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 6.1-stepwise: NRA: implement controls stepwise, enforcing the basic-level controls before adopting expanded-level ones, and only when the legal basis and resources exist

What does 6.1-stepwise require?

The GMRF recommends moving from basic-level controls (law, classification, essential principles, declaration of conformity, QMS, labelling, advertising, exceptional situations, establishment registration, listing, import controls, adverse event reporting, FSCA notification, withdrawal, safety alerts and market surveillance) to expanded-level controls (clinical investigation oversight, CAB oversight, recognised standards, nomenclature, UDI, advertising review, QMS audits, submission review, post-market surveillance review, market surveillance systems, inspections, local production and regulatory testing) only once the basic ones are effectively enforced, the law provides for them and resources are available, implementing expanded elements stepwise according to national priorities.

Maintained by Gerard Blokdyk

Other controls in 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

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices controls