Canada Regulatory Framework Medical Device registration

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Canadian Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Canadian market:

Major Regulations

RegulationYear
Canadian Medical Devices Regulations 2017

General Guidance Documents

DocumentYear
Guidance for labeling medical devices 2015
Guidance on the Content of Quality Management System Audit Reports 2011
ISO 13485 Audit Guidelines 2007
Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices 2006
Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices 2013
NOTICE: Transition to the Revised Version of ISO 13485 2016
Risk-based Classification System 2015
The Risk Based Classification System of In Vitro Diagnostic Devices 2016
Use of FDA Guidance Materials to support Canadian MDL 2016

Specific Guidance Documents

DocumentYear
Guidance on Investigation of Reported Medical Device Problems 2011
Labelling of In Vitro Diagnostic Devices 2016
Notice – Applications for Investigational Testing Authorization (ITA), for Medical Devices, in the “Non-eCTD Electronics-Only” Format 2017
Preparation of an Application for Investigational Testing – In Vitro Diagnostics Devices 1999
Preparation of an Application for Investigational Testing – Medical Devices 1999
Preparing new MDL or amendment for private label medical devices 2011
Private Label Medical Devices Questions & Answers 2011
Private Label Medical Devices 2011
Recall Policy (POL-0016) 2015
Vigilance: Mandatory Problem Reporting for Medical Devices 2011

Forms and Applications

DocumentYear
Canada MDL renewal fees guidance 2017
How to complete new Canada MDL application 2015
Medical Device Establishment Licence Application Form and Instructions 2012

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