CALL FOR COMMENTS on the PROPOSED document "Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices”


                                          
 

The proposed AHWP document "Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices” is prepared by AHWP Working Group 1a-IVDD, based on the final document GHTF/SG1/SG1/N063:2011 developed by GHTF Study Group 1. 

If you have any comments, please send them to the AHWP Secretariat (secretariat@ahwp.info) and copy to the AHWP WG1a Chair, Ms. Liu Li-Ling (lll@fda.gov.tw) and WG1a Co-chair, Mr CHERN Jiin Feng Jeffrey (JFChern@itri.org.tw) on or before 26 Nov 2013.

Thank you.

Download file:Proposed_WG1a_3.pdf