WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 5.5-5.7-NRA: Government: appoint an NRA with independent decision-making, defined governance and public performance reporting, adequate and transparent funding (fair, reviewed user fees if any), and a code of conduct and conflict-of-interest policy

What does 5.5-5.7-NRA require?

Implementation needs an NRA, within a ministry or as an accountable agency, able to decide independently within the law, with defined governance, checks and balances, published performance reports, power to issue regulations and enforce, and the ability to designate and monitor conformity assessment bodies. Its resources (staff, infrastructure, IT) should match its mandate and grow with expanded controls; any user fees should be predictable, transparent, non-discriminatory, proportionate and periodically reviewed, and reliance can reduce costs. The NRA, its staff, committees and CABs should act consistently, impartially and transparently under a code of conduct and a conflict-of-interest policy, with decisions based on science.