Categories: Medical Devices

Regulatory Body for Medical Devices

New Delhi, March 17, 2018: 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 there under, as per the details given below:

The Minister of State (Health and Family Welfare), Smt Anupriya Patel stated this in a written reply in the Lok Sabha here today.

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