Canada: Classifying Your Medical Device in Canada

Hello everyone and welcome back to Medtech Compliance Chronicles! Now that we have a general idea of who Health Canada is and what they do, it is time to jump right into Canada’s medical device regulations. As we have with all countries we have covered so far, the first step is to determine what class our device falls into on the Canadian market. Before a medical device can be sold or imported into Canada, it must first be classified according to the risk it poses to patients and users. Classification is the cornerstone of all medical device regulation, it determines which requirements apply and how much supporting evidence is needed to demonstrate the device’s safety and effectiveness. 

Health Canada uses a four-tier classification system, ranging from Class I (lowest risk) to Class IV (highest risk). This system applies both to general medical devices and in vitro diagnostic devices (IVDDs). Each category has its own set of classification rules defined in Schedules 1 and 2 of the Medical Devices Regulations. For general medical devices, classification is based on how the device interacts with the body and whether it is active or non-active. For IVDDs, classification hinges primarily on the potential impact the test result has on public health or individual patient care. In this post, we will break down the classification approach used for both general medical devices and IVDDs in Canada to help you identify where your product fits and what regulatory pathway it must follow.

Classifying General Medical Devices

The classification of general medical devices in Canada is based on a four-tier risk model defined in Schedule 1 of the Medical Devices Regulations. All devices are placed into Class I, II, III, or IV, with Class I representing the lowest level of risk to the user or patient and Class IV the highest. This risk-based approach ensures that regulatory scrutiny increases in proportion to the device's potential to cause harm. The classification rules outlined in Schedule 1 are largely determined by how a device interacts with the human body, whether it is invasive or active, and the duration and nature of that interaction.

The first distinction the classification system calls out is whether a device is considered invasive or non-invasive. An invasive device is defined as one intended to come into contact with the surface of the eye or to penetrate the body, either through a natural orifice or artificial opening. The level of invasiveness, including the duration of contact, significantly influences the device’s risk class. For example, a surgical instrument that only temporarily enters the body to perform one simple function (i.e. a scalpel) is typically classified as Class II. Devices designed for long-term use within the body, exceeding thirty days, or those that come into contact with the central nervous or circulatory system, such as implantable pacemakers or artificial heart valves, are considered higher risk, frequently falling into Class III or even Class IV, due to the critical nature of their application and the potential for serious consequences if they malfunction.

Beyond invasiveness, the classification system also distinguishes between active and non-active devices. An active device is defined as a medical device that relies on a source of energy other than that generated by the human body or by gravity for its operation. This energy can be electrical, electromagnetic, mechanical, thermal, etc. The classification of active devices considers their purpose and how they transmit or withdraw their energy. For example, active therapeutic devices that administer or remove energy to or from the body in a non-hazardous way, such as an infusion pump, are generally classified as Class II. However, if the active therapeutic device poses a significant risk due to its method of energy delivery or the potential for serious harm if it fails, such as certain defibrillators or radiation therapy systems, it could be elevated to Class III or IV. Devices that directly or indirectly influence the central nervous system or are used to monitor vital physiological parameters where an inaccurate reading could lead to immediate danger, are also classified at a higher risk level.

Finally, there are special rules that apply to specific types of general medical devices, overriding the general principles of invasiveness or activeness when necessary. These rules address unique risks associated with certain materials or intended uses. For instance, devices that are manufactured from or incorporate human or animal cells, tissues, or their derivatives, such as certain tissue-engineered products or devices with animal-derived components, are automatically classified as Class IV due to the inherent biological risks involved. Another example includes devices specifically intended for disinfecting or sterilizing blood, tissues, or organs for transfusion or transplantation; these are also designated as Class IV, reflecting the critical importance of preventing contamination in such procedures. Conversely, devices used to disinfect or sterilize other medical devices are typically classified as Class II. These special rules highlight Health Canada’s nuanced approach to classification, ensuring that devices with particular inherent risks are subjected to the most stringent regulatory oversight, regardless of their general invasive or active characteristics. The overarching principle is that if multiple rules apply to a device, the rule resulting in the highest risk classification will always be the one that determines its final category.

