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Health Canada Medical Device Regulations

Major Regulations

DocumentLanguageNumberPublished
Canadian Medical Devices Regulationsen SOR 98-28202/2017

General Guidance Documents

DocumentLanguageNumberPublished
Guidance for labeling medical devicesen Labeling07/2015
Guidance on the Content of Quality Management System Audit Reports en GD2116/2011
ISO 13485 Audit Guidelinesen 07-103218-3492/2007
Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devicesen 06-120629-3689/2006
Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devicesen 13-117237-8911/2013
NOTICE: Transition to the Revised Version of ISO 13485 en 16-108859-62708/2016
Risk-based Classification Systemen GD00604/2015
The Risk Based Classification System of In Vitro Diagnostic Devicesen GD00709/2016
Use of FDA Guidance Materials to support Canadian MDLen 16-108407-75308/2016

Specific Guidance Documents

DocumentLanguageNumberPublished
Guidance on Investigation of Reported Medical Device Problemsen GUI-00653/2011
Labelling of In Vitro Diagnostic Devicesen GD01204/2016
Notice – Applications for Investigational Testing Authorization (ITA), for Medical Devices, in the "Non-eCTD Electronics-Only" Formaten 16-115240-46801/2017
Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devicesen GD010/Rev00-MDB2/1999
Preparation of an Application for Investigational Testing - Medical Devicesen GD009/Rev00-MDB2/1999
Preparing new MDL or amendment for private label medical devicesen CAN-0032/2011
Private Label Medical Devices Questions & Answersen CAN-00603/2011
Private Label Medical Devicesen CAN-0054/2011
Recall Policy (POL-0016)en POL-001605/2015
Vigilance: Mandatory Problem Reporting for Medical Devicesen GUI-005910/2011

Forms and Applications

DocumentLanguageNumberPublished
Canada MDL renewal fees guidanceen 13-117237-8904/2017
How to complete new Canada MDL applicationen CAN-01207/2015
Medical Device Establishment Licence Application Form and Instructionsen Form 029212/2012

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