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 |