Medical Device Regulations and Standards

In Canada, approvals for medical devices are obtained through Health Canada's Therapeutic Products Directorate, which applies the Food and Drug, and Medical Devices Regulations under the authority of the Food and Drugs Act to product approvals.

• Health Canada's website has a section for medical device regulations:
  • Acts and Regulations
  • Guidance Documents
  • Medical Devices Active Licence Listing (MDALL)
• Quality System Requirements for Medical Devices: 2010 Reference Guide
  A reference guide explaining the current legislative, regulatory, and quality system requirements applicable to medical devices in Canada, Europe and the United States.