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並前往http://www.fdaghana.gov.gh/images/stories/pdfs/downloads/drugs%20guidelines/medical%20devices/GUIDELINE%20FOR%20REGISTRATION%20OF%20SOFTWARE%20AS%20MEDICAL%20DEVICE.pdf

guideline for registration of software as medical device

IMDRF SaMD WG N10 / Software as a Medical Device: Key Definitions b. GHTF/SG1/N70:2011 “Label and Instructions for Use for Medical Devices”.

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