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 6.2.3-NRA-registers: NRA: run establishment registration and device listing systems, check them periodically, publish them, and specify listing data and nomenclature

What does 6.2.3-NRA-registers require?

The NRA should operate registration of distributors, importers, authorized representatives and local manufacturers, and an information system for device listings, specify the data required, check the validity of registrations at set intervals, and make registration and listing information publicly accessible (for example through a portal) so purchasers and users can identify legally marketed devices and responsible parties; it should be clear that listing is not authorization.

Maintained by Gerard Blokdyk

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