Guidance to apply for a Manufacturer’s Certificate to Export licenced medical devices from Canada (GUI-0097)

From Health Canada's Regulatory Operations and Enforcement Branch

Who this guide is for

• Any Canadian Manufacturer looking to supply certification that their medical devices can be marketed in Canada.
• Anyone located in Canada who plans to get an MCE in order to export medical devices from Canada to a foreign country.

In this guide

• About this Document
  • Purpose
  • Scope
  • Background
• Guidance
  • 4. How to apply for a certificate
    • Who can apply
    • Requirements you must meet
    • How to apply
    • Documents you must provide with your request
    • How to complete the MCE form
    • Where to submit your application
  • 5. Certificate approval or rejection
    • What happens once you apply
    • Service standards for certificate approval
    • Refusal to issue a certificate
    • If your application is rejected
    • For more information
  • Appendices
    • Appendix A - Manufacturer's Certificate to Export licensed Medical Devices from Canada
    • Appendix B - Glossary
    • Appendix C - References

View complete guide
Download PDF (328.5KB, 14 pages)

Details and history

Published:

November 21, 2019

For assistance

Our service hours are Monday to Friday from 8 a.m. to 6 p.m. (local time) and closed statutory holidays.

By email: hc.mce.questions-cfe.sc@canada.ca

Service standards:We aim to provide the information requested by email within 15 business days. For requests that are more complicated, an estimate of the time required to answer will be provided.