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 6.3.3.3-NRA-inspect: NRA: inspect registered establishments on a risk basis (scheduled or unannounced), rely on trusted inspections where possible, and license, suspend or withdraw registrations for uncorrected nonconformities

What does 6.3.3.3-NRA-inspect require?

The NRA should have power to inspect any registered manufacturer, importer or distributor, announced or not, to confirm that their premises, procedures and records allow compliance, prioritising higher-risk products, facilities with recent adverse findings and those not yet inspected, and relying on inspections by reference regulators, CABs or WHO where possible while keeping the right to inspect. It may license establishments for renewable periods and suspend or withdraw registration or licence where significant nonconformities are not corrected.

Maintained by Gerard Blokdyk

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