Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare

Transcription

1 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan KotlaRoad, New Delhi-l10002 To_ /' ~~.~-Care Pharmaceuticals Pvt. Ltd., _ R-2-B-24, (Kh No. 28/8), Mahavir Enclav.e, Palam, New Delhi SUB: - Registration of MIs Bio-scaffold International Pte. Ltd., 61 Science Park Road, # , The Galen, Singapore Science Park II, Singapore under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application no. nil dated 21/11/2009 received by this office vide dairy no dated 12/11/2009 and replies received by this office vide diary no dated 17/01/2011, dated 21/03/2011 and dated 07/1 0/2011 on the subject Cited above. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewith for the manufacturing site alongwith the name(s) of medical device(s) imported under the said Certificate subject to the following s,onditions. (--'". t. Thenied.lcaldevice(s)shall confop1~~ standards/ specifications mentioned in the Second Schedule ofthedfyg ~crcosmetics Act! ISO / MDD / or-such other - ~~~stan~dat.ds..qlspe.cificatio~~.ed1>yj:his-directorate.-~ ~\:..' OJ "" - 2.-Q~sp1.!te,itany;inrespecf ()ftlj.ej>ayirie1!t()ff~saildsubn1issiori6f TR6~1iaI1an; --~-~--~ Shallhe-settlecLbetweeIl-the-bank-and-the-appLicant-.-e~-~--~~-, The medical device will be required to be withdrawn from sale from the market in case any undesirable reactions due to failure of the device or Its accessones are ~-====-====~----br-ought--to=iiglit-at- any-stage;---'fhis-brrectorate--should-6e-lmormed-of adverse reports on the medical device, if any. 4. This registration in no' way relieves you-of the responsibility of complying with o~er provisions. of the Drugs & Cosmetics Act and RuJes thereunder, and any other provisions of any other Act and Rules applicable in the matter concerned.

2 5. Each consignment of the medical device(s) to be imported by you shall be accomp~~(:tbya testl.analysis reports.- 6. Based on this registration, applications for the import of medical device(s) endorsed in the enclosed Registration Certificate shall be considered for the issue of Form 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration Certification.. 8. The Registration Certificate is being issued under the condition that you are r_equired to-submit--a--d-uly---o. ~. _u peco e pro. uctalongwithitscodeslssued by the National regulatory Authority of Ireland at the time of submission of application f~r the grant of Form 10 License. Please note that Registration Certificate issued is liable to be suspended / cancelled, if any of the condition stipulated above is not complied with, apart from any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. \ I. ~ >:-. -V ;,.;;- (Dr. V.G Somani) Drugs Controller Generar(lndia) --~ ~~~=----=---= ============================---=

3 :,)!,\..... GOVERN Central Druas::,.danlCIJIb'II 1'''-.'-IIIIIi1i- I; fill".", IITU Bill, IEWlaII;';.. 2U.IIIl '.:7.:;<"':': ",".. - -"..,," -, ~;~!-:~/,~,-:-,.,~:,,:--:.,: Form 41,. (See rule 27-A).. "\<~>;:f:>:" '-..-;;<:t~~1j ':' - ''-';'. -I,,~..,-. '.-'~.t".',,-.:. -. :~~~,..\ ;":';"c,;, :=~~" ~:.."'.) ~". Regi$tration CertifICate issued fqr,'biiportof devices into India Under Drugs and COS1r'l.etU:$ Rules, RegzstratlOn.certijicate No;:, MD.751, -'....- Date:; zeij..i~e~~,i lull. :.':<\,:-::': MIs Rio-scaffold International Pte;. Ltd., having faetoi'ypremises at 61 Science ParkR.~d,#02-01/06, ~.A~l~fa The Gal~n,Singa~Oresc~~n~ep~rk ~L sin:apo~6.i~~~n~egistered under manufacturer and IShereby ISSUedthiSRegJ.stratiOn~cate. " ~O.(> ;.i. Namo(s) of de\;~si,'~cll~~ ~ ~ 'on ::~:' j.;,,: Please refer to the' en~los~~t ~.'~:.:':I\,..< -" ";?'-" This RegistrationCertiSteshall be in fo 011to31-1O-2~~..iiissooner 0 }6~ )~~ "~.., suspended or cancelledund~~

4 _.0< '.-.---, '-" _------"""---". -: '.,--.' The Registration Certificate shall be displayed at a prominent place by theauthorised agent ' The manufacturer or his authorised agent in India shall comply with the conditions of the import licence issued under the Drugs and Cosmetics Rules, The manufacturer or his authorised agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation ofauthorisation, and/or not of standard quality report of any device pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the device is marketed/sold or distributed. In such cases, action equivalent to that taken with reference to the concerned device in the country of origin orin the country of marketing shall be followed in India also, in consultation with and as per the directions of the licensing authority. The licensing may, owever, direct any' fllrther ltiodificaiion-to-thls-course--o{action, including the withdrawal of the device from Indian market The manufacturer or his authorised agent in India shall inform the licensing authority within 30 days in writing in the event of any change in manufacturing process, or in labelling or in testing, or in documentation of any of the device pertaining to this Registration Certificate. In such cases, where there shall be any major change/modification in manufacturing or in testing, or in documentation, as _the case may be, the manufacturer or his authorised agent in India shall obtain necessary approval within 30 days by submitting.a separate application along with the registration fee, as specified in clause (ii) of sub rule (3 )of rule 24-A. 5. The manufacturer or hisautborised.agent in India shall inform the licensing authority imttlediately m writingiiahe-e\fentof any change in the ~~Mi~~~ ~~fi; ~d /oraddr~sof the regist~.office! factory pretilises 0peratingunder~sRegi~tion aily' sucl:i change in tile CotiStitiltio~~f-fu~'fi~ ~cjjor- ~(i&e;s _. "-'--"'-'"'--'--_"':"-~_'_------'-_._".'.'- ---,--", ~.--"-----_."- -.-_ ~ ~ _: ~-_._- Conditions of the Registration Certificate <:;ertifieate: Where _ _..._._"------, " : _ =talc"'=ec:::s-=place,the current Registmtion Certificate shall be deemed to be valid for 8 : ' '...:. _-_..:"..~~_:.~::.~,:'7::~'_:_:"~w~.:---~:.~. :'~-~~.'7::~-,'=:~~':":_:-:-.='" - -..~;-~...::;'"'~~'~~<~:-""~:.~:'~::..::~~ :~~,:-::':c::_:::,:,:"_-0-: 0 ~,=--=-=maximunfperiod'_oftlu'eecmi)ri11iffiorit-tlie.aate <)nwliicn. the change has taken place ---41mwn less, in the meantime; a--rresn RegistIiiIori-CertifiCat~hflSb;~ ~~'fr~l"ilthe -- licensing authority in the name of the.firm with the changed constitution of the firm aannclo;1',oor-r Ciclll1laID'1ll2g;eedIT11audidress of the registered office or factory premises.

