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

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