Canadian Medical Device Classification Consulting

ANSWERED ON THIS PAGE:

  • What is the device classification scheme in Canada?
  • How does classification impact registration requirements for our device?
  • Our device is being sold in Europe or the US – will the classification be the same?

Before medical device and in-vitro diagnostic (IVD) device manufacturers can legally sell their products in Canada, they must comply with Health Canada's medical device regulations. However, it is important to know the correct medical device classification for your product before starting the registration process. Proper classification is the key to minimizing your registration costs and time to market.

Determining Your Device Classification in Canada

Medical devices are classified according to Health Canada's risk-based system. There are four device classifications--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 through IV using a set of 9 rules, which can be found in Schedule 1, Part 2 of the CMDR.

Device classification dictates the type of license required for your product, as well as quality management system requirements. Class II, III, and IV devices require a product-specific Canadian Medical Device License (MDL) and ISO 13485:2003 or ISO 13485:2016 certification. Class I products require a Medical Device Establishment License (MDEL), which is held by the manufacturer or distributor.

Same classification as Europe and the United States?

The Canadian classification rules for medical devices are very similar to those in the EU Medical Devices Directive / Regulation. However, you should not assume that your CE Marking classification will be the same in Canada as in other jurisdictions.

For example, many Class I products in the US are Class II in Canada, while some Class II products in the US are Class III in Canada. Note that the Canadian classification rules for IVDs are very different to those in the EU In Vitro Diagnostics Directive, but will be similar to those in the new IVD Regulation (IVDR 2017/746).

Why choose Emergo to assist with medical device classification?

Emergo has assisted hundreds of medical device and IVD companies with Health Canada licensing and 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 product.
  • We can assist you in preparing the Medical Device Establishment License (MDEL) or Medical Device License (MDL) application for your device.
  • Our Canada team will communicate with Health Canada on your behalf before, during and after the registration process as needed.

Our in-depth knowledge of Canadian medical device regulations ensures we can provide the most efficient and cost-effective regulatory strategy for your device.

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