CALL FOR COMMENTS on the PROPOSED Document "Guidance for Additional Considerations to support Conformity Assessment of Companion In vitro Diagnostic Medical Devices"

 
                                          
 

The proposed document " Guidance for Additional Considerations to support Conformity Assessment of Companion In vitro Diagnostic Medical Devices" is prepared by AHWP Working Group 2.

 Download file: Proposed_Guidance for Additional Considerations to support Conformity Assessment of Companion In vitro Diagnostic Medical Devices.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 WG 2 Chair, Mr. Wen-Wei TSAI (tww@fda.gov.tw ) or Co-Chair, Ir Prof. Albert POON (apoon.email@yahoo.com ) on or before 7 Dec 2017.

 

Thank you for your attention.