It’s been a long time coming but it looks as though India will achieve a new Medical Device Law starting 2018. The new rules incorporate many elements of the GHTF framework but with local variations around extent of third party assessment and things like local labeling and shelf life requirements.
The latest step is the publication of a medical device classification list – setting out the various risk classifications for 250 different devices and IVDs. This approach is reminiscent of the practice in China – where classification rules exist but they are applied by the regulator to develop a classification catalog. Contrast that to the approach in Europe and elsewhere where the manufacturer applies the rues and then justifies their approach to the regulator.
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