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 5.2-5.4-plan: Government and NRA: carry out a gap analysis with stakeholders, publish a risk-based implementation plan aligned with resources, and monitor implementation with indicators (such as the WHO global benchmarking tool) reported publicly

What does 5.2-5.4-plan require?

Before introducing or revising regulation, the NRA should analyse existing controls against international guidance, seeking views from patients, health care and industry, to set priorities (for example import controls first where there is little local production). Once the law is adopted it should publish an implementation plan driven by public health priorities and resources, with risk management built in, time for awareness and drafting, and performance indicators and a baseline (the WHO GBT plus medical devices offers functions and indicators), reporting progress to parliament and the public; a modest law properly enforced is preferable to a broad one that cannot be.

Maintained by Gerard Blokdyk

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