Obtaining a medical device license Health Canada requires a clear regulatory strategy and precise interaction with the authority. From establishment licensing to product-specific applications, Sobel supports manufacturers across different stages of the Canadian medical device licensing pathway.
Medical device licensing is a core regulatory requirement that supports lawful market access and ongoing compliance in Canada.
Medical device licensing is a legal requirement in Canada. Without the appropriate MDEL or MDL, manufacturers are not authorized to place medical devices on the Canadian market.
Missing, incorrect, or outdated licenses can result in regulatory holds, interruptions to commercial activities, or enforcement actions by Health Canada, directly impacting business continuity.
Structured licensing and regulatory support helps manufacturers navigate application requirements, respond to regulatory interactions, and maintain compliance throughout the product lifecycle.
Holding the appropriate medical device license is essential to legally place and maintain medical devices on the Canadian market. Licensing is not a formality — it is a condition for doing business in Canada.
Medical device licensing in Canada involves different obligations depending on your role, device class, and regulatory stage. Sobel offers modular services that can be contracted individually or combined, allowing you to engage the level of support that best matches your regulatory needs:
Ideal for companies required to hold an establishment license in Canada, this service supports manufacturers, importers, and distributors in preparing and submitting the MDEL application. Sobel assists with the completion of the applicable form and supports communication with Health Canada.
Designed for manufacturers applying for product-specific licensing, this service supports Class II, III, and IV medical device applications in Canada. Sobel assists with the preparation of the relevant application form and regulatory communication, helping align licensing activities with Health Canada requirements.
Best suited for manufacturers seeking comprehensive regulatory support, this package covers the full Class II application process. Sobel supports regulatory classification, application preparation, gap analysis, submission, and interaction with Health Canada.
Intended for manufacturers who already have documentation in place, this service focuses on compiling and submitting a Class II medical device application based on existing materials. Sobel supports application structuring and submission activities, while additional consulting can be engaged if documentation gaps are identified.
Suitable for companies needing ongoing regulatory guidance, this service provides written support for day-to-day regulatory affairs questions. Manufacturers submit queries via Sobel’s project management platform and receive structured written responses.
Recommended for manufacturers receiving feedback or general communications from the authority, this service supports the interpretation of messages and regulatory expectations. Sobel provides strategic guidance to help companies understand regulatory context and define next steps.
Our role is to provide clarity, structure, and regulatory guidance while maintaining clear boundaries between consulting support and manufacturer responsibilities.
Sobel supports manufacturers with additional regulatory services that complement licensing and support ongoing compliance in the Canadian market:
Medical device licensing in Canada requires clarity, structure, and regulatory awareness. Sobel helps manufacturers navigate Health Canada requirements with confidence, supporting both initial applications and long-term regulatory compliance. Talk to our team and strengthen your medical device licensing strategy in Canada.
1. What is a medical device license Health Canada and when is it required?
A medical device license Health Canada is a legal requirement to place and maintain medical devices on the Canadian market. Depending on your role and device class, you may need an establishment licence (MDEL), a product licence (MDL), or both.
2. What is the difference between MDEL and MDL?
The Medical Device Establishment License (MDEL) applies to companies performing regulated activities such as importing or distributing devices in Canada, while the Medical Device License (MDL) applies to the medical device product itself. Both are issued by Health Canada, but they serve different regulatory purposes.
3. Are MDEL and MDL mandatory to operate in Canada?
Yes. When applicable, holding a valid MDEL and/or MDL is mandatory. Operating without the required licence may result in regulatory actions, interruption of commercial activities, or market access restrictions.
4. What is the difference between the Full Package and Partial Package for Class II applications?
The Full Package provides end-to-end regulatory support, including classification, gap analysis, application preparation, submission, and review support. The Partial Package focuses on compiling and submitting a Class II application based on existing documentation.
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