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.GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
Do you need assistance with Medical Device Registration in Canada or go-to-market strategy?
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“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.