Responding to concerns from medical device manufacturers, India’s national regulatory body for pharmaceuticals and medical devices has issued a clarification of what is considered an implantable medical device. Under a new definition published in December by the Central Drugs Standard Control Organization (CDSCO), to be considered implantable a device must be intended to be partially or totally introduced into a human or animal body or natural orifice, or to replace an epithelial surface or the surface of the eye by surgical intervention.
The clarification comes as government health officials remain deeply divided over what role CDSCO should play in regulating the growing medical device industry. One proposal calls for establishing a regulatory agency for medical devices that would be separate from that overseeing pharmaceuticals. But while many other Asian nations have established separate regulatory agencies for devices and pharmaceuticals, in India the proposal remains controversial.