For Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada, there is no mandatory annual review required by Health Canada. However, manufacturers are responsible for maintaining compliance with regulatory standards and may need to update their licenses if there are significant changes to the device or its labeling, or if new safety or efficacy data arises.

Obtaining an MDL allows manufacturers to legally sell and market their IVD devices in Canada, providing access to a substantial healthcare market.

Obtaining an MDL allows manufacturers to legally market and sell their IVD devices in Canada, opening up access to a large and regulated healthcare market.

Obtaining an MDL allows manufacturers to legally market and sell their IVD devices in Canada, opening up access to a large and regulated healthcare market.

Activities: Gathering documentation, conducting performance testing, and establishing a Quality Management System (QMS). The time required will depend on the complexity of the device and the completeness of the data.

Class II in vitro diagnostic (IVD) medical device MDL registration refers to the regulatory process through which a medical device intended for diagnostic purposes is licensed for use in Canada. This classification indicates that the device poses a moderate risk to patients and requires a higher level of scrutiny compared to Class I devices.

Confirm that your device is classified as Class II IVD by reviewing the Medical Device Regulations and the Health Canada classification rules.

Identify Classification: Confirm that your device qualifies as a Class II IVD by reviewing the classification criteria set by Health Canada.