Hi Friend,
Well, MS and LCMS have wide range of application. They are widely used in all kind of laboratory ranging from chemistry lab to complex Bio-analytical labs.
Ask yourself whether your MS and LCMS are going to test any specimen (blood, plasma, urine, tissue) for diagnosis and that is too for clinical purpose (have effect of test result on health of patient). Only MS and LCMS those are used for clinical testing will be covered under In-vitro diagnostic devices. LC and LCMS used in clinical trial for detecting drug in blood of subject are “probably” not covered under IVD.
Next point, classification of IVD device depends on which type of tests they are going to perform. If your devices are used in testing where slight mistake leads to death of patient or incurable damage like HIV testing etc, it will be considered as class III. LCMS may be class I or class III depending on tests it would perform. In case if LCMS is going to perform all tests (diagnosis of simple disease to high disease) it will be classified as highest class.
So right now it’s only puzzle to consider LCMS as IVD device. In US, clinical MS are classified as class II devices.
I don’t know whether JMDN codes are for IVD or only for MD. Link for JMDN codes is uploaded in another elsmar discussion page. I can’t share it here.
Also check Mass spectrometry society of Japan (jssm.net), you may get something informative.
Have a nice day and waiting for your decision whether MS is IVD in Japan or not.
