Medical Device Regulatory Requirements in Canada
| Regulatory Authority |
Health Canada |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, II, III, IV |
| Medical Device Regulations |
Medical Device Regulation (SOR /98-282)
| Click Here
|
| IVD Classification |
I, II, III, IV |
| In Vitro Diagnostics Regulations |
Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs) |
| Registration Process |
Guidance on how to complete the application for a new medical device licence
| Click Here
|
| Registration Timeline |
Class 1: 120 calendar days
Class II: 2 months
Class III and IV: 4 to 8 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Submission for Canada may be in English or French, but labeling documents must also be provided in French |
| Database |
Medical Devices Establishment Licence listing
Medical Devices Active Licence listing
| Click Here
|
| Adverse Event Reporting Form |
Download |
| Additional Information |
Class I requires Medical Device Establishment License whereas Class II,III, IV requires Medical Device License (MDL) |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025