The process for periodic updates of the Class I in vitro diagnostic (IVD) medical device MDL registration in Canada involves several key activities to ensure ongoing compliance with Health Canada’s regulations. Below is an outline of the process for maintaining and updating your MDL registration periodically:

1. Annual MDL Renewal

• Renewal Application: The MDL (Medical Device License) for a Class I device is valid for one year. To maintain the license and continue marketing the device in Canada, you must submit an annual renewal application to Health Canada.

  • The renewal application should be submitted prior to the expiration of the current MDL to avoid interruptions in your ability to market the device.
  • A renewal fee will also be required to continue holding the MDL.

• Submit Required Information: As part of the renewal, you may need to confirm that there are no significant changes to the device or the information on record.

  • If there are changes to the device (e.g., design modifications, new indications), you may need to provide updated documentation.

2. Updating Information on File with Health Canada

• Changes in Device Information: If any important details related to the device change, you must notify Health Canada and update the device registration accordingly. Key updates may include:
  • Manufacturer details (e.g., change of address, contact person).
  • Device labeling (e.g., if new labeling claims are introduced, or there are language or format changes).
  • Device characteristics (e.g., a change in materials or intended use).
  • Authorized Representative: If the Canadian Authorized Representative (CAR) changes, you must inform Health Canada.
• Updating Clinical Data or Performance Information: If you acquire new clinical or performance data that affects the safety, efficacy, or risk assessment of the device, this information must be submitted to Health Canada.
  • This includes new clinical trial data, performance data, or post-market surveillance findings that might impact the device’s safety profile.

3. Reporting Adverse Events and Device Modifications

• Adverse Event Reporting: If any adverse events or incidents occur with your device (such as malfunctions or injuries), you must report them to Health Canada as required by the Medical Device Regulations (MDR).
  • These reports should be submitted within 10 days for serious incidents and within 30 days for non-serious events. Failing to report adverse events promptly can lead to regulatory actions.
• Device Modifications: If your device undergoes significant modifications (such as a change in design, material, or manufacturing process), you must submit an updated registration to Health Canada, even if the device remains classified as Class I.
  • Changes could include modifications to performance claims, testing protocols, or indications for use.
  • For minor changes, you may be required to provide updated documentation without needing a complete re-application.

4. Maintenance of Quality Management System (QMS)

• Ongoing QMS Compliance: Even after the initial MDL registration, you must ensure that your Quality Management System (QMS) continues to comply with regulatory requirements.
  • Regular internal audits should be conducted to identify any gaps in compliance or deviations from the QMS.
  • If you are using ISO 13485 as your QMS standard, ensure that it remains valid and compliant with Health Canada's expectations. Regular audits and updates may be required to maintain ISO certification.

5. Update Device Establishment License (MDEL)

• Review and Update MDEL: If you or your authorized representative are distributing the device in Canada, ensure that your Medical Device Establishment License (MDEL) remains valid.
  • Any changes in the establishment (e.g., new distribution locations, change of responsible person) must be reported to Health Canada.
  • MDEL renewal may be required on an annual basis to continue distributing your device in Canada.

6. Regular Review of Regulatory and Compliance Standards

• Monitor Changes in Regulations: Health Canada may update the Medical Device Regulations (MDR) or other relevant guidance documents. You need to regularly review these updates to ensure continued compliance.
  • For example, Health Canada may update its safety or labeling standards, and you will need to align your device with these changes.
• Updates to International Standards: If international standards (such as ISO 13485, ISO 14971, etc.) change, ensure that your device and its associated documentation are updated to reflect these changes.

7. Health Canada Inspections and Audits

• Prepare for Inspections: Health Canada may conduct inspections of your manufacturing facility, especially if your device is involved in complaints, recalls, or safety incidents.
  • Regularly review your compliance with regulatory requirements to ensure you are prepared for any audits or inspections.
• Respond to Audit Findings: If any non-compliance or issues are identified during an inspection, you must take corrective actions and report these back to Health Canada.

8. Annual Fee Payment

• Pay Maintenance Fees: The annual MDL renewal fee must be paid to Health Canada to maintain your license. Failure to pay the fee can result in suspension or cancellation of your MDL, halting your ability to sell or distribute the device in Canada.
• Keep track of the payment deadlines and ensure that fees are submitted promptly.

9. Record Keeping and Device Traceability

• Maintain Device Records: Ensure that all records related to your device (including manufacturing, distribution, adverse events, and modifications) are kept up to date and can be easily accessed for inspection or audits.
• Device Traceability: Ensure that you can trace the device from manufacture to distribution. This is important in case of a recall or regulatory inquiry.

Summary of Periodic Update Process for MDL Registration:

1. Annual MDL Renewal: Submit the renewal application and pay the associated fee each year.
2. Update Device Information: Notify Health Canada of any changes in device information, such as labeling, manufacturer details, and clinical data.
3. Adverse Event Reporting: Report adverse events and incidents promptly as per regulatory requirements.
4. Device Modifications: Submit updates for significant changes to the device or its labeling.
5. Maintain QMS Compliance: Ensure ongoing adherence to quality management standards, conducting internal audits regularly.
6. Update MDEL: Ensure that your Medical Device Establishment License (MDEL) remains valid if applicable.
7. Monitor Regulatory Changes: Stay informed of changes in regulations or standards and update your device accordingly.
8. Health Canada Inspections: Prepare for inspections and audits, taking corrective action where necessary.
9. Maintain Record Keeping: Keep accurate records of all device activities and ensure traceability.

By following these steps and staying on top of periodic updates, you will ensure that your Class I in vitro diagnostic device remains compliant with Canadian regulations and that your MDL registration stays valid.

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