Draft Guidance Document - Guidance on supporting evidence to be provided for Class III and IV in vitro diagnostic device licence applications and amendments

Health Canada is pleased to announce the release of the draft Guidance Document: Guidance on supporting evidence to be provided for Class III and IV in vitro diagnostic medical device licence applications and amendmentsfor a 60-day comment period.  Once final, it will replace the 1998 Guidance for Manufacturers in Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications V.2.

This document is intended to aid manufacturers in the preparation of scientific information to be provided in support of Class III and Class IV in vitro diagnostic device licence applications and application amendments filed pursuant to the Canadian Medical Devices Regulations.

How to Get Involved

This consultation is open for comment starting August 22, 2012 until October 21, 2012. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

DED_Manager@hc-sc.gc.ca

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
2934 Baseline Road
Address locator: 3403A
Ottawa, Ontario

Telephone: 613-954-0297
Fax: 613-954-0297

Consultation Document

Interested parties are encouraged to provide comments and suggestions by October 21, 2012.

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 Device Evaluation Division.