Health Canada Private Label Medical Device License Service

Guaranteed Performance. Trusted Expertise.

Looking for an expert partner to manage the entire process to obtain or amend your Health Canada private label medical device license application(s)?

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 Private Label Medical Device License applications. We manage the entire application process on behalf of our clients to help them obtain Health Canada Private Label Medical Device Licenses. This includes:

  • A comprehensive review of the medical device, original equipment manufacturer (OEM), and private label manufacturer information

  • A gap analysis vs. Health Canada requirements

  • Preparation of application package

  • Application submission to Health Canada

  • Facilitating responses to any Health Canada questions

  • Private label medical device license issuance to the client by Health Canada

  • Ongoing license maintenance

  • We advise and help the private label manufacturers implement and manage the various agreements and regulatory compliance frameworks they need to have with the original manufacturers 

  • We advise and help the private label manufacturers obtain the applicable Health Canada licenses

  • Finally, we help the private label manufacturer comply with the provisions of the Food and Drugs Act and Medical Devices Regulations initially and on an ongoing basis to confirm they have procedures and systems in place to handle complaints, perform mandatory problem reporting to Health Canada, and manage recalls etc.

Background:

Health Canada recognizes that certain businesses sell medical devices under their own brand names or trademarks while the actual devices are manufactured by other original manufacturers. These businesses are commonly referred to as private label manufacturers, even though most of the manufacturing activities are carried on by the original manufacturers. Health Canada has specific licensing requirements that must be adhered to by anyone marketing medical devices as a private label manufacturer.  

More information?

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