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NMPA Issues the Writing Specification for Periodic Risk Evaluation Reports of Medical Devices

CCFDIE| Updated: 2020-06-24

To implement the requirements of theProvisions for Medical Device Adverse Event Monitoring and Re-evaluation (SAMR and NHC Order No.1), regulate and guide medical device registration applicants to write the periodic risk evaluation reports, NMPA has organized to formulate the Writing Specification for Periodic Risk Evaluation Reports of Medical Devices, which was issued on June 30, 2020.