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	Language	Number	Published
Canadian Medical Devices Regulations	en	SOR 98-282	02/2017

General Guidance Documents


Document	Language	Number	Published
Guidance for labeling medical devices	en	Labeling	07/2015
Guidance on the Content of Quality Management System Audit Reports	en	GD211	6/2011
ISO 13485 Audit Guidelines	en	07-103218-349	2/2007
Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices	en	06-120629-368	9/2006
Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices	en	13-117237-89	11/2013
NOTICE: Transition to the Revised Version of ISO 13485	en	16-108859-627	08/2016
Risk-based Classification System	en	GD006	04/2015
The Risk Based Classification System of In Vitro Diagnostic Devices	en	GD007	09/2016
Use of FDA Guidance Materials to support Canadian MDL	en	16-108407-753	08/2016

Specific Guidance Documents


Document	Language	Number	Published
Guidance on Investigation of Reported Medical Device Problems	en	GUI-0065	3/2011
Labelling of In Vitro Diagnostic Devices	en	GD012	04/2016
Notice – Applications for Investigational Testing Authorization (ITA), for Medical Devices, in the "Non-eCTD Electronics-Only" Format	en	16-115240-468	01/2017
Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices	en	GD010/Rev00-MDB	2/1999
Preparation of an Application for Investigational Testing - Medical Devices	en	GD009/Rev00-MDB	2/1999
Preparing new MDL or amendment for private label medical devices	en	CAN-003	2/2011
Private Label Medical Devices Questions & Answers	en	CAN-006	03/2011
Private Label Medical Devices	en	CAN-005	4/2011
Recall Policy (POL-0016)	en	POL-0016	05/2015
Vigilance: Mandatory Problem Reporting for Medical Devices	en	GUI-0059	10/2011

Forms and Applications


Document	Language	Number	Published
Canada MDL renewal fees guidance	en	13-117237-89	04/2017
How to complete new Canada MDL application	en	CAN-012	07/2015
Medical Device Establishment Licence Application Form and Instructions	en	Form 0292	12/2012

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