Health Canada
www.hc-sc.gc.ca
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Drugs and Health Products
Medical Devices
Current Consultations
- Consultation - Proposed Changes to the Therapeutic Products Directorate’s List of Recognized Standards [2011-11-23]
Past Consultations
- Draft Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs)
Date: 2011-06-13 - Consultation on the Draft Guidance Document GD211: Guidance on the content of quality management system audit reports
Date: 2011-01-07 - Consultation - Draft Guidance Document - Preparation of the Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications
Date : 2010-10-13 - Consultation - Draft Revisions - Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits intended to be used in the Laboratory
Date: 2010-08-10 - Consultation on the Proposed Changes to the Therapeutic Products Directorate's List of Recognized Standards
Date: 2010-04-19 - Consultation on the Release of Draft Guidance Document - Keyword Index to Assist Manufacturers in Verifying the Class of In Vitro Diagnostic Devices (IVDD)
Date: 2009-09-22 - Consultation on the Release of Draft Guidance for the Interpretation of Significant Change of a Medical Device
Date:2009-07-14 - Consultation on the Release of Draft Guidance Document - Medical Device Applications for Implantable Cardiac Leads
Date: 2009-06-01 - Consultation - Evaluation of Phase I of the Summary Basis of Decision Initiative
Date: 2009-04-08 - Discussion Paper for Consultation: Investigational Testing of Medical Devices
Date: 2007-07-25
