In Canada, the duration of a Class III in vitro diagnostic medical device (IVD) Medical Device License (MDL) registration is indefinite, meaning there is no set expiration date once Health Canada grants approval. However, the license remains valid as long as the device complies with ongoing regulatory requirements.

Class III in vitro diagnostic medical devices (IVDs) Medical Device License (MDL) registration in Canada is a regulatory process that ensures these devices meet Health Canada’s standards for safety, effectiveness, and quality before they are marketed in the Canadian market. Class III IVDs are considered moderate- to high-risk devices, often used in critical diagnostic areas where accurate results are essential for patient health decisions. Because of this, they undergo a more detailed review compared to lower-risk classes.

The application process for a Class III in vitro diagnostic medical device (IVD) Medical Device License (MDL) registration in Canada involves several detailed steps to ensure compliance with Health Canada’s regulatory requirements.

Confirm Class III Classification: Verify that your device qualifies as Class III by assessing its intended use, risks, and features. This classification ensures you're meeting the appropriate regulatory requirements.

Preparing the application, gathering all technical documentation, and ensuring compliance with regulatory requirements can take several weeks to a few months, depending on the readiness of the data and documentation.

Determine Device Classification: Confirm that your device is classified as Class III according to Health Canada’s classification criteria. This involves assessing the intended use and risk factors associated with the device.

Maintain compliance with the quality management system standard for medical devices, which includes requirements for documentation, record-keeping, and management reviews.

Compliance with Medical Devices Regulations: Ensure ongoing adherence to the Medical Devices Regulations (SOR/98-282) under the Food and Drugs Act, which govern the manufacturing, labeling, and distribution of medical devices.