Medical devices regulation 2.0 draws industry’s ire – Feedback

The second draft of the medical devices regulations, which were notified by the Union health ministry on Wednesday, four months after the first draft was issued, have once again drawn industry flak. The fresh rules, while dividing the medical devices into four groups on the basis of risk, have capped their shelf life at five years. Companies, mostly multinationals (MNCs), protested saying the rules were too stringent, citing global norm of 10-year validity for medical devices.

Among other guidelines, the new draft wants companies to specify manufacturing date along with expiry date on packaging. This move, according to MNCs, will restrict import of devices into India. Overall, the import laws for medical devices have been made tougher. For instance, the licensing authority will not allow import of any medical device, whose total shelf-life claim is less than three months and if it has less than 40 per cent residual shelf-life as on date of import.

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