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Treatment of adverse events and medical device recalls

The fifth chapter of adverse events and medical device recalls46th national medical device adverse event monitoring system for medical device adverse event collection, analysis, evaluation and control.47th medical apparatus production enterprise, and use should be produced by the operation or use of the medical device adverse event monitoring; found or suspected adverse events adverse events of medical devices shall be in accordance with the provisions of the food and drug administration departments of the State Council, reports to the medical device adverse event monitoring agency.No units or individuals found or suspected adverse events adverse events of medical devices, the right to food and drug supervision and management departments or medical device adverse event monitoring agency reported.48th State food and drug supervision and management departments should strengthen the construction of information network of medical device adverse event monitoring.Medical device adverse event monitoring bodies should strengthen information on medical device adverse event monitoring initiative to collect information on adverse events; adverse events or adverse event report received, verification should be carried out promptly, investigation, analysis, assessment of adverse events, and to the food and drug administration and health and family planning department in charge of handling proposals.Medical device adverse event monitoring agency shall publish contact information, facilitate the operation of medical equipment manufacturing enterprises, and use of medical device adverse events reported.49th food and drug supervision and management departments should be based on medical device adverse event assessment warning issued in a timely manner the information and ordered a moratorium on the production, marketing, import and use of control measures.People's Governments above provincial food and drug supervision and management departments should be in conjunction with the health and family planning department and relevant departments to cause sudden, mass grave injury or medical device adverse event death investigated and processed in a timely manner and similar medical instruments to strengthen the monitoring organization.