NMPA issued 2020 Adverse Events Report on March 22, 2021, summarizing over 530,000 reports, 35.25% rise from the year before.
“Medical device manufacturers should take the initiative to collect all suspicious medical device adverse events in their products from medical device operators and users. Enterprises that produce Class II and Class III medical devices should also establish corresponding systems to ensure the traceability of their products.”, according to Decree 1 “Medical Device Adverse Event Reporting and Reevaluation” issued in August 2018.
Legal representative will play a far more significant role than ever before, as Decree 1 requires all the adverse events information be provided to your legal representative to compile and report to China regulatory authority. It is important to collect the information and make them available to your legal representative because NMPA increasingly relies on post-market surveillance to achieve full regulatory compliance.
China Med Device, LLC is an NMPA certified legal representative. We can help you fulfill the pre and post market legal agent requirements without your need to setup office in China. For more details on legal representative related regulations, email us at info@ChinaMedDevice.com.
Highlights from the Reports
The end users file the most reports, accounting for 85.03%, followed by suppliers and device manufacturers.
Classified by decree of the adverse events, deaths stand for 0.04% of the total reports, serious injuries make up 6.13%, the others occupy 93.83%.
Non-active medical devices account for 64.42% of the reports; active medical devices and IVD reagents account for 22.15% and 0.69% respectively. 12.75% of the reports are due to that manufacturers failed to fill out the structural characteristics of the medical devices.
By device category, infusion, nursing, and protection equipment got most reports, standing for 42.26%, followed by diagnostic and monitoring equipment and physical therapy device. The top ten devices are as follow:
The report says that the NMPA pays attention to international cooperation of post-market surveillance. NMPA collected and published AEs of heart valves, urinary catheters, insulin pumps, ventilators and other medical devices issued by the US, UK, Australia, and Canada.
It is also establishing Adverse Event Terminology and Coding (AET) and Patient Registration (PR) projects of the International Medical Device Regulatory Forum, and participating in the National Regulatory Report (NCAR) project, to accelerate information exchange with global regulatory authorities.
A Periodic Risk Evaluation Report is required to submit to NMPA, according to Decree No. 1 Administrative Measures of Medical Device Adverse Event Monitoring and Re-evaluation. It is the obligation of each Market Authorization Holder to fulfill the requirement and submit this report at certain time point.
We have formulated the template of Periodic Risk Evaluation Report. Email info@ChinaMedDevice.com to get a copy.