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 6.2.3.2-listing: Submit and keep current a listing of each device placed on the national market, using an internationally recognised nomenclature and information consistent with the technical documentation

What does 6.2.3.2-listing require?

Manufacturers, authorized representatives, importers and distributors should list each device with the NRA when it is placed on the national market and keep the listing current, giving the data set the NRA specifies, including standardized generic names from an internationally recognised nomenclature where possible, consistent with the technical documentation. A listing lets the NRA see what is on the market and contact the responsible party, but is not a market authorization.

Maintained by Gerard Blokdyk

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