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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

Regulation	Year
Canadian Medical	2017

General Guidance

Document	Year
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

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

Regulation	Year
Canadian Medical	2017

Document	Year
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

Document	Year
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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