Expanding into the Canadian market? Whether you're a Med Tech innovator, IVD developer, or a SaMD manufacturer, securing a licence from Health Canada is a critical regulatory milestone. Elexes supports companies in preparing and submitting their Health Canada licence application with precision and speed. Our regulatory experts simplify the process and ensure your product complies with the Canadian regulatory requirements, accelerating your path to Canadian market entry.
Navigating the Health Canada medical device licence (MDL) can be a complex process, especially with evolving regulatory frameworks and submission expectations. At Elexes, we specialize in helping manufacturers of medical devices and in vitro diagnostics (IVDs) to successfully register their products with Health Canada. Whether you’re a first-time applicant or managing multiple licences, we ensure that your submission is accurate, timely, and compliant with all applicable Canadian regulatory requirements.
Before any medical device or IVD can be marketed in Canada, it must be evaluated and approved by Health Canada. The process of submitting a Health Canada license application requires a comprehensive understanding of product classification, supporting documentation, and submission formats. Depending on the product’s risk level and intended use, manufacturers must meet specific regulatory requirements, which may include clinical data, ISO certifications, and bilingual labeling.
At Elexes, we take the guesswork out of this process. Our team ensures that your application not only complies with the Medical Devices Regulations (SOR/98-282), but also aligns with current Health Canada expectations to avoid costly delays or rejections. Elexes creates MDEL listings, prepares and submits MDL applications, and files annual updates with Health Canada.
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
With years of experience and a proven track record, Elexes’ regulatory consultants understand the nuances of the Health Canada licence application process, including:
Guidance on Medical Device Licence (MDL) requirements and preparation of necessary documentation such as risk-based classifications, performance & clinical evidence, and quality (ISO 13485:2016) certificates under the Medical Device Single Audit Program (MDSAP).
Strategic planning and support for IVD device registration with Health Canada, including submission of analytical performance data, labeling review, and bilingual requirements.
What Elexes Offers for Health Canada Licence Applications
Tailored strategy based on device classification, intended use, claims, and market goals.
Preparation of manufacturer evidence, safety and effectiveness summaries, and product labels that align with Canadian regulatory expectations.
Complete preparation and submission of your Health Canada licence application via the appropriate channels, along with ongoing communication with Health Canada on your behalf.
Timely responses to clarifications or requests for additional information from Health Canada to prevent delays in approval.
Guidance on Medical Device Single Audit Program (MDSAP) certification requirements as part of your licensing package.
Ready to Launch in Canada?
Our regulatory team is ready to support your Health Canada licence application—from first draft to market approval and continued compliance and maintenance support.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
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 -
CEO Masterlink, Arizona
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President ViDava, Florida
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Manager Outset Medical, California
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MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York
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