Periodic Safety Update Report Guideline Released: Post-market Oversight Further Upgraded

Reporting Requirements

The guideline makes clear that the Periodic Safety Update Report should cover all product vigilance data to ensure completeness and continuity of information.

For newly registered Class II and Class III medical devices, companies should submit reports annually. For renewal registration products, companies should complete an overall summary at the end of the registration cycle.

Reports should be written in Chinese and submitted through the national adverse event monitoring system or retained for inspection.

In terms of format, the report consists of a cover page, table of contents, and main body. The cover highlights the responsible entity and vigilance contact information; the table of contents should be detailed to three levels; and the main body should focus on core safety information, emphasizing standardization and traceability.

Core Content

●Basic product information: This section defines the evaluation object and covers medical device name, model specifications, registration certificate information, structure and composition, scope of application, and changes.

●Marketing status: By collecting sales volume, usage volume, or other applicable indicators across different regions and time periods, companies can evaluate actual product use scale and patient exposure.

●Summary analysis of vigilance data: As the core module of the report, this section should systematically organize and analyze vigilance data collected domestically and overseas.

●Product issue analysis: Calculate occurrence rates by product problem, such as malfunction or defect.

●Adverse event distribution: Analyze adverse events by harm manifestation.

●Root cause analysis: List proportions by different investigation conclusions or event root causes.

●Trend analysis: Identify abnormal changes and explain control measures taken due to safety issues.

●Other risk information: Include other evidence related to product safety, such as literature research, domestic and overseas regulatory alerts, PMCF or real-world study results, and updates to risk management documents.

●Standards and regulatory changes: Analyze the potential impact of changes in industry standards or regulations on product safety.

●Conclusion: Based on the data and information above, comprehensively evaluate product safety during the reporting period.

●Benefit-risk assessment: Focus on changes in adverse event occurrence rate and severity, controllability of risk causes, effectiveness of risk control measures, and whether the overall benefit-risk balance has changed.

●Vigilance plan adjustment: Clarify whether the vigilance plan needs to be adjusted.

●Attachments: Include registration approval documents, instructions for use, references, and other necessary supporting materials to ensure report completeness and traceability.

Impact on Companies

Implementation of the guideline will place higher requirements on medical device companies. On one hand, companies need to establish a sound vigilance data collection and management system. On the other hand, they also need to improve statistical analysis and risk evaluation capabilities.

Report quality will directly affect regulatory communication and the compliance of continued product marketing.