Medical Device Establishment License

Class I medical devices are considered to be the lowest risk category of medical devices in Canada, as they are intended to be used for relatively simple medical procedures. These devices have a low potential for harm if they malfunction or are used improperly.

Examples of Class I medical devices include:

• Wound care equipment
• Non-surgically invasive devices, such as bandages, crutches, and stethoscopes
• Surgical masks

The regulatory requirements for Class I medical devices in Canada are generally less stringent than for higher-risk devices, such as Class II, III, and IV devices. However, Class I medical devices are still subject to certain regulatory requirements such as:

• Labeling
• Advertising
• Reporting of adverse events

Manufacturers of Class I medical devices are required to demonstrate that their products are:

• Effective for their intended use
• Provide evidence to support any claims they make about the device
• Subject to periodic inspections by Health Canada to ensure compliance with regulatory requirements.

Overall, the regulatory requirements for Class I medical devices are designed to ensure that these devices are safe, effective, and of reasonable quality, and to minimize the risk of harm to patients. However, the regulatory burden for Class I devices is generally lower than for higher-risk devices, in recognition of the lower potential risks associated with these products.

Class II medical devices are considered to be medium-risk devices in Canada. They are intended for use in more complex medical procedures than Class I devices, but still have a moderate potential for harm if they malfunction or are used improperly.

Examples of Class II medical devices include:

• x-ray machines
• insulin pumps
• diagnostic imaging equipment

Manufacturers of Class II medical devices are required to provide evidence to demonstrate that their products are safe and effective for their intended use.

Manufacturers of Class II medical devices are also subject to certain regulatory requirements, and need to comply with the Medical Devices Regulations, including:

• Labeling
• Advertising
• Reporting of adverse events
• Subject to periodic inspections by Health Canada

Class III medical devices are considered to be medium-to-high risk devices in Canada, as they are intended to be used for more complex medical procedures and have a higher potential for harm if they malfunction or are used improperly.

Examples of Class III medical devices include:

• Hip implants
• Glucose monitors
• Ultrasound diagnostic imaging equipment
• Surgically invasive devices that are intended to be absorbed into the body
• Devices that are intended to remain in the body for at least 30 consecutive days.

Health Canada requires that manufacturers of Class III medical devices provide more extensive evidence:

• Safety
• Efficacy through clinical trials
• Testing
• Demonstrate that the benefits of the device outweigh the potential risks
• Ensure compliance with ISO 13485 for Quality Management System (QMS)
• Rigorous reporting requirement for adverse events and recalls

Class IV medical devices are considered to be the highest risk category of medical devices in Canada, as they are intended to be used for the most complex medical procedures and have the highest potential for harm if they malfunction or are used improperly. Examples of Class IV medical devices:

• pacemakers
• surgically invasive devices that diagnose, control, or correct a defect in the central cardiovascular system

In addition to the regulatory requirements for Class III devices, manufacturers of Class IV medical devices are subject to even more rigorous quality management and reporting requirements. They are also required to comply with international standards for risk management, such as ISO 14971.