Application Fee for Class II MDL: The application fee for a Class II MDL is typically less than for higher-risk Class III and IV devices. As of recent guidance, Class II application fees are around CAD $5,000 to CAD $6,000, but these can vary.

To process Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada, manufacturers must meet Health Canada's requirements to ensure the device’s safety, quality, and effectiveness.

The process for Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada involves a series of steps to ensure compliance with Health Canada’s regulations.

In Canada, Class II in vitro diagnostic (IVD) medical device registration refers to obtaining a Medical Device License (MDL) for Class II diagnostic devices, regulated by Health Canada under the Medical Devices Regulations (SOR/98-282). This license is required for devices intended to diagnose, treat, or monitor health conditions through analysis of samples from the human body, such as blood or tissue.

Confirm that your IVD device is classified as Class II. You can refer to the Medical Devices Regulations (SOR/98-282) for classification criteria.

Documentation and Application Preparation: This phase can take several weeks to several months depending on how quickly the manufacturer can gather the necessary technical, clinical, and regulatory documentation. This includes compiling clinical evidence, risk management documentation, quality management system information, and labeling.

Ongoing Monitoring: Manufacturers must implement a post-market surveillance plan to continuously monitor the safety and effectiveness of the device once it is on the market. This involves collecting data on device performance, adverse events, and user feedback.

Legal Authorization: MDL registration grants legal permission to market and sell the device in Canada, ensuring compliance with federal regulations and facilitating entry into the Canadian healthcare market.