CDSCO has issued a guidance document clarifying how software-based and AI-enabled medical devices will be regulated under the Medical Devices Rules, 2017. This provides a clear compliance roadmap for innovators and manufacturers, distinguishing between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), and introducing risk-based classification (Classes A-D).
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- ›Regulatory Body: Central Drugs Standard Control Organisation (CDSCO)
- ›Governing Act: Drugs and Cosmetics Act, 1940
- ›Target this Data: CDSCO issued guidance on software-based medical devices under MDR 2017
- ›Target this Nodal Body: Central Drugs Standard Control Organisation (CDSCO)
- ›Target this Legal Point: Drugs and Cosmetics Act, 1940 and Medical Devices Rules (MDR), 2017
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