Guidance on how to interpret "significant change" of a medical device: Process and procedures

On this page

• Introduction
• Significant changes: Amendment application
• Minor change
• Non-significant changes
• Recall

Introduction

You may still have questions even after you review this and other relevant guidance documents. Contact the Medical Device Directorate by email clearly stating "Significant change guidance request" in the subject line along with the related licence numbers. Your email should:

• include your assessment and current interpretation of your proposed change using this guidance
• provide specific areas of the proposed change that are not addressed by the guidance document
• include a list of all additional guidance documents consulted as part of your assessment

Send the email to meddevices-instrumentsmed@hc-sc.gc.ca.

Significant changes: Amendment application

For submitting an amendment application to medical device licences, you must use the application form specific to the device class. For the application forms refer to:

• Medical device application and report forms

You must also submit the supporting pre-market review documentation and evidence applicable to device's risk classification. Note that identical changes made to Class III and IV devices may require different review components. All the review components must include information and documentation that is relevant to the proposed change.

For more information, consult:

• Guidance on how to complete the application for a new medical device licence

Health Canada will process your application in accordance with the following guidance document:

• Management of applications for medical device licences

Minor change

The new facility must be covered under your quality management system certification where:

• the manufacturer's name and address on the device labelling remain the same, but a new manufacturing facility (that is not a supplier or contract manufacturer) is added.

For medical device licences under Part 1, you must also submit an amended Company Template (CO) xml to make changes to existing device licences:

• Regulatory enrolment process web forms

Download and fill out the application attestation form to confirm that the manufacturing specifications are the same at the new facility. If you can make this declaration, we may amend your licence without needing additional safety and effectiveness data.

Non-significant changes

All non-significant changes that do not require a minor amendment, including changes to labelling, must be documented within the quality management system. After consulting this guidance, if the changes are not deemed significant, you must still report changes related to information or documents originally submitted with your medical device application to Health Canada. This is done at the time of annual renewal.

Recall

You are required to assess changes arising because of a recall to determine if they may constitute a significant change. Examples include changes to labelling, device design or design specifications. When submitting an amendment related to a recall, clearly indicate in your amendment application that it is related to a recall. This should not delay notifying customers of the recall and providing temporary measures to mitigate the risk associated with the recall.

For more information on what constitutes a recall and the recall process, consult:

• Guide to recall of medical devices (GUI-0054)

If you need additional guidance on whether a corrective action resulting from a recall requires an amendment to the licence, contact the Medical Devices Directorate by email at meddevices-instrumentsmed@hc-sc.gc.ca.