No relief to medical device makers: Health Minister declines to relax last date for registration of medical devices
As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action, an official source said.;
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New Delhi: Majority of the medical devices in India will come under the licensing regime from October 1 as notified by the central government, with Union Health Minister Mansukh Mandaviya refusing to relax the deadline for compulsory registration. According to official sources, the government has received several representations from manufacturers and their associations seeking extension of the October 1 deadline for registration of Class A-low risk and Class B-low to moderate risk medical devices.
In a review meeting held last week, Mandaviya categorically stated there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe.
He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration.
As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action, an official source said.
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