Health Canada unveils draft guidance for makers of Class III, IV devices

10/15/2010 | Clinica (subscription required)

Health Canada has released a draft guidance on requirements for manufacturers seeking to secure licenses for their medium- and high-risk medical devices. The draft document integrates the country's requirements with those of the Global Harmonization Task Force's Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices. Health Canada has set a Dec. 12 deadline for feedback on the proposed guidance.

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