5 CIDtrlI_. : ~""~T~--.,; ~: -,,!:< 'i--/,:~'".tj)~;:.' ~-!':',.'( " >{":""~"~'"--",.-'- "--_::-=--~~==~~... --=~"~i7~ GOIEIUlfll' IF 11111,:/':' SIIldlrd'C'''I~'<;':''', "'111011,',",'.fitii liilffi' ~~-"~Wenlie, NAME(S) OF MEDICAL DEVICES, WlBCH MAY BEIMP0RTED UNDER.,.... REGISTRATION CERTIFICATENO.l\lJ) DATED :VALID UPTO. -':.' \:.;,"--"/"" ':."';' '; ~l..r"i;-g-o\ltb~ _ ':. :l'_~'~ - ~':--_.,.',:,;----=----"--:"-_-,---,--,..:;-,-~.. _ oor):~'~-i.;'':.,,:._'_,.. ~-:~::;Li~{':,': ;/: -~-.-.-~:.;:;:~-;;~~ :,:~~~~~..;-,;<~;.. ~',-.>. './:.:-<',.,:j.;.~~;~'~t> '>',.'. :':~:;:'..:.: ~,:~;.:':-,:",{,. -.~.~.. -',' ::_:):~-~.:~.',"-::

6

7 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-ll NOV 2011 To" _~ \...MIs. Dashmesh Sonail Healthcare Pvt. Ltd., 42, Kamlesh, Shere Punjab Society, Plot No.36814, Andheri (East) Mumbai Maharashtra IS ration of MIs. Zhanjiang Star. Enterprise Co. Ltd., having factory premises at No.49 Jinchuan Road, Zhanjiang, People's Republic of China under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application No. NIL dated 19/07/2011 received by this office vide dairy no dated 21/07/2011 and reply received by this office vide diary no dated on the above noted suject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewith for the manufacturing sitealongwith the name(s) of medical device(s) imported under the said Certificate subject to the follcnving conditions. ~n"lj, t""h -~ 1. The medical device(s) shall conform to th~t~~ds 1 specifications mentioned in the Second Schedule of the Drugs~~hretics standards or specifications apprqvelt''6)rthis Directorate. VJ Act! ISO 1 MDD / or 1)uchother 2. Dispute, if any, in respect of the payment of fees and submission of TR6 challan, shall be settled between the bank and the applicant. 3. The medical device will be require~:klh~withdra:wn-f-f-om-sale-irom-the-mark-et-in _~_- case any undesirable reactions due to failure of the device or its accessories are brought to light at any stage. This Directorate should be informed of adverse ---r..eports on the-medieat-device, if any. 4. This registration in no way relieves you of the responsibility of complying with other provisions of the Drugs ~ Cosmetics Act and Rules thereunder, and any other provisions of any other Act and Rules. applicable in the matter concerned.

8 5. Each consiglunent of the medical device(s) to be imported by you shall be accompanied by a test / analysis reports. 6. Based on this registration, applications for the import of medical device(s) endorsed in the enclosed Registration Certificate shall be considered for the issue of Form 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration Certification. 8. This registration certificate is being issued under the condition that you are required to submit duly notarized Certificate of Marketability issued by Germany in respect of the product "Foley Catheter (Latex)" at the time of submission of applicationjor grant of Form 10 License. ( As the same submitted by you has not been notarized) Please note that Registration Certificate issued is liable to be suspended / cancelled, if any of the condition stipulated above is not complied with, apart from any other condition that may b(;:taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. ;y.hi $- --- ~ (Dr. V.G. Somani) DrugsCon.troUerGeneral (India) --~ -==--=~-=-=---=--=--==---=--=--=-=-=~=--~------=--~ -=--=-=~-=--- -:~== -=--==- --

9 ..,~ '~",,:<i';~,.:.-,- '....~-..,-."---'---" ".:,~:.. :>:,:. ':....,,. GOVERNM.:D~INDIA Central DrugS Standard Controlo nisation MinisllYof Health & FamUl Welfare FDABI4V1A11,IOTlA ROAD,NEWDEllI "711'.2 IINDW Form 41 (See rule 27-A) Registration Certifzcate issued/or import of devices into India Under Drugs and Cosmetics Rules, MIs. Zhaniiang Star Enterprise Co. Ltd., having factory premises at No.49 Jinchllan Road, Zhanjiang, People's Republic of China has been registered under rule 27-A as a manufacturer and is hereby issued this Registration Certificate. 2. Name(s) of devices(s), which may be imported under thi!>registration Certificate: Please refer to the enclosed list 3. This Registration Certificate shall be in force from to unless it is soonel"suspended or cancelled under the rules. 4. This Registration Certificate isissued through the office of the. manufacturer ()rhls auth()ris d~el1findia MIs. Dashmesh SonailHealthcare Pvt Ltd., 42, KamleshtShereEuniabSociety,~PlotNo:~814, Andheri (East) Mumbai Maharashtra who will be responsible for the businessactivitii;l~ oft1:lel1lanufacturer c..cc.,.. c.c"'.c=c'.c..==~c;= ~=,===",;"cc,-.::c,..o="c=".c.", c"... --,."". "-iff:~'" ',. -",-..._.",..~~.."-'.. c, :':._, ~.'C.". in India, in all respects... if"> f;j'(.'.,'..... " m m' '~,~. r:.;(,'i,,7i.,,...,.. "'.,mc"./ :t-":_, 5: flilsregistrationcertificateis-subject tqc,t~(i)ritlitionsstatedioyerleaf and to such otherco.nditt<>nsas may be..,.... ") '9';~pJlOA.RDCOJ,'''Jjia..' ".. '... '. '..._,',' ',,',.. "",' specified in the Act and the Rules, from ti~t' ~O-9\.... "t. ~.~ V<;~.. '.', LICENSINGA!JtHORITY..,.-- :',...,... :,.;.'; S~StarnP ~.. ~(<:t<." +C"I*1I4'\.~.'~ (>n«i') ~..r'n"l'rf"r~~ft''m ~~l:lfut~<f>'"'l'r"r >i?fjb>t 1!I5.lft.'q'~<J\=qn m, 3lT~.il.31'I ~... '. ~110002

10 .. '0 Immediately 1. The Registration Certificate shall be displayed at a prominent place by the authorised agent. 2. The manufacturer or his authorised agent in India shall comply with the conditions of the import licence issued under the Drugs and Cosmetics Rules, The manufacturer or his authoijsed agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorisation, and/or not of standard quality report of any device pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the device is marketed/sold or distributed. In such cases, action equivalent to that taken with reference to the concerned device in the country of origin or in the country of marketing shall be followed in India also, in consultation with and as per the directions of the licensing authority. The licensing authority may, however, direct any further modification to this course of.action, including the withdrawal of the device from Indian market. 4. The manufacturer or his authorised agent in India shall inform the licensing authority within 30 days in writing in the event of any change in manufacturing process, or in labelling or in testing, or in documentation of any of the device pertaining to this Registration Certificate. In such cases, where there shall be any major change/modification in manufacturing or in testing, or in documentation, as the case may be, the manufacturer or his authorised agent in India shall obtain necessary approval within 30 days by submitting a separate application along with the registration fee, as specified in clause (ii) of sub rule (3) of rule 24-A. 5. The manufacturer or his authorised agent in India shall inform the licensing authority in writing in the event of any change in the constitution of the firm and foroaddress"of-theregistered--office/factory premisesoperating"t.l.tldetthisregistrati _<:::~itiglte. Wh~r~any.sych..cllange.in _the. constitutiond)lthefirm.~ndlor. addr.ess takes place, the current Registration Certificate shall be deemed to be valid for a ma;xinlullipel iod of ttneemonths frotrl the date on which theciiange _h~taken place.. UiiTess;ln"tne o meantime, a Tiesh ltegistrationc-ertlficate hasbeentaken-fiomtbe licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premises

11 GOVERNMENT OF INDIA Central DruBS Standard. Control Organisation Ministrv oflea lib & Familv Welfare FDABHAWAN,KOllA ROAD,NEW DELHI-no 002 [INDIAl NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD- 293 DATED VALID UPTO v ~ L-- - LICENSING AUTHORITY Seal/Stamp.,. &lol. N'ti'i -m i'ofl 'IftlI ~ ~ ('Ifmf) ~ TIm <;l'lf.'r;hlfc'l~ ~ vci <UnIT, 'l>",muj i~ ~.~.l:(. ';<A, <iil,: dl.(r,s, 3lT,{.ei.3iI..,~ ~~

12

13 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 Dated 2. C; 1..~.'""\,I "...J (::..,,1 l.u n11: TQ /' ~s. Smith & Nephew Healthcare Pvt. Ltd., (C&F Elian Trading Co)B1dg No 2-3 & 15-17, Rajlaxmi Complex, Opp. Hanuman Bus Stop, Kalher, Thane Bhiwandi Road, Dist- Thane Maharashtra SUB: -Registration of Mis. Smith & Nephew Inc., Endoscopy Division, 150 Minuteman Rd., Andover MA 01810, USA having factory premises at Mis. Smith & Nephew Inc, 130 Forbes Boulevard, Mansfield, Massachusetts, USA under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application No.SNI/30/2011dated 29/03/2011 received by this office vide dairy no.15l11 dated 31103/2011 and reply received by this office vide diary no dated 28/09/2011 on the above noted suject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewith for the manufacturing site alongwith the name(s) of medical device(s) imported under the said Certificate subject ~.~~\following conditions. r.'~ 1. The medical device(s) shall confo~tq.thistandards 1 specifications mentioned in the Second Sche~ule~fthe D~,s:apdto~me~ics Ac~ ISO 1 MDD / or such other standards or specifications apprqved by this DIrectorate. _ 2, Dispute, if any, inrespectofthepayment-of fees andsubmissionoftr6- challan, _~..~ shah--be-sett:l-ed-betweerrthe-banlcarn:t1heapplicant The medical device will be required to be withdrawn--fr-on:l--sale----fr..qm-th?-mar-k-e+-ii ~ case any undesirable reactions due to..failur.e-.of-the--d.e i-ce--gr-i-ts--agge-sser-ie-s---ar-e brought to light at any stage. This Directorate should be informed of adverse reports on the medical device, if any. 4. This registration in no way relieves you of the responsibility of complying with other pro.visions of the Drugs & Cosmetics Act and Rules theteunder, and any other provisions of any other Act and Rules applicable in the matter concerned.

