WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Recommendations to governments and NRAs: legal basis, NRA set-up, resources, reliance and the stepwise controls – 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 5.9-reliance: Government and NRA: provide in law for reliance on and recognition of reference regulators, CABs and WHO, keep national-only functions in-country, and join information-sharing networks

What does 5.9-reliance require?

The law should state how far the NRA may use the assessments and decisions of reference regulatory authorities, CABs or WHO (including prequalification and abridged pathways), revising legislation within a reasonable time if reliance is prohibited, while the NRA keeps final responsibility for what is supplied. Some functions remain national: import controls, registration of local parties, handling domestic adverse events, market surveillance, monitoring field safety corrective actions and withdrawals, though work-sharing can help. The NRA should join formal and informal information-sharing networks, including for prompt contact on serious public health threats.

Maintained by Gerard Blokdyk

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