ORTHOPAEDIC ORDER

~;f~~0;;~ ~ ~ ) (ffi ~~ D) ~f'\u _ I(?,:::/"~' f; f0 .~~~<~;?~.:)\ icl~' X.19029/2/2011-D~QC ~"~~\. tt Oy-f1/"'J rr:.)· I NO.•••••••.•• \. ::>~\ Government ofIndIa ~~J: l (:~ ( cvY' C:>L-qf Jt..~istry of Health & Family Welfare 1 - I \ '\ 0_ r._\' \' Y''/'( /7 ); .• ( II ,.n :"i )l Nirman Bhavan, NewDelhi r ~:;~~: P ~~)~:;;; Dated the \0 May, 2011 ORDER V" Subject: ~~itatr.~.... 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)- Orthopedic 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 Orthopedic Medical Devices. The committee is hereby constituted with the following composition with immediate effect: S~:-N~)1-Nameof Expert --r----------------- 1 Prof. Shishir _~_as~()~L__ ~ Prof Sudhir Prof. and Head, Department of GTB Hospital, New Kumar Ortho aedics Delhi .-----.~_..~_-_.~_.._._---------- Dr. H.S. Chabbra Medical Director and Head of Indian Spinal Injuries I Ortho aedics Sine Centre,_De!~L _ 1_-------_._-.--------- ------- Prof. Mandeep S. Prof. and Head, Department PGIMER Chandigarh Dhillon Ortho aedics _._--.._--_..-..-._------------_~_--- Dr. V.K. Goyal Chief Specialist of Orthopaedics Deen Dayal Upadhyay 1 _L ~ _ Hos ital, Ne'ATJ?5H!L__ (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 re!=:e~rchindustry 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:., Assessment of Risk versus Benefit to the patient ,. Innovation vis- a-vi~ existing device option ., 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 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 willbe 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 ComI!littee should submit their Bio-data as per the format annexed at Annexure-B. (Sudhir Kumar) Under Secretary to the Government ofIndia Telefax: 23062292 Copy to . ~ce of Drugs Controller General (India) - to inform all members of MDAC-Orthopedic 2. Secretary(H&FW)jDG, Dte.GHSj AS&DG(CGHS)jSS&FAjJS(R)jDirector (Drugs) 3. Cash(Health) SectionjIFD