Current Consultations

• Consultation on the Proposed Changes to the Therapeutic Products Directorate's List of Recognized Standards for Medical Devices [2013-03-15]
• Consultation on the Draft Guidance Document: Preparation of Summary Technical Document (STED)-based Class III and IV Premarket in vitro diagnostic device licence applications and amendments [2012-08-22]
• Draft Guidance Document - Guidance on supporting evidence to be provided for Class III and IV in vitro diagnostic device licence applications and amendments [2012-08-22]

Past Consultations

• Consultation - Proposed Changes to the Therapeutic Products Directorate's List of Recognized Standards [2011-11-23]
• Draft Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In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• Consultation on the Draft Guidance Document GD211: Guidance on the content of quality management system audit reports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• Consultation - Draft Guidance Document - Preparation of the Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications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• Consultation on the Release of Draft Guidance Document - Keyword Index to Assist Manufacturers in Verifying the Class of In Vitro Diagnostic Devices (IVDD)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• Consultation on the Release of Draft Guidance for the Interpretation of Significant Change of a Medical Device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• Consultation on the Release of Draft Guidance Document - Medical Device Applications for Implantable Cardiac Leads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
  • Summary of Stakeholder Input: To Strengthen the Regulatory Framework for Investigational Testing of Medical Devices in Canada
    Date: 2009-05-14

Additional Resources

• Acts & Regulations
• Association Meetings
• Scientific/Expert Advisory Committees
• Scientific/Expert Advisory Panels