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