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

DocumentLanguageNumberPublished
Canadian Medical Devices Regulationsen SOR 98-28202/2016

General Guidance Documents

DocumentLanguageNumberPublished
Guidance for labeling medical devicesen Sect 21 & 236/2014
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
Licensing Requirements for Inter-dependent Medical Devices - Noticeen CAN-0014/2002
Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devicesen 13-117237-8911/2013
Recognition and Use Of Standards under the Medical Devices Regulations en CAN-0029/2006
Risk-based Classification Systemen GD00604/2015
The Risk Based Classification System of In Vitro Diagnostic Devices - DRAFT en GD007/RevDR-MDB1/1998

Specific Guidance Documents

DocumentLanguageNumberPublished
Guidance for the Labelling of Medical Devicesen CAN-00706/2004
Guidance on Investigation of Reported Medical Device Problemsen GUI-00653/2011
Guidance on Transition to IEC 60601, 3rd Eden 60601 3rd Ed6/2012
Guide to Recall of Medical Devices en GUI-00543/2011
Labelling of In Vitro Diagnostic Devices - DRAFTen GD012/RevDR-MDB6/1998
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-0062005
Private Label Medical Devicesen CAN-0054/2011
Vigilance: Mandatory Problem Reporting for Medical Devicesen GUI-005910/2011

Forms and Applications

DocumentLanguageNumberPublished
Canada MDL renewal fees guidanceen 13-117237-899/2009
How to complete new Canada MDL applicationen CAN-0123/2011
Medical Device Establishment Licence Application Form and Instructionsen Form 029212/2012