If you are looking to bring your medical or IVD device to the Canadian market, navigating Health Canada regulations is a non-negotiable first step. At Elexes, our team of Health Canada regulatory consultants ensures that your product complies with the Medical Devices Regulations (SOR/98-282) under the Food and Drugs Act.
We don’t just interpret the regulations, we apply them strategically to your product and business model. Whether you’re a domestic manufacturer, a foreign entity, or an importer, we’ll guide you through licensing, classification, labeling, and post-market surveillance requirements.
With our in-depth understanding of Canadian medical device licensing, we help determine your device’s classification (Class I to IV), prepare and submit Medical Device License (MDL) or Medical Device Establishment License (MDEL) applications, and address Health Canada queries proactively.
Elexes supports every aspect, from pre-market strategy to post-market vigilance. Our Health Canada compliance consultants also ensure that your submissions comply with applicable guidance documents and align with the Risk Management and QMS requirements under ISO 13485 and MDSAP.
Explore our ISO 13485 Certification Services and MDSAP Auditors support for a complete regulatory ecosystem.
If your organization falls under any of the categories below, our services are tailored for you:
⦿ Manufacturers or developers of Class I to IV medical or IVD devices.
⦿ Importers or distributors operating in the Canadian market.
⦿ Foreign companies seeking market access in Canada.
⦿ Businesses undergoing Health Canada inspections or compliance audits.
With Elexes, you gain a trusted advisor who understands both the letter and spirit of Canadian regulations. We are your partners in risk reduction, compliance readiness, and smoother market entry
We simplify regulatory complexity into actionable, compliant steps. Choose Elexes for a partnership that delivers results.
Health Canada’s licensing system can be complex, but we’ve simplified it into these clear visual pathways. Explore our infographics to understand your next steps:
Let Elexes take the complexity out of Canadian compliance.
Manufacturers, importers, and distributors of Class I–IV devices in Canada require an MDEL, except for manufacturers of Class I devices selling directly to end users and solely to ultimate consumers.
An MDL is required for Class II–IV device manufacturers to legally sell in Canada, while an MDEL is required for companies distributing or importing medical devices.
With accurate submissions, MDLs typically take 60–90 days. MDELs may take 30–45 days. Timelines can extend based on device risk class and Health Canada’s queries.
Yes, MDSAP certification is mandatory for Class II–IV devices sold in Canada. ISO 13485 forms the basis of the MDSAP program and is strongly recommended.
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 -
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