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Drugs and Health Products

Standards

The following is a link to the list of national and international medical device standards recognized by the Therapeutic Products Directorate (TPD). Unless otherwise indicated, the complete standard, including appendices and attachments, is recognized. The email contact for the sponsor of the standards list is DED_manager@hc-sc.gc.ca

List of Recognized Standards
Date: 2010-07-26

Notice - Date for Transition from the Second to the Third Editions of IEC 60601-1 and IEC 60601-1-2 on the Health Canada’s List of Recognized Standards
Date: 2008-10-03

Notice: Updated Guidance on the Recognition and Use Of Standards under the Medical Devices Regulations
Date: 2006-09-22

Guidance Document - Recognition and Use of Standards under the Medical Device Regulations
Date: 2006-09-22

Declaration of Conformity
Date: 2006-09-22