Canada, with its population of over 38 million, relies heavily on imports to meet approximately 70% of its domestic demand for medical devices. The country's medical device sector is witnessing a surge in demand, fueled by an increase in chronic diseases and an aging population.
This presents a significant opportunity for global medical device manufacturers who are prepared to navigate CMDR Canada medical device registration and approval requirements.
Health Canada regulates medical devices sold in Canada in accordance with the Canadian Medical Device Regulations (CMDR). Pure Global can assist with Canada's medical device registration, ensuring CMDR approval to sell in the Canadian market.
Canada categorizes medical devices into four classes based on the risk they pose. This classification influences the regulatory requirements for approval:
The path to market involves:
Foreign manufacturers benefit from not having to appoint a local license holder, streamlining the process for market entry.
We offer comprehensive support to streamline your market access in Canada:
Classifying and grouping your products to define the regulatory pathway.
Assisting with the compilation of the technical dossier for MDL or MDEL applications.
Acting as your local representative for submission to ANVISA and coordinating certifications from INMETRO or ANATEL, as necessary.
The primary regulatory authority for medical device registration in Canada is Health Canada. Pure Global can assist with navigating the registration process to ensure compliance with the Canada Medical Device Regulations (CMDR) and secure approval to sell medical devices in the Canadian market.
Medical devices in Canada are classified into four classes based on their risk levels, in accordance with Health Canada regulations medical devices: • Class I (low risk): Requires a Medical Device Establishment License (MDEL) for manufacturers or importers. • Class II, III, and IV (higher risk): Require a Canadian Medical Device License (MDL) and certification through the Medical Device Single Audit Program (MDSAP)
To bring a medical device to the Canadian market, you need to: 1. Classify your product correctly according to MDR Canada. 2. Obtain an MDEL for Class I devices. 3. Obtain an MDL for Class II, III, and IV devices. 4. Undergo MDSAP certification for Class II, III, and IV devices
No, foreign manufacturers do not need to appoint a local license holder to sell medical devices in Canada. This provision helps streamline the health canada medical device approval process for foreign medical device manufacturers.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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