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X.19029/2/2011-DFQC
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, Government ofIndia \'7t{. ~(\::~_
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1.> 7.-Cf-<'L1t,!?o,rinistry of Health & Family Welfare
}1-- Nirman Bhava 'n 0, NewDelhi
Dated the May, 2011
Subject: - Constitution of Medical Device Advisory Committee (MDAC) to advice drugs
Controller General (India) DCG (I) in matters for Review of Applications of new
Medical Device & Clinical Trials- regarding.
11. has been decided to constitute a Medical Device Advisory Committee IMDAC)-
Miscellaneous Devices to advise DCG(I)in matters related to review and regulatory approval
of New medical Devices & Clinical Trials (except for Investigational New Medical Devices) of
Miscellaneous Medical Devices. The committee is hereby constituted with the following
composition with immediate effect:
r~~-~----~~~-~-~--~-~----~------
I Sr. No. Name of Expert
f~ ~~-~-~--------~~-~--
I 1 Dr. S.K. Acharya Prof. and Head, Department of
Gastroen terolo
Dr. Madhuri Prof. and Head, Department of
Behari Neurolo
._ ..----_.__ ._.__..,---~----
Dr. Prof. and Head, Department of
~~ItCha--n~d--r~a--l~a.k_~h-a----- Anesthesiolo
Dr. R.C. Deka Prof. and Head, ENT AIIMS
~It~~_:JY-C~~~Misra Prof. and Head, Sur e AIIMS
(i)To undertake in-depth evaluation of non-clinical data, clinical trial data, etc, furnished by
the applicant for approval offollowing:
• New Medical Device to be introduced for the first time in the country.
• Global clinical trials
(iii) Preparing Guidelines for clinical research industry in evolving acceptance criteria for
marketing approval ofnew Medical Device.
(iv) Defining roadmap for research industry for appropriate development of new Medical
Device relevant to Indian population.
(v) While considering for approval of new Medical Device the committees will examine the
essentiality and desirability ofnew Medical Device in terms of:'r Innovation vis- a-vis existing device option
Unmet medical need in India
)1'
2. Applications for new Medical Device and Global clinical trials can be evaluated by the
committee either through meeting or by circulation ofthe applications.
5. The experts nominated as a member for the committee should not have any conflict of
interest as per the declaration given at Annexure-A.
6. The members of the committee shall hold office for a period of three years but shall be
eligible for re-nomination provided that the persons nominated continue to hold their
offices in their respective organization by virtue ofwhich they are nominated.
7. In case a member retires during the term of validity, an alternative member from the same
Institute or from some other Institute will be nominated as member for the committee.
8. Office of Drugs Controller General (India) {DCG(I)}will initially examine such applications, if
any particular data is lacking same will be informed to the applicant within 45 working
days or else the data will be forwarded to the members ofthe committee.
9. The members of the committee should be in a position to give their expert opinion within a
period of 6 weeks from the receipt of such proposal.
10.The members of the committee should follow the Principle of Confidentiality with respect to
the documents submitted by the applicants.
11.The members of the Committee should submit their Bio-data as per the format annexed at
Annexure-B.
S.
\A.-"'~
(Sudhir Kumar)
Under Secretary to the Government ofIndia
Telefax: 23062292
Copy to :
~ffice of Drugs Controller General (India) - to inform all members of MDAC-
Miscellaneous Devices.
2. Secretary(H&FW)/DG, Dte.GHS/AS&DG(CGHS)/SS&FA/JS(R)/Director (Drugs)
3. Cash(Health) Section/IFD