Post-market Periodic Risk Evaluation Report Mandatory For License Holder In China

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

  2. Global market approval information, for each country where the product is approved

  3. Risk control measures taken by the regulatory authority or the manufacturer

  4. Adverse Event Reporting Information

  5. Other Risk Information

  6. Product Risk Evaluation

  7. Conclusions

  8. Attachments (NMPA certificate)

  For full version of how to write PRER, please click Common FAQ | BradyKnows (bradyknowsmedical.com).

  BradyKnows has experienced QA team to ensure your compliance in China market. Please feel free to reach out us for how to write and submit PRER via info@bradyknowmedical.com