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 |  |
EN | SOR 98-282 | 02/2016 |
| Guidance for labeling medical devices |  |
EN | Sect 21 & 23 | 6/2014 |
| 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 |
| Licensing Requirements for Inter-dependent Medical Devices | |
EN | CAN-001 | 4/2002 |
| Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices | |
EN | 13-117237-89 | 11/2013 |
| Recognition and Use Of Standards under the Medical Devices Regulations | |
EN | CAN-002 | 9/2006 |
| Risk-based Classification System |  |
EN | GD006 | 04/2015 |
| The Risk Based Classification System of In Vitro Diagnostic Devices | |
EN | GD007/RevDR-MDB | 1/1998 |
