Regulatory body for medical devices


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
Cardiac Stents 06-10-2005
Drug Eluting Stents 06-10-2005
Catheters 06-10-2005
Intra Ocular Lenses 06-10-2005
I.V. Cannulae 06-10-2005
Bone Cements 06-10-2005
Heart Valves 06-10-2005
Scalp Vein Set 06-10-2005
Orthopedic Implants 06-10-2005
Internal Prosthetic Replacements 06-10-2005
Ablation Devices 25-01-2016