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 6.3.3.3.1-distribution: Manufacturers select and contract qualified distributors and specify storage, handling, transport, installation, servicing, traceability and disposal requirements; distributors run a basic QMS and follow good distribution practice

What does 6.3.3.3.1-distribution require?

Because storage, warehouse practice, transport, installation, servicing, storage duration and user training can affect a device after it leaves the manufacturer, the manufacturer should choose and contract suitably qualified distributors (with adequate facilities, information systems and staff), specify where appropriate the requirements for storage, handling, transport, installation, servicing, traceability records and disposal, and periodically check that distributors comply. Distributors should operate a basic QMS covering their activities and follow good distribution practice, which ISO 13485:2016 (with GHWP guidance for distributors and importers) can support; widespread good distribution practice helps keep falsified products out of the supply chain.

Maintained by Gerard Blokdyk

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