Legislation and Guidelines - Medical devices

Acts and Regulations

The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs and medical devices offered for sale in Canada are safe, effective and of high quality. The TPD also administers fee regulations for drugs and medical devices under the authority of the Financial Administration Act. All Federal Acts and associated Regulations are available on the Justice Canada Web site.

• Notices and Early Consultation - There are no current notices or early consultations.
• Canada Gazette Part I
• Canada Gazette Part II
• Memorandum of Understanding (MOU) - Schedule F

Additional Resources

• Guidance Documents
• Policies

How to find the Medical Devices Regulations :

• Go to the Justice Canada Web site.
• Type Medical Devices Regulations in the Title field.
• In the yellow box beside Search in , select Regulations, then select Search.

How to find Schedules of the Medical Devices Regulations:

• Select Canada Gazette Part II.
• From the list of Schedules, write down the SOR number of the desired document (at the end of each title, in brackets). E.g. Schedule No. 1293 - Quality Systems (SOR/2003-173)
• From the introductory paragraph, select the Canada Gazette Part II link.
• Scroll through the list of titles/dates by the appropriate SOR number.
  OR
• Enter the SOR number under quick search and select the Submit (>>) button.

How to find help to resolve an issue:

• Food and Drugs Act Liaison Office