14 5. Each consignment of the medical device(s) to be imported by you shall be accompanied by a test / analysis reports. 6. Based on this registration, applications for the import of medical device(s) endorsed in the enclosed Registration Certificate shall be considered for the issue of Form 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized fqr this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration Certification. 8. This registration certificate is being issued under the condition that you are required to submit Detailed Shelf life Validation Report in respect of product " FOOTPRINT ULTRA SUTURE ANCHOR" and Detailed Biocompatibility Study Report including the protocol and Test report in respect of " TWINFIX ULTRA Ti" at the time of submission of application for grant of Form 10 License, (as the same have not been submitted by you) Please note that Registration Certificate issued is liable to be suspended / cancelled, if any of the condition stipulated above is not complied with, apart from any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. ~'b' (Dr.V.G. Somani) Drugs Controller General (India)

15 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministrv 01 Health & Familv Wellare FDA8HAWAN, KOTtA ROAD,NEWDELHI-ll0 002 [INDIAJ Form 41 (See rule 27-A) Registration Certificate issued for import of devices into India Under Drugs and Cosmetics Rules, 1945 ~.. ~~~R~egistrallim~JCLZte-N-c..:-MI>-4J-l l:)me:l-5- ~~'-- i',=.v2- {Ht---~ Mis. Smith & Nephew Inc., Endoscopy Division, 150 Minuteman Rd., Andover MA 01810, USA., having factory premises at MIs. Smith & Nephew Ine, 130 Forbes Boulevard, Mansfield, Massachusetts, USA has been registered under rule 27-A as a manufacturer and is hereby issued this Registration Certificate. Name(s) of devices(s), which may be imported under this Registration Certificate: Please refer to the enclosed list 6""\ O~ This Registration Certificate shall b~ Me from to unless it is sooner suspended or. ~-c./ cancelled under the rules....,/",\v,..'v 4. This Registration Certificate is issued through the office of the manufacturer or his authorised agent India Mis. Smith & Nephew HeaIthcare Pvt Ltd (C&F Elian Trading Co) Bldg No 2-3 & 15-17, Railaxmi -._,~--,,---,,-,,~~---"~-- -_.' "- --~...;~.._~~-----, ,..'.. '"... _--- --~ Complex, ODD' HanumanBus Stop,Kalher, Thane Bhiwandi Road, Dist- Thane Maharashtra who will be responsiblefbrthe businessactivities,ofthe manufacturer in India, in all respects,.. -~ _._~--~ This Registration Certificate is subjectto!h~c:q!14iti9i1s$tat~dqveileafandjosllch other conditions as may be.. _-~_.- -~ ~-.. --~ -... :\tt-~o"rdc~_._....._,,. ~,..._~_... '_..._~._._ ~ ~-~---.speeifi ed'in-the-a-ct-and-theiillj-es~-rr(jmli~-- e. ~o:;~ ~ ~ $ 6 u z \ -I---~ ~ ~ ~ ~~~ - 0' V\IC ~t- Place: New Delhi O~I-t'A(rH.GO"'_." ~,,' ~ LICENSING AUTHORITY

16 1. The Registration Certificate shall be displayed at a prominent place by the authorised agent. 2. The manufacturer or his authoris~d agent in India shall comply with the conditions of the import licence issued under the Drugs and Cosmetics Rules, The manufacturer or his authorised agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorisation, and/or not of standard quality report of any device pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the device is marketed/sold or distributed. In such cases, action equivalent to that taken with reference to the concerned device in the country of origin or in the country of marketing shall be followed in India also, in consultation with and as per the directions of the licensing authority. The licensing authonty may, however, direct any further modification to this course of action, including the withdrawal of the device from Indian market. 4. The manufacturer or his authorised agent in India shall inform the licensing authority within 30 days in writing in the event of any change in manufacturing process, or in labelling or in testing, or in documentation of any of the device pertaining to this Registration Certificate. In such cases, where there shall be any major change/modification in manufacturing or in testing, or in documentation, as the case may be, the manufacturer or his authorised agent in India shall obtain necessary approval within 30 days by submitting a separate application along with the registration fee, as specified in clause (ii) of sub rule (3) of rule 24-A. 5. The manufacturer or his authorised agent in India shall inform the licensing authority immediately in writing in the event of any change in theconstitution /oraddress.of the registered. officelfactorypremi Certificate. Where any such change in the constitution ofthefirm of the firm and ses.operating -under this Regi stration and/or address takes place, the current Registration Certificate shall be deemed to be valid for a maximum period of three months from1hed1l.temtwh1ctf1hechange has mken place._..._... ~..==.ul1.ie~l.fu fni ill~il1!i!12e-,-.afr.e~bjsegistr!!1:iqn C~rj:IDcate JlasJ')~~~jak~!1.1rQ!11.J~.... licensing authority in the name of the firm with the changed constitution of the finn......_... ~a~nd~/.~o~r ~ch~a~ng..ed addre..slofthe.registere.d..a:ffic.e..dlf.aq.tql~_.pre.mise.s...._

