Indian Regulators to Expand Coverage of Medical Devices

Following recent meeting of India’s Drug Technical Advisory Board and Drug Consultative Committee, proposals to expand the list of Notified medical devices requiring registration have emerged.

Our sources in India tell us of a proposal to bring 20 new products under the scope of Notified Devices in an effort to provide clarity regarding pacemakers, defibrillators, dental implants, neurological implants, thermometers, blood pressure apparatuses and other devices.

In addition, regulators have proposed bringing more IVD products into the Indian registration process.

We will keep you informed as we learn more.

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