Canada Medical Device Registration

Qserve is your regulatory consultancy partner for medical device registration services in Canada.
Health Canada

Canada Medical Device Registration

In Canada, the regulatory submission process for medical devices is overseen by Health Canada, specifically by the Medical Devices Directorate, the national authority that monitors and evaluates the safety, effectiveness, and quality of diagnostic and therapeutic medical devices in Canada. The applicable regulation is the Medical Devices Regulations (SOR/98-282) under the Canadian Food and Drugs Act. 

Canada is an attractive market for medical device manufacturers for several reasons. The Canadian medical device industry is highly diversified, and Canada's aging population provides an opportunity to focus on medical devices to aid older population groups. Qserve can support building the MDSAP-compliant quality management system and help you with Canada Medical Device Registration.

“Our experts offer comprehensive services to streamline the process of bringing your products to the Canadian market and ensuring successful registration.”  

Regulatory Compliance in Canada

Canada Medical Device Registration

Overall, the regulatory system for medical devices in Canada shares similarities with both the FDA and EU regulatory systems. Like the EU, Canada utilizes a risk-based classification approach and emphasizes conformity assessment to demonstrate compliance with regulatory requirements, especially for high-risk devices. However, Canada also shares similarities with the FDA system depending on a device's respective risk class.

We are an experienced partner in EU-MDR, EU-IVDR, and US FDA market access. Qserve has extensive expertise in market access in the US, Europe, and Canada and knows the essential requirements to receive Health Canada approval and guide the process for Canada Medical Device Registration.

Benefits of Qserve engagement

Worldwide support

  • Qserve is a leading regulatory consulting firm offering medical devices and in vitro diagnostic regulatory and quality affairs services.
  • We specialize in helping clients achieve and maintain market access around the world.
  • Our team of experienced regulatory and quality experts have a deep understanding of the regulatory landscape and can help manufacturers navigate the complex requirements.
  • Qserve uses a practical approach to support you every step of the way. 

Do you need assistance with Medical Device Registration in Canada or go-to-market strategy?

Qserve is your trusted partner for market access in Canada. 

Contact us


Market access Canada

Do you want to learn more about market access in Canada and its regulation?

We help you with a quick overview of:

  • The Medical Devices Directorate authority
  • Classification system
  • Conformity assessment routes
  • MDEL license
  • Important guidance links

More information

How Qserve can help

Meet our global registrations team to talk about our services:

  • Regulatory market access strategy
  • Registration support in Canada
  • Risk classification assessment
  • Translation of labels and IFUs based on requirements
  • Compile Technical Documentation 
  • Set up your MDSAP QMS-compliant system
  • Gap analysis
  • Risk management
  • Clinical studies and evaluation
  • Post-market surveillance

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