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
7.Conclusions
8.Attachments (NMPA certificate)
