WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 8.5-SF: Report suspected substandard or falsified devices to the NRA, buy and distribute only through reliable sources, and use UDI and track-and-trace tools to protect supply chain integrity

What does 8.5-SF require?

Substandard and falsified devices arise from manufacturing errors or deliberate deception and can enter both online and legitimate supply channels, often with fake certification marks. The GMRF expects proportionate legal powers and sanctions, effective oversight of import, distribution and sale, reporting mechanisms that encourage health care providers, distributors and others to report suspicious devices, public awareness about buying from reliable sources, and use of UDI and track-and-trace systems to protect supply chain integrity and detect falsified products early.