Guidance on how to interpret "significant change" of a medical device: Overview

Date published: March 31, 2026

On this page

• Purpose
• Scope and application
• Policy objectives
• Policy statements
• Note about guidance documents in general

Purpose

This document provides guidance on how to interpret "significant change" as defined in the Medical Devices Regulations. Its purpose is to help manufacturers determine whether a proposed change to a Class III or IV medical device licence is significant and requires them to submit an amended medical device licence application before implementing the change.

The guidance presents the types of changes included in the regulatory definition of significant change, along with detailed examples, so that manufacturers may interpret and apply the regulations consistently.

Scope and application

Section 34 of the regulations describes changes that require the manufacturer to submit a medical device licence amendment application. This includes when a significant change is proposed to a licensed Class III or IV medical device in accordance with subsection 34(a) of the regulations.

You should also consult this document for proposed changes to a Class II medical device that's intended to be used with a separate Class III or IV medical device. When a change may affect the safety and effectiveness of the Class III or IV medical device, you may have to submit an amendment application for the higher-risk device before implementing the change in the Class II device.

Specific types of changes included in the definition of significant change in the regulations are presented, along with related examples, to help you understand the difference between a significant and non-significant change. A modification to a medical device may involve changes to its design, function, safety, manufacturing, packaging, finishing or labelling. The examples provided are for illustration purposes only and may not apply in all cases. It's not feasible to describe all possible changes that could be made to a medical device.

This guidance does not apply to medical devices authorized under Part 1.1, in the context of an urgent public health need. Information submitted in applications made under Part 1.1 cannot be used to support a change in a medical device licence under Part 1.

For amendments to authorizations under Part 1.1, refer to the Guidance on Medical devices for an urgent public health need. If you are not sure whether your authorization under Part 1.1 is a significant change under section 68.13(a) of the regulations, email us at: meddevices-instrumentsmed@hc-sc.gc.ca.

This guidance does not apply to drug-medical device combination products that are subject to the Food and Drugs Regulations. However, the guiding principles in this document may help you determine if you should submit additional medical device-related evidence before you market a combination product for which there is a proposed change to the medical device components. This guidance does apply to combination products subject to the Medical Devices Regulations.

For more information on drug-medical device combination products, consult:

• Policy on drug/medical device combination products

Policy objectives

Our objective is to support consistent and predictable regulatory decision-making by providing guidance on Health Canada's interpretation of "significant change". This will help manufacturers identify when a licence amendment is required. It will also help ensure that changes that may affect the safety, effectiveness or quality of Class III and IV medical devices are reviewed by Health Canada before implementation.

Policy statements

When a proposed change to a Class III or IV medical device licence is a significant change, you must submit a medical device licence amendment application and obtain an amended licence before you can market or sell the modified device in Canada.

For guidance on the safety and effectiveness evidence required in such an application, consult the applicable Guidance documents for medical devices.

In some cases, a proposed change to a medical device may impact the structure of the current licence and require a new licence application be submitted rather than an amendment.

For more information on how your proposed changes may affect your licence structure, consult:

• Guidance for determining medical device application type

All changes to the medical device, including changes to labelling, must be documented in your quality management system. After consulting this guidance, if the changes are not deemed significant, you must still report changes related to information and/or documents submitted with your medical device application to Health Canada at annual renewal time. We suggest that you itemize these changes in a table and provide a brief rationale as to why the change is not considered significant.

If you are unable to determine whether your proposed change is significant after going through all applicable sections, you should contact the Medical Devices Directorate by email at meddevices-instrumentsmed@hc-sc.gc.ca for additional information. Provide a complete description of your proposed change as well as why you were unable to determine the significance of your change.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, effectiveness or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the regulations and other applicable guidance documents.