Regulatory compliance for Canada
Regulatory compliance for Canada
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).
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.
