Health Canada Medical Device License (MDL) Service: Class II, III, IV

Guaranteed Performance. Trusted Expertise.

Looking for an expert partner to obtain or amend the Health Canada MDL for your Class II, III, or IV medical device(s)? Manage the entire application process?  

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 License (MDL) applications. We manage the entire application process for Class II, III, or IV Health Canada MDLs on behalf of our clients. This includes:

  • A comprehensive review of the medical device & manufacturer information

  • A gap analysis vs. Health Canada requirements

  • Pre-submission consultation with Health Canada (as needed)

  • Preparation of application package

  • Application submission to Health Canada

  • Facilitating responses to any Health Canada questions

  • MDL issuance to the client by Health Canada

  • Ongoing MDL maintenance training for the client

Background:

As per Health Canada, medical devices are classified into one of four classes by means of classification rules, where Class I represents the lowest risk and Class IV represents the highest risk. Class II, III and IV medical devices must be licensed prior to importation or sale in Canada. A licence is issued to the device manufacturer for each application submitted, provided the requirements of the Medical Devices Regulations (MDR) are met.

More information?

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