Yes, the Class I in vitro diagnostic medical device MDL (Medical Device License) registration in Canada requires annual renewal, but it does not require an annual review or re-evaluation of the device by Health Canada.

Key Points on Annual Renewal for Class I IVD MDL:

1. Renewal Requirement:

   • The MDL for a Class I device is valid for one year.
   • Manufacturers must submit a renewal application to Health Canada before the expiration of the MDL to continue marketing the device in Canada.

2. No Re-Assessment of the Device:

   • Unlike higher-risk devices (Class II, III, and IV), Class I devices generally do not undergo a re-assessment of their safety, effectiveness, or performance during the renewal process.
   • The renewal is primarily an administrative process to confirm that the manufacturer still meets regulatory requirements and that the device remains compliant with Health Canada's Medical Device Regulations (SOR/98-282).

3. Process for Renewal:

   • To renew the MDL, manufacturers typically submit an online renewal form via the MDE (Medical Device Establishment) Online Portal.
   • The renewal application is relatively straightforward. Manufacturers may need to update or confirm details about the device and ensure that all documentation (including labeling and instructions for use) is still in compliance.

4. No Major Documentation Change:

   • Class I devices typically do not require substantial new documentation or technical data during renewal, unless there have been changes to the device or its labeling.

5. Failure to Renew:

   • If the renewal is not submitted on time, the MDL will expire, and the device will no longer be legally authorized to be marketed or sold in Canada. The device would need to be removed from the market until a renewal is approved.

Summary:

• Annual Renewal is required for the MDL of Class I IVD devices in Canada.
• The renewal process is administrative, and does not require a re-assessment or review of the device unless there are significant changes.
• Failure to renew on time will result in the expiration of the MDL and suspension of marketing authorization.