A Guideline for AE Surveillance by Medical Device Registration Applicants

On April 10, 2020, NMPA released a notice for providing a guideline for adverse event surveillance by medical device registration applicants. This guideline is to guide and standardize the medical device registration and filing applicants in the surveillance of adverse events. NMPA is enhancing post market surveillance since 2018, and will do overseas onsite facility inspection. Bradynuoen can provide training and mock up inspection on overseas facility.

Link: http://www.nmpa.gov.cn/WS04/CL2138/376402.html