How Authorities Should Communicate Globally About Device Threats

Only those countries signed up to the International Medical Device Regulators Forum are automatic members of the new global communication system for risky devices and IVDs.

The International Medical Device Regulators Forum (IMDRF) has published a post-market surveillance national competent authority report (NCAR) exchange criteria and report form.

This 18-page guidance document describes “a two-way communication system involving confidential information for serious public health issues.”