Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form.
Title:
Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form.
Origin/Publisher:
IMDRF
Document Type:
Guidance
Content:
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.