After NMPA certification, the safety review strategy for medical devices in China involves continuous monitoring and evaluation. Here’s a general outline of the execution procedures:
Post-Market Surveillance (PMS): Manufacturers must establish a PMS plan to monitor device performance, gather user feedback, and identify any adverse events.
Adverse Event Reporting: Any adverse events must be reported to the NMPA within specified timelines. This includes serious incidents and potential device failures.
Periodic Safety Update Reports (PSUR): Manufacturers are required to submit PSURs, summarizing the safety and performance data collected over a specific period, typically annually.
Risk Management: Continuously assess and update risk management files based on new data and market experiences, adjusting device usage instructions and labeling as necessary.
Field Safety Corrective Actions (FSCA): If significant safety issues arise, manufacturers must implement corrective actions and notify both the NMPA and affected users promptly.
Regulatory Compliance Updates: Stay informed about changes in regulations that may affect device safety and effectiveness, ensuring ongoing compliance.
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