Periodic Risk Assessment Report Implementation of Medical Device Adverse Events

In May 2020, National Center for ADR Monitoring, China released a further description for the regular risk assessment report implementation of medical device adverse events, which elaborates the time and data collection range of regular risk assessment report on medical devices. Please email info@inspirativemed.com to get the detail information.   

A Periodic NMPA Risk Assessment Report is required to submit to NMPA, depending on the initial NMPA registration time, as part of compliance, according to Article 38 of the Administrative Measures of Medical Device Adverse Event Monitoring and Re-evaluation (Decree No. 1 of State Administration for Market Regulation and National Health Commission, published in Aug 13, 2018, effective since Jan 1, 2019). It is the obligation of each Market Authorization Holder to fulfill the requirement and submit this report at certain time point.

This checklist is used to provide a rough idea to the MAH, to identify what kind of information shall be included in this report. Such information shall be provided to your China legal agent, China Med Device (CMD), to compile to a final report. It is important to collect the information and make them available to CMD, because NMPA is relying on post-market surveillance to achieve full regulatory compliance.

The submission deadline is September 30, 2020.

Link: http://www.cdr-adr.org.cn/tzgg_home/202005/t20200506_47347.html#