Typical timeline
2–12 months
Class I establishment licensing can move in roughly 60 days; Class III/IV MDL review takes considerably longer.
Canada
Health Canada Medical Device License
Canada's medical device licensing system, built on ISO 13485 and MDSAP certification.
Overview
What Health Canada MDL is and why it matters
Health Canada classifies medical devices into four classes (I–IV, increasing risk). Class I devices require only an establishment license; Class II–IV devices require a Medical Device License (MDL), which depends on a valid ISO 13485 certificate — Canada participates in the Medical Device Single Audit Program (MDSAP), which lets a single audit satisfy multiple countries' requirements.
Requirements
What you'll need
The documentation and evidence a complete submission is normally built from.
- Device classification (Class I–IV)
- ISO 13485 certificate, typically via an MDSAP audit
- Medical Device License application for Class II–IV
- Establishment License for Class I
- Bilingual (English/French) labeling
Planning ranges
Typical timeline and estimated cost
Ranges illustrate general market patterns for this pathway — they are not a quote for a specific product.
Estimated cost
$5k–$60k
Cost is largely driven by the ISO 13485/MDSAP audit rather than the MDL application fee itself.
Timelines and costs above are typical ranges illustrating general market patterns, not a quote or regulatory conclusion for your specific product. Actual figures depend on device classification, target country, and applicant readiness — professional review is required before relying on this for a business decision.
Where this applies
Applicable countries
Jurisdictions that recognise this certification. Scope and conditions still vary by product classification.
Canada
Related
Regulatory Pathways
FAQ
Frequently asked questions
What is MDSAP?
The Medical Device Single Audit Program lets one audit, conducted by an authorized auditing organization, satisfy the regulatory requirements of multiple participating countries including Canada, the US, Australia, Brazil, and Japan.
Reviewed packages
Buy a defined outcome
Pay for a market-access outcome — not a feature tour
Market Entry Sprint from $2,500 · Strategy Session $500 · Pathway Brief $1,800. Professional review required before business use. No patient data on public forms.
Reviewed launch planning
Need a Health Canada MDL pathway brief?
Health Canada MDL pathway briefs start at $1,800. Or book a $2,500 Market Entry Sprint that includes regulatory pathway outline, evidence flags, and a review call.
Professional review is required before business use.