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Canada Boosts Postmarket Device Safety With New Reporting Rules

Executive Summary

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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Global Medtech Guidance Tracker: January 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six guidance documents have been posted on the tracker since its last update.

Canada Proposes Stricter Postmarket Requirements

The proposed regulatory changes aim to provide Health Canada with greater authority to monitor the safety of marketed devices and to take action.

Canadian Health Minister To Get More Post-Market Powers Over Companies

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.

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