Guidelines for Writing Medical Device Vigilance Plans (Trial) Released

Basic Requirements

The guideline makes clear that the medical device vigilance plan is an important document within the vigilance system and should follow risk management principles.

At minimum, it should cover product scope, vigilance objectives, data collection, risk analysis, risk control, vigilance reporting, and plan review.

Companies should define the scope of vigilance data collection and risk evaluation methods based on product risk characteristics, take timely control measures, and ensure effective implementation of vigilance activities.

The vigilance plan should also state whether active monitoring will be conducted, whether risk information for similar products will be searched, and whether regular risk identification activities will be performed. Relevant vigilance activities should then be implemented strictly according to the plan.

Core Content

The guideline builds the overall framework of the medical device vigilance plan around risk management. The key content includes:

●Product scope and vigilance objectives: Companies should define product series, structural principles, target users, and use scenarios. The core objective is to identify risks that were not fully discovered before market approval, with focus on risk trend changes, updates to known risks, and relevant use information.

●Data collection and risk analysis: The guideline emphasizes multiple data sources, including adverse event monitoring, user feedback, and literature. It also requires standardized methods to evaluate risk severity and probability, ensuring consistency with the existing risk management system.

●Risk control and vigilance reporting: Companies should establish records for risk identification and control, and prepare trend reports or periodic safety update reports when risk trends become abnormal, supporting closed-loop risk management.

●Plan review: The guideline requires regular evaluation of vigilance plan implementation, with necessary revisions and improvements based on review results.

Industry Impact

Overall, implementation of the Guidelines for Writing Medical Device Vigilance Plans (Trial) will help the industry shift from compliance-driven practices to risk-driven management.

It can improve post-market safety and effectiveness of medical devices and also provides important support for more science-based regulation.