Canada Boosts Postmarket Device Safety With New Reporting Rules
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.
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The proposed regulatory changes aim to provide Health Canada with greater authority to monitor the safety of marketed devices and to take action.
Health Canada is tightening its post-market oversight of medical devices. In addition, it is establishing a new division to review marketing applications for digital health technologies.