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 5.8-9.3-capacity: NRA: build and maintain regulatory competence through recruitment, retention, formal selection and annual training plans, evidence of staff competence, expert committees and external expertise

What does 5.8-9.3-capacity require?

The NRA needs general regulatory competencies (public health, analysis, communication, information handling, crisis management) and device-specific knowledge (the regulatory system, standards and harmonization, QMS, device technologies), even when it relies on others. It should recruit and retain competent staff, map training needs, set and annually review individual training plans, formally select, train, approve and assign staff for reviews, audits, market surveillance and enforcement, keep evidence of their competence, and draw on expert committees, CABs, WHO, regional centres of excellence and other regulators, with confidentiality agreements and declarations of interest for external experts.

Maintained by Gerard Blokdyk

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