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

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 (

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