India’s CDSCO Expands List of Devices Requiring Registration

India’s Central Drugs Standard Control Organization (CDSCO) is expanding its list of devices that require registration for market authorization, including all implantable devices and “other high end equipment.”

The list includes all implantable medical devices, CT scan and MRI equipment, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separators.

The full list will be published in the official Gazette and will go into effect 12 months after the date of publication.