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From device classification and licensing to establishment requirements and post-market obligations, compliance is essential before and after market entry. At QSS, we help medical device companies understand Health Canada requirements and move through the compliance process with clarity, accuracy, and confidence.
Canada is a highly regulated market for medical devices. Health Canada sets strict requirements to ensure products are safe, effective, and properly monitored throughout their lifecycle.
Compliance is not a one‑time step. Licensing, quality systems, establishment responsibilities, and post‑market obligations must all work together.
Without a clear understanding of these requirements, companies may face delays, refusals, or compliance actions.
We provide practical guidance so you can meet Health Canada requirements without unnecessary complexity.
Medical device compliance requirements depend on your device type, risk class, and role in the supply chain. Common requirements include:
Medical Device Licence (MDL)
Most Class II, III, and IV devices require a Medical Device Licence before being sold in Canada.
Medical Device Establishment Licence (MDEL)
Manufacturers, importers, and distributors must hold an MDEL to legally conduct business activities in Canada.
Device Classification and Regulatory Pathway
Devices must be correctly classified to determine licensing, evidence, and review requirements.
Post‑Market Compliance
Ongoing obligations include reporting incidents, maintaining records, and responding to regulatory requests.
We offer end‑to‑end support across the medical device compliance lifecycle in Canada. Our services are designed to align with Health Canada requirements while supporting your business goals.
Medical Device Licence (MDL) Registration
We help prepare and submit Medical Device Licence applications so your device can be legally marketed in Canada.
Medical Device Establishment Licence (MDEL) Registration
We support MDEL applications, renewals, and ongoing compliance for manufacturers, importers, and distributors.
Software as a Medical Device (SaMD) Registration
We guide companies through Health Canada’s SaMD requirements, including classification, documentation, and licensing.
We’ve worked with a wide range of medical device companies across different categories and risk classes, including:
Diagnostic devices
Monitoring equipment
In vitro diagnostic devices
Wearable medical devices
Medical software and digital health tools
Clinical and hospital equipment
Home‑use medical devices
Not all medical devices require a Medical Device Licence (MDL). Class I devices do not require an MDL, but companies involved in manufacturing, importing, or distributing may still need to meet other regulatory requirements, such as holding a Medical Device Establishment Licence (MDEL) and complying with post-market obligations.
Health Canada classifies medical devices from Class I (low risk) to Class IV (highest risk). The classification is based on factors such as intended use and level of risk, and it determines the type of licence required, the amount of supporting evidence needed, and the level of regulatory oversight involved.
Medical device classification depends on how the device is intended to be used, the risks associated with its use, and how it achieves its purpose. Health Canada provides classification rules, but interpreting them can be complex. We help assess classification early to ensure the correct regulatory pathway is followed from the start.
This depends on both your medical device and your role in the supply chain. An MDL applies to the device itself, while an MDEL applies to companies that manufacture, import, or distribute medical devices in Canada. Many businesses require both, and identifying this early helps avoid delays or compliance gaps.
Yes, but only if your device and business meet Health Canada’s regulatory requirements. Online marketplaces often require proof of compliance, such as valid licences, before allowing products to be listed or remain active on their platforms.
No. FDA approval does not replace Health Canada requirements. While U.S. approvals may support aspects of a Canadian submission, medical devices must meet Health Canada’s regulatory requirements before they can be sold in Canada.
No consultant can guarantee approval. Our role is to help prepare accurate, complete submissions aligned with Health Canada requirements.
Stay informed about Health Canada updates, regulatory changes, and practical compliance guidance for medical devices.