Canada Proposes 30-Day Limit For Hospitals To Report Safety Incidents With Devices
Health Canada wants to make it mandatory for certain hospitals to report safety incidents relating to drugs and medical devices, and it is inviting feedback on the minimum information that should be submitted in relation to such incidents and the reporting timelines.
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The Canadian government has made it mandatory for hospitals to report medical device incidents and serious adverse reactions in their control irrespective of where these incidents originate.
The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.
Days before the EU Clinical Trial Regulation is set to come into effect, a new initiative has been launched to track and support its successful implementation and help deliver other trial-related reforms.