WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Placing on the market: establishment registration, authorized representatives, importers and distributors, listing, import documents, UDI and distribution – 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 6.2.3.3-import: Supply the import documentation the NRA requires (QMS certificates, proof of authorization in the exporting country, declaration of conformity, test reports), import through designated ports and do not release devices without NRA authorization

What does 6.2.3.3-import require?

Beyond registration and listing, the NRA may require import documents such as QMS certificates, proof that the exporting country authorized the device, the declaration of conformity and test reports; it may approve import documents before shipment, and may verify products on arrival at the port or at the importer's site, including sampling suspected falsified devices or lot verification testing for IVDs. Customs should not release devices unless the NRA has authorized them for the market, and the NRA may designate official ports of entry.

Maintained by Gerard Blokdyk

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