Health Canada Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Canada.
| 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 |
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