Before medical device in-vitro diagnostic (IVD) device manufacturers can legally sell their products in Canada, they must comply with the medical device regulations set forth by Health Canada.
It is important to know the correct medical device classification for your product prior to starting the registration approval process. Improper classification can have a staggering impact on the regulatory approval process and its associated costs.
Determining Your Device Classification in Canada
Medical devices are classified based on Health Canada’s risk-based classification system. Devices in Canada are classified as Class I, II, III and IV using a set of 16 rules found in Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282. IVDs are also classified as Class I, II, III and IV using a set of 9 rules can be found in Schedule 1, Part 2 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282.
Same classification as Europe and the United States?
The Canadian classification scheme is very similar to the European system, but you should not assume that your CE Marking classification will be the same in Canada. Many Class I products in the US are Class II in Canada. Some Class II products in the US are Class III in Canada.
Proper classification has a big impact. While Class II, III and IV devices require a product specific Canadian Medical Device License (MDL) and ISO 13485:2003 certification, Class I products are regulated by the Medical Device Establishment License (MDEL), which is held by the manufacturer or distributor.
Why choose Emergo to assist with medical device classification?
Emergo has assisted hundreds of medical device and IVD companies with Health Canada compliance. Our Canadian team specializes in regulatory support for medical devices and can help you determine the proper Health Canada classification if unclear.
- We will clarify whether your product is a medical device, cosmetic, natural health, medicinal or combination produc
- Our in-depth knowledge of the Canadian medical device regulations ensures that we provide the most efficient and cost-effective regulatory strategy for your device.
- We will assist you in preparing the Medical Device Establishment License (MDEL) or Canadian Medical Device License (MDL) application for your device.
- Our Canada team will communicate with Health Canada on your behalf during and after the registration process as needed.
Please contact us for more information on medical device classification and registration in Canada.