Device Label & Documentation Review Service

Guaranteed Performance. Trusted Expertise.

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 Device Label & Documentation Review. We provide the following Medical and IVD devices’ label and documentation review services: 

  • Review labeling materials such as product labels, package labels, user manuals, inserts for use (IFU) for conformance with Canadian regulations

  • Perform a gap analysis and provide a written label review to identify the label changes needed to attain compliance

  • Provide recommendations to effectively integrate product marketing claims with labelling compliance

Background:

Medical and IVD devices offered or imported for sale or use in Canada must meet the labelling requirements specified by Canadian Medical Devices Regulations (MDRs) and Health Canada. We put our expertise in this area to use for clients and help them become or stay compliant.

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