India Finalizes New Regulations Specifically for Devices

India has finalized new regulations that separate out devices for the first time from broader drug regulations.

Effective on Jan. 1, 2018, the regulations will free device manufacturers from compliance with regulations written for pharmaceuticals. For example, India’s drug regulations mandate four-phase clinical trials, whereas the new device regulations require two-phase trials.

Starting on Jan. 1, 2022, all medical devices sold in India will require a unique device identification (UDI), including a device identifier and a production identifier. A device identifier is a global trade number. A production identifier would include a serial number, lot or batch number, software version, and manufacturing and/or expiration date.