India Settles On Classifications For Nearly 600 Devices, IVDs

The final list of medical devices and IVDs classifies products according to India’s imminent new rules for medtech products. It contains about 100 fewer entries than the original draft issued in June.

ABCD
India's new classification system has four risk classes • Source: Shutterstock

As the countdown begins to the introduction of new medical device rules in India on Jan. 1, 2018, the health care products regulator has finalized and published a list of nearly 600 medical devices and IVDs clarifying how these products will need to be classified under the coming regulations.

The list, which classifies products according to their level of risk, contains around 100 fewer entries than the draft version of the document that was issued for public consultation in...

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