Team Elexes 
Compliance Assurance
Stay compliant with industry regulations and standards.
Cost-effective
Achieve regulatory success with Elexes, all within your budget.
PC: Canva
Top Health Canada Consultants for MDL, MDEL & CMDR Compliance
Canada boasts one of the largest and most regulated markets for healthcare. Whether introducing a new medical device or making modifications to existing ones, the trick becomes navigating through the very complex regulatory pathway of Health Canada.
At Elexes, our experienced Health Canada consultants help you streamline your licensing and documentation processes while ensuring full compliance with Canadian Medical Device Regulations (CMDR).
Understanding Health Canada Medical Device Requirements
Canada’s licensing process may resemble other jurisdictions, but it involves unique requirements that require a deep understanding of both the CMDR and Canadian market expectations.
Canadian Medical Device Classification
Health Canada categorizes devices into Class I to IV. Each classification brings its own level of regulatory scrutiny, documentation, and licensing steps.
Mandatory Establishment Licensing (MDEL)
If you’re importing, distributing, or manufacturing Class I devices, you’ll need an MDEL. Unlike the Medical Device License (MDL), this license focuses on company activities.
Bilingual Labeling & Safety Standards
Products marketed in Canada must comply with both English and French language requirements, alongside compliance with Canadian Standards Association (CSA) and ISO standards for safety and performance.
Services by Health Canada Regulatory Experts at Elexes
PC: Canva
Our Health Canada consulting services include:
⦿ Classification determination and regulatory pathway strategy
⦿ Medical Device License (MDL) applications for Class II, III, IV
⦿ MDEL guidance for Class I devices, importers, and distributors
⦿ Quality Management System (QMS) aligned with MDSAP
⦿ Clinical evidence review & gap analysis (for Class III/IV)
⦿ Labeling, Instructions for Use (IFU), and UDI compliance
⦿ Preparation of Technical Files and Safety/Effectiveness Data
⦿ Communication with Health Canada on behalf of clients
End-to-End Support for Canadian Regulatory Success
Initial Assessment & Strategy
⦿ Evaluate your device’s intended use and risk profile
⦿ Determine whether MDL or MDEL is required
⦿ Map out a submission timeline that fits your launch goals
Technical Documentation & License Application
⦿ Create compliant documentation per CMDR
⦿ Submit MDL/MDEL with Health Canada
⦿ Respond to deficiency letters or additional information requests
Post-Market Support & Renewals
⦿ Help with Annual License Renewal processes
⦿ PMS (Post-Market Surveillance) and Incident Reporting
⦿ Label updates or device modifications requiring new filings
PC: Canva
Why Choose Elexes as Your Health Canada Partner?
With 50+ clients licensed in Canada, Elexes combines regulatory experience, engineering insights, and strategic foresight to simplify your path to compliance. Our Health Canada regulatory consultants don’t just review documents; we act as your regulatory partner from planning to market launch.
Health Canada Approval Pathways – Visual Infographics
Ready to Access the Canadian Market?
Take the guesswork out of Canadian compliance. Partner with Elexes’ Health Canada consultants to get licensed faster and smarter.
FAQs
Frequently Asked Questions!
Yes. Depending on the class of the device, you will need either a Medical Device License (MDL) or a Medical Device Establishment License (MDEL).
The timeline varies by class. Class II–IV MDLs may take 45–120 days, while MDELs typically process in 20 business days.
Yes, especially for Class II–IV devices. MDSAP certification is required to demonstrate QMS compliance.
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
So, if you are looking for a consultancy with deep expertise, experience, and established relationships with regulatory authorities, which can significantly enhance a company's regulatory journey and increase the likelihood of successful product registration and market access, all you have to do is
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
We’ve More
Than 256+ Global
Clients
The Best RA & QA Consultants
Clients Testimonials
Amazing Feedback About Our Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
“
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
“
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
“
Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
“
Popular Clients
We’ve 200+ Global Premium Clients
Looking For Regulatory Assistance?
Let's Talk How We Can Help You?
