Global harmonisation in definition and classification of IVDs

It is necessary to develop new regulatory system, in order to meet the recent trend where new types of IVDs for medical decisions, those for prognosis and risk assessment and those based on advanced technology are increasing. This should be based on the global classification defined by International Medical Device Regulators Forum (IMDRF).


  • For the purpose of global harmonisation, Japan should expand the definition (scope) of IVDs and define classification based on intended use and risk.