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

Transcription

1 Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 F. No.: MD/2007-DC (Re registration 2010) (End. 1) Dated - 1 MAR ZQ1Z To ~ajanand Medical Technologies Pvt. Ltd., Sahajanand House, Parsi Street, Saiyedpura, Surat SUB: - Endorsement No. 1 to R.c. No. MD- 274 to Manufacturing Site of Mis Arthesys, 20 rue Traversiere92230 Gennevilliers, France under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application dated and received by this office vide diary nos dated , dated and replies received vide Diary no 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 tnesecorid Schedule ofthe Drugs and Cosmetics Act.! ISO/ MDD I or such other standards or specifications approved by this Directorate. 2. Disl"ute, if any, in respect of the payment of fees and subm~ssion of TR6 challan, shall be settled between the bank and the applicant. 3. The medical device will be required to be withdrawn from sale from the market in case any undesirable reactiol1s~du~.to fa.il:ureof the device Qr its a.ccessories are. brought t6 light at ariystage. This DirecforateshotildbeirifonnedoCadverse reports on the medical device, if any. 4.. This registration in no way relieves you of the responsibility of complying with ~.-~ ~--- --other provisions Qfthe Drugs.-&-CosmetiGs-AGt-and-Rules-thereunder-,..and -any other provisions of any other Act and Rules applicable in the matter concerned.

2 GOVERNMENT OF INDIA NUnistlYof Health & Familv Welfare FDABHAWAN, KOTLAROAD, NEW DELHI-no 002 lindiaj NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER ENDORSEMENT - 1, DATED - ';. 1 F\P,.H TO REGISTRATION 3,...'1tI~ CERTIFICATE NO. MD- 274 DATED VALID UPTO ENDORSEMENT NO CYGNUS II Co- CrCoronary Stent system (Non Sterile) 2. PEGASEAspiration C-atheter(Sterile and Non Sterile) 3. [YNXPTACatfjeter(SferUe~ari(rN()n - sterile).l1"l:ms~tj--i~ee ()NLY. ~(;,SC; ""UARD co",,~ q,o,-? Date: ~ 1 (,;"~; L1CENSIN~ORITY --~ ~------~~---~----~ ~--~-----~~~ ~ c------s- ea 11Stamp----- Dr. G. N. SINGH Drugs Controller Genera! (India) ~~e.genera!of Health Se!'ViC$s MInIstry of Heallh & Family Welfare FDABhawan, Kolia Road, 1.1:0. New Delhi

3 Directorate General of Health Services Ministry ofhealtb & Family Welfare No.: MD/2011-DC Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 To / Vs Ir,dia Medtronic Pvt. Ltd, Plot No.609, Survey/Shed-188 (Part), Chamunda Camp., Kasheli Village, Dist. Thane Bhiwandi Maharashtra. SUB: Registration of Mis Meditronic Inc, 710, Medtronic Parkway Minneapolis, MN having manufacturing premises at Mis Medtronic Inc Coral Sea Street NE Mounds View, Minnesota under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application no. SH/RP/CDRM-NW-Registrationl5011 dated received by this office vide dairy no dated and reply received vide dairyno dated on the above noted subject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewith for the manufacturing site along with the name(s) of medical device(s) imported under the said Certificate subject to the following conditions. 1. The medical device(s) shall confonn to the standards I specifications mentioned in the Second Schedule of the Drugs and Cosmetics Actl ISO I MDD I or such other standards or specifications approved by this Directorate. ~_. 2. Dispute, if any, in respect of the payment of fees and submission of TR6 challan, ~1I~U~~~~~!!L~~_ ~!~~_e~~_t!1~j?~~k~!1(j~!1"@ ~ pli~a1'l.t_:. ~ ~. 3." The medical device will b~required tope withdrawnfrpulsalejromthe,market in ---- caseanyundesitable -react10nsdue tofaitliteof-tnedeviceot its accessories are brought to light at any stage. This Directorate should be informed of adverse -----repoasontllelnedlcatdevlce;ifany ~_Ihis_J:e.gistration_in.nowaY_.!elieves_ you olthe_r.es.ponsibilit}'-olcomplyingwith 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. _

