Canadian Institutes of Health Research
570,556 snapshots · latest May 3, 2026
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Health Canada
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Public Health Agency of Canada
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Draft Guidance Document: Identifying and Labelling Medicinal Ingredients in New Drug Products This guidance document is being distributed for comment purposes only. Draft date: 2019/04/08 Download the alternative format (PDF format, 252 KB, 11 pages) Foreword Guidance documents…
Consultation on draft guidance document for software as a medical device (SaMD) Current status: Closed This consultation ran from January 23 to March 29, 2019 Who was the focus of this consultation We engaged with: Interested public parties Healthcare professionals Medical device…
Medical device real-world data and evidence in Canada: An environmental scan highlights Background The Health Products and Food Branch (HPFB) at Health Canada is leading an initiative, “ Regulatory Review of Drugs and Devices (R2D2) ”. The Marketed Health Products Directorate…
Notice: Device Advice: Health Canada launching a new pilot project to formalise a framework aimed at offering regulatory advice to medical device manufacturers September 5, 2018 Our file number: 18-110819-613 Under the " Regulatory Review of Drugs and Devices " initiative, Health…
ARCHIVED - Notice: Australia Canada Singapore Switzerland (ACSS) Consortium - New Chemical Entities Work Sharing Trial Phase I (2021-02-18) Notice to the reader: This is an archived page. Please refer to the ACSS title for the most current version . April 30, 2018 Our file…
Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Guidance document Download the alternative format (PDF format, 657 KB, 46 pages) Organization: Health Canada Date published: 2019-06-26 Forward Guidance documents are meant to…
Risk Communication - Protecting Canadians through Information 2011 ISBN: 978-1-100-18263-6 (PDF Version) Cat. No.: H164-134/2011E (PDF Version) (PDF Version - 673 K) Communicating about risk is a key component of any risk management plan. At Health Canada, communicating risks…
Medical device application and report forms Application forms listed below must accompany medical device applications filed by a manufacturer or sponsor. Medical Device Licence Application Fee Form [2025-03-21] Health Canada and FDA eSTAR pilot: Notice to industry [2023-01-10]…
Applications for medical device investigational testing authorizations guidance document Download the alternative format (PDF format, 484 KB, 46 pages) Organization: Health Canada Date published: 2018-10-01 Date adopted: October 6, 2017 Effective date: October 1, 2018 Foreword…
Guidance documents on medical devices Device Advice: e-Learning tool Guidance documents help explain how we apply policies, laws and regulations. Learn how medical devices are licensed and monitored in Canada . Access specific guidance documents related to medical devices. Expand…
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