All Medical Devices To Be Regulated From December 1
The health ministry has proposed to notify all medical devices from December 1, expanding the span of regulation to ensure safety and efficacy of a variety of such products used for diagnosis.
EW DELHI: The health ministry has proposed to notify all medical devices from December 1, expanding the span of regulation to ensure safety and efficacy of a variety of such products used for diagnosis, treatments and other medical interventions in human beings and even in animals.
The ministry published a gazette notification on Friday with the proposal defining all medical devices as drugs and seeking public comments within one month. It later also notified a separate set of draft rules under which these devices will be regulated once the final notification is issued. Once the final notification is in place, all medical devices including software, equipments, accessories and contraceptives will be regulated under Drugs and Cosmetics Act and firms will have to seek an approval from the Drugs Controller General of India to manufacture, import and sell any medical devices in the country.
Sushmi Dey | TIMES NEW NETWORK | October 19, 2019