Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
**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 forms for exchange of reports between IMDRF members. Other forms of information exchange may be addressed in the future.
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 IMDRF members participation in the NCAR Exchange Program.
References
The following documents were used in the development of this document.
• GHTF/SG2/N57R8:2006 Medical Devices Post Market Surveillance: Content of Field Safety Notices.
• IMDRF/AE WG/N85: 2024 Common Data Set for Adverse Event Data Exchange between IMDRF Regulators
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