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?
Health Canada device classification
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 means we can provide the most efficient and cost-effective regulatory strategy for your device.
Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.
Common questions regarding Canadian medical device classification
What is an MDEL?
Manufacturers of Class I devices in Canada must apply for a Medical Device Establishment License (MDEL) unless they solely import or distribute though a licensed distributor/importer. The MDEL is not a device specific license, but rather it applies to the applicant and their company; one MDEL is sufficient per manufacturer and may cover a range of Class I devices.
What is an MDL?
Manufacturers of Class II, III, and IV products will require a Medical Device License (MDL) application to Health Canada for review and approval. MDLs are specific to the device/device family, with separate MDLs submitted for separate devices or device families.
What are the specific QMS requirements for Class II, III, and IV devices?
ISO 13485:2003 or 2016 is mandatory for all Classes II-IV devices. In addition, the manufacturer must have CMDCAS (Canadian Medical Device Conformity Assessment Systems) embedded into their ISO 13485 quality management system (QMS), and the QMS must be audited and certified by an ISO registrar that is recognized by Health Canada.
However, Health Canada is participating in the Medical Device Single Audit Program (MDSAP). In accordance with Health Canada's announced MDSAP transition plan, CMDCAS certificates will no longer be accepted after 31 December 2018. Manufacturers will be required to submit valid MDSAP certificates no later than 01 January 2019 to maintain their MDL.