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Canadian Guidance Clarifies New Formats For Marketing Applications

 
• By Neena Brizmohun

Health Canada is planning to adopt the International Medical Device Regulators Forum’s Table of Contents formats as of April 1.

Canada
Canada is supporting the global convergence of documentation requirements for devices • Source: Shutterstock

Health Canada has published draft guidance relating to its planned implementation in April of the International Medical Device Regulators Forum’s Table of Contents (ToC) formats for use in medical device and IVD marketing authorization applications.

The draft guidance incorporates content from the IMDRF ToC documents and regional guidance specific to the Canadian context.

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