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.

Key Factors Affecting MDL Registration Duration

1. Ongoing Compliance:

   • Post-Market Surveillance: Manufacturers must maintain a post-market surveillance system to monitor the device’s safety and performance in real-world use. This includes reporting any adverse events, conducting regular performance reviews, and addressing any issues that may arise.
   • Quality Management System (QMS): Health Canada requires manufacturers to have a compliant QMS (e.g., ISO 13485) that is regularly audited. Non-compliance or audit issues could affect the validity of the license.

2. License Amendments:

   • Any significant changes to the device, such as modifications to its intended use, design, or manufacturing processes, may require an amendment submission to Health Canada. This ensures that any updated device version also meets safety and effectiveness standards.

3. Annual Fees and Market Authorization Renewals:

   • While the MDL doesn’t expire, Health Canada may require annual fees to keep the license active, as well as ongoing adherence to regulatory and post-market monitoring requirements.

4. Health Canada’s Right to Revoke or Suspend:

   • Health Canada reserves the right to revoke, suspend, or request a re-evaluation of the license if the device no longer meets regulatory standards or if serious safety concerns arise.

Summary

The MDL registration for a Class III IVD device does not have a set expiration date and remains valid indefinitely, provided the manufacturer continues to meet regulatory requirements, performs required post-market monitoring, and makes any necessary amendments in case of device changes.