Regulatory authority
Health Canada (HC)
Classification
I, II, III, IV
Quality System
As of January 1, 2019, certificates issued by the CMDCAS are no longer accepted. All manufacturers of Class II, III and IV devices must switch to the Medical Device Single Audit Program (MDSAP) to obtain the ISO 13485 certificate following a successful audit by an accredited Auditing Organization.
Procedure
Medical Devices and IVD Devices are subject to registration. To market their devices in Canada, manufacturers must obtain a license.
There are two types of licenses issued by Health Canada: the (1) Medical Device Establishment Licence (MDEL) required for Class I medical devices and the (2) Medical Device Licence (MDL) for all the other classes.
Class I medical device manufacturer who intends to sell their medical devices directly to the user in Canada must obtain an MDEL. The manufacturer who intends to sell to the importer on site must obtain it if he is not already in possession of it.
Class II, III and IV medical device manufacturers who intend to place their devices on the Canadian market must have an MDL following the issuance of the ISO 13485 certificate.
Links
Most documents listed below were published by Health Canada.
Links for Medical Device Regulations
Health Canada – Drug and Medical Device Recall Listings
Major Regulations
Canadian Medical Devices Regulations . en . SOR 98-282 . 02/2017
General Guidance Documents
Guidance for labeling medical devices . en . Labeling . 07/2015
Guidance on the Content of Quality Management System Audit Reports . en . GD211 . 06/2011
ISO 13485 Audit Guidelines . en . 07-103218-349 . 02/2007
Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices . en . 06-120629-368 . 09/2006
Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices . en . 13-117237-89 . 11/2013
NOTICE: Transition to the Revised Version of ISO 13485 . en . 16-108859-627 . 08/2016
Risk-based Classification System . en . GD006 . 04/2015
The Risk Based Classification System of In Vitro Diagnostic Devices . en . GD007 . 09/2016
Use of FDA Guidance Materials to support Canadian MDL . en . 16-108407-753 . 08/2016
Specific Guidance Documents
Guidance on Investigation of Reported Medical Device Problems . en . GUI-0065 . 03/2011
Labelling of In Vitro Diagnostic Devices . en . GD012 . 04/2016
Notice – Applications for Investigational Testing Authorization (ITA), for Medical Devices, in the “Non-eCTD Electronics-Only” Format . en . 16-115240-468 . 01/2017
Preparation of an Application for Investigational Testing – In Vitro Diagnostics Devices . en GD010/Rev00-MDB . 02/1999
Preparation of an Application for Investigational Testing – Medical Devices . en . GD009/Rev00-MDB . 02/1999
Preparing new MDL or amendment for private label medical devices . en . CAN-003 . 02/2011
Private Label Medical Devices Questions & Answers . en . CAN-006 . 03/2011
Private Label Medical Devices . en . CAN-005 . 04/2011
Recall Policy (POL-0016) . en . POL-0016 . 05/2015
Vigilance: Mandatory Problem Reporting for Medical Devices . en . GUI-0059 . 10/2011
Forms and Applications
Canada MDL renewal fees guidance . en . 13-117237-89 . 04/2017
How to complete new Canada MDL application . en . CAN-012 . 07/2015
Medical Device Establishment Licence Application Form and Instructions . en . Form 0292 . 12/2012 |