India Expands Regulation of Medical Devices

Moving to implement a series of first-time regulations on its growing medical device industry, the Indian government has announced that ultrasounds and other imaging devices sold in the country will soon require registration. The recent announcement by India’s Central Drugs Standard Control Organization (CDSCO) affects a broad range of imaging equipment, including X-Ray machines, CT scans, and both MRI and PET equipment. It is the latest move by India to implement a 2017 law that established regulations on the medical device industry.

Previously, the medical device industry in India was largely unregulated, with only a small number of product families requiring registration by the government. These few product families were treated as pharmaceuticals under the regulations. But India’s Drug Control Administration is expanding its oversight by establishing regulations tailored to the medical device industry.

Along with imaging equipment, other products such as dialysis machines, defibrillators, bone marrow separators, and all implantable medical devices will also require CDSCO registration. The new regulations are expected to go into effect no earlier than October 2018, with a six month grace period for compliance.

More than 80% of medical devices utilized in India are imported. Of those, one quarter are produced by U.S. manufacturers.