Our Services
End-to-end support for medical device market entry and cross-border distribution.
Canadian Market Entry Process
A simplified overview of bringing medical devices to Canada
Classification
Device Class I-IV based on risk
Manufacturer Prep
MDSAP + MDL (Class II+)
Import Setup
CARM Portal + Customs
Distribution
Multilingual labels + Compliance
Import & Distribution
We help international manufacturers bring their medical devices into the Canadian market through our licensed distribution network.
- ✓Licensed MDEL holder for medical device imports
- ✓Warehousing and logistics coordination
- ✓Distribution partnerships with healthcare facilities
- ✓Multilingual labeling compliance
Export Services
Canadian manufacturers can leverage our international network to reach new markets in Asia, Middle East, Africa, and beyond.
- ✓Market entry to China, Turkey, India, and more
- ✓Export documentation and compliance support
- ✓International partner sourcing
- ✓Certificate of Free Sale facilitation
Regulatory Consulting
Navigate Health Canada's regulatory requirements with expert guidance from professionals who understand both the technical and practical aspects of device certification.
- ✓Medical Device License (MDL) guidance
- ✓Device classification (Class I, II, III, IV)
- ✓Quality Management System (QMS) preparation
- ✓Documentation review and gap analysis
Clinical Trial Support
We conduct and assist with clinical trials for medical devices, providing end-to-end research management from study design to regulatory submission.
- ✓Clinical trial design and protocol development
- ✓Site selection and patient recruitment
- ✓Data collection and statistical analysis
- ✓Regulatory submission support
Markets We Serve
Connecting medical device markets across the globe
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Canada, USA, European Union, UK, China, Turkey, India, South Korea, Namibia
Ready to Get Started?
Contact us to discuss your specific needs and how we can help you enter new markets.
Contact Us