The SFDA’s classification system generally follows international standards, such as those outlined by the Global Harmonization Task Force (GHTF), now succeeded by the International Medical Device Regulators Forum (IMDRF), and may also be influenced by the classification systems of other regulatory authorities. While specific details of the SFDA’s classification criteria may not be readily available, it typically includes classes similar to those found in other regulatory frameworks, such as:
Saudi Arabia classifies medical devices into four classes and uses the same 22 classification rules found in the MDR:
IVD classifications are similar to those defined in the EU IVDR:
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