Reporting system for adverse drug reactions and medical device adverse events 1 In order to strengthen the safety supervision of listed medical devices, re-evaluate the listed medical devices, eliminate those with serious adverse reactions, continuously improve the quality of medical devices, safeguard public interests, and encourage relevant units and individuals to monitor and report adverse drug reactions and medical device adverse events. 2. Adverse drug reactions mainly refer to harmful or unexpected reactions that have nothing to do with the purpose of drug use under the normal dosage and usage of qualified drugs approved for marketing. Adverse medical device events refer to any harmful events that occur or may occur under the normal use of approved and qualified medical devices and have nothing to do with the expected use effect of medical devices. 3. For adverse drug reactions or medical device adverse events, the person in charge of drug or medical device quality in each department should collect (find out the location, time and basic situation of adverse reactions or adverse events) and make records, and report to the medical device quality management committee (group) or the person in charge quickly. 4. Department of drug quality director should assist clinical staff to further understand the occurrence of adverse drug reactions or medical device adverse events, and fill in the Adverse Drug Reaction Report Form or the Adverse Medical Device Event Report Form as required, and report it to the county drug administration or the autonomous region adverse drug reaction monitoring center. 5. Hospitals should pay attention to the collection of adverse drug reactions and clinical use of medical devices in our hospital. At the same time, we should also pay attention to the adverse drug reactions or medical device adverse events received by patients in other departments and collect relevant information. If the situation is true, you should also fill in the feedback in time. 6. Adverse drug reactions and medical device adverse events should be reported regularly step by step, and can be super-reported when necessary. General adverse drug reactions are reported to the local drug regulatory authorities (or online) every quarter. Among them, new or serious adverse reactions should be reported within/0/5 days from the date of discovery, and death cases should be reported in time. 7. The person in charge of the quality of drugs or medical devices in various departments fails to monitor and report adverse drug reactions and medical device adverse events in accordance with the provisions of relevant laws and regulations, and if the circumstances are serious and cause adverse consequences, under any of the following circumstances, the food and drug supervision department shall hand them over to the health authorities at the same level for punishment. (1) Failing to report the adverse drug reactions as required; (two) found that the adverse drug reactions are not reported; (3) Concealing information about adverse drug reactions.
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