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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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.
EU Multistakeholder Project Aims To Give eConsent The ‘Place It Deserves’
The EU Forum for Good Clinical Practice is working on boosting the use of electronic informed consent, the uptake of which in clinical trials has been poor.
Global Medtech Guidance Tracker: May 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-seven documents have been posted on the tracker since its last update.