In Vitro Diagnostics - Singapore
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In Vitro Diagnostic Medical Device Definition
Any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination with any other reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, that is intended by its product owner to be used in vitro for the examination of any specimen, including any blood or tissue donation, derived from the human body, solely or principally for the purpose of providing information:
Concerning a physiological or pathological state or a congenital abnormality;
To determine the safety and compatibility of any blood or tissue donation with a potential recipient thereof; or
To monitor therapeutic measures; and includes a specimen receptacle;
Classification Systems for IVD Medical Device
IVD medical devices are classified into 4 classes and 7 rules, based on the individual risk and public health risk level.
Table 1:Classification system for IVD Medical Devices
Source : HSA guidance document GN-14 (Guidance on Risk Classification of IVD)
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