4 GOVERNMEBT OF INDIA Central DruD~Standard CentrolOrganisation Ministry of Health & famuvwelfare FDABRAWAN, KOllA ROAD,NEW DELHI IRiDIAl Form 41 (See rule 27-A) Registration Certificate issuedfor import of devices into India Under Drugs and Cosmetics Rules, ]945,>'c l. Mis Meditronic Inc, 710, Medtronic Parkway Minneapoiis, MN having factory premises at MIs Medtronic Inc Coral Sea Street NE Mounds View, Minnesota has been registered under rule 27-A as a manufacturer and is hereby issued this.registrationcertificate.. '.',,',>. -'.::- :.,' ;"".'.. ;':-- Name(s) of devices(s), which may b~jmported under this Registratior{C~~Iiificate: - '"'r ~, ;,," ".,._ ""c. Please refer to the enclosed Iist"lJi:!te:..;<. '" ~,", ~ - '7'" -''''<:'~i~,..k:i;'k:_:~'-: '-<:..- " i~..;::.:, ~~~~' -...~:;::<:'t~.~,;,~~;/;:.~,~-1~~1tj3,;~~~-~-~~<~;~:_~.::.~,,';::":-~ ~~,_ This Registration Certifi ~te shall be in for~ejf~gm'jl'6~02;2012 to unless it is sooner suspended 'i:.~ ' or cancelled ;under the rules. 'rl;",,~,»\\~;'.u:;p:.:,;~' >~>'~~, '." x'"''.,("'~. -<;:'~,.;'''''''-'%' ":,';-:,:,;';';.<i,>' "04" <"~""; ;('=""",;<=-:.ji"."'" ~""-'",,,_ 4. This Registration CertifiCliteisjss\J~JJifOpgbth~qffice oqhe';rnal1wagttir r'ior)hisauthorised agent in India c(. ~ M/slndia Medtronic Pvt..Ltd,Plot No. 609,'StirV~y7Sh'~ti~i88 (Part), Chamunda Comp, Kasheli Village, Dist. ThaneBhi~a'fidi42130 ;:;~ IMah;~~~~Chtf~:1~R6/,~{~i'ibe responsible:f~rthebusi -,.._,...~ _.._._~-_ ~,-:,-""'~,'''J:IT: "',::;:y,~~:y;lf;<':::.:;-:;,;~~;:.;~.~;.,, the manufacturer in India, in all respects. ness activities of 5. This Registfafi011 Celtificate is subjecttothe.conditions statedoyeil~aral1dto' such oiller conditions as may be. ~~~Ei~~~9_il~_tl!tS'EtaJiC[t}}~}l~1~S-,-!ro~~~~~.~~U~j 1ne~~~._..~_~..._~ ~~~_.._~~~~ ~_c_~_~.~.

5 GOVERNMENT OF INDIA Central Drug~Standard Control Organisation MinistrvolHealth&Familv Wellare ~.. _- FDARHAWAN, KOlLA ROAD,NEW DELHI [INDIA] NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD-966 DATED VALID UPTO AtfarD Sele~t ~Qi!1e~athefer~.S...et, Left (62381':EL).,=' 'Yf:;:-)(;~>t~: ';:,(:;'7,",,:,)( ' 2. Attain Veriti"alloon <~~ Catli'eter Model 6215 ~~art D~Ji~"'('~"'V"::~;~l ". rr:,i;, ;;,",)0) ONL yr' Q-i' ",s' :c\f'l'\of>.rd. CONrll, '" 0. "" i' \ ~ CDSC DSCO~ Place: New Delhi \~,/ LICENSING UTHORITY o~ ~{Io "'~(TH GOV<~"'" -----~ ~ Se~~ ~~~:_StNGH _,,., '-- ~.'. Drugs Co~tro'lIe~General (India) ~.o.~t~.,, ~ ~7"~.~,JJ-4m ~ ~--- Ote. General ofhealth Services M~n,s.tryof Health & Family Welfare,OhBhdwan, KotlaRoad, LTO, New De1hl

