CALL FOR COMMENTS on PROPOSED document "Principles of In Vitro Diagnostic (IVD) Medical Devices Classification"Submission Dossier for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices"

 
                                          
 

The proposed document "Principles of In Vitro Diagnostic (IVD) Medical Devices Classification"Submission Dossier for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices" is prepared by AHWP Working Group 2.

 Download file:03_AHWP-WG2-WP003-2016 IVD Submission Dossier__20160912.pdf 

 Download file:AHWP Comments Template_verMay2014.docx 

If you have any comments, please send them to the AHWP Secretariat (secretariat@ahwp.info) with the template below and copy to the AHWP WG2 Chair, Dr Wen-Wei Tsai (tww@fda.gov.tw) and WG2 Co-chair, Mr Albert Poon (apoon.email@yahoo.com) on or before 28 Oct 2016.

 

Thank you for your attention.