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  • Mobile Medical Device Registration Technical Review Guidelines Released
    Jan 12, 2018

    With the rapid development of cloud computing, big data and artificial intelligence, mobile computing technology has been widely used in medical devices. In order to implement the "Opinions on Deepening the Innovation of Examination and Approval System for Drugs and Encouraging Innovative Medical Devices" (Office Word [2017 ) No. 42), to promote the innovation and development of the medical device industry and to strengthen the supervision and guidance on the registration of mobile medical devices. Recently, the State Food and Drug Administration released the first review of the registration of mobile medical devices Guiding Principles".

    This guideline applies to equipment and / or software that implements one or more medical uses using a noninvasive "mobile computing terminal." Clarified the definition, type, judgment principle and registration declaration data of mobile medical device. This guideline should be used in combination with the Guiding Principles for Medical Device Software Registration Technology Review, Guiding Principles for Medical Device Network Security Registration Technology Review and Guidelines for Technical Review of Registration of Medical Device Products.