6 Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 -j ~ To, /' V~~edicon Surgical Technologies Pvt. Ltd., 203, Damji- Shamji Ind., Complex 9, LBS Marg, Kurla (West), Mumbai SUB: - Registration of MIs Medicon cg, Gansacker 15, Tuttlingen, Germany 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 Q and received by this office vide diary no dated and reply received vide diary no 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 I specifications mentioned in the Second. Schedule of the Drugs and Cosmetics Act! ISO I MDD I or such other standards or specifications approved by this Directorate. 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 required to be withdrawn from sale from the market in case any undesirable reactions due to failure of the device or its accessories are._.-~-_._.. -. bj:qllght_j6]ighlala.llysjag~,_.tlils_[)ii~clqmte h(:ml<:l]i~~.fufqjjri~q_.oiacly~rse reports on the medical device, if any. 4. This registration in no way relieves you of the responsibility ()fcomplying with 9.!h~Ll?!9yi~i()Q~_9I1h~_Rl'l!gs & Cosmetics Act and Rules thereunder, and any other provisions of any other Act and Rl.llesappHcl:lble In-the matter concel:nea.._-

7 GOVERNMENT OF INDIA Ministrv of Health & Familv Welfare FDABHAWAN,KOILA ROAD,NEW DELHI-ll0 002 [INDlAJ Form 41 (See rule 27-A) Registration Certificate issued for import of devices into India Under Drugs and Cosmetics Rules, 1945 L Mis Medicon eg, Gansacker 15, Tuttlingen, Germany 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 this Registration Certificate: Please refer to the enclosed list 4, This Registration Certificate is issued through the office of-the rnanufacturerorhis authorised agent in India Mis Medicon Surgical Technologies Pvt. Ltd., 203, Damji- Shamji Ind., Complex 9, LBS Marg, Kurla (West), Mumbai-A Who wilibe respollsible.fo!: the business activities of the manufacturer in -India;i nallrespects.- c 5. This Registration Certificate is subject to the conditions stated overleaf and to such other conditions as may be specified in the Act and the Rules,Jromtime to time.

8 GOVERNMENT OF INDIA Ministry of Health & Familv Welfare FDABHAWAN, KOTLAROAD,NEW DELHI lindl1ll NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD- 883 DATED VALID UPTO Name of the products Implant Art osteosynthesis; Implant for Osteosynthesis for OMF - Surgery and Neuro- Surgery: CMSSystem MICRO System MINISyst~m._c..Mandjbu~ar-System Distraction Devices: M~rtdibfjJstractDevic-es Alveolar ridge Distract devices TransantralMaxilia Distractor.M~ngibParalleLDi$tract device ~JJEMS=(IWQ[Ql;,JJ:y

9 CentralDrugs Standard Control Organisation Directorate General of Health Services FileNo: MD/2012- DC [Old F. No MD/2007- DC) Ministry of Health & Family Welfare To./ ~s_ ~n Solutions, - # 26 & 27,!Ind Floor, WZ 26 Nangli Jalib, B-1 Janak Puri, New Delhi-l10058 Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 SUB: - Registration of manufacturing site of MIs. Wright Medical Technology, Inc., having manufacturing premises at 5677, Airline Road, Arlington, TN USA 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 07112/2011 received by this office vide Diary No dated 04/02/2011 and reply received vide diary no dated on the subject cited above. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewith for _themanujacturingsitealongwiththe name(s) of medical device(s) hnported under the said Certificate subject to the following conditions. 1. The medicaldevice(s) shall conform to the standards 1specifications mentioned in the Second Schedule of the Drugs and Cosmetics Act! ISO 1 MDD 1 or such other standards or specifications approved by this Directorate. 2. Dispute, if any, in respect of the payment of fees and submission of TR6 challan,.shaubesettledbetweenthebankanathe applk~ant. 3. The medical devicewill be required to be withdrawn from sale from the market in -case aiiyundesirable reactions due to failure of the device -or its accessories.are brought. to light at any stage. This Directorate should be informed of adverse --repons-on--the-medigal-devige,-ifany ~ This registration in no way relieves you of the responsibility of complying with ~-~-othefl'fovistonsofthe-drugs-&- Co-smetics-Act- a:nd-r.ules~hereunder,-and -any other provisions of any other Act and Rules applicable in the matter concerned.

