tirid~filiricc~icrc~rt1ficcat~subject:

Transcription

1 _..o ss0r.ie~-are Central Drugs StandardCo~trol Organisation Directorate General of Health Services Ministry of Health & Family Welfare.,-:4?-flOd.-antl3.)~cdmjnjstnLtitto-=B..hcawa.n. _.o O -Kotli-RoarliNewDelhi-1IOlJOZ - _ SUB.:- Registration of manufacturing site of MIs Beijing Medical Target Technologies, Inc. having factory premises at 3 rd Floor, Beikong Building, No. 10 Baifuquan Rd. Changping Tech. Zone, Beijing, P.R. China through Lepu Medical Technology (Beijing) Co. Ltd. and its medical device under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your letter Nil dated 08/12/2010 received by this office vide Diary No dated 08/12/2010 and reply received by this office vide diary no dated 26/07/20 II regarding the cited subject above. --R:egistratroneertiiicate in Form 41 umier the.drugs and Cosmetics Ruies is tirid~filiricc~icrc~rt1ficcat~subject: toj.hee{9wm --Conditions. ; ~ ~ tf~~'''-:-~.,. 1. The medical devi~(s) shaij conform to the standards / specifications mentioned in -the-secoo-o Schedule ofthedrugs and Cosmetics Act! ISO / MDD / or such other standards or specifications approved by this Directorate. 2~nrspute; ifany; in respect of the payment of feesanasiibriiission oftr6chrillifu, shall be settled between the bank and the applicant. 3:0=.:-th~ifi~df2~jd:eviceWillbereguited 15 oewithdtawh froth sale froth:the market in...~ broughite light-atany stage.. This Directorate should he informed of adverse rep6ftsoritheriledical device, if any.. _ 0 =-=~~=====~4~ This registration In no wayreiieves'you-oftfleresponsigitfty o'rcomplylllgwith =_~===~. =cc~ other provisions of the Drugs & Cosmetics Act and Rules thereunder, and any o_. o._~ other provisionsorany other AcTaii<D{tl1esappHcabIeln-fne O matter- concenled~

2 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 ~-..-::..:-:.~~=-:::.:::_:._~~--~~-:v~-::..._:==-:'_:~=~~=_= =----::': -~.~ of Form 10 Licence under th..e-.rules.-:-.:::== --:::. ===_=:::"-' :-TIliS--Re~tr:atiQn~-certincaiels~being issued under the condition tlratduring the pendency of Registration, the applicant may be required to deposit inspection fee as stipulared-::::j.j.w1ef -lahse -{5F-of =R.y~-24 fit Effie efia:b1e=lhspectