set up warehouses across provinces in accordance with regulations.
#Futures Market Intelligence#medicine#food and beverage#medical device#in vitro diagnostics11-09 14:57