Eligibility

SR&ED for Medical Device Companies in Canada

Canadian medical device companies can claim SR&ED for prototype development, clinical validation, and regulatory testing. Learn what qualifies and how to document it.

SREDY.IO · Editorial Team 2026-06-20 6 min read

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What medtech work qualifies for SR&ED

Canadian medical device companies can claim SR&ED for the technical work that goes into developing, testing, and validating new devices. The key is systematic investigation of technological uncertainty, not regulatory compliance.

  • Prototype development requiring systematic investigation of design alternatives
  • Clinical validation studies designed to resolve technological uncertainty
  • Manufacturing process innovation requiring technical investigation
  • Materials testing for new device components with unknown properties
  • Software development for device control systems with novel requirements

Regulatory vs. R&D work

Regulatory compliance work itself does not qualify for SR&ED. But the underlying R&D that generates the data for regulatory submissions commonly does.

Preparing FDA or Health Canada submissions is not SR&ED. But the clinical validation, prototype testing, and design verification that produced the data for those submissions may be eligible. Separate the two clearly in your documentation.

medical devices medtech eligibility Canada

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Useful next steps

SR&ED eligibility checklist → Refund estimator → Sample T661 package → Documentation guide →

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