Health Canada to propose post-market amendments to Medical Devices Regulation
- request analytical issue reports from a manufacturer when there is a suspicion of a safety concern;
- require manufacturers to prepare annual reports and notify Health Canada of any significant change in the safety of a medical device;
- compel manufacturers to conduct a reassessment and require tests and studies; and
- require manufacturers to provide notification to Health Canada of any:
risk communications;
changes to labelling;
recalls, assessments and suspensions; or
revocations occurring in other countries.
Published June 27, 2018
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