ARCHIVED Medical devices for use in relation to COVID-19: Appendices

On January 3, 2024, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need). These regulations broaden the scope of Part 1.1 of the Medical Devices Regulations apply to other public health emergencies. For more information, please refer to the notice.

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Appendix A: COVID-19 medical device application form

Appendix B: Attestation example

ATTESTATION
Under paragraph 68.11(2)(j) of Part 1.1 of the Medical Devices Regulations, a manufacturer is required to attest to the availability of documented procedures for certain activities. Check [ ] the relevant attestation.

[ ] I, the Manufacturer, have objective evidence to establish that I have documented procedures in place with respect to distribution records, complaint handling, incident reporting and recalls. I submit this attestation in partial fulfillment of the application submission requirements of Part 1.1 of the Medical Devices Regulations.

I, as a senior official of the manufacturer of this application, hereby attest that I have direct knowledge of the item checked above and declare that these identified statements are true and that the information provided in this application and in any attached documentation is accurate and complete.

Where a person is named in Item X of this application, I hereby authorize that person to submit this application to the Minister on my behalf. I further authorize the Medical Devices Directorate to direct all correspondence relating to this application to the person named in Item X of this application.

Name:
Title:
Signature:
Date:

Appendix C: COVID-19 medical device authorization amendment form

Appendix D: COVID-19 private label application form

Appendix E: COVID-19 private label amendment application form

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