Critical medical devices and diagnostic equipment will be regulated by India’s health ministry. Under the Medical Devices Rules, 2017, which will come into effect from January 1, 2018, prices of devices such as catheters, stents and orthopedic implants, heart valves, intra-ocular lenses, syringes and needles will be regulated by the government.
“The devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central [federal] government by notification in official gazette, after consultation with the Board, fall under the definition of drugs,” Drugs Controller General of India G.N. Singh said in a notice, giving out a list of 15 medical devices notified so far .
The new rules will also require critical devices to undergo trials in India before they are approved for launch. Implantable devices such as stents will be part of the high risk category and will be monitored directly by the government regulator, reports the Times of India.
