Regulatory compliance for Canada
Health Canada Medical Regulations
If you are new to the Health Canada Medical Device Regulations, it can be difficult to navigate through the various regulations, guidance documents, and requirements. Health Canada is the department of the Canadian Government responsible for the national health policy. Regarding medical devices, Health Canada is taking care of the issuance and maintenance of medical device licenses. Medical devices are regulated in Canada according to SOR/98-282.
Canada is part of the Medical Device Single Audit Program
(MDSAP) and co-founder of the International Medical Device Regulators Forum
(IMDRF).
Canada Medical Device Classification
Health Canada Medical Regulations
The Canadian risk-based classification of medical devices is subdivided into four classes: I (low risk), II (medium risk), III (high risk), and IV (maximum risk). Manufacturers must follow the 16 classification rules presented in Schedule 1 (Part 1) of SOR/98-282 to ensure the correct classification of the medical device. Manufacturers of Class I medical devices are required to obtain a Medical Device Establishment License (MDEL). At the same time, manufacturers of higher-risk class devices such as Class II/III/IV must obtain a Medical Device License (MDL) to sell their medical devices legally in Canada.
There are substantial differences in the classification and rules for IVDs compared to medical devices. These can be found in Schedule 1 (Part 2) of SOR/98-282 and exist of 9 rules. Please
contact our experts for more information.
Registration routes in Canada
Registration process
Should the manufacturer of Class I medical devices or in vitro diagnostic devices aim to market their products directly in Canada without utilizing a distributor, they are obligated to obtain a Medical Device Establishment License (MDEL). If the manufacturer opts for distribution through one or more distributors within Canada, they must also undergo the application process for an MDEL. Put differently, distributors and importers based in Canada must apply for an MDEL, irrespective of the risk classification of the medical device or in vitro diagnostic device.
For manufacturers dealing with Class II-IV devices intending to sell their products, applying for an MDL is the prerequisite. The key distinction between an MDEL and an MDL lies in the fact that the MDL constitutes product approval, while the MDEL serves as a permit for the company, distributor, or importer itself.
In obtaining an MDL, manufacturers are required to demonstrate certification under the ISO 13485 quality management system through the Medical Device Single Audit Program (MDSAP). This certification must align with the specifications outlined in the Health Canada Medical Regulations.
Both license application procedures require submitting documents in electronic format to Health Canada, following the submission requirements set by Health Canada.