10 GOVERNMENT OF INDIA Cenlral Drugs Siandard Control Organisation Ministrv 01Health & Family Wellare FDAIHAWAN, KOnA ROAD,NEW DElHI-ll0 002 [lndlal Form 41 (See rule 27-A) Registration Certifteate issuedfor import of devices into India Under Drugs and Cosmetics Rules, MIs. Wright Medical Technology, Inc., having manufacturing premises at 5677, Airline Road, Arlington, TN USA has been registered under ru\~'~7s~ ~\, \~,,-,~\ \,,/ l' '" ~ ~~ ~-1]1~l!facturer and is hereby issued this Registration ';"-~ '''_e_ \"./ f 'V Certificate.,~ r".. Name(s) of devices(s), Which~~be?',~, 'V# importedun<l, Please refer to the enclosedj~t. O! 3. This Registration Certifi~shallbe.in fore or cancelled under the ru@. 4.. This Registration CertificatQ India MIs Mn Solutions # 26& 27 IIn Registration o C~cate: V-r7 "::'",l:<", '(j' to ~less it is sooner suspended lj. Z , India who will be~sponsible for t of the manuf8;'c~"urer in India, in all respects. '~~"~~~ 'O~ ",~ 5. This Registration Certifi9a.t~ is:.s)lpjectto the~~,d#i.~ms3:~~~d overleaffti\<l to such other conditions as may "...,,_, '~;L~.:_:..,- _: "_._,,._-.:.._~,~,:-":'-~_", '"...'-"~~:"-~ c- - -,----.,.'-- be.specifiedinihe-act.and the.ruj.e,tfmm time to t4me~ --.. :""'[,."--,--_... I.,~ (tl~~ /.'.":~ L1CENS~ IGAUTHORITY

11 GOVERNMENT OF INDIA Ministrv of Health &_FamiIVWelfare FDABHAWAN,KOllA ROAD,NEWDElHI-ll0 002 lindial NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD-I072 DATED 16/02/2012 VALID UPTO 15/02/2015. New Delhi Date: """ '"

