WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Manufacturer obligations: essential principles, technical documentation, clinical evidence, QMS, declaration of conformity, labelling and promotion – 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 6.2.2.5-advertising: Advertise and promote devices only within their authorized intended purpose, with evidence-backed claims, to appropriate audiences, and never falsely, misleadingly or deceptively

What does 6.2.2.5-advertising require?

Manufacturers, importers and distributors that promote devices, online included, should make sure promotion targets suitable audiences, makes only claims supported by evidence, covers only devices authorized for the market, matches the intended use and other labelling, and is not false, misleading or deceptive. Where misleading advertising is a problem the NRA may require pre-clearance, and breaches can lead to corrected materials, warning letters, seizure, fines, court orders or blocking the device from the market.

Maintained by Gerard Blokdyk

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