Introduction This document was developed by the IMDRF National Competent Authority report (NCAR) Exchange Program Working Group as an update to the original document (N79) authored by Study Group 2 of the Global Harmonization Task Force (GHTF) in relation to the GHTF Exchange Program. This document concerns a two way communication system involving confidential information for serious public health issues. This document will provide guidance, procedures and for exchange of reports between IMDRF members. Other forms of information exchange may be addressed in the future. 1. Scope This document provides guidance on: the criteria to be used for deciding when to exchange information, the procedures to follow when exchanging information, the forms to use for exchanging information, the requirements for members participation in the NCAR Exchange Program. 2. References The latest revision of GHTF SG2 N57 Medical Devices Post Market Surveillance: Content of Field Safety Notices. 3. Definitions NCAR Secretariat The organization which facilitates and monitors the exchange of NCARs between reporting National Competent Authorities (NCAs) and other NCAR participants in accordance with this guidance. The NCAR Secretariat is the recipient and repository of all NCARs. The NCAR Secretariat monitors the quality and consistency of the NCAR Exchange Program and circulates NCARs in line with the provisions of section 6.1 of this guidance. The NCAR Secretariat produces and publishes statistical analysis /reports regarding participation and report exchange on a periodic basis. The NCAR Secretariat also maintains an updated list of participants in the NCAR Exchange Program and keeps this list publicly available on the IMDRF website. The NCAR Secretariat does not assess or propose action on the NCARs received; this is the responsibility of the originator and recipients of the NCAR. Field Safety Corrective Action - FSCA
Introduction This document was developed by the IMDRF National Competent Authority report (NCAR) Exchange Program Working Group as an update to the original document (N79) authored by Study Group 2 of the Global Harmonization Task Force (GHTF) in relation to the GHTF Exchange Program. This document concerns a two way communication system involving confidential information for serious public health issues. This document will provide guidance, procedures and for exchange of reports between IMDRF members. Other forms of information exchange may be addressed in the future. 1. Scope This document provides guidance on: the criteria to be used for deciding when to exchange information, the procedures to follow when exchanging information, the forms to use for exchanging information, the requirements for members participation in the NCAR Exchange Program. 2. References The latest revision of GHTF SG2 N57 Medical Devices Post Market Surveillance: Content of Field Safety Notices. 3. Definitions NCAR Secretariat The organization which facilitates and monitors the exchange of NCARs between reporting National Competent Authorities (NCAs) and other NCAR participants in accordance with this guidance. The NCAR Secretariat is the recipient and repository of all NCARs. The NCAR Secretariat monitors the quality and consistency of the NCAR Exchange Program and circulates NCARs in line with the provisions of section 6.1 of this guidance. The NCAR Secretariat produces and publishes statistical analysis /reports regarding participation and report exchange on a periodic basis. The NCAR Secretariat also maintains an updated list of participants in the NCAR Exchange Program and keeps this list publicly available on the IMDRF website. The NCAR Secretariat does not assess or propose action on the NCARs received; this is the responsibility of the originator and recipients of the NCAR. Field Safety Corrective Action - FSCA
imdrf-tech-150326-pms-ncar-150410.docx