**Executive Summary:**
This office order announces the constitution of the Medical Devices Technical Advisory Group (MDTAG) to advise the Central Drugs Standard Control Organization (CDSCO) on matters related to medical device regulation. The group is composed of representatives from various government bodies, industry associations, and medical professionals. Meetings will be convened by the Drugs Controller General of India (DCGI) at least once every four months.
**Key Points / Main Content:**
* **Establishment of MDTAG:**
* MDTAG is established with the approval of the Ministry of Health & Family Welfare.
* The purpose of MDTAG is to advise CDSCO on medical device regulation.
* **Composition of MDTAG:**
* Chairperson: Drugs Controller General India, CDSCO HQ, New Delhi
* Member Secretary: Deputy Drugs Controller India, Medical Devices Division, CDSCO HQ, New Delhi
* Members include representatives from: DST, NIB, ICMR, AERB, DRDO, BIS, IIT (New Delhi), DEITY, Sree Chitra Tirunal Institute, NHSRC, State Drugs Controller (Haryana), CII, MTAI, ADMI, AIMED, FICCI, AMCHAM India, Notified Body, and medical experts (Dr. Sandeep Bansal, Dr. S.N.Bhattacharya, Dr. Vijay Kumar Jain, Dr. Arjun Ahuja).
* **Terms of Reference:**
* Examine issues related to the implementation of medical device regulations.
* Advise CDSCO on strengthening medical device regulations, including "Make in India" and "Ease of Doing Business" initiatives.
* Address matters with the Drugs Consultative Committee (DCC), Drugs Technical Advisory Board (DTAB), and the Ministry as required.
* **Working Method:**
* Meetings will be called by DCGI at least once every four months at CDSCO HQ, New Delhi.
* The group may co-opt other experts as needed.
* Government official members stationed out of Delhi will have their travel and daily allowance (TADA) paid as per government norms, from the IPC budget.
* **Action Required by Organizations:**
* All associations/government departments are requested to nominate their representative, including name, designation, contact number, and email ID, and inform the CDSCO office at the earliest.
**Impact Analysis:**
* **CDSCO:**
* *Impact:* Receives expert advice from MDTAG on medical device regulation.
* *Action Required:* Facilitate MDTAG meetings and consider recommendations.
* **Government Departments (DST, NIB, ICMR, AERB, DRDO, BIS, DEITY, NHSRC):**
* *Impact:* Contribute expertise to MDTAG's advisory role.
* *Action Required:* Nominate a representative and actively participate in MDTAG meetings.
* **Industry Associations (CII, MTAI, ADMI, AIMED, FICCI, AMCHAM India):**
* *Impact:* Provide industry perspectives and expertise to MDTAG.
* *Action Required:* Nominate a representative and actively participate in MDTAG meetings.
* **Medical Professionals (Dr. Sandeep Bansal, Dr. S.N.Bhattacharya, Dr. Vijay Kumar Jain, Dr. Arjun Ahuja):**
* *Impact:* Provide medical expertise to MDTAG's advisory role.
* *Action Required:* Actively participate in MDTAG meetings.
* **State Drugs Controller, Haryana:**
* *Impact:* Provides perspective on medical device regulation at the state level.
* *Action Required:* Participate actively in MDTAG meetings.
Key Entities Referenced
Medical Devices Technical Advisory Group MDTAG: Advisory group constituted to advise CDSCO on matters related to the regulation of medical devices.
Central Drugs Standard Control Organization CDSCO: The Indian regulatory body responsible for the regulation of pharmaceuticals and medical devices.
Drugs Controller General India: Chairperson of the Medical Devices Technical Advisory Group MDTAG.
Ministry of Health Family Welfare: The Indian government ministry responsible for health policy.
New Delhi: Location of CDSCO headquarters and several member institutions.
Indian Council of Medical Research ICMR: One of the member organizations represented in the MDTAG.
Haryana state: Represented by the State Drugs Controller as a member of the MDTAG.
Drugs Controller General India DCGI: Officer responsible for calling the meetings of the advisory group.
File No: 29/ Misc/3/2018-DC (305)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, Kotla Road, New Delhi
Dated: 22.07.2019
Office Order
Subject: Constitution of Medical Devices Technical advisory group (MDTAG) to
advise CDSCO on matter related to regulation of medical devices - Reg.
With the approval of Ministry of Health & Family Welfare, Govt. of India vide letter
no. X.11035/428/2018-DRS dated 05.07.2019; it has been decided to constitute a
Medical Devices Technical Advisory Group (MDTAG) to advise CDSCO on matter
related to regulation of medical devices as per the following composition:
Chairperson- Drugs Controller General (India), CDSCO (HQ), New Delhi
Member Secretary- Deputy Drugs Controller (India), Medical Devices Division, CDSCO
(HQ), New Delhi.
Members:
1. Representative from DST (Department of Science & Technology)
2. Representative from NIB (National Institute of Biologicals)
3. Representative from ICMR (Indian Council of Medical Research)
4. Representative from AERB (Atomic Energy Regulatory Board)
5. Representative from DRDO (Defence Research and Development
Organization)
6. Representative from BIS (Bureau of Indian Standards)
7. Representative from IIT, New Delhi
8. Representative from DEITY (Department of Electronics and Information
Technology)
9. Representative from Sree Chitra Tirunal Institute for Medical Sciences and
Technology
10. Representative from NHSRC (National Health Systems Resource Centre)
11. State Drugs Controller, (Haryana state)
12. Representative from Cll (Confederation of Indian Industry)
13. Representative from MTAI (Medical Technology Association of India)
14. Representative from ADMI (Association of Diagnostics Manufacturers of
India)
15. Representative from AIMED (Association of Indian Medical Device Industry)
16. Representative from FICCI (Federation of Indian Chambers of Commerce &
Industry)
17. Representative from AMCHAM India (American Chamber of Commerce in
India)
18. Representative from Notified Body.19. Dr. Sandeep Bansal, HOD of Cardiology, VMMC & Safdarjung Hospital, New
Delhi
20. Dr. S.N.Bhattacharya, Prof & Head, Dept. of Dermatology, University College
of Medical Sciences, New Delhi
21. Dr. Vijay Kumar Jain, Associate Professor, Dept. of Orthopaedics, RML
Hospital, New Delhi
22. Dr. Arjun Ahuja, Professor & Head, Seth G.S. Medical College & KEM
Hospital, Mumbai
TERMS OF REFERENCE:
_ To examine the issues relating to implementation of Medical Devices regulations.
To suggest CDSCO regarding strengthening of medical devices regulations in
the country including Make in India, Ease of doing business etc. and taking up
matters with DCC, DTAB and Ministry as per requirement.
Working method:
The meeting will be called by DCG(I) at least once in four months at CDSCO,
1.
HQ, New Delhi.
2.
The group may co-opt other experts from relevant field as deemed necessary.
The TA/DA for Govt. Official members (out stationed) shall be paid as per
Government of India norms and shall be borne from IPC budget.
All associations/Government departments are requested to nominate their
representative (one) indicating name, designation, contact no. and email id
and inform this office at the earliest.
Lp.
a
(Dr. S. Eswara Reddy)
Drugs Controller General (India)
To;
All members of the Group
Copy to:
1. PPS to DGHS
2. PS to JS(R)
3. Director cum Scientific Advisor, IPC Ghaziabad
4. CDSCO website