12 Central Drugs Standard Control Organisfition Directorate General of Health Services,!'... Ministry of Health & Family Welfare Food and Drug Administri'JtioI1 Bhawan Kotla Road, Newpelhi-ll0002 To /' ~ MED-EL India Private Limited, 505 Fifth Floor, Pragati House, Nehru Place, New Delhi-ll0019 SUB: - Registration of MIs. MED-EL Elektromedizinische Gerate Gmb.lI, having factory premises at Worldwide Headquarters, Furstenweg, 77a,.lnnsbruck A-6020, Austria under the provisions of Drugs & Cosmeticsl{ules for the purpose of import of medical devices in lndia. Please refer to your application No. MED-ELlDCGI/2011 datedq3/ received by this office vide dairy no (FTS-68168) dated 03110/11 and.j\dditional Documents received by this office vide diary no (71660) dated 18/10/11 on the above noted suject. Registration Certificate in Form 41 under the Drugs and Cosrri~~i~sRules is herewith for the manufacturing site alongwith the.name(s) of medical device(s)imported under the said Certificate subject to the following conditions.. l.~ The 111ediCaldevice(sJ shalrc()nfo1ti11.oth~ ~t~clard~ I specificati(msj#~t~()ned in the Second Schedule of the Drugs and Cosmetics Act; ISO I MDDI()~~o.ch other standards or specifications approved by this Directorate Dispute, if any, in respect of the paymentoff~es and supmission QL~~~hallan, - shallbesettledbetweeh the balikandthe-:apilitcm~_.~ ~_ '.'.3-~;F-~. ~ ~ ,...c-...e.--_----..,;;,' 3. The medical device will be requiredtobe,?,itedrawn frol11salefro~_w~_~atketin caseanytll1ci~sit~blereacti611s duetofail~reof the' device or its acce$spriesare brought to light at any stage.. This Directorate should be informed:9radverse. [epqrtsoilthe.medical.d{}v.j0e,-ifany.'-~cc-_,--,-, ~ o:::~._-~ ~'-;~' - ct'", ~ "" :" :' Tfiis-reglstration in no way relieves youo(ti}eresponsibility ofcotupl~ji1gwith -other provisions of the Drugs&CosrneticsAct and Rules thereuncl r~';andai1y other provisions of any other Act an.d Rules applicable in the matter con9~rned. ;-'-',.,.,,:..._.._

13 GOVERNMENT Of INDIA Ministrvll~Health&FamilVWellare FDABHAWAN,IOTlA ROAl, IEW DElHI [I1DIAJ Form 41 (See rule 27-A) Registration CertiflCllte issued for import of devices into India Under Drugs and Cosmetics Rules, 1945 ~ -.-,"~ Date~ l I 2JllZ I. MIs. MED-EL Elektromedizinische Gerate GmbH., having factory premises at Worldwide Headquarters,. Furstenweg, 77a, Innsbruck A-6020, Austria.hasb~JJ regis~ered under rule 27-A as a manufacturer and is hereby issued this Registration Certificate,,~" Please refer to the encjosedust 4. This Regis~i(»):tC~rti:tiJ;ate. is-issued authorised agent India MIs. MED-EL India Private Limited,505 Fifth Ft66r,'PragatFHouse, Nehru Place, New Delhi-llOOl9 who will be responsible for the business activities of the manufsctureririlndia, < "':"--.,.:':, ' \:-~.;>;""" in ajl respects.._~._"_thi~.j~egistration.certifi-~t:is.subjecuo-th~~ns_st~e~erl <mdirrsuch:othet~onaitionsasmay"6especified in the Act and the Rules, from t~)o f.:::\.. J ""~ seo \ ~ ~ I q. #' "~L1li:GcWt"""'"-" "

14 GO.VEIIMENT OF INDIA Ministry of Heahh & Family Welfare FDAIHAWAN, KOrlA ROAB, tlew DfLHI-ll NDIAJ NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD-572 DATED VALID UPTO Name.ofthe Products 1. C 40+Cpchlear Implant System 2. PULSARCI1oo9o~~1~a~lmplant.~ystem 3. SONA TATI10?qg~~t~i~;r:Jrnplant'System. ITEM('.)J~)~F t;. ONLY.. >,. :,/,.,' ';t":';;-",.,':>' c,,'..:... ','; :"'~-"'. ' -/.0 ::<':;>,; <" ",,(.' ;'->';,:-:y:':.- /'"<:'",:',,-,OJ" ~'=.~'-";~. j, 2 ~-: ifr;://g:~>;:;:: ~XL~.':~' ~;';{L-:_,'~ ;:'.>',-::'1;:.:':"9':' ':';':'" i:'_:'.;:'~;;::::': ~;;~HOPJrY.~.~_: :Lo.SeaIlStamp- '0 Dr.G.N '".. Drugs '.',."? Dte. General of Health.-MinIstry of Health & F"m;j, 'FDABnawan. Kotla """)1 New [1~:h;"'I -1 '~i~.. n2

