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    5 MDACReproductive Urology Order

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    Ravi
    The document constitutes the Medical Device Advisory Committee (MDAC) for Reproductive & Urology devices to advise the Drugs Controller General of India on regulatory approval of new medical devices and clinical trials. The committee consists of 5 experts from leading hospitals and departments. The committee will evaluate applications for new devices and clinical trials, develop guidelines for research, and define priorities based on risk/benefit, innovation, and unmet needs in India. Members will maintain confidentiality and declare any conflicts of interest. The committee term is 3 years with the option to renew members.

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    5 MDACReproductive Urology Order

    Uploaded by

    Ravi
    44 views2 pages
    The document constitutes the Medical Device Advisory Committee (MDAC) for Reproductive & Urology devices to advise the Drugs Controller General of India on regulatory approval of new medical devices and clinical trials. The committee consists of 5 experts from leading hospitals and departments. The committee will evaluate applications for new devices and clinical trials, develop guidelines for research, and define priorities based on risk/benefit, innovation, and unmet needs in India. Members will maintain confidentiality and declare any conflicts of interest. The committee term is 3 years with the option to renew members.

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    5MDACReproductiveUrologyOrder

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    The document constitutes the Medical Device Advisory Committee (MDAC) for Reproductive & Urology devices to advise the Drugs Controller General of India on regulatory approval of new medical devices and clinical trials. The committee consists of 5 experts from leading hospitals and departments. The committee will evaluate applications for new devices and clinical trials, develop guidelines for research, and define priorities based on risk/benefit, innovation, and unmet needs in India. Members will maintain confidentiality and declare any conflicts of interest. The committee term is 3 years with the option to renew members.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    44 views2 pages

    5 MDACReproductive Urology Order

    Uploaded by

    Ravi
    The document constitutes the Medical Device Advisory Committee (MDAC) for Reproductive & Urology devices to advise the Drugs Controller General of India on regulatory approval of new medical devices and clinical trials. The committee consists of 5 experts from leading hospitals and departments. The committee will evaluate applications for new devices and clinical trials, develop guidelines for research, and define priorities based on risk/benefit, innovation, and unmet needs in India. Members will maintain confidentiality and declare any conflicts of interest. The committee term is 3 years with the option to renew members.

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    X.

    19029 /2/20 Il-DFQC


    Government of India
    f1.> f}.~ 104'8.1~)istry of Health & Family Welfare
    Nirman Bhavan, New Delhi
    r~ I
    #
    Dated the\o 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.

    It has been decided


    to constitute a Medical Device Advisory Committee (MDAC)-
    Reproductive & Urology to advise DCG(I) in matters related to review and regulatory
    approval of New medical Devices & Clinical Trials (except for Investigational New Medical
    Devise) of Reproductive & Urology Medical Devices. The committee is hereby constituted
    with the following composition with immediate effect:

    Sr Noe-,:-~i Expert

    1 I Dr. Suneeta Prof. and Head, Department of


    JMi!t?:l _ Obstetrics and G necolo
    Prof. and Head, Department of
    2 [DrS~~~g~rwaJ
    Ne hrolo

    :1:Of~;;;::b
    5
    prof. and
    Urolo
    Prof. and
    Head,

    Head,
    Department

    Department
    Obstetrics and G necolo
    J Pr:QL_J1~~~J'vl§lnQal Prof. and Head, De artment of Urolo
    of

    of
    VMMC &, Safdarjung
    Hos itah.Q~Ll1i
    RML Hospital, Delhi

    (i) To undertake in-depth evaluation of non-clinical data, clinical trial data, etc, furnished by
    the applicant for approval of following:
    • 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 of new Medical Device.

    (iv) Defining roadmap for research industry for appropriate development of new Medical
    Device relevant to Indian population.

    (v) While conside~ing for approval of new Medical Device the committees will examine the
    essentiality and desirability of new Medical Device in terms of:
    , Assessment of Risk versus Benefit to the patient
    y Innovation vis- a-vis existing device option
    y Unmet medical need in India

    2. Applications for new Medical Device and Global clinical trials can be evaluated by the
    committee either through meeting or by circulation of the 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 of which 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 of the 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.

    >. ~' \'v


    (Sudhir Kumar)
    Under Secretary to the Government of India
    Telefax: 23062292
    Copy to :
    ~fice of Drugs Controller General (India) - to inform all members of MDAC-
    Reproductive & Urology.
    2. Secretary(H&FW) I DG, Dte. GHS I AS&DG(CGHS)I SS&FAI JS(R) I Director (Drugs)
    3. Cash(Health) Section/IFD

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