Draft guidance on how to interpret ‘significant change’ of a medical device: Overview

Date revised: February 7, 2024
Replaces: Guidance for the Interpretation of Significant Change of a Medical Device (2011)

On this page

• Purpose
• Scope and application
• Policy objectives
• Policy statements

Purpose

This guidance document has been updated to expand on the definition of “significant change” in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant.

Medical devices are classified into 1 of 4 risk classes (I to IV). The classification rules are set out in Schedule I of the regulations. According to these rules, Class I is the lowest risk and Class IV is the highest risk. All Class II, III and IV medical devices sold or imported for sale in Canada must be licensed under Part 1, Section 26 or authorized under Part 1.1 of the regulations.

Note: References to an authorization or a device as an authorized device mean a license or a device licensed under Part 1 or an authorization or a device authorized under Part 1.1 of the regulations.

Scope and application

In the regulations, section 34 describes 6 instances when a manufacturer must apply for an amended medical device licence. Similarly, section 68.13 describes the instances when a manufacturer must apply for an amended authorization. Under these sections, the manufacturer must submit an amendment application when a “significant change” is proposed to a Class III or IV device.

This guidance document will help you identify these “significant changes”. It outlines the crucial elements of what constitutes a significant change. Specific types of changes (such as a change in design or manufacturing processes) are addressed and related examples are provided to help you understand the difference between a significant and non-significant change. Please understand that these are examples only and may not apply in all cases.

Note: Before a device to which a significant change applies can come onto the market, you must obtain Health Canada’s approval of an application to amend your authorization. For guidance on the safety and effectiveness evidence that you should submit in this type of application, consult the following web page:

•  Guidance documents for medical devices  

If your questions were not answered in the guidance documents, contact the Medical Device Directorate by email: meddevices-instrumentsmed@hc-sc.gc.ca.

A significant change is only 1 type of change that may require you to obtain an amended medical device authorization.

Use this guidance document to assess each change separately as well as the collective impact of all the changes when you are:

• considering several simultaneous changes in the evolution of an authorized device
• changing 1 or more component parts in cases where the medical device is authorized as a system, test kit, group, family or group family

It may be useful to compare the proposed changes side by side with the current authorized device.

To determine how your proposed change(s) to a device may impact the structure of a current authorization, you should consult:

• Guidance for the interpretation of sections 28 to 31: Licence application type  

In some cases, you may have to file a new application for an authorization rather than apply for an amendment.

A modification to a device may involve changes to its design, function, safety, manufacturing, packaging, finishing or labelling. Thus, it is not feasible to outline all the possible changes that could be made to a device. If you have outstanding questions about a particular change, please contact the Medical Devices Directorate by email: meddevices-instrumentsmed@hc-sc.gc.ca.

Note: If you become aware that what is known about the benefits and risks associated with a an authorized device have changed, you may have to report this information to Health Canada.

For more information on this regulatory obligation, consult:

• Guidance on summary reports and issue-related analyses for medical devices

Policy objectives

Our objectives with this guidance document are to make it clear to you:

• what changes are considered “significant”
• when you must obtain an amendment to your authorization before making the modified device available in Canada

Policy statements

If you determine that the proposed change to a Class III or IV medical device is a significant change and you wish to market the modified device in Canada, you must apply to Health Canada to amend your authorization. This includes a change to a compatible Class II device where that change may affect the safety and effectiveness of a Class III or IV device with which it interacts.

You may only sell the modified medical device, or components, in Canada once you receive an amended medical device authorization from Health Canada.

An amendment is also required for medical devices that are modified due to corrective actions or recalls if those changes are considered significant.

If you are concerned that the regulatory review process could introduce delays that may cause immediate harm to patients, contact the Medical Devices Directorate immediately to discuss alternate approaches. You may email us at meddevices-instrumentsmed@hc-sc.gc.ca.

Examples of changes that may cause harm if delayed include a cybersecurity update or a labelling change that adds an important public health and safety contraindication, warning or precaution.

For a change that is not “significant”, you may submit a minor licence amendment. Use the forms and refer to the guidance documents listed on the Process and procedures page.

You must document all changes in your quality management system. If changes are not significant as outlined in this guidance but concern the information and/or documents you originally submitted with your medical device application, you must report these changes to Health Canada at the time of annual renewal. We suggest that you itemize these changes in a table and provide a brief rationale describing why the change is not significant.