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Canadian CMDR Consulting for Health Canada Medical Device Registration

ANSWERED ON THIS PAGE:

  • What is the medical device registration process in Canada?
  • What is the difference between an MDEL and an MDL?
  • Does our ISO 13485 certification meet QMS requirements in Canada?

With a population of 35,000,000 and a well-organized national healthcare system, Canada is a lucrative market for medical device manufacturers.

Before you can market your medical device in Canada, you must comply with the Canadian Medical Devices Regulations (CMDR) and obtain the required level of approval from Health Canada.

Health Canada medical device licensing

In Canada, you are required to obtain a Medical Device Establishment License (MDEL) if you intend to market your Class I device, or a Medical Device License (MDL) for your Class II, III, or IV device. If you intend to distribute medical devices into Canada, you will require a MDEL.

Your MDL or MDEL application must be in full compliance with the Canadian Medical Devices Regulations (CMDR) and submitted to Health Canada in conjunction with the appropriate documentation required for your device class.

Our Canadian medical device approval process chart offers a detailed look at the steps required for Health Canada approval.

Health Canada CMDR Quality System Requirements and ISO 13485

Health Canada requires manufacturers of Class II, III, and IV medical devices to meet the quality system requirements of ISO 13485, plus additional QMS requirements outlined in the CMDR. Before your device can be sold in Canada, your CMDR-compliant quality system must undergo an audit by a Health Canada accredited ISO Registrar.

Let us assist with CMDR and Health Canada Regulatory Compliance

With offices in British Columbia and Ontario and consultants across the country, Emergo specializes in helping medical device and IVD companies meet the CMDR so they can gain access to the Canadian market. Here's why you should choose us:

  • We can help you implement or modify your ISO 13485 quality system so that you are in full compliance with Health Canada Medical Device Regulations.
  • We will complete and file the Canadian Medical Device License (MDL) or Medical Device Establishment License (MDEL) application on your behalf.
  • We can provide onsite employee training and auditing on ISO 13485 and the CMDR.

Our experienced consultants have assisted hundreds of medical device companies with Health Canada licensing and CMDR compliance.

Common CMDR questions

What are the QMS requirements for Class I devices in Canada?
There is no requirement to implement a full quality management system that is certified to ISO 13485; however, you are obligated to implement a limited set of quality procedures (e.g., related to product recall). If your medical device is Class II, III, or IV, you must demonstrate compliance with ISO 13485 and the CMDR.

Can our existing Notified Body audit us for compliance with the CMDR?
Maybe. Most ISO Registrars are also European Notified Bodies, but not all Notified Bodies are Health Canada accredited Registrars. See if your Notified Body is on this Health Canada list.

Does the CMDR specify any Country of Origin requirements?
There is no requirement in the CMDR that a company must obtain approval in their own country (the country of origin) as a prerequisite to registration in Canada.