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 requires MDEL Annual License Review (ALR) application to be received before April 1, 2021.
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 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

Served clients in over 100 countries

Registering over 6000 health products

Completed over 12000+ projects

100% success rate with MDEL and MDL

Health Canada Medical Device Licensing Solutions

Medical Device Licence (MDL) Solutions

Medical Device Establishment Licence (MDEL) Solutions

MDEL Renewal Solutions

FDA Medical Devices Licensing Solutions

FDA Compliance

We will cover you with FDA compliance solutions to sell medical devices in USA.

Trusted US Agent

We will act as your most trusted US Agent or manage 510(k) submissions of registrations.

Medical Device Registration

Help you register your overseas or Canadian medical devices with FDA.

Regulatory Experts

Our experts ensure you meet requirements of exporting and selling medical devices in USA.

Connect with our Medical Device Compliance Expert

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.

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