India Issues Draft Medical Device Regulations Separate from Drug Law
Indian medical device market regulators have released new draft regulations following the government’s recent announcement that it would scrap the Drugs and Cosmetics (Amendment) Bill of 2013 in favor of separate laws for drugs and devices.
Within days of the government’s announcement, the Central Drugs Standard Control Organization (CDSCO) released draft regulations for medical devices to be finalized after obtaining comments from industry and official publication in the Gazette of India.
The draft Medical Device Rules 2016 touch on all major aspects of device registration in India, including device definitions and classification, Notified Body roles, validity of licenses and related issues. Upon initial analysis by Emergo consultants in India, the proposed rules align closely with international standards developed by the International Medical Device Regulators Forum’s predecessor organization, the Global Harmonization Task Force (GHTF).
The rules would apply to all medical devices and in vitro diagnostic (IVD) devices currently covered under the country’s Drugs and Cosmetics Act of 1940, as well as any devices “specified from time to time by the Central Government.”
The draft will likely go through more rounds of review and revision following industry feedback before final publication; once the rules are published in the Gazette, Emergo will provide an in-depth analysis of the new Indian registration system.