WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.2.3.1-registration: Register each local manufacturer, authorized representative, importer and distributor establishment with the NRA, with a separate registration for each role, and notify significant changes promptly

What does 6.2.3.1-registration require?

Distributors, importers, authorized representatives and local manufacturers that place devices on the market or make them available should register their establishments with the NRA, with a separate registration for each activity where one company holds more than one role. Significant changes, for instance to ownership, premises, the named responsible person or the activities covered, should be reported quickly so the register stays accurate; the NRA uses it for inspections, field safety corrective action monitoring and enforcement and may publish it.