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
The Pharma Times News Bureau

Recent Posts

Lung Cancer in India: Understanding Risk Factors and the Importance of Early Detection

By Dr. Pavan Yadav, Lead Consultant - Interventional Pulmonology & Lung Transplantation, Aster RV Hospital.…

17 hours ago

10 Winter Skin Care Tips Dermatologists Swear By

Dr. Priyanka Kuri, Consultant - Dermatology, Aster Whitefield Hospital, Bengaluru  Winter weather brings a host…

3 days ago

Fighting Viral Hepatitis in India: Prevention, Risks, and the Path to Better Health

By Dr. Naveen Ganjoo, Senior Consultant - Hepatology & Integrated Liver Care, Aster RV Hospital…

4 days ago

Hon’ble Prime Minister Shri Narendra Modi Inaugurates LyfiusPharma’s Flagship Penicillin-G Facility at Kakinada, Andhra Pradesh

Under the Production Linked Incentive(PLI)scheme, Lyfius Pharma Private Limited(LyfiusPharma) invested ₹2,500 crores in Penicillin-G( Pen-G)facility…

5 days ago

SpOvum® Launches ARTGPT Redefining Patient Support in Assisted Reproductive Technology (ART)

Launched for 1st time in India, ARTGPT is designed to address queries regarding A.R.T treatments Product created…

1 week ago