Health Canada Medical Device Regulations
Most documents listed below were published by Health Canada and are in PDF format.
Links for Medical Device Regulations
Major Regulations
| Document | Language | Number | Published |
|---|---|---|---|
| Canadian Medical Devices Regulations | en | SOR 98-282 | 02/2017 |
General Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| Guidance for labeling medical devices | en | Labeling | 07/2015 |
| Guidance on the Content of Quality Management System Audit Reports | en | GD211 | 6/2011 |
| ISO 13485 Audit Guidelines | en | 07-103218-349 | 2/2007 |
| Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices | en | 06-120629-368 | 9/2006 |
| 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
| Document | Language | Number | Published |
|---|---|---|---|
| Guidance on Investigation of Reported Medical Device Problems | en | GUI-0065 | 3/2011 |
| 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 | 2/1999 |
| Preparation of an Application for Investigational Testing - Medical Devices | en | GD009/Rev00-MDB | 2/1999 |
| Preparing new MDL or amendment for private label medical devices | en | CAN-003 | 2/2011 |
| Private Label Medical Devices Questions & Answers | en | CAN-006 | 03/2011 |
| Private Label Medical Devices | en | CAN-005 | 4/2011 |
| Recall Policy (POL-0016) | en | POL-0016 | 05/2015 |
| Vigilance: Mandatory Problem Reporting for Medical Devices | en | GUI-0059 | 10/2011 |
Forms and Applications
| Document | Language | Number | Published |
|---|---|---|---|
| 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 |