October 28, medical device vigilance pilot work will be held in Shandong. The meeting summarized the results achieved since the launch of the vigilance pilot work, in-depth analysis of the pilot problems and study the deployment of the next step.

The meeting pointed out that medical device vigilance is a comprehensive enhancement of the current adverse event monitoring and re-evaluation work. Since the start of the pilot work, the pilot units in accordance with the State Drug Administration “Medical Device Vigilance System Pilot Work Program” unified deployment of positive action in the vigilance system framework construction, practice exploration and other aspects of progress. The pilot work has played an important role in identifying and eliminating product risks, enhancing product quality and improving the quality and safety of medical devices throughout their life cycle.

The meeting requested that the pilot units should continue to promote the construction of medical device vigilance system, explore the active monitoring mode, enhance the intelligent monitoring means, continuously strengthen the awareness of vigilance responsibility of the registrant, the filer and the medical institutions, accelerate the implementation of supporting documents and the transformation of vigilance results, and steadily push forward the pilot of medical device vigilance in a deep and practical way.

The State Drug Administration Device Supervision Division, Drug Evaluation Center, the pilot provincial Drug Administration and medical device monitoring agency representatives to participate in the meeting.