Health Canada Medical Device Regulations

Most documents listed below were published by Health Canada and are in PDF format. 

Links for Medical Device Regulations

Health Canada - Drug and Medical Device Recall Listings

Major Regulations
Document Number Published Language
Log in Canadian Medical Devices Regulations SOR 98-282 02/2017 English
General Guidance Documents
Document Number Published Language
Download NOTICE: Transition to the Revised Version of ISO 13485 16-108859-627 08/2016 English
Download Use of FDA Guidance Materials to support Canadian MDL 16-108407-753 08/2016 English
Download The Risk Based Classification System of In Vitro Diagnostic Devices GD007 09/2016 English
Download Guidance for labeling medical devices Labeling 07/2015 English
Download Risk-based Classification System GD006 04/2015 English
Download Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices 13-117237-89 11/2013 English
Download Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices 06-120629-368 9/2006 English
Download Guidance on the Content of Quality Management System Audit Reports GD211 6/2011 English
Download ISO 13485 Audit Guidelines 07-103218-349 2/2007 English
Specific Guidance Documents
Document Number Published Language
Download Private Label Medical Devices Questions & Answers CAN-006 03/2011 English
Download Notice – Applications for Investigational Testing Authorization (ITA), for Medical Devices, in the "Non-eCTD Electronics-Only" Format 16-115240-468 01/2017 English
Download Labelling of In Vitro Diagnostic Devices GD012 04/2016 English
Download Recall Policy (POL-0016) POL-0016 05/2015 English
Download Vigilance: Mandatory Problem Reporting for Medical Devices GUI-0059 10/2011 English
Download Preparing new MDL or amendment for private label medical devices CAN-003 2/2011 English
Download Private Label Medical Devices CAN-005 4/2011 English
Download Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices GD010/Rev00-MDB 2/1999 English
Download Guidance on Investigation of Reported Medical Device Problems GUI-0065 3/2011 English
Download Preparation of an Application for Investigational Testing - Medical Devices GD009/Rev00-MDB 2/1999 English
Forms and Applications
Document Number Published Language
Download How to complete new Canada MDL application CAN-012 07/2015 English
Download Canada MDL renewal fees guidance 13-117237-89 04/2017 English
Download Medical Device Establishment Licence Application Form and Instructions Form 0292 12/2012 English