Answer
Apr 07, 2023 - 10:23 AM
Class II Medical Devices are medical devices that are considered medium to high-risk and require pre-market approval from Health Canada before they can be sold in Canada. These devices are classified based on their intended use, the potential risk to the patient, and the level of regulatory control needed to ensure their safety and effectiveness.
Some examples of Class II Medical Devices that are registered with Health Canada include:
- Surgical gloves
- Sterile surgical instruments
- Infusion pumps
- Patient monitors
- Automated external defibrillators (AEDs)
- Diagnostic imaging equipment, such as X-ray machines and ultrasound machines
- Haemodialysis machines
- Electrocardiogram (ECG) machines
- Blood glucose monitors
- Respiratory devices, such as nebulizers and CPAP machines
Overall, Class II Medical Devices are considered to be of moderate to high risk, and their regulation is crucial in ensuring their safety and effectiveness. By being registered with Health Canada as Class II Medical Devices, these products have undergone a rigorous approval process, which includes testing, clinical evaluations, and ongoing monitoring to ensure their ongoing safety and efficacy.
