Draft guidance on how to interpret ‘significant change’ of a medical device: Process and procedures

On this page

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

Significant changes: Amendment application

For licences under Part 1, you must use a form specific to the device class when applying to amend a medical device licence:

• Class III Medical Device Licence Amendment Application Form
• Class IV Medical Device Licence Amendment Application Form

For authorizations under Part 1.1, you must use the form for authorization amendments:

• COVID-19 medical device authorization amendment form

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

• Management of applications for medical device licences

You must also submit a premarket review document applicable to the risk classification of the device. Identical changes made to Class III and IV devices may result in different review components being required. The review components must contain information and documents that are relevant to the change.

For more information, consult the:

• Guidance on how to complete the application for a new medical device licence
• Medical devices for use in relation to COVID-19

Recall

You are required to assess changes occurring because of a recall to determine if they may be significant. Examples of changes include those involving labelling, device design or design specifications required to bring a medical device back in line with previous performance specifications.

If you need further guidance on whether a corrective action requires an amendment of the authorization, contact the Medical Devices Directorate by email at  meddevices-instrumentsmed@hc-sc.gc.ca.

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

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

GUI-0054 provides guidance on how to comply with sections in the Medical Devices Regulations that relate to medical device recalls, such as:

• keeping medical device distribution records
• recalling medical devices
• reporting medical device recalls to Health Canada
• writing procedures for distribution record keeping and recalls

This guidance also provides contact information for where to submit a notification of a recall to the nearest office of Health Canada’s Regulatory Operations and Enforcement Branch (ROEB).

Minor change form

Where the manufacturer's name and address on the device labelling is the same but a new manufacturing facility that is not a supplier or contract manufacturer is added, the new facility must be covered by your quality management system certification.

For medical device licences under Part 1, you must also submit a minor change form to make changes to existing device licences:

• Medical devices licence amendment minor change form

This form will:

• facilitate the approval of the device licence amendments
• support a change to the name and/or address of the manufacturing facility for Class III and IV devices

The Template for Attestation Letter isin the appendix of the minor change form. Use this template to declare the manufacturing specifications are the same in the new manufacturing facility and add the letter to the minor change form. If you can comply with this attestation, an amended authorization may be issued without further evidence of safety and effectiveness.

For authorizations under Part 1.1, manufacturers are required to inform Health Canada of changes to an address using the authorization amendment form.

Non-significant changes

Non-significant changes should be documented in the quality management system and reported to us at annual renewal.