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Proposed Documents related to Conformity Assessment under the Medical Device Administrative Control System

The following documents relating to conformity assessment of medical devices have been published:

  1. Guidance Notes GN-04: Conformity Assessment Framework and Conformity Assessment Bodies
  2. Technical Reference TR-001: Principles of Conformity Assessment for Medical Devices
  3. Technical Reference TR-002: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

Please click here to go to our section Guidance Notes to download the "Guidance Notes" and Technical References.

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Last Revision Date : 15 December 2012