According to the "supervision and management of medical devices regulations" stipulates that the state to establish a medical device adverse event monitoring system, the medical device adverse events in a timely manner to collect, analyze, evaluate, control.
Article 47 of the medical device production and management enterprises, the use of units should be produced and operated or the use of medical devices to carry out adverse event monitoring; found that the medical device adverse events or suspected adverse events, shall be in accordance with the provisions of the state dug burning hospital food and drug supervision and management department, to the medical device adverse event monitoring technology agency report.
Any unit or individual found medical device adverse events or suspected adverse events, the right to food and drug supervision and management departments or medical device adverse event monitoring technical institutions.
Subjects include: medical device manufacturers, operation and use of units
The work process is: the collection of the report, summarize, analyze, investigate, verify, evaluate, feedback
The state establishes a medical device adverse event monitoring system, the medical device adverse events in a timely manner, to collect, analyze, evaluate, and control.
Intercept the first medical device production and management enterprises, the use of units should be the production of tour rolling business or use of medical devices to carry out adverse event monitoring; found that the medical device adverse events or suspected adverse events, should be in accordance with the State Council food and drug supervision and management of the number of departments of the simple grinding, to the medical device adverse event monitoring technical institutions to report.