Licence your medical device or IVD for the Canadian market.
MDSAP-based quality evidence, licence applications by class, and the post-market reporting that keeps a licence in good standing.
Key facts
Pathways
- Class I: no device licence; sold through MDEL holders
- Class II: Medical Device Licence (MDL) application with declarations of conformity
- Class III and IV: MDL application with premarket review of safety and effectiveness evidence
- Investigational testing authorisation for clinical studies of Class II to IV devices
- Medical Device Establishment Licence (MDEL) for importers and distributors
What you will need
- Device description and intended use
- MDSAP certificate covering the device
- Declaration of conformity and labelling (Class II)
- Summary or full premarket review evidence (Class III and IV)
- Labelling in English and French
Sequence and decision points
- 01ClassifyApply the Canadian classification rules for devices or IVDs.
- 02MDSAP certificationComplete an MDSAP audit covering Canadian requirements.
- 03Prepare the applicationAssemble the licence application for the device class.
- 04Submit and reviewScreening, review and responses to Health Canada questions.
- 05LicenceMDL issued and listed.
- 06DistributionImporters and distributors operate under MDELs.
An MDSAP certificate is required for Class II, III and IV licence applications.
No legal representative is required; the manufacturer holds the licence. Importers and distributors need an MDEL, and you can appoint a regulatory correspondent.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
Health Canada publishes review targets by class, with Class II applications reviewed fastest. Application fees and an annual right-to-sell fee apply.
After market entry
- Mandatory problem reporting: 10 days for death or serious deterioration, 30 days for incidents that could cause them
- Recall reporting
- Summary reports: every two years for Class II, annually for Class III and IV
- Licence amendments for significant changes
- Reporting of foreign risk notifications
- Annual licence renewal and right-to-sell fee
How we help
- Canadian classification and licence strategy
- MDSAP readiness and mock audits
- MDL application preparation
- Bilingual labelling review
- Summary reports and problem reporting
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about Canada
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Is MDSAP mandatory?
Yes, for Class II to IV licence applications, which must include an MDSAP certificate.
Do we need a Canadian legal entity?
No. Foreign manufacturers can hold an MDL directly. Importers and distributors need an MDEL.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.