Consultation on five Medical Device Forms

Health Canada is pleased to announce the release of the following five draft forms for a 60-day comment period.

1. Draft New Class III Medical Device Licence Application Form
2. Draft New Class IV Medical Device Licence Application Form
3. Draft Class III Medical Device Licence Amendment Application Form
4. Draft Class IV Medical Device Licence Amendment Application Form
5. Draft Declaration of Conformity Form

How to Get Involved

This consultation is open for comment starting July 24, 2015 until September 22, 2015. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

devicelicensing-homologationinstruments@hc-sc.gc.ca

Device Licensing Services Division
Medical Devices Bureau
Health Canada
2934 Baseline Road, Tower B
Postal Locator: 3403A
Ottawa, ON
K1A 0K9

Telephone: 613-957-7285
Fax: 613-957-6345

Consultation Document

Interested parties are encouraged to provide comments and suggestions by September 22, 2015.

Reporting to Canadians

Health Canada will make the results of this consultation available on this web site.

If you have any questions, contact us at Medical Devices Bureau.