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  • Accept technical guidelines for clinical trial of medical devices released
    Jan 12, 2018

    In order to implement the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Innovation of Examination and Approval System to Encourage Innovative Medical Devices (No. [2017] 42), strengthen the management of the registration of medical device products and further improve the registration examination Quality, to encourage the development of medical device innovation, recently, the State Food and Drug Administration released the "acceptance of medical devices overseas clinical trial data technology guidelines."

    This guideline is used to guide the medical device to accept the clinical trial data of the overseas clinical trial as the work of clinical evaluation when applying for registration in our country. The Guiding Principles put forward the ethical principles, the principle of legality and the scientific principles of accepting data from overseas clinical trials and clarified the data requirements and technical requirements of data from overseas clinical trials. The guiding principles expound the considerations and technical requirements for accepting data from overseas clinical trials from the technical review requirements, the population to be tested and the differences in clinical trial conditions, and give the clinical implications of different factors on the clinical data Specific examples.