WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Post-market obligations: adverse events, field safety corrective actions, withdrawals and post-market surveillance – 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-withdrawal: Cooperate with NRA enforcement against unsafe or non-compliant devices, including withdrawal, quarantine and disposal, and review technical documentation and revise labelling when unforeseen harm shows it is inadequate

What does 6.2.4.3-withdrawal require?

NRAs enforce through measures such as suspending or withdrawing the registration of manufacturers, representatives, importers or distributors, removing devices from the list of marketed devices, quarantine and disposal, public alerts, warning letters, prosecution and penalties. Manufacturers may be required to review their technical documentation and revise labelling, including precautions and warnings, where a device proves linked to unforeseen harm and the labelling inadequate, and should supply the additional safety information the NRA asks for before it issues a public alert.

Maintained by Gerard Blokdyk

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