Indian Medtech Finds Errors In New Draft List Classifying Devices, IVDs
India’s industry association claims that some of the products on the regulator’s new draft list classifying over 700 medical devices and IVDs have been categorized incorrectly. The list is expected to be finalized at least three months before new medical device rules come into effect in January 2018.
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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.
India’s draft guidance describes fundamental design and manufacturing requirements that, when met, indicate a medical device or IVD is safe and performs to its specification.
India’s new draft list explains how over 700 medical devices and IVDs will be classified under new rules that will come into force in January 2018.