The world of medical devices is ever-evolving, driven by innovation and a commitment to improving healthcare outcomes. In Canada, the classification of medical devices is a crucial step in ensuring their safety and effectiveness. The classification process helps regulatory authorities, manufacturers, and healthcare professionals understand the level of risk associated with different devices.
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 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. Medical devices are categorized based on their risk level, intended use, and potential impact on patients. 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.
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).
Class I Medical Devices: These devices pose the lowest risk and include items like bandages, examination gloves, and basic surgical instruments. They are subject to general safety and labeling requirements.
Class II Medical Devices: Devices in this class have a moderate level of risk and include products like hearing aids, infusion pumps, and diagnostic imaging equipment. They require compliance with specific safety and effectiveness standards.
Class III Medical Devices: Devices in this category carry a higher risk and often include implantable devices and life-sustaining equipment. Rigorous clinical data and evidence are required to demonstrate their safety and effectiveness.
Class IV Medical Devices: This class involves devices with the highest risk, such as heart valves and implantable neurostimulators. These devices require a comprehensive assessment of safety, efficacy, and clinical performance.
The application review time for each class of medical device license differs:
Class II medical devices have a 15 calendar day review time target.
Class III medical devices have a 75 calendar day review time target.
Class IV medical devices have a 90 calendar day review time target
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.
Determining Device Classification: The classification of a medical device is based on factors like intended use, duration of contact with the body, and potential harm to patients. Manufacturers are responsible for correctly classifying their devices according to Health Canada’s guidance.
Implications of Classification: The classification of a medical device has far-reaching implications. It dictates the regulatory pathway the device must follow, the level of evidence required for approval, and the scope of post-market surveillance. Manufacturers must adhere to the specific regulations associated with their device’s class.
Consulting Experts for Classification: Navigating the classification process can be complex, especially for novel and innovative devices. Many manufacturers seek guidance from regulatory consultants who specialize in medical device regulations. These experts help manufacturers accurately classify their devices and develop a clear regulatory strategy.
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.
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 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.
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.
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.
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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