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FDAnews Device Daily Bulletin

India Classifies 462 Devices, 250 IVDs Under New Regs

July 19, 2017

India’s Office of the Drug Controller General (DCGI) has classified 250 medical devices and 25 in vitro diagnostics under new device regulations that become effective in January 2018.

India’s device regulations separate devices from drugs for the first time. The new regulations classify devices into four risk-based categories — Class A to Class D — with Class D devices carrying the highest risk. The criteria by which devices are classified is specified in Rule 4, Chapter 11 of the new rules.

The DCGI enforces rules for importing and manufacturing higher-risk Class C and Class D devices.  It also oversees clinical trials and inspections for devices in these classes.  Of the newly classified devices, 84 fall under Class D, 157 fall under Class C, 198 are now under Class B, and 23 under Class A.

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