Should Medical Device Licensing Rules Be Simplified?

Official title: Canada Gazette, Part I, Volume 159, Number 45: Regulations Amending the Medical Devices Regulations (Establishment Licences)

Closed Regulations & Permits Health & Safety
Health Canada wants to cut red tape for companies that import medical devices like pacemakers, hip implants, and diagnostic equipment. Right now, both foreign sellers and Canadian importers need separate licenses—a requirement other countries don't have. The proposed changes would also require companies to share supplier information and keep better safety records.

Why This Matters

Medical devices affect everyone—from the pacemaker in your grandmother's chest to the COVID test at your pharmacy. When licensing rules are too complicated, some companies skip Canada entirely. That can mean fewer choices and longer waits for the devices you need. Better tracking also helps catch unsafe products faster.

What Could Change

Foreign distributors selling through Canadian importers would no longer need their own license. All license holders would have to report their suppliers annually. Companies would face clearer requirements to document their safety procedures—something inspectors found lacking. The government estimates $1.8 million in costs but $2.3 million in savings for foreign distributors over 10 years.

Key Issues

  • Should foreign distributors selling through licensed Canadian importers still need their own license?
  • Should all license holders be required to report supplier information annually?
  • Should safety documentation requirements be made more explicit in the regulations?

How to Participate

  1. Review the proposed regulatory amendments in the Canada Gazette to understand the changes.
  2. Submit your comments by email to prsd-questionsdspr@hc-sc.gc.ca by the deadline.

Key Documents