Canada Regulatory Framework Medical Device registration

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 Devices Regulations	2017

General Guidance Documents

Document	Year
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

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

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