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
Registering over 6000 health products
Completed over 12000+ projects
100% success rate with MDEL and MDL
We will cover you with FDA compliance solutions to sell medical devices in USA.
We will act as your most trusted US Agent or manage 510(k) submissions of registrations.
Help you register your overseas or Canadian medical devices with FDA.
Our experts ensure you meet requirements of exporting and selling medical devices in USA.
In addition to your licensing needs, please feel free to contact us in case you need our help in coaching, training, mock audits, accompanying your team when Health Canada conducts on-site audits of your MDEL. We are committed to standing by you throughout your journey in your medical device business.
