WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Recommendations to NRAs: pre-market, market and post-market oversight, pathways and implementation – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.2.4.3-NRA-enforce: NRA: enforce against non-compliant, unsafe or falsified devices with proportionate measures, consult manufacturers before public alerts, inform the public and share concerns with the auditing NRA or CAB

What does 6.2.4.3-NRA-enforce require?

NRAs must monitor compliance by registered parties and act when public health is at risk, using measures from suspension or withdrawal of registration and delisting to quarantine and disposal, public alerts, warning letters, prosecution and fines, informing the public appropriately. Before issuing a public alert they should request information from and consult the manufacturer (and possibly external advisers). Where an imported device is judged unsafe, the NRA should consider telling the NRA or CAB that audits the manufacturer, and for falsified devices it should work with other regulators, customs, police, the judiciary, manufacturers and patient groups, and document a local destruction procedure so falsified products are not re-exported.

Maintained by Gerard Blokdyk

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