Medical Health Devices Licensing Experts for Canada & USA

More than 6000 Licenses Successfully Delivered. Book your free consultation session with one of our licensing experts today. 

? 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.

30 Minutes Free Consultation

Type of License You Require for Importing or Distributing Medical Devices

Class I to IV Medical Devices

If you distribute or import class I to IV medical devices, you require an MDEL.

Class I Medical Devices

If you manufacture class I medical devices in Canada (eg. shields, masks, gowns, toothbrushes, etc.), you require an MDEL.

Foreign Businesses

If you manufacture, market or distribute medical devices to Canadian resellers from any other country (businesses outside Canada), you require an MDEL.

Are You Ready for an MDEL Audit by Health Canada?

Medical Devices related to COVID-19

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).

Why Quality Smart Solutions

mdel license application canada

Served clients in over 100 countries

Registering over 6000 health products

Completed over 120,000+ services

100% success rate with MDEL and MDL

Health Canada Medical Device Licensing Solutions

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Medical Device License (MDL) Solutions

Medical Device Establishment License (MDEL) Solutions

health canada medical device license
class 1 medical device canada license

MDEL Renewal Solutions

FDA Medical Device Licensing and Facility Registration Solutions

510(K) Pre-Market Notification

Help you register your medical devices, if required through a 510(k) pre-market notification.

Medical Device Facility Registration

We will register your device facility or activity through a secure online FDA portal.

Medical Device Label Compliance

Ensure your label adheres to FDA medical device label regulations as per applicable 21 CFR sections.

Trusted US Agent

We will act as your most trusted US Agent for your registered medical device facility.

Seeking Medical Device Compliance Help?
Contact Us Today

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.

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