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)

Open 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 that doesn't exist in the U.S. The proposed changes would also require companies to share supplier information and follow clearer safety procedures.

Why This Matters

Ever had trouble getting a medical device your doctor recommended? Some foreign companies skip the Canadian market because our licensing rules are more complicated than other countries. These changes could mean more devices available here. They'd also help Health Canada track down faulty products faster when safety issues pop up.

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 for documenting safety procedures—something inspectors found lacking during audits.

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 procedure documentation requirements be made more explicit in 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.

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