Health Canada Medical Device Regulations
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 |