Notice on Registration of Urgent Clinically Needed Medical Devices (2020, No. 22)
On October 29, 2020, CMDE announced a Notice for the registration of urgent clinically needed medical devices. These medical devices are used for the treatment of diseases that are seriously life-threatening and for which there is no effective treatment. This is a special situation described in item 5 of Article 2, item (1), of the Medical Devices Priority Approval Procedure: “urgently needed in clinical and for which there is no approved registration in China for the predicates”. For medical devices that are used to treat serious life-threatening diseases without effective treatment, CMDE will give priority to the review, and may grant approvals with conditions if it meets the requirements of the Guidelines for Conditional Approval of Medical Devices. For more information about how the Urgent Clinically Needed Medical Devices, please contact Bradynuoen (Email: info@inspirativemed.com).
