WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.3.2-NRA-review: NRA: verify manufacturers' QMS by audit or reliance on valid certificates, review submissions against transparent criteria using harmonized formats, apply extended review triggers, and handle changes with guidance

What does 6.3.2-NRA-review require?

The NRA should be able to verify that manufacturers meet QMS requirements, through its own trained inspectors or designated CABs, or by relying on valid ISO 13485 certificates (typically three to five years) of appropriate scope from recognised CABs and other jurisdictions' audits, keeping the right to inspect on suspicion. Market authorization decisions should follow transparent published criteria, prescribe the form of approval and allow post-market follow-up; the NRA should accept harmonized electronic formats such as the IMDRF table of contents or the ASEAN CSDT, publish criteria for more extensive review (innovative technology, new intended use, device type new to the manufacturer, high incident rates, hazardous materials, public health concerns, classification disagreements, devices not authorized elsewhere, lay life-supporting use, self-tests), issue guidance on changes, consider local factors (language, power supply, population, health care conditions), and use expert committees under confidentiality and interest declarations while keeping the final decision. Indicative review times by class are given in section 7.