Health Canada Medical Device Establishment License (MDEL) Service: Class I, II, III, IV

Guaranteed Performance. Trusted Expertise.

Looking for an expert partner to manage the entire application process to obtain a Health Canada Medical Device Establishment License (MDEL) for any of your class I, II, III, or IV medical devices? 

How we can help:

With our team’s 2,000+ projects & services and 25+ years in-depth Canadian market commercial and Health Canada regulatory expertise, we are fully positioned to help our clients from all over the world with virtually any project for the Canadian market, including Health Canada Medical Device Establishment License (MDEL) applications. We manage the entire application process on behalf of our clients to help them obtain a Health Canada medical device establishment license (MDEL) for class I, II, III, or IV medical devices. We will:

  • Develop up to eight (8) standard operating procedures (SOPs) custom prepared for client’s product portfolio and operations to satisfy Health Canada MDEL requirements

  • Review existing SOPs and bring them up to compliance with Health Canada MDEL requirements

  • Perform a gap analysis vs. Health Canada requirements

  • Advise clients on how to mitigate any gaps

  • Prepare a custom MDEL application package as per client’s product portfolio and operations

  • Enable application submission to Health Canada

  • Facilitate responses to any Health Canada questions post-submission

  • Realize the MDEL issuance by Health Canada

  • Provide post-license client training for MDEL maintenance

Background: Who requires Health Canada MDEL?

Do you or your firm perform or plan to perform any of the regulated activities listed below, as it pertains to medical devices in Canada, whether online or offline or both?

As per Health Canada, any person or firm who imports into Canada, or sells in Canada, a medical device for human use requires an establishment license (some exceptions apply).

Please note that the Medical Devices Regulations apply to

(a) the sale and advertising for sale of a medical device; and

(b) the importation of a medical device for sale or for use on individuals, other than importation for personal use. 

The definition of “sell” in the Food and Drugs Act is:

“Sell” includes

(1) Offer for sale

(2) Expose for sale

(3) Have in possession for sale

(4) Distribute to one or more persons, whether or not the distribution is made for consideration

(5) Lease

(6) Offer for lease

(7) Expose for lease

(8) Have in possession for lease 

If the answer is ‘Yes’ to any of the above, then there is a high likelihood that Health Canada MDEL requirements will apply to your situation.

Please contact us to confirm or to discuss next steps.

More information?

Health Canada MDEL image .jpg

Third Party Mark Notice: All third-party brand names and logos used on this website are the property of their owners and are used for identification purposes only without endorsement.