Medical Device Registration in Canada Canada Medical Device Classification

Get professional help with medical device classification in Canada. We can help you with registering and obtaining In Vitro Diagnostic (IVD) Medical Device License (MDL) from Health Canada as well as In Vitro Diagnostic Device submissions 510(k)  in the US.  Get up to speed on the important qualification procedure for all medical devices used in Canada!

Medical Device Regulations

Medical devices have different classes and most classes require licensing. To ensure the device’s safety, quality and efficacy, the Therapeutic Products Directorate (TPD) and more specifically, the Medical Devices Bureau regulates medical devices in Canada.

Medical device classification in Canada is determined by Health Canada’s risk-based practice. There are four device classifications, Class I, Class II, Class III and Class IV. Classification of medical devices dictates the type of license required for your product. 

Health Canada Medical Device Classification

Medical Device Registration in Canada & Classification

A thermometer is an example of a Class I medical device. Class I medical devices are excluded from requiring a medical device license. But, for Class II, III, and IV medical devices, a license is mandatory before being allowed to sell in Canada. Class II, III, and IV devices require a product-specific Canadian Medical Device License (MDL).

Review Time for Different Medical Device Classes

The application review time for each class of medical device license differs:

Class II

Class II medical devices have a 15 calendar day review time target.

Class III

Class III medical devices have a 75 calendar day review time target.

Class IV

Class IV medical devices have a 90 calendar day review time target

Categories of Medical Devices Class II, III, and IV

Understanding the classification system for medical devices is key to understanding how these devices are regulated and what qualifications may be required for their use.  Medical device classification in Canada is broken into four major categories, Class I to Class IV. The GMDN system takes into account the complexity of a given device and places them under an appropriate category. Class II, III and IV devices tend to have greater impact on health or are inherently invasive in nature and therefore require more stringent regulatory controls and testing before market authorization.

Establishing Quality Management Programs for Manufacturers

Manufacturing of medical devices in Canada requires production sites meet the Quality Management Program (QMP) criteria. The QMP should cover all stages of device manufacturing, and should include product-specific requirements such as labeling, packaging and handling procedures. Manufacturers must also demonstrate they have a system in place to review any potential instability with the product and to handle customer complaints if required.

Medical Devices Classification Class ll, lll, lV
Adopting the Global Medical Device Nomenclature (GMDN)

Adopting the Global Medical Device Nomenclature (GMDN)

All medical devices used in Canada are required to be classified in accordance with the Global Medical Device Nomenclature (GMDN). This internationally-recognized system establishes and applies consistent product descriptions to ensure regulatory appropriateness and accurate registration procedures. By adopting the GMDN, Canadian institutions are able to promote patient safety and capitalize on global trends when developing effective medical device policy.

Notarial Requirements for Medical Device Approval

To obtain approval for a medical device in Canada, manufacturers must submit the product to Health Canada for classification and obtain the necessary manufacturing licence. In this process producers may also be required to have an independent notary sign off on the fabrication process of the device, attesting that it has been manufactured according to all standards established by Health Canada. Notarial requirements also include verification of products for radiation safety and compliance with Canadian Regulations including any safety warnings or labels.

Health Canada’s Fee for Class II, III and IV License Applications

Health Canada imposes a license application review fee that applies to Class II, III and IV medical devices. The fees will vary depending on the class and whether the device contains human or animal tissue or if the device is for In- Vitro diagnostic use (Class IV). As of April 1, 2022, Health Canada fees start at $522 and increase annually. Once the license is issued, your medical device will be listed on Health Canada’s public website.

IVD medical device
Medical Device Classification in Canada

How We Help with Health Canada Medical Device Registration in Canada

We have experience serving thousands of medical device companies entering the Canadian market. We will help you.

  • Confirm your medical device classification in Canada.
  • Complete and file MDL or MDEL applications on your behalf.
  • Act as your regulatory correspondent with Health Canada for your device registration.
  • Develop, implement and modify your quality management system to meet Canadian requirements.
  • Make sure the annual license fee payable to Health Canada is paid on time.
  • Provide on-site auditing to confirm compliance with Health Canada’s medical device regulations.

Frequently Asked Questions

Medical device classification in Canada is determined by Health Canada’s risk-based practice. There are four device classifications, Class I, Class II, Class III, and Class IV. Classification of medical devices dictates the type of license required for your product. 

Medical devices have different classes, and most classes require licensing. To ensure the device’s safety, quality, and efficacy, the Therapeutic Products Directorate (TPD) and more specifically, the Medical Devices Bureau regulates medical devices in Canada by enforcing the Medical Device Regulations.

Class I medical devices are excluded from requiring a medical device license. But, for Class II, III, and IV medical devices, a license is mandatory before being allowed to sell in Canada. -A thermometer is an example of a class I medical device. Class I devices are low risk whereas Class IV devices are considered high risk.

Class I:  Do not require a medical device license i.e., Thermometer

Class II:  These medical devices have a 15-calendar day review time target.

Class III: These medical devices are typically reviewed over the course of 75 days.

Class IV: These medical devices have a time target of 90 days to review.

Health Canada imposes a license application review fee that applies to Class II, III and IV medical devices. The fees will vary depending on the class and whether the device contains human or animal tissue or if the device is for In- Vitro diagnostic use (Class IV). As of April 1, 2022, Health Canada fees start at $522 and increase annually. Once the license is issued, your medical device will be listed on Health Canada’s public website.

We have experience serving thousands of medical device companies entering the Canadian market. We will help you.

  • Confirm your medical device classification in Canada.
  • Complete and file MDL or MDEL applications on your behalf.
  • Act as your regulatory correspondent with Health Canada for your device registration.
  • Develop, implement, and modify your quality management system to meet Canadian requirements.
  • Make sure the annual license fee payable to Health Canada is paid on time.
  • Provide on-site auditing to confirm compliance with Health Canada’s medical device regulations.

Class I medical devices do not require licensing due to the minimal harm and simple design.  In terms of Class II devices, though they are non-invasive to use they can potentially present a higher degree of danger.  Therefore, these devices need a higher level of quality assurance and must comply with regulations to ensure they won’t cause harm.

  • Pacemakers
  • Defibrilators
  • Implanted prosthetics
  • Cochlear implants

These devices have a mid-high risk for the user and are the most common type of medical device.  Some examples of these devices include pregnancy tests and powered wheelchairs. 

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