Canada Consults On Mandatory Reporting Of Device Incidents By Hospitals
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.
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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.
The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.