17 > 7.. GOVERNMENT OF INDIA. Central Drugs Standard Control Organisation Ministrv of Health & Familv Welfare FDA8HAWAN, KOILA ROAD,NEWDElHI lindlaj NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD- 431 DATEDO VALID UPTO ,EnoiJQt.tQU > 2....E.~IScrews 3. BIORCI SCREW 4. ULTRt\. E~~'l''''fix 5. ' TWIN4FI~~I.l )SU'F RANCHOR ULTRA ::6. TAG AI.l~'~~~i'."'" TAG 3.7 Ml\f:ROD II 8&'.~~~sa dt~ire1\.nc?nr?.bi0511~~r~.(2tibialfixation,~o.. FOOTi~'ltt~!IJ~!~raSuture Anchor l~.,_twinf'i~! T~ri~HA 12.>:tJWINFiX:HL"~t. PK ,TWINFIX<>:r{1JLTRA:BRAID. ITEM(St:fJ{STeENONLY.....,_...._...._' ~.... ~W~'\~?ARD co~!eer~'..-..-_ _-_--_ - -_--"---~._-._ c'" "" ~ \ $ 6 u " New Delhi Date: 2 j. \J,~~. LICENSING AUTHORITY ~au~~rlr~ 'fl'htl=ft' 1ftlT ~ ~ ('1m!) ~q <'t<n '~I1~'?TR'fll ~-.:~ l~ci ur~; -<?':<"illij ;!~ ~.";I.", : "'" ;;jl".cl.;ffi. '.' I,0002

18

19 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-ll ,...."," -.-" ~ -,' I ~ Of" ""'11 ~ i...) [-;'''; V (. \I : To./ VIs. India Medtronic Pvt. Ltd., 1241 Solitaire Corporate Park, Building No. 12, 4 th Floor, Andheri Ghatokapr, Link Road, Andheri East, Mumbai India. SUB: - Registration of additional Medical Devices to RC No. MD-64, manufactured by MIs. Medtronic Inc. 710 Medtronic Parkway, NE Minneapolis, MN USA having manufacturing site at MIs. Medtronic Ireland Parkmore Business Park West Galway Ireland under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application No. YD/SH/CY-NW-MD-64/2011 dated 14/02/2011 received by this office vide dairy no dated 17/02/2011 and reply received by this office vide diary no dated 11/ Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewith for the manufacturing site alongwj.tp the name(s) of medical device(s) imported under the said Certificate subje~)~ the following conditions. t. The medical device(s) shall Confow.i1P<;te standards I specifications mentioned in the Second Schedule of the DJ1!~ri'd Cosmetics Actl ISO I MDD lor such other standards or s ecifications -1' rbved b this Directorate Dispute,.if.any.,in respectoflhe_pay.menlof _fees..and_ uhmissiqi1_pltrf5 _~h~ll'!i1,. shall be settled between the bank and the applicant. _ rtl1e mearcal-device-wi11-oe-re-qulreci"lobewlt-rrdrawn-fmm-sare-fromihe-market-irr case any-undesifa51 e reactions due to failure -orm:ede-vlce-ori-rs-acc-e-ssorre-s--are brought to light at any stage. This Directorate should be informed of adverse reports on the medical device, if any. 4. This regis~ration in no way relieves you of the responsibility of complying with other provisions of the Drugs & Cosmetics Act and Rules thereunder, and any. other provisions of any other Act and Rules applicable ~nthe matter concerned.

20 5. Each consignment of the medical device(s) to be imported by you shall be accompanied by a test / analysis reports. 6. Based on this registration, applications for the import of medical device(s) endorsed in the enclosed Registration Certificate shall be considered for the issue of Form 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration Certification. Please note that Registration Certificate issued is liable to be suspended /.cancelled, if any of the condition stipulated above is not complied with, apart from any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. 1\ ~ 4'&-- V',--- "' (Dr. V. G Somani) Drugs Controller General (India)

21 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministry of Health & FamilvWelfare FDA8HAWAN, KOlLA ROAD,NEW DELHI-ll0 002 lihdiaj NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER ENDORSEMENT NO. 10 DATED 2. 5 [,[ev 2011 TO REGISTRATION CERTIFICATE NO. MD-64 DATED VALID UPTO ENDORSEMENT NO Endurant sten.t G~<System ITEM(S) O~ <I'/I:l»i,. '" f'.:/','; (' '1~'./ '. ~ (',''0 "y only Y ~.-Y LICENSING AUTHORITY

22

23 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 To, / ~s B.L. Lifesceince Pvt. Ltd., D-31, Site IV, Kasana, Surajpur Greater Noida (U.P) SUB: - Registration of MIs Acme Monaco Asia Pte. Ltd., 12 Tannery Lane, # , Santat Building Singapore under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application no. NIL dated and received by this office vide diary no dated , and reply received vide dairy nos dated and dated on the above noted subject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is issued herewith for the manufacturing site alongwith the name(s) of medical device(s) imported under the said Certificate subject to the following conditions. 1. The medical device(s) shall conform to the standards / specifications mentioned in the Second Schedule of the Drugs and Cosmetics Act! ISO / MDD / or such other standards or specifications approved by this Directorate. 2. Dispute, if any, in respect of the payment of fees and ~ubmission of TR6 challan, shall be settled between the bank and the applicant. 0"'''\ 3. The medical device will be required to be wi!,adftrwnfrom sale from the market in case any undesirable reactions due to~.fq,i{uityof the device or its accessories are brought to light at any stage. Thfs;:Drrectorate should be informed of adverse reports on the medical device, if any: 4. This registration in no way relieves you of the responsibility of complying with other provisions of the Drugs & Cosmetics Act and Rules thereunder, and any other provisions of any other Act and Rules applicable in the matter concerned. I'" () '.

