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Indian Regulators Open Comment Period for Proposed Medical Device Rules


  • Draft medical device regulations have been published in India’s Official Gazette.
  • Industry has 30 days (until mid-November 2016) to comment on proposed regulatory changes.
  • Draft regulations would create separate registration and oversight systems for drugs and medical devices.

India Medical Device Rules 2016 published in Official GazetteFollowing the publication of draft medical device rules in India’s Official Gazette on October 17, 2016, the country’s Ministry of Health and Family Welfare has opened a 30-day comment period whereby industry and other interested parties may submit feedback regarding the new proposals.

The new regulatory proposals, first covered by Emergo in summer 2016, would establish two separate laws for pharmaceuticals and medical devices. Oversight of all medical devices and in vitro diagnostic products falling under the existing Drugs and Cosmetics Act of 1940 would shift to the new regulatory system designed solely for devices.

Following the comment period and review of industry feedback, the Indian government will finalize the draft regulations, although no specific timeframes for such a move have been provided. Still, the government seems to be moving forward at a steady pace with these new and long-awaited changes.

For more information on Indian medical device registration, watch our video overview and download our regulatory process chart.

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