How To Write Periodic Risk Evaluation Report (PRER)
2022-06-30
As per Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events, NMPA has regulatory requirements for Periodic Risk Evaluation Report (PRER) to enhance post-market surveillance.
The license holder shall:
conduct continuous research on the safety of certified medical devices
summarize and analyze the adverse event reports
monitoring data and domestic and foreign risk information of the product
evaluate the risks and benefits of the product
record the risk control measures taken
write the post-market Periodic Risk Evaluation Report (PRER)
PRER Report Contents:
1. Product information
Name
Certificate number
License holder information
Product model numbers
Product composition
Intended use
Validity period
2.Global market approval information, for each country where the product is approved
Listing status
Date of market approval, first time to market, date of market withdrawal (if applicable)
Model number approved in each country
Risk control related requirements associated with the market approval
Intended use approved in each country
Product variances in each country compared to China
3.Risk control measures taken by the regulatory authority or the manufacturer
Withdrawal of market approval
Suspended production or sales
Notice to medical device user or facilities to stop using the product
Recalls
Self-inspection of the production quality management system and rectification of related problems
Modification on IFU, label, user manual, etc.
Improvement on production process, design, product technical requirements, etc.
Medical device re-evaluation
Change registration or filing
Other risk control measures
4.Adverse Event Reporting Information
Individual AE
Group AE
5.Other Risk Information
6.Product Risk Evaluation
Benefits to the patients
Warnings, precautions, contraindications and risk factors
Adverse effects, adverse events, and complications
