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Unlock the Canadian Market: Get Your Medical Device Licensed with Confidence

Bringing a medical device to market in Canada isn’t just about innovation—it’s about navigating a complex regulatory framework. With the right partner by your side, your path to Health Canada approval can be smooth, swift, and stress-free.

Save time obtaining (MDEL Registration/Renewal, SaMD, IVD, MDL).


Quality Smart Solutions worked diligently and helped with multiple levels including license registration, regulations, and much more. We will always look to Quality Smart Solutions for additional support.
Alexander Fiscalini
ToonOut Ltd.

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!
Don Gauvreau
Sapro
Adopting the Global Medical Device Nomenclature (GMDN)

Are You Ready for an MDEL Audit by Health Canada?

  • Health Canada conducts remote/virtual assessments of MDEL holders as soon as the MDEL is obtained.
  • You must present copies of standard operating procedures related to MDEL activities
  • You must follow good practices by adhering to procedures, generating records
  • As an MDEL holder, you must answer a series of questions
  • You must provide responses in 3 to 5 business days.
As a prominent Canadian medical device consultant, we help clients meet medical device regulations, assist with Health Canada approval, MDL License, and MDEL Application. We also support businesses with the medical device renewal process, medical establishment license in order to set up a medical device manufacturing facility.
  • Importing medical devices into Canada: When do you need an MDEL Import Agent?

As a foreign company that does not have a presence in Canada wants to enter the Canadian market, an MDEL Import Agent is able to register your products in Canada. Else way, a Canadian company may also use an MDEL Import agent especially when you want to offload the legal responsibilities relating to the importation of medical devices to professionals who understand and meet compliance requirements.

  • Seeking an MDEL Importer? We can help!

Importers should ensure that the device they are bringing into Canada is compliant with all the necessary regulations. The costs of non-compliance can be huge – in terms of monetary losses and reputational damage as well.

Save yourself the heavy cost of yearly licensing fees, yearly compliance, and regulatory requirements – export your devices stress-free!  Our medical device import partners are long standing MDEL holders serving hundreds of medical device companies and have the infrastructure to be your MDEL import partner. 

Type of Licenses You Require for distributing or Importing Medical Devices into Canada!

Class I to IV Medical Devices

If you distribute or import class 1 to 4 medical devices including covid antigen or molecular test kits you require a 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.

FDA U.S Medical Device Licensing?
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Medical Device Regulations (MDEL & MDL) - Frequently Asked Questions

  1. If you distribute or import class I to IV medical devices (including COVID-19 antigen test kits) you require a Medical Device Establishment License (MDEL).
  2. If you manufacture Class I medical devices in Canada (eg. shields, masks, gowns, toothbrushes, etc.), you require an MDEL.
  3. If you manufacture, market, or distribute medical devices to Canadian resellers from any other country (businesses outside Canada), you require an MDEL.

Covid-19 test kits, either antigen or molecular (PCR) based, are In-Vitro Diagnostics Tests (class IV) devices. These test kits can be registered faster under the Interim Order Authorization pathway (IO).  Health Canada has published a list of medical devices that have received interim order Authorization.

  • The testing device is registered with Health Canada under interim order or permanent medical device license. If the device is not registered, then this process must happen first before importation and/or distribution is permitted.
  • If you intend to import and sell directly to consumers, you will need a medical device establishment license (MDEL)
  • If you intend to resell these devices to a retailer or reseller, you must obtain an MDEL with the distributor activity (note that one MDEL can cover one or more activities i.e. importing and/or distributing)
  • As an MDEL holder you must follow the practices and procedures based on the respective activities you plan to conduct. Standard Operating Procedures are required for your business.
  • If your business generates revenue under $5 million you may qualify as a small business and your Health Canada application fees will be reduced by approximately 25%
  • Health Canada fees for an MDEL are due before license issuance (Health Canada will notify you via email) and an annual renewal fee is due when you submit your license renewal each year by April 1. Please note that MDEL fees are not prorated.
  • You must follow good practices by adhering to procedures and generating records
  • As an MDEL holder, you must answer a series of questions from Health Canada
  • You must provide responses in 3 to 5 business days.
  • Health Canada conducts remote/virtual assessments of MDEL holders as soon as the MDEL is obtained.
  • You must present copies of standard operating procedures related to MDEL activities
  • We can confirm the class of your medical devices anddetermine whether a license is required, and confirm if they qualify for fee exception
  • We will collect important information, such as device details, manufacturer quality systems qualifications, global market history, clinical or non-clinical evidence,
  • etc
  • We can help prepare the MDL application and, if applicable, a dossier to support your device
  • We can act as your regulatory correspondent with Health Canada to answer questions on your behalf
  • We can prepare and submit your MDEL application and answer all questions asked by Health Canada
  • We can develop and write SOPs for your MDEL activities to ensure you have the foundational procedures to establish a sound quality management system
  • We submit a small business fee reduction application form in case your business qualifies as a small business
  • After you are licensed, we can conduct a routine audit of your activities and review standard operating procedure updates
  • We can help complete and submit the MDEL Renewalapplication (ALR package) before April 1
  • We will confirm if all supporting documents are complete and if there have been any changes to your activities since the last renewal
  • We will evaluate and verify all the information to avoid refusal
  • We will check if any product for which licenses are listed has not been withdrawn from the Canadian market

The MDEL is issued by Health Canada for activities of manufacturing, importing, or distributing medical devices for use in Canada. 

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