15 Central Drugs Standard Control Organis1)tion Directorate General of Health Services} Ministry of Health & Family Welfare Food and Drug Admin'ist~*tion Bhawan Kotla Road, Newt>elhi-l To _/ ~/s~ Boston Scientific InternationaIB.V.,. (C & F Parekh Integrated Services (P) Ltd) C-40, Okhla Industrial Area, Phase II, New Delhi-20 SUB: - Registration of MIs. Boston Scientific Corporation, One Bos*on Scientific Place, Natick, MA , USA having factory premises afm/s. Phillips Medical, 428 Technology Drive East, Menomonie WI 54571, USA under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application No. BSC/F40/1115 dated 20/05/2011 received by this office vide dairy no dated24/05/2011 and reply received by this office vide diary no dated 09/12/11 on the above noted suject. -~_._.,-----~~.. ~--~-- 2..Dispute, if any, in respect of the paymen(of fees and submission ~R~ challan.r ~.-. ~lmllb.e..se1tledbet~@ll-the--bank-amtfhrapplic~---~_._- ~"',-._~:;..~...;:--,..,:.,;_:~_':';i; ",,< _3.!hemedicaLdevieClwillberequiredm~oec-wiihdfawllfrol11sale fromtll~tilarket ill case any undeslrabl~' re~ctions due to failure of the device or its 'acc $$ories_'li~_..broug!1j.j9.jight_at.any...stage.- =F-hiS'-BireCtuta:te--snouTiIOe-lnfoirn~a:,'otad~erse reports on the medical de\li(;!,jfany~ ,_.. -~,-"-"----,,,,,,:,.,-", -' ".'-"- -..~-._.'. 4. This registration in nowayreli'eves yoaofthe responsibility of col1l~l~l1g with other provisions of the Drugs & Cosmetics Act and Rules thereund~t.",;';;mdany other provisions of any other Act and Rules applicable in the mattetcol),~ej,'ned.,..,--,:.,)".',:," "\....,,-.,.. " < "';'. -; f::::-,~,>.,>:\';';>,,.}~if'

16 - ',''C-'' ',... ':',::,-'f<.,-,'.<:.\,,\~ -, GOVERNrltlJ\OF INDIA Central DrugsSlIndard Ministry of Health &FIQIIIVWel'are controli~'ti'isation FDABHAWAN,KOTLAROAD, NEW DEI.1IJ:~.1'.02I1NDIAJ Form 41 (See rule 27"A) REGISTRATION'C RTIFICATE Registration Certificate issuedfor import of devices into India Under Drugs and Cosmetics Rules, MIs. Boston Scientific Corporation, One Boston Scientific Place, Natick, MA , USA having factory premises at MIs. Phillips Medical, 428 Technology Drive East, MenomonleWl54571, USA has been registered under rule 27-A as a manufacturer and is hereby issued this Registrationc:::ertifi ate. 2. Name(s) of devices(s), which may be importedunder:thisregistration Certificate: Please refer to the enclosed list 3. This Registration Certificate shall be in force from 16-02~2012to 1> unless itissoprersuspended or cancelled under the rules. 4. This Registr~ti~cn.~.~~lfls~t~i~_lss~edJb[<)~gh)beQfflce~Q i?ejuanufactureror his authortsed~ent --India Mis. -B~ston Scientific International B.V., (C&F,Pa~hlntegrated Services (P)Li~),C-40, Okhla Industrial Area, Phase-H, New Delhi-20 who will betesponsible for the busitie$:sj:t()tivities of the -'''..'. ":~.:,>;:;?; -,"j.''---.':,'',ce', -;:».<{ ";':;}~",/:

17 '",':-', }?,{,,;:~L' ~- C " r~~,-: ;;';--".. -4+~... ~'!".~-C-:: ':_-r:':"~~--~' ---' - GOVERNIIJQF INDIA Central Drugs-Standard Clntrll'0i811isatiln MlnislI 01Health & F _'Wellare FDIIIAWAII.KOTlAROAD. NEW DUm.fl1oell2 (lndial NAME(S) OF MEDICAL DEVICES, WHICH MAYBE IMP()~rJi,D UNDER REGISTRATION CERTIFICATE NO. MD-967 DATED :i VALID UPTO \' ' NameofitHe~,rpf(()duct '>Z.:$eAItStamp,,;.~.,,~~~\;;:;;-; :'.'..'.,}'{i(> Dr. G. N_ SiNGH ~;PfUS~Con!rO!lerGeneral (India) ;'-.,1Rie, 'Generai of Heal~h Servi,,es cmirii$fr'y(lf Health & Fam>J;t \'Ve:f,m:..;.~Bl1awan, Kot/a F(cs:,1 LT.O.. :"',,"X<~,,> 'NewD>:::ih;_cl'~'" - 2

18 Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 To ~Boston Scientific International B.V 100A, The Capital Court, OlofPalme Marg, Munirka New Delhi-l10067 SUB: - Registration of additional Medical Devices to RC No. MD-164, manufactured by MIs. Boston Scientific Corporation One Boston Scientific Place, Natick, MA having manufacturing site at MIs. Boston Scientific CorpQration, 5905 Nathan Lane, Plymouth, MN under the provisions of Drugs & Cosmeti~s Rules for the purpose of import of medical devices in India. Please refer to your application No. BSC/F40/11/13 dated 25/10/2011 received by this office vide dairy no (FTS-73358) dated 28/1 0/11. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewith for the manufacturing site alorigwith the name(s) of medical device(s) imported under the said Certificate subject to the following conditions. 1;.Themedicaldevice(s) shall conform to the standards 1specifications mentioned in the Second Schedule of the Drugs and Cosmetics Act! ISO / MDD I or such other standards or specifications approved by this Directorate 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 required to be withdrawn from sale from the market in case any. undesirable..reactions.due to failure of the device or.its accessories are broughf {alight at any stage. ThisDifedonit6 should be irifori:rii~d()f adverse [~RO@_Q!Ltb_~_m.~c.i!fal<:l~"!fe,_if (llly~ 4. Tliis-iegis'trcitioniiiri()-Way relieves youofthefesponsibilityofcomplying with other-provisions of the Drugs & Cosmetics..A<?tandRulesthereunder,.and any other provisions of any other Act and Rules applicable in the matterconcemed.

19 GOVERNMENT OF INDIA Minist", of He.allh& Familv Welfare FDABUWAN, KOTIARDAD,NEWDELHI-ll0 002 ONDIAl NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER ENDORSEMENT NO. 01 DATED -;. 1 ~1t\H lq1z TO REGISTRATION CERTIFICATE NO. MD-164 DATED VALID UP TO ENOO'RENTNO Epic Self ExpandingNi~itj;gl::~~~ularStent with Delivery System - ITE~~IO~iONLY <C'"'., '>::""/::-<"L,-', ',t,\> "<J) ~~f'"-t2:; ~~--'-----'--~----'----'..._ _._------~~~.~~-_ &i,,~o~rpcoal'~,,< 0«-" ' 011;;,.._~ _.~-_._-_._._----_...~---- ~_-:-~; c... ~.. ~~ _,,--,- -'Newl5efhr- ";'0-",;... '. ~,,~o, LI~~N.,~ING AUTHORITY :nate' c:..,. '~t' \~~; }\ftzu'z.,_~1l7h,<;ove~" t Seal/Stamp - -,-,-- - -' - - ' -Dr, G,N, SINGH Drugs Controller General (II Ole, General of Health Sel'l! lvllolsiry of Health & Family W FOP. 2"2\\<3n, KOlls Ro:,," I New G~lh;-1!00Qil~.