24 5. Each consignment of the medical device(s) to be imported by you shall be accompanied by a test / analysis reports. 6. Based on this registration, applications for the import of medical device(s) endorsed in the enclosed Registration Certificate shall be considered for the issue of Form 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration Certification. 8. This registration CertifICate is being issued under the condition that you are required to submit the D~ly Notarized and Valid copy of Form 28, approved by Central Licensin~~tliOrity at the time of submission of application for grant of Form 10 Licence. Please note that Registration Certificate issued is liable to be suspended / cancelled, if any of the condition stipulated above is not complied with, apart from any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. (Dr. V.G. Somani) Drugs Controller General (India)

25 , GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministrv of Health & Familv Welfare FDABNAWAN, KOYlA ROAD,NEW DELNI-ll0 002l1NDIAJ Form 41 (See rule 27-Al Registration Certificate issued for import of devices into India Under Drugs and Cosmetics Rules, 1945 I)., Date: L.','111 'i 'j,: l LL' Mis Acme Monaco Asia Pte. Ltd.. 12 Tannery Lane. # Santat Building Singapore has been registered under rule 27-A as a manufacturer and is hereby issued this Registration Certificate. Name(s) of devices(s), which may,be.,lrnported under this Registration Certificate: Please refer to the enclosed H~( ~""';~ ('\.:~ i;;<pv This Registration Certifi~te shall be in fotcefro~~~sfk~llto unless it is sooner suspended ~1!p,.",'t.,...~.,<f:,: ~>, (f'!:,:<:~/';',;,~:; ":,">1:, ~;,/: This Registration Certificat~:i~ i~s~~)~eqlj~~ thei9ffi~f()f~t~etap~~+letll(erpr his authorised agent in India Mis B.L. Lifesceince Pvt. t:td.; D::31~Sitel",i'l{asa~~r~lirajpur,Greater Noida (V.Pl.Who will be responsible for the busine~s activities ofthe:~iu1uf~aturer:lrt'iridia, in all respects. This Registration Certificate.js;;subject to t~~'~~miiti~~~:statectoverleaf aild::to such other conditions as may be specified in the Act and th~"~dl~s",from tiriljtbliine.

26 1. The Registration Certificate shall be displayed at a prominent place by the authorised agent. 2. The manufacturer or his authorised agent in India shall comply with the conditions of the import licence issued under the Drugs and Cosmetics Rules, The manufacturer or his authorised agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorisation, and/or not of standard quality report of any device pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the device is marketed/sold or distributed. In such cases, action equivalent to that taken with reference to the concerned device in the country of origin or in the country of marketing shall be followed in India also, in consultation with and as per the directions of the licensing authority. The licensing authority may, however, direct any further modification to this course of action, including the withdrawal of the device from Indian market. 4. The manufacturer or his authorised agent in India shall inform the licensing authority within 30 days in writing in the event of any change in manufacturing process, or in labelling or in testing, or in documentation of any of the device pertaining to this Registration Certificate. In such cases, where there shall be any major change/modification in manufacturing or in 1esting, or in documentation, as the case may be, the manufacturer or his authorised agent in India shall obtain necessary approval within 30 days by submitting a separa1e application along with the registration fee, as specified in clause (ii) of sub rule (3) of rule 24-A. 5. The manufacturer or his authorised agent in India shall inform the licensing authority immediately in writing in the event of any change in the constitution of the firm and lor address of the registered office! factory premises operating under this Registration Certificate. Where any such change in the constitution of the firm and/or address takes place, the current Registration Certificate shall be deemed to be valid for a maximum period of three months from the date on which the change has taken place unless, in the meantime, a fresh Registration Certificate has been taken from the licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premises. ut,'p 11 t~!

27 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministry of Health & Familv Welfare FDABHAWAN,KOILA ROAD,NEW DELHI-ll0 002 lindiaj NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD- 670 DATED VALID UPTO Date: I) i.:.;...' 2011 L. '" ""."

28

29 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 To ~ _ / \...,MIs B L Lifesciences Pvt. Ltd., A-245, Okhla Industrial Area, Phase-I, New Delhi SUB: - SUBJECT: - Registration of manufacturing site of Mis BioE LLC, having factory premises at Mis BioE LLC, 4280, Centerville Road, St Paul, MN 55127, USA under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Sir, Please refer to your application no. 06/10/2010 dated 06/10/2010 received by this office vide Diary No and dated 13/10/2010 reply received vide diary no dated 01/06/2011 on the subject cited above. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewith for the manufacturi site alongwith the name(s) of medical device(s) imported under the said Ce' te subject to the following conditions. The medical device(s) shall conform to the standards I specifications mentioned in the Second Schedule of the Drugs and Cosmetics Act! ISO / MDD / or such other standards or specifications approved by this ~N;tctorate. 2. Dispute, if any, in respect of the p~&~fees and submission oftr6 challan, shall be settled between the b~1he applicant. ( X" 3. The medical device will be ~quired to be withdrawn from sale from the market in case any undesirable reactions due to failure of the device or its accessories are brought to light at any stage. This Directorate should be informed of adverse reports on the medical device, if any. 4. This registration in no way relieves you of the responsibility of complying with other provisions of the Drugs & Cosmetics Act and Rules thereunder, and any other provisions of any other Act and Rules applicable in the matter concerned.

