570 556 captures · dernière capture : 3 mai 2026
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386 223 captures · dernière capture : 14 avr. 2026
243 880 captures · dernière capture : 28 avr. 2026
Natural health products good manufacturing practices pre-inspection package: Overview Overview Checklist for manufacturers Checklist for packagers Checklist for labellers Checklist for importers Information requested before an inspection On this page Purpose Licensable activities…
Cancellation of MDELs for non-compliance with annual licence review requirements: 2025 MDEL Bulletin, June 13, 2025, from the Medical Devices Compliance Program On this page About the annual licence review MDEL holder responsibilities Cancellation of MDELs To resume licensable…
Consultation on modernizing the medical device establishment licensing (MDEL) framework- Phase II Bulletin, November 17, 2025, from the Medical Devices Compliance Program On this page Proposed amendments Consultation process Contact us Proposed amendments Health Canada is…
How Health Canada inspects medical device establishments (GUI-0064): Overview Overview About inspections Assessing your compliance with the Food and Drugs Act Assessing your compliance with the Medical Devices Regulations Checklists Corrective action plan template Replaces…
Handling complaints about medical devices (GUI-0065): Overview Overview About complaints Step-by-step guide Checklists Glossary References Version: 2 Date issued: December 24, 2025 Replaces: Guidance on Investigation of Reported Medical Device Problems, version 1 (March 25, 2011)…
Risk classification guide for observations related to inspections of clinical trials of human drugs (GUI-0043): Background Background Assigning risk to an observation Assigning an inspection rating Sample observations Definitions References Disclaimer: This document does not…
Explanatory notes for drug establishments on the preparation of a site master file (GUI-0005) Download in PDF format (317 KB, 14 pages) Organization: Health Canada Date published: 2026-04-10 On this page About this document Content of site master file Appendices About this…
Health Canada responds quickly to potential medical device shortages during COVID-19 Medical Devices Compliance Program Bulletin March 26, 2021 On this page About Interim Order (IO) No. 2 Exceptional importation and sale Reporting medical device shortages About Interim Order (IO)…
Health Canada updates list of medical devices for mandatory reporting of shortages MDEL Bulletin May 20, 2021 from the Medical Devices Compliance Program On this page Mandatory reporting of medical device shortages Reporting shortages of specified medical devices Reporting…
Archived Notice: Technical requirements for anti-microbial claims for medical masks On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in…
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