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The CFDA announced today that it simplified the re-registration process of medical devices. Manufacturers are no longer required to submit product standard, testing reports for registration purposes, and IFU if there is no change in the product, its standard, and its IFU, or if the only change is the address of production. If the change(s) is with the product's intended use, model, specification, standard, performance, structure, or composition,the manufacturer is required to submit technical information relevant to the changes but no longer need to submit complete product standard, testing reports for registration purposes, nor IFU.
http://www.sda.gov.cn/WS01/CL0087/94917.html
http://www.sda.gov.cn/WS01/CL0087/94917.html
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