30 5. Each consignment of the medical device(s) to be imported by you shall be accompanied by a test / analysis reports. 6. Based on this registration, applications for the import of medical device(s) endorsed in the enclosed Registration Certificate shall be considered for the issue of Form 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration Certification. Please note that Registration Certificate issued is liable to be suspended / cancelled, if any of the condition stipulated above is not complied with, apart from any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. v,4-~-. (Dr. V. G. Somani) Drugs Controller General (India)

31 GOVERNMENTOFINDIA Central Drugs Standard Control Organisation Ministrv of Health & Familv Welfare FDABHAWAN,KOlLA ROAD,NEW DElHI-ll0 002l1NDlAJ Form 41 (See rule 27-A) 7 ('11 '"'U 2. Name(s) of devices(s), whichl11~ybe importedtmderthjsr,ygistration Certificate: Please refer to the enclosed list:.~.~,.. '~--.,,~<-',;u,,: <"''-:')-:'''. <: " ::_'~'_::,:'>.il,<)'} 3. This Registration Certifi)ate shall be i~jqe~~tn,(jh.!\ to '2014 unless it is sooner suspended or cancelled unde:.tber~i~\~,;j'y' "".~\" -,...t'f,j"".... ~.~ This Registration Certific<,l:!S? is issued thro India MIs B L Lifescien~~' Pvt. Ltd. r'\" -'~:~i~r:: ;-:-':_:~:'-:;::',',' ;',':"':':'?','o":',,\>.;'~>;\_ India who will be responsible'($~\jhe busines~.l,\phyitiesof.ibemanufactur r in India, in all respects. 5. This Registration Certificate is subject tottb,e,conditionsstated Qverleaf and to such other conditions as may be specified in the Act and the Rules, from time to'time; Date: 2. 5 I. "'j 2011

32 1. The Registration Certificate shall be displayed at a prominent place by the authorised agent. 2. The manufacturer or his authorised agent in India shall comply with the conditions of the import licence issued under the Drugs and Cosmetics Rules, The manufacturer or his authorised agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorisation, and/or not of standard quality report of any devke pertaining to this Registration Ccrtificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the device is marketed/sold or distributed. In such cases, action equivalent to that taken with reference to the concemed device in the country of origin or in the country of marketing shall be followed in India also; in consultation with and as per the directions of the licensing authority. The licensing authority may, however, direct any further modification to this course of action, including the withdrawal of the device from Indian market. 4. The manufacturer or his authorised agent in India shall inform the licensing authority within 30 days in writing in the event of any change in manufacturing process, or in labelling or in testing, or in documentation of any of the device pertaining to this Registration Certificate. In such cases, where there shall be any major change/modification in manufacturing or in testing, or in documentation, as the case may be, the manufacturer or his authorised agent in India shall obtain necessary approval within 30 days by submitting a separate application along with the registration fee, as specified in clause (ii) of sub rule (3) of rule 24-A. 5. The manufacturer or his authorised agent in India shall inform the licensing authority immediately in writing in the event of any change in the constitution of the firm and lor address of the registered office! factory premises operating under this Registration Certificate. Where any such change in the constitution of the firm and/or address takes place, the current Registration Certificate shall be deemed to be valid for a maximum period of three months from the date on which the change has taken place unless, in the meantime, a fresh Registration Certificate has been taken from the licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premises.

33 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministry of Health & Familv Welfare FDABHAWAN,KOrlA ROAD,NEW DElHI-ll0 002 lindiaj NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD-855 DATED 01/11/2011 VALID UPTO 31/10/2014. :'-,:.<- ""','-.. :.'..''... ' : ':..' :,.,'.:..... ';": ',,..: -: :... '.: PrepaCyt~~c~"i; ~>~""9,cessing System ~IF;Mti>~$()~]]Y Indication: The PrepaCy!~ c~yj:j~9~raj:jl.!qoa) PfO:c~~~tUg y~!emis intended for use in cell processing laborat().,ries to process~udstqr.et~~c1eated cells (TNC) from human umbilical cord blood priqr to bankin~t.~,,~~~.c\'c). ~ ~~:<"~:~' >,~ :~, ~ P"> ~ f~:,~ I> New Delhi Date: 2 5 j'-jo\! 6;) 7. I'll

34

35 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare ----CD Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 Dated To... /. ~. Abbott Healthcare Pvt. Ltd. 4 Corporate Park, Sion Trombay Road, Chembur, Mumbai SUB: - Endorsement to RC No. MD-256A of Manufacturing site MIs Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA having factory premises at MIs Abbott Vascular, Ynez Road, Temecula, California 92591, USA under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application dated 07/03/2011 received by this office vide dairy no dated 07/03/2011 and reply received by this office vide diary no dated 07/07/2011 on the subject cited above. - r"''''' " RegistrAtion Certificate in Form 41 under,tht~~s and Cosmetics Rules is herewith for the manufacturing site alongwith the n~) of medical device(s) imported under the said Certificate subject to the follo~tions. if', " )~ 1. The medical device(s) shall conform to the standards I specifications mentioned in the Second Schedule of the Drugs and Cosmetics Act! ISO I MDD I or such otherstandards or specifications approved this Directorate. f.1 "~ 2. -Dispute;ifany, inrespectoftliepaymeiit offees aiiosllbriiission 6(TR6 challan, shall be settled between the bank and the applicant. 3~ The.medicaldevice will be required to be withdrawn from sale from. the market in case any undesirable reactions due to failure of the device or its accessories are brought to light at any stage. This Directorate should be informed of adverse reports on the medical device, if any. 4. This registration in no way relieves you of the responsibility of complying with other provisions of the Drugs & Cosmetics Act and Rules thereunder, and any other provisions of any other Act and Rules applicable in the matter concerned.

