Health Canada & FDA Regulatory Consulting | Arora 297 Consultancy

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Walk Away With a Clear Regulatory Roadmap

Most companies lose months — and thousands of dollars — trying to figure out regulatory requirements on their own. One 30-minute call with a senior expert changes that.

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Know exactly what's required
No more guessing which pathway, which forms, or which agency.
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Get a realistic timeline
Know when you can realistically launch and what can slow you down.
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Avoid costly mistakes
A wrong first step can delay your launch by 6–12 months. We prevent that.

Medical Device Importer Readiness Program (Canada)

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Be inspection-ready before Health Canada knocks.

This program prepares medical device importers operating in Canada to meet their obligations under the Medical Devices Regulations (MDR). We focus on importer responsibilities, documentation readiness, and practical preparation for Health Canada compliance verification and inspection activities.

Book a Medical Device Importer Readiness Call

Who this program is for

  • First-time medical device importers entering Canada
  • MDEL applicants or MDEL holders
  • Distributors expanding into regulated medical device portfolios
  • Foreign manufacturers appointing a Canadian importer
  • Companies anticipating or responding to Health Canada inspections

What you get

  • Importer role & MDR obligation mapping
  • Compliance gap assessment
  • Importer SOPs, forms & evidence index
  • Complaint, recall & traceability readiness
  • Inspection preparation guidance

Program structure

  • Phase 1: Regulatory scoping & importer responsibility mapping
  • Phase 2: Quality & system readiness assessment
  • Phase 3: Documentation & inspection evidence package
  • Phase 4: Inspection readiness & mock verification (Enterprise)

Program levels

  • Starter: Starting at CAD 2,500
  • Core: Starting at CAD 5,500
  • Enterprise: Custom quoted

    • Prefer to implement internally?

    For experienced teams that want professionally structured documentation without full consulting engagement, we offer a self-purchase SOP and forms toolkit aligned with Health Canada expectations for medical device importers.

    View Toolkit & Buy
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