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? Health Canada MDEL Annual License Review (ALR) was due by April 1, 2021. If you didn’t renew and need assistance with filing your MDEL contact us today.
If you distribute or import class I to IV medical devices, you require an MDEL.
If you manufacture class I medical devices in Canada (eg. shields, masks, gowns, toothbrushes, etc.), you require an MDEL.
If you manufacture, market or distribute medical devices to Canadian resellers from any other country (businesses outside Canada), you require an MDEL.
This infographic summarizes the most sought after medical devices and their respective classifications. Please note that Health Canada
has issued an ‘Interim Order’ which helps expedite the approval of medical devices for sale in Canada.
| Group | Medical Devices | Licence |
|---|---|---|
|
Class I |
KN95 Mask
N85 Mask
Face Shield
Gown
|
Not Applicable |
|
Class II |
Infrared contactless thermometer Contact thermometer Latex, vinyl, nitrile or similar medical gloves |
Yes |
|
Class III |
In Vitro Diagnostic Test Kits (serological or nucleic acid) |
Yes |
Please note that fees for medical devices are currently waived (however, fees for medical device establishment licenses ie. MDEL, are not waived).
Served clients in over 100 countries
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Help you register your medical devices, if required through a 510(k) pre-market notification.
We will register your device facility or activity through a secure online FDA portal.
Ensure your label adheres to FDA medical device label regulations as per applicable 21 CFR sections.
We will act as your most trusted US Agent for your registered medical device facility.
NOTE: Class 2, 3 and 4 medical devices in Canada require that the manufacturer of the device have MDSAP (Medical Device Single Audit Program) before the device application can be filed with Health Canada.
