New Delhi, 16.03.18: The National Health Policy, 2017 recommends strengthening regulation of medical devices and establishing a regulatory body for medical devices to unleash innovation and the entrepreneurial spirit for manufacture of medical device in India. The policy supports harmonization of domestic regulatory standards with international standards.
In line with the above recommendations, Ministry of Health & Family Welfare has notified Medical Devices Rules, 2017 for comprehensive regulation of Medical devices notified under the Drugs and Cosmetics Act, including their import, clinical investigation, manufacture, sale and distribution. The new rules are harmonised with the international regulatory practices and provide comprehensive legislation for the regulation of Medical Devices to foster India specific innovation and provide a fillip to Make in India.
A separate and dedicated wing is set up under Drug Controller General of India for effective implementation of new medical Devices Rules, 2017 with effect from 1.1.2018.
Presently 15 notified categories of medical devices are regulated under the provisions of Drugs and Cosmetics Act, 1940 and Rules 1945 thereunder, as per the details given below:
|S.No.||Name of the device||Notification Date|
|Disposable Hypodermic Syringes||17-03-1989|
|Disposable Hypodermic Needles||17-03-1989|
|Disposable Perfusion Sets||17-03-1989|
|In vitro Diagnostic Devices for HIV, HbsAg and HCV||01-09-2002|
|Drug Eluting Stents||06-10-2005|
|Intra Ocular Lenses||06-10-2005|
|Scalp Vein Set||06-10-2005|
|Internal Prosthetic Replacements||06-10-2005|