20 Central Drugs"Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-II0002 To /". ~s. Becton Dickinson India Pvt. Ltd, No.34, Assisi Nagar, West Thottam, Modhavaram, Chennai-51 SUB: -Registration of Mis. Becton Dickinson Medical (Singapore) Pte Limited, having factory premises at 30, Tuas Avenue 2, Singapore under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application No. BDRCIRA/111/11 dated 10106/2011 received by this office vide dairy no (FTS-38349/2011) dated and reply received by this office vide diary no (FTS-88047) dated 27/12/11 on the above noted suject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewith for the manufacturing site alongwith the mime(s) of medical device(s) imported under the said Certificate subject to the following conditions. 1. The medical device(s r shaltconfortrl to the standards I specifications mentioned in the Second Schedule of the Drugs and Cosmetics Actl ISO / MDD 1 or such other standards or specifications approved by this Directorate. 2. Dispute, if any, in respect of the payment of fees and submission of TR6 challan, sha:llbe settled between the bank and the applicant. 3. The medical device will be required to be withdrawn from sale from the market in....ya~~al1ytlll<:l.esira]:>lereactioj.1.s.d.uetqfi:lul;lr~of tbecieyi~~qril~i:l<;gessorie~.. are brought to light at any. stage. This Directorate should be informed of adverse...-.reports.on.themedicalde:v.ice,.ifany This registration in no way relieves you of the responsibility of complying with 6tlierptoVisionsof the Drugs & C6snletics Act-andRfiles.theteundet,a.nd any other provisions of any other Act and Rules applicable inthe matter concerned.

21 GOVERNMENT OF INDIA Ministrv of learb & Familv Welfare FDABHAWAN,KallA ROAD, NEW DElHI l1NDIAl Form 41 (See rule 27-A) Registration Certificate issuedfor il11portof devices into India Under Drugs and Cosmetics Rules, MIs. Becton Dickinson Medical (Singapore) Pte Limited., having factory premises at 30, Tuas Avenue 2, Singapore has been registered under rule 27-Aas a manufacturer and is hereby issued this Registration Certificate. 2. Name(s) of devices(s), which may be imported un&fthisregistrationcertificate: Please refer to the enclosed list 3. This Registration Certificate shall be in force from to unless it is sooner suspended or cancelled under the rules. 4. This Registration Certificate i~.issued throllghtheoffice 9fthe.mapufacturer or his.authorised agent India MIs. Becton Dickinson fndiapvt. Ltd,No.34,As;i~iN;g~~,W~st Thottam, Modhavaram, Chennai-51 who will be responsible for the business activities of the manufacturer in India, in all respects. 5. This Registra,tiOl1CeItificateis subject10 the conditions stated~verleafandtosuch 0therconditions as may be. _..._.. _.... _.specifie.d..in.the.act.and.the..rules,.irom.t~me-t() tj.me "_..~-~~~-_. -_.~.-.._-... :,\",tloardconr~.,fe" 0( CJs>q" <t" #\ ~ 0 u z

22 GOVERNMENT OF INDIA Ministrv of Health & familv Welfare FDA IJHAWAN, KolLA ROAD, NEW DELHI-11o 002 lindiaj NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD-I032 DATED VALID UPTO Name of the Products 1.0ispo~able Hypodermic NeE!dles 2.0isposable Hypp~~rrnic Syrii)ges 3.0isposableiHY~e~~rll'l.icSyringes with Needles 4.1:10 Insyte ;lntr~!,~~<:)~s'catheters 5.80 Vacutai ITEM(S)FIVEONL Y _._._~- I). LICENSING.AfTHORITY Seal/Stamp.. Dr. G. N. SINGH Drugs Controller General (India} Ole. Genera! of Health Service" iv1mislry of Heafth 8:!=a:n;!v V'Je:f~f FD.L.Bh2V /2~..r::~lc; RuBe;, rot.g. C~;:-~\>:i- -;-:f/:'r";!