CMDR medical device registration and approval from Health Canada is required for all medical devices before they can be legally marketed. Class I devices are exempt from licensing but must be registered by the importer or distributor. Class II, III, and IV devices require a Medical Device Licence (MDL) and a Medical Device Single Audit Program (MDSAP) certificate.
Determine if your product qualifies as a medical device under the Medical Devices Regulations (SOR/98-282). If it does, identify the correct classification (Class I, II, III, or IV) and define the scope of licensing required for Canada medical device registration.
Establish a Quality Management System (QMS) that complies with ISO 13485:2016. For higher-risk devices (Class II and above), proceed with an audit under the Medical Device Single Audit Program (MDSAP).
For Class II, III, and IV devices, ensure your QMS is audited by an Auditing Organization (AO) accredited under MDSAP. Confirm all operational processes meet Health Canada’s standards.
Prepare your application for the appropriate license:
Ensure all device labeling and instructions meet Canadian requirements, including bilingual labeling in English and French and required content elements.
Maintain compliance with Health Canada medical device registration requirements by tracking device performance and conducting post-market surveillance to monitor safety and effectiveness. Licenses do not expire, but require annual fees. MDEL holders must submit an Annual Review application and pay renewal fees by April 1 each year. MDL holders must pay an annual maintenance fee by November 1.
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.
Costs typically range from $5,000 to $25,000 USD when outsourcing compilation and submission, depending on device classification, regulatory pathway, and specific requirements. This does not include internal compliance or testing expenses.
Time-to-market varies by classification. Class II–IV devices typically take 15 to 90 days for MDL approval. Class I devices require an MDEL, which can take around 120 days. Total timelines may extend 2 to 10 months depending on device complexity and Health Canada requests.
No. While international certifications like FDA 510(k) or CE Mark can support your quality evidence, Health Canada requires independent review and licensing. Each device must meet Canadian-specific regulatory and labeling standards.
No, foreign manufacturers do not need to appoint a local license holder to sell medical devices in Canada.
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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