Guidelines on Product Adverse Event Risk Assessment for Medical Device Registrants

NMPA (CFDA) issued the “Guidelines on Product Adverse Event Risk Assessment for Medical Device Registrants” (No. 78 of 2020) on November 27, 2020. Based on the Guidelines, risk assessment of medical devices mainly includes but is not limited to the following aspects: 1) Adverse event investigation and verification; 2) Data monitor and literature analysis; 3) Other risk information analysis; 4) Product inspection; 5) Risk analysis and assessment; and 6) Risk control. There are strict requirements for drafting a risk assessment report. Bradynuoen can help you with all the risk assessment process.

Link: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201127173533191.html