In the dynamic landscape of medical device regulations in India, any alteration to

A Predicate Device in the context of a 510(k) submission refers to a

š—”š—®š˜š—¶š—¼š—»š—®š—¹ š—£š—¼š—¹š—¶š—°š˜† š—¼š—» š—„š—²š˜€š—²š—®š—暝—°š—µ & š——š—²š˜ƒš—²š—¹š—¼š—½š—ŗš—²š—»š˜ š—®š—»š—± š—œš—»š—»š—¼š˜ƒš—®š˜š—¶š—¼š—» š—¶š—» š˜š—µš—² š—£š—µš—®š—暝—ŗš—®-š— š—²š—±š—§š—²š—°š—µ š—¦š—²š—°š˜š—¼š—æ

The Indian government approved the š—”š—®š˜š—¶š—¼š—»š—®š—¹ š—£š—¼š—¹š—¶š—°š˜† š—¼š—» š—„š—²š˜€š—²š—®š—暝—°š—µ & š——š—²š˜ƒš—²š—¹š—¼š—½š—ŗš—²š—»š˜ š—®š—»š—± š—œš—»š—»š—¼š˜ƒš—®š˜š—¶š—¼š—»

Regulation of all medical devices in India by Oct 1, 2023

Starting October 1, 2023, š’‚š’š’ š’š’š’-š’š’š’•š’Šš’‡š’Šš’†š’… š‘Ŗš’š’‚š’”š’” š‘Ŗ š’‚š’š’… š‘Ŗš’š’‚š’”š’” š‘« š‘“š’†š’…š’Šš’„š’‚š’ š’…š’†š’—š’Šš’„š’†š’”