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 6.2.3.1.2-importer: Importers and distributors register, supply only conforming devices with proper labelling and instructions, pass feedback and complaints to the manufacturer or representative, keep traceability and follow the manufacturer's storage, handling, transport and maintenance requirements

What does 6.2.3.1.2-importer require?

Anyone importing or distributing devices should at least be registered with the NRA, and regulation may require them to undertake that the devices they import or distribute meet safety and performance requirements and come with the proper documentation, labels and instructions; that customer complaints and feedback about adverse events and incidents reach the manufacturer or authorized representative; that devices can be traced through the part of the supply chain they handle; and that they follow the manufacturer's requirements on storage, handling, transport and, where relevant, maintenance.

Maintained by Gerard Blokdyk

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