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 other countries don't have. The proposed changes would also require companies to share supplier information and follow clearer safety procedures.

Why This Matters

Medical devices affect everyone—from the masks you wear to the pacemaker keeping your grandmother alive. These rules determine which devices reach Canadian hospitals and pharmacies. Simpler licensing could mean more device options and lower costs. But the government also wants better tracking when safety problems arise.

What Could Change

Foreign distributors selling through licensed 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 still need a Canadian license if they sell through a licensed Canadian importer?
  • 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 being proposed.
  2. Submit your comments by email to prsd-questionsdspr@hc-sc.gc.ca by the deadline.

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Key Documents