India Moves to Further Strengthen Regulations on Import, Sale of Medical Devices

In a further tightening of its regulations on the sale of medical devices, India’s regulatory authority has announced a new list of devices that must obtain import and manufacturing licenses in order to be sold in the country.

In accordance with the new regulations issued in April by the Central Drugs Standard Control Organization (CDSCO), import licenses will be required on implantable medical devices, dialysis machines, cell and bone marrow separators, defibrillators, and X-ray machines. The devices affected by the new regulations also include CT, MRI, and PET equipment. Obtaining the licenses will require applying for approval to Indian regulators.

The new regulations are already mandated for a broad range of other medical devices, from surgical dressings and disposable hypodermic syringes to heart valves. For the new group of devices affected by the mandate, manufacturers have a grace period of between six and 24 months to comply with the requirements.

Since 2017, when India passed a law establishing regulations on the medical device industry, authorities have sought to put in place a robust regulatory mechanism for devices. 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 device product families were treated as pharmaceuticals under the regulations.