Canada Medical Devices Regulation

Links for Medical Device Regulations

Health Canada – Drug and Medical Device

Here below a list of relevant PDF Guidance Documents:

Document Download Language Number Published
Canadian Medical Devices Regulations pdfdownload EN SOR 98-282 02/2016
Guidance for labeling medical devices pdfdownload EN Sect 21 & 23 6/2014
Guidance on the Content of Quality Management System Audit Reports pdfdownload EN GD211 6/2011
ISO 13485 Audit Guidelines pdfdownload EN 07-103218-349 2/2007
Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices pdfdownload EN 06-120629-368 9/2006
Licensing Requirements for Inter-dependent Medical Devices pdfdownload EN CAN-001 4/2002
Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices pdfdownload EN 13-117237-89 11/2013
Recognition and Use Of Standards under the Medical Devices Regulations pdfdownload EN CAN-002 9/2006
Risk-based Classification System pdfdownload EN GD006 04/2015
The Risk Based Classification System of In Vitro Diagnostic Devices pdfdownload EN GD007/RevDR-MDB 1/1998



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