WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.3.1-NRA-premarket: NRA: oversee clinical investigations, recognise and supervise CABs, adopt a nomenclature system and a UDI system aligned with international practice, and control advertising

What does 6.3.1-NRA-premarket require?

At the expanded level the NRA should have power to authorize and oversee clinical investigations (requiring prior authorization and ethics oversight, collecting progress and serious incident reports, and suspending or stopping investigations that cause harm, without demanding local studies absent a sound scientific reason); set criteria for recognising CABs for QMS audits and pre-market reviews by device category, supervise them and consider relying on certificates from CABs elsewhere while keeping final decisions; select an internationally recognised nomenclature (such as EMDN, GMDN or UMDNS) through a stakeholder committee judging harmonization, free accessibility, governance, update frequency, use in source countries, language and interoperability, and implement it with mapping, a single-system transition plan and evaluation; adopt a UDI system following IMDRF guidance, accrediting issuing agencies and linking UDI-DI records to nomenclature terms; and strengthen advertising control, including pre-clearance or independent pre-clearance bodies where misleading promotion is a problem.