Freyr provides comprehensive support for all Canada medical device Regulations
- Medical Device Classification for Canada
- Canadian Medical Device Registration Support
- Pre-submission meetings with Health Canada
- MDSAP
- Medical Device Licensing (MDL)
- Medical Device Establishment License (MDEL)
- Canada ISED Representative
- Medical Device Importer Solutions
- Labeling services as per Health Canada labeling requirements for Medical Devices
- Post Market Surveillance Support
Experience seamless approval process for Medical Devices in Canada
Proven Success Story: How Freyr Secured Canadian Market Access for a Top US Manufacturer
Discover how Freyr’s expertise helped a leading US-based manufacturer secure Canadian market approval faster.
![On-Time Submissions]( "On-Time Submissions")
The Challenge
A complex approval process.
![Proven Track Record]( "Proven Track Record")
The Solution
MDL approval + MDSAP Stage II readiness.
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The Result
Faster market entry, seamless compliance.
Celebrating Customers Success
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Registration and AR Services
Malaysia and Indonesia
Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.
Robert Menadue
Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company
Why Businesses choose Freyr for Canada Medical Device Approvals?
![End-to-End Solutions]( "End-to-End Solutions")
End-to-End Solutions
From classification to post-approval services, we provide full coverage of Health Canada medical device regulation.
![Proven Expertise]( "Proven Expertise")
Proven Expertise
We’ve helped companies navigate the complex Canada medical device regulations with precision.
![Faster Market Access]( "Faster Market Access")
Faster Market Access
Get your products to market quickly with our streamlined services for Canada medical device registration.
Frequently Asked Questions
Timelines depend on device classification and submission quality. Freyr’s streamlined process ensures faster approvals by eliminating common delays and errors.
We provide ongoing post-market surveillance, labeling updates, and compliance monitoring to keep your device market-ready and fully compliant with Health Canada’s Regulations.
If you’re manufacturing, importing, or distributing devices in Canada, an MDEL is mandatory. Freyr guides you through the application process effortlessly.
Freyr’s experts will analyze the rejection, address the issues, and resubmit with an improved strategy to ensure approval.
With 200+ experts, 1,350+ approvals, and extensive experience in 40+ countries, Freyr simplifies complex Regulatory processes to help you reach the market faster and with confidence.
Ready to launch your device in the Canadian market?
We will handle the hard part, you handle the growth, let us know your requirements in brief. Our team will get in touch with you for the best-fit solutions.
