This self-purchase toolkit provides professionally structured SOPs and forms for companies importing medical devices into Canada under the Canadian Medical Devices Regulations (MDR). It is built for organizations that want to implement internally using credible, practical documentation.
If you require role clarification, gap assessment, customization, or inspection preparation, the Medical Device Importer Readiness Program is the appropriate option.
Two options to match your operational maturity and documentation needs.
Best for: New or small importers needing baseline MDR-aligned documentation.
CAD 695
Buy Core ToolkitBest for: Importers seeking near-inspection-ready documentation while implementing independently.
Includes everything in Core, plus:
CAD 1,295
Buy Expanded ToolkitTo maintain regulatory integrity, the following are not provided as self-purchase templates:
These SOPs and forms are provided as general regulatory support tools and do not constitute regulatory or legal advice. Applicability depends on device class, importer role, and specific business operations. Use of templates alone does not guarantee compliance with Health Canada requirements or inspection outcomes.
If you require role clarification, gap assessment, SOP customization, or inspection preparation, upgrade to the Medical Device Importer Readiness Program.
Book a Readiness Call