Expert Solutions for Regulatory Medical Devices
Entering the Canadian market demands strict compliance with Health Canada’s framework. Sobel provides end-to-end support for regulatory medical devices in Canada, helping you classify your product, prepare licensing applications, and meet quality and safety standards with confidence.
This solution is designed for companies entering or operating in the U.S. medical device market:
Medical Device Manufacturers
requiring strategic guidance to obtain an MDL and comply with Health Canada regulations.
International Companies
looking for Canadian representation and support in MDL/MDEL processes.
Importers & Distributors
needing compliance with establishment licence obligations and regulatory documentation.
Regulatory Affairs Teams
seeking assistance with technical files, QMS alignment, and post-market surveillance.
Clarity on Medical Device Compliance in Canada
Bringing a medical device into Canada involves multiple regulatory steps — from classification and licensing to quality system compliance. For many manufacturers, these requirements raise important questions about documentation, timelines, and Health Canada expectations:
What is the difference between MDL and MDEL?
An MDL (Medical Device Licence) applies to individual medical devices, while the MDEL (Medical Device Establishment Licence) is required for companies that manufacture, import, or distribute devices in Canada. Sobel supports companies in determining which licences are needed and managing the submission process.
How are medical devices classified in Canada?
Health Canada divides devices into four classes (I to IV) based on risk. Class II, III, and IV devices require an MDL, while Class I typically requires only an MDEL.
What quality requirements apply to medical devices in Canada?
Most devices require compliance with ISO 13485 under the MDSAP (Medical Device Single Audit Program). Sobel provides QMS consulting, training, and preparation for audits to align your processes with Canadian and international expectations.
What happens if a company is not compliant with Health Canada regulations?
Non-compliance can result in licence refusal, market withdrawal, product seizure, or fines. Working with experts in regulatory medical devices in Canada helps prevent these risks and ensures smoother access to the market.
With Sobel’s guidance, compliance in Canada becomes a structured, efficient process — reducing risks and accelerating approvals.
How Sobel supports your regulatory journey
Complying with Health Canada’s medical device framework requires precision at every stage: classification, technical documentation, MDL or MDEL applications, and quality system. Each step requires accuracy and strategic preparation.
Sobel provides hands-on expertise to simplify this journey. We assist in preparing technical files, developing risk and clinical evaluations, and ensuring QMS alignment with ISO 13485 and MDSAP.
Our consultants also guide you through biological evaluations, post-market documentation, and training programs to prepare your team for ongoing compliance.
Whether acting as your regulatory partner for submissions or supporting post-approval requirements, Sobel helps your company move faster and with greater confidence in the Canadian market.
Our services for compliance in Canada
Our team combines technical expertise and regulatory insight to help your medical device succeed in the Canadian market.
- Toxicological Risk Assessment
TRA aligned with ISO 10993-18 and Health Canada expectations.
- Biological Evaluation Plan & Report
BEP, BER and safety services supporting Health Canada submissions.
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- Technical Documentation
Structured and compliant documentation aligned with regulatory requirements.
- Medical Device License Support
Regulatory support for licensing applications and ongoing compliance.
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- Quality Management Support
Medical device quality management aligned with regulatory expectations.
Confidence in Canadian compliance
We deliver comprehensive support for regulatory medical devices in Canada, helping manufacturers, importers, and distributors achieve compliance with confidence.
Working with us, you gain:
Tailored expertise in regulatory medical devices in Canada.
Reduced risk of licensing delays or regulatory rejections.
Ongoing support to maintain compliance after market entry.
Training and preparation to strengthen your regulatory team.
Your trusted partner for regulatory medical devices in Canada
Sobel provides tailored expertise to help you achieve and maintain Health Canada compliance, ensuring long-term success in the Canadian healthcare industry.
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