INDIA OFFICIALLY REQUIRES FIRST NEW DEVICES TO BE REGISTERED UNDER NEW MEDICAL DEVICE RULES, 2017

India’s Central Drugs Standards Control Organization (CDSCO) has officially added four medical devices to the list requiring registration. The four new additions are:

(1) glucometers,
(2) blood pressure monitoring devices,
(3) nebulizers, and
(4) digital thermometers.

Manufacturers and Importers of products under these categories need to immediately apply for import licenses in Form MD-14 of the Medical Device Rules, 2017. Products without valid registrations may not be imported and marketed after January 1, 2020.

The mandate was published in the Gazette of India on December 3rd, 2018 by the Ministry of Health and Family Welfare (Department of Health and Family Welfare). The published announcement constitutes Gazetting, officially implementing the new policy. The resolution to regulate this list of devices was originally raised 5 months earlier at the July 25th, 2018 Drugs Technical Advisory Board (DTAB) meeting.

It is worth noting that prior DTAB meetings yielded announcements that various other devices would soon require registration. However, since, they have not been Gazetted to date.

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