Lok Sabha Question No. 3537 (UNSTARRED), answered on 2018-03-16
Subject: Regulatory Body for Medical Devices
Ministry: HEALTH AND FAMILY WELFARE
Asked by: BOORA NARSAIAH GOUD

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

LOK SABHA UNSTARRED QUESTION NO. 3537 TO BE ANSWERED ON 16 TH MARCH, 2018

## REGULATORY BODY FOR MEDICAL DEVICES

## 3537. DR. BOORA NARSAIAH GOUD:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) the details of items classified as 'medical device';
- (b) whether the National Health Policy mandates to set up a regulatory body for medical d and if so, the details thereof;
- (c) the initiatives taken to set up one such body to oversee various aspects of medical the country; and
- (d) the time by which a national regulator for medical devices would be set up and all devices  now  under  Drug  and  Cosmetics  Act would  come  under  the  purview  of  the  new regulator?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE ( SMT. ANUPRIYA PATEL )

- (a): Presently 15 notified categories of medical devices are regulated under the provis Drugs and Cosmetics Act, 1940 and Rules 1945 thereunder, as per the details in the Annexure .

(b) to (d): The National Health Policy, 2017 recommends strengthening regulation of medical devices and establishing a regulatory body for medical devices to unleash innovation a entrepreneurial  spirit  for  manufacture  of  medical  device  in  India.  The  policy  su harmonization of domestic regulatory standards with in ternational standards.

In line with the above recommendations, Ministry of Health & Family Welfare has notif Medical Devices Rules, 2017 for comprehensive regulation of Medical devices notified un the Drugs and Cosmetics Act, including their imp ort, clinical investigation, manufacture, sale and distribution. The new rules are harmonised with the international regulatory practices an provide comprehensive legislation for the regulation of Medical Devices to foster India innovation and pr ovide a fillip to Make in India.

A  separate  and  dedicated  wing  is  set  up  under  Drug  Controller  General  of  India effective implementation of new medical Devices Rules, 2017 with effect from 1.1.2018.

……………….

## Annexure

|   S.No. | Name of thedevice                                  | Notification Date   |
|---------|----------------------------------------------------|---------------------|
|       1 | Disposable Hypodermic                              | 17- 03- 1989        |
|       2 | Syringes Disposable Hypodermic                     | 17- 03- 1989        |
|       3 | Needles Disposable Perfusion Sets                  | 17- 03- 1989        |
|       4 | In vitro Diagnostic Devices for HIV, HbsAg and HCV | 01- 09- 2002        |
|       5 | Cardiac Stents                                     | 06- 10- 2005        |
|       6 | Drug Eluting Stents                                | 06- 10- 2005        |
|       7 | Catheters                                          | 06- 10- 2005        |
|       8 | Intra Ocular Lenses                                | 06- 10- 2005        |
|       9 | I.V. Cannulae                                      | 06- 10- 2005        |
|      10 | Bone Cements                                       | 06- 10- 2005        |
|      11 | Heart Valves                                       | 06- 10- 2005        |
|      12 | Scalp Vein Set                                     | 06- 10- 2005        |
|      13 | Orthopedic Implants                                | 06- 10- 2005        |
|      14 | Internal Prosthetic                                | 06- 10- 2005        |
|      15 | Replacements Ablation Devices                      | 25- 01- 2016        |