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View the guidance on registration/reregistration of IVD kits at www. fdanews. com/ext/resources/files/01/01-14-IndiaIVDreg.pdf the guidance on import of notified kits at www. The FDA s final UDI rule and draft guidance published in September change how devicemakers label their products. The guidance finalizes a draft issued last spring IMDRM May 2013. To achieve global harmonization regulators must implement UDI systems without regional or national differences IMDRF stresses. View the bill...
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