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Browse and search historical snapshots. This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded. For up-to-date recommendations, always consult the official source website.

For background on coverage and capture methods, see Methods & coverage.

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Changes made to list of non-prescription drugs: Notice of modification Date: October 28, 2022 Health Canada's Regulatory Operations and Enforcement Branch has amended the following list: List of non-prescription drugs for which the testing requirements set out in subsections…

Access Consortium statement on Good Manufacturing Practice inspections reliance and recognition evidence Date: November 21, 2022 On this page Background Commitment to reliance and recognition arrangements Background Good manufacturing practice (GMP) ensures that medicinal…

Updates to the guidance on medical device establishment licensing (GUI-0016) MDEL Bulletin September 6, 2023, from the Medical Devices Compliance Program On this page Background Key changes in the guide Contact us Background On September 6, 2023, Health Canada's Regulatory…

Annex 7 to the Good manufacturing practices guide - Selected non-prescription drugs (GUI-0066): Overview Overview Guidance Definitions References Download the alternative format (PDF format, 433 Kb, 22 pages) Organization: Health Canada Date published: September 29, 2023 Document…

What medical device establishment licence holders need to know about annual licence review for 2024 MDEL Bulletin, November 15, 2023, from the Medical Devices Compliance Program On this page About the annual licence review ALR application packages Cancelling your MDEL Reminder…

Amendments to the Medical Devices Regulations to address future public health emergencies: Notice Date published: January 3, 2024 On this page Background About the amendments Changes related to all medical device manufacturers Changes related to Class I medical device…

Share your views: Draft guidance on how to interpret ‘significant change’ of a medical device Current status: Closed This consultation ran from February 7, 2024, to April 22, 2024. This guidance: helps manufacturers determine when a change made to a device is significant explains…

Consultation for GUI-0080 - Canada.ca

Health CanadaCaptures 12Latest capture Apr 11, 2026en

Consultation for GUI-0080 Drug Establishment Licensing Bulletin 165, February 14, 2024 On this page About the consultation Overview of key changes Overview of items under review How to participate About the consultation Health Canada has opened Guidance: How to demonstrate…

Cancellation of MDELs for non-compliance with annual licence review requirements MDEL Bulletin, May 28, 2024, from the Medical Devices Compliance Program On this page About the annual licence review MDEL holder responsibilities Cancellation of MDELs To resume licensable…

How to develop a corrective and preventive action plan (CAPA) Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived.…

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Early release: coverage is bounded to the current corpus, and features may change.