Classifying In Vitro Diagnostic Devices (IVDDs)

As is common in many regulatory frameworks, Canada recognizes the inherent difference between general medical devices and IVDDs. The purpose of IVDDs is to provide information for the diagnosis, monitoring, or treatment of medical conditions. Similar to general medical devices, IVDDs are also classified into four risk-based classes (Class I to Class IV), where Class I represents the lowest risk and Class IV the highest. However, the specific rules used to determine an IVDD’s classification are different from those for general medical devices and place a strong emphasis on the potential threat the device’s failure or an erroneous result poses to either public or individual health.

The core of IVDD classification revolves around the potential public and individual health risks. The most stringent rules, leading to higher classifications, are applied to IVDDs intended to detect transmissible agents, incurable and / or life threatening conditions, with particular consideration given to the ease of which the condition could spread through the community. For example, an IVDD designed to screen donated blood, blood components, tissues, or organs for transmissible agents like HIV or hepatitis viruses, to ensure their safety for transfusion or transplantation would be classified as Class IV. This highest classification reflects the profound public health risk associated with contaminated blood or tissue products entering the supply chain. If an IVDD detects a transmissible agent that causes a serious disease with a risk of propagation within the Canadian population, such as a test for a pathogen during an epidemic, it is generally classified as Class III. These devices carry a moderate public health risk because an accurate and timely diagnosis is crucial to mitigating the spread of disease and managing its impact on the community. Conversely, IVDDs used to detect infectious agents that are not easily transmitted within a population or that cause diseases that resolve on their own with minimal intervention, are typically classified as Class II, as their public health impact is considered low.

Beyond transmissible agents, IVDD classification also considers the potential impact on individual health, particularly when an erroneous result from the device could have severe consequences for a patient. An IVDD is often classified as Class III if an incorrect result could place a patient in an imminent life-threatening situation or lead to a major negative health outcome. This applies to critical diagnostic tests where the device provides information that is essential to, or even the sole determinant, for a diagnosis or  treatment decision. For instance, an IVDD used to diagnose life-threatening conditions such as meningitis or septicemia, where a delay or misdiagnosis could be fatal, would fall into Class III. In contrast, IVDDs where an erroneous result is less likely to cause death, severe disability, or other major negative health impacts, and / or where the device is not the only factor in a diagnosis or treatment decision, are commonly classified as Class II. Examples of such devices include tests for common conditions like influenza B, where a false result, while inconvenient, typically does not pose an immediate danger to the individual. Finally, IVDDs with minimal public or individual health risks, such as general laboratory equipment or universal diagnostic reagents, are typically classified as Class I.

IVDDs also have several special rules to ensure proper regulatory oversight even in unique scenarios. For instance, if an IVDD, including its associated analyzers, reagents, or software, is intended to be used in conjunction with another IVDD, the classification of both devices will be that of the IVDD that represents the higher risk. This ensures that the overall system is regulated at the most protective level. Additionally, near patient IVDDs, IVDDs intended for self-testing by nonprofessional individuals, face specific considerations. Common self-tests, like pregnancy or cholesterol tests, are Class II due to their lower individual risk, while all other near patient IVDDs are automatically class III.

Conclusion

The landscape of medical device regulation is fundamentally built upon risk-based classification systems. This is why the first step to understanding a new region’s regulations is to understand their classification system. Classification determines the type and extent of evidence you must prepare, the pathway for market authorization, and the level of scrutiny your submission will receive. A thorough understanding of Health Canada's rules are indispensable for manufacturers, importers, and distributors. Always remember the importance of reading all classifications rules when determining your device’s classification, as more than one rule can commonly apply and the rule leading to the highest classification will be the rule that determines the final classification! This knowledge will facilitate a smoother and more predictable path to market authorization. Join us next time as we take the next step toward bringing our medical device to market in Canada!