Writing Specification for Periodic Risk Evaluation Report of Medical Devices
On July 2, 2020, to further implement the Management Measures for the Adverse Event Monitoring and Reevaluation of Medical Devices, NMPA released a Writing Specification for Periodic Risk Evaluation Report of Medical Devices to standardize and guide medical device registrants for the Periodic Risk Evaluation Report writing. In general, this Specification elaborates more specific requirements and removes unreasonable requirements. Meanwhile, global adverse events are required to be reported explicitly. Please email info@chinameddevice.cn to get the detail information.
