Health Canada Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Canada.
Related services for Canada:
- Health Canada Medical Device License (MDL) and MDEL Registration
- Health Canada IVD Registration and Approval
- Health Canada Medical Device Classification
- Health Canada Medical Device Adverse Event Reporting
- Health Canada CMDR Medical Device Registration and Approval
- Health Canada CMDCAS, MDSAP and ISO 13485 QMS Compliance
Related resources:
- Health Canada Regulatory Approval Process for Medical Devices
- CANADA – Overview of Medical Device Industry and Healthcare Statistics
- Canada Medical Device Market Overview
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Food and Drugs Act | F-27 | 2018 | English |
| Log in | Medical Devices Regulations | SOR 98-282 | 02/2017 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Fees for the Review of Medical Device License Applications | 2015 | English | |
| Log in | Guidance Document for Mandatory Problem Reporting for Medical Devices | 2011 | English | |
| Log in | Guidance on How to Complete the Application for a New Medical Device License | 2018 | English | |
| Log in | Guidance on Medical Device Establishment Licensing | GUI-006 | 2020 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Guidance on the Risk-Based Classification system for Non-in Vitro Diagnostic Devices (non-IVDDs) | 2015 | English | |
| Log in | Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDS) | 2016 | English | |
| Log in | Guidance for the Labeling of In Vitro Diagnostic Devices | 2016 | English | |
| Log in | Guidance for the Labelling of Medical Devices | 2015 | English |
