Lok Sabha Question No. 149 (UNSTARRED), answered on 2019-06-21
Subject: Medical Devices
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Raksha Nikhil Khadse

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

## LOK SABHA UNSTARRED QUESTION NO. 149 TO BE ANSWERED ON 21 ST JUNE,2019

## MEDICAL DEVICES

## 149. SHRIMATI RAKSHA NIKHIL KHADSE:

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

- (a) whether the Government proposes to cover the commonly used medical devices under the Drugs & Cosmetics Act to enable the Government to ensure their quality & performance and if so, the details thereof;
- (b) the list of the new medical devices a ded along with the devices notified earlier;
- (c)  whether  the  Government  also proposes  to  bring  the  high - end  medical devices  like  MRI equipment, CT Scan equipment, X - ray machines etc. under the purview of drug law; and
- (d) if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a) to (d) : The Government has covered a number of medical devices under the Drugs & Cosmetics  Act to  ensure  the ir  quality  and  performance. The  list  of  notified  medical  devices which are being regulated along with those which have been notified to be regulated f specified date is annexed.

The list includes high end medical devices like MRI Equipment, CT scan Equipment,  X -Ray Machines, etc .

## ANNEXURE

|   S.No | List of notified medical devices which are regulated   |
|--------|--------------------------------------------------------|
|      1 | Disposable Hypodermic Syringes                         |
|      2 | Disposable Hypodermic Needles                          |
|      3 | Disposable Perfusion Sets                              |
|      4 | In vitro Diagnostic Devices for HIV, HbsAg and HCV     |
|      5 | Cardiac Stents                                         |
|      6 | Drug Eluting Stents                                    |
|      7 | Catheters                                              |
|      8 | Intra Ocular Lenses                                    |
|      9 | I.V. Cannulae                                          |
|     10 | Bone Cements                                           |
|     11 | Heart Valves                                           |
|     12 | Scalp Vein Set                                         |
|     13 | Orthopedic Implants                                    |
|     14 | Internal Prosthetic Replacements                       |
|     15 | Ablation Devices                                       |
|     16 | Blood Grouping Sera                                    |
|     17 | Ligatures, Sutures and Staplers                        |
|     18 | Intra Uterine Devices (Cu-T)                           |
|     19 | Condoms                                                |
|     20 | Tubal Rings                                            |
|     21 | Surgical Dressings                                     |
|     22 | Umbilical tapes                                        |
|     23 | Blood/Blood Component Bags                             |
|     24 | Organ Preservative Solution                            |

|   S.No | List of medical devices notified and to be regulated from a specified date (as mentioned in the brackets)   |
|--------|-------------------------------------------------------------------------------------------------------------|
|      1 | Nebulizer (w.e.f 1 st January, 2020)                                                                        |
|      2 | Blood Pressure Monitoring Device ( w.e.f 1 st January 2020)                                                 |
|      3 | Glucometer ( w.e.f 1 st January 2020)                                                                       |
|      4 | Digital Thermometer ( w.e.f 1 st January 2020)                                                              |
|      5 | All implantable medical devices Equipment ( w.e.f 1 st April 2020)                                          |
|      6 | CT Scan Equipment ( w.e.f 1 st April, 2020)                                                                 |
|      7 | MRI Equipment ( w.e.f 1 st April 2020)                                                                      |
|      8 | Defibrillators ( w.e.f 1 st April 2020)                                                                     |
|      9 | PET Equipment ( w.e.f 1 st April 2020)                                                                      |
|     10 | X-Ray Machine ( w.e.f 1 st April 2020)                                                                      |
|     11 | Dialysis Machine ( w.e.f 1 st April 2020)                                                                   |
|     12 | Bone marrow cell separator ( w.e.f 1 st April 2020)                                                         |