Health Canada Medical Device Regulations

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Major Regulations
Document Number Published Language
Log in Food and Drugs Act F-27 2018 English
Log in Medical Devices Regulations SOR 98-282 02/2017 English
General Guidance Documents
Document Number Published Language
Log in Fees for the Review of Medical Device License Applications 2015 English
Log in Guidance Document for Mandatory Problem Reporting for Medical Devices 2011 English
Log in Guidance on How to Complete the Application for a New Medical Device License 2018 English
Log in Guidance on Medical Device Establishment Licensing GUI-006 2020 English
Specific Guidance Documents
Document Number Published Language
Log in Guidance on the Risk-Based Classification system for Non-in Vitro Diagnostic Devices (non-IVDDs) 2015 English
Log in Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDS) 2016 English
Log in Guidance for the Labeling of In Vitro Diagnostic Devices 2016 English
Log in Guidance for the Labelling of Medical Devices 2015 English