36 5. Each consignment of the medical device(s) to be imported by you shall be accompanied by a test / analysis reports. 6. Based on this registration, applications for the import of medical device(s) endorsed in the enclosed Registration Certificate shall be considered for the issue of Form 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable' inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration Certification. Please note that Registration Certificate issued is liable to be suspended / cancelled, if any of the condition stipulated above is not complied with, apart from any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. V"+J:: ; (Dr. V. G Somani) Drugs Controller General (India)

37 , ~-, '",;, -, ~' '; ".-.-~"l3}-~~~::.~,.~ _,c_ ".;:,;',:'-"', GOIERfIIllloF INDIA CentralDrulsStlndlnl ClnUlI"'~.isatiln.,. IIID & 81_"WO1111re FDAlIawu,IITIIIIID,IEW ;",,. _~n...z IIIOIIl NAME(S) OF MEDICAL DEVICES, WIDCR MAY BE IMPORcTED UNDER... ENDORSMENT D~TED 2.s i'j,~\,-tftllffgistration CERTIF'ICATE NO. MD- 256A VALID UPTO 't.- :'~~.\,,~-'::./ ":'...~::+., --~< ~,Y;"" New Delhi Date: l"" c' 2. :J ~\ v l011 V'If~~, ~ -'--'-----:----:~"7':7.-~-:";::;';;':;~~" LlCENSINij~~trhIORITY.-r.llfi::Ww. t,ift "m':~1'~~ (otml) 1('qJ~:mr\ f:;l'~mmll. ~l~";~',l?ji'm,,'~l, ~~~~3~aD.<:::~:<--;::,i-,,:: ~

38

39 Central-DrugsStandara~kttrolOrgani~~~l1 Dire~t~rateGeneral:QfHe~lthServices'~~ Ministry of Health'~ Fanuly Welfare., ' Food and Drug Administtat:1o-:i\JJhawan, Kotla Road, New p 1,l.tr..l Dated 2.5 To ~ Abbott Healthcare Pvt. Limited, 4 Corporate Park, Sion Trombay Road,Chembur, Mumbai SUB: -Amendment in Brand name of the Product on the Registration certificate No. MD-256A dated 01/05/2010 & Import License No. MD-256A",426 dated 05/05/2010valid up to 30/04/2013-reg. Please refer to your letter no. NIL dated 15/02/2011 received by thisoffice vide diary no dated 15/02/2011 and reply received by this office vide diary no dated 19/10/2011 on the subject matter. This is with reference to correction in brandname 9! ~:h~1>rbductregist~redto the Registration Certificate No. MD-256A issued 011 Ol/.Q ,0"""and Form 10'Litense MD- 256A-426 issued on05/05/20lo valid up to 30k~~(}13'1ssued by this office.ta~name of the products is hereby amended as follows: - "'... S.NO. 1. Name of the Device Read as' Peripheral Stent and Delivery$ysfem HeI'Culink Plus) (RX All the other conditions of Registration Certificate and Form remain same. Copy to: Asstt;-Drugsc:untrolle-r-(It-- New CustomHouse Anne:xe Ballard Estate, Fort, Mumbai

40

41 rr" ~':,:' "::.:..: ~,~~~,:,:",*S~:.;~,:,_ _, ",': ~',:,i'~ "'i';i:': X:"; :', ",j",'~,t:: Central Drugs Standard (Jontrol Organis~#~~ Directorate General o~health Services',',. Ministry of Bealtlt&'I?amilyWelfa.re Food and Drug Administra,ti~nBhawan Kotla Road, NewD~'b.i~ll0002 Dated 2. L:. :.. '.. ".".',.) 'Z01\..J i... '. ~. MIs. Abbott Healthcare Pvt. Ltd. 4 Corporate Park, Sion Trombay Road, Chembur, Mumbai ~ SUB: - Endorsement to RC No. MD~307of Manufacturing site Mis Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA ha",mgfactory premises at Mis Abbott Vascular, 2653LYnez Road, Temecula, California 92591, USA under the provisions of Drugs & Cosmetics Rules.for the purpose of import of medical devices.in.lndia. Please refer to your application dated 14/12/2010 received by this9:fftce vide dairy no dated 14112/2010 and reply received by this office vide diary>no dated 20109/2011 on the subject cited above. ","; Registration Certificate in Form 41 under the Drugs and Cosmetics Rule~isherewith for the manufacturing site alongwith the name(s) of medical device(s) impotte(junder the said Certificate subject to the following conditions.. <'~;:. 'p, r\.~..,y' 1. The medical device(s) shall conform to thei4~~~ 1 specificationsl1l~tiqned in the Second Schedule of the Drugs and.p~~etics Act! ISO I MDDloi;suchother staridards or specifications approvel;l1"iiirsdirectorate..'.:l~ ;,..,cc.o.)t".c.=.s.~,,,,,~,,_ ~,.~.... ;c.:;:.,,. 2;-Dispute; if-any; in respect-of thepaymen~2.ofteesaridslifimissionot''f~6: lianan, shall be settled between the bank and the i\lpplicant.,:. 3. The..medicaldevice will be.requiredto-be:withdrawn from salefront~~tnarket in case any undesirable reactions <lueto-fai~e-of the device or its ac~'$sgri,esare brought to light at any stage. This Directorate should be informed'9r~dverse reports on the medical device, if any.,,:;,". :",:~.;:i : 4. This registration in no way relieves you of the responsibility of coni~~;ing with other provisions of the Drugs & Cosmetics. Act and Rules thereund<i*,,;';;lul.d any other provisions of a,nyother Act and RuleS~plicable in the matterc~ed. :,:;}~;.,.:_,,<.",",;'~;'~':'L,'>.-:!;:,...< :v ~i'({;:<:~ ':. >~~ :~:: :i ' "'~;'r'.;~";:i-:';:>';i -i" ;:,"-'<.'.