A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product.
View this resource Bookmark this resourceOrphan Drug or Medical Device Designation
Japanese Orphan Drugs/Medical Devices/Regenerative Medical Products Designation
Published by IRDiRC
Regulatory AffairsJ-ODDMedical ProductMHLWResearch and Drug DevelopmentMHLW or PMDA RegulatoryOrphan Drug or Medical Device DesignationOrphan Drug DesignationEarly Access SupportIn Japan, drugs, medical devices, and regenerative medical products can be designated as orphan drugs, medical devices, or regenerative medical products based on the Article 77-2 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics if they are intended for use in basically less than 50 000 patients in Japan and for which there is a high medical need.
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Humanitarian Use Device
Published by IRDiRC
Regulatory AffairsEarly Access SupportMedical DeviceHumanitarian Use DeviceSafe Medical Devices Actthe Safe Medical Devices Act to create a new regulatory pathway for device products intended for diseases or condition that affect small (rare) populations that defined HDEs and HUDs.
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