Health Canada intends to adopt GHTF Summary Technical Documentation (STED) format for class III and IV device applications

Health Canada intends to adopt GHTF Summary Technical Documentation (STED) format for class III and IV device applications

The Therapeutic Products Directorate (TPD), Health Canada has announced that it intends to adopt the Global Harmonization Task Force’s STED guidance document published February 21, 2008 to encourage and support the global convergence of documentation requirements for medical devices.  Adoption of the STED as a basis for demonstrating conformity to the Essential Principles of Safety and Performance of Medical Devices (or ‘Essential Principles’) will most likely occur by way of a phased-in approach.  Once fully implemented (July 1, 2010), manufacturers would be expected to submit Canadian premarket applications for Class III and IV medical devices based on the STED guidance document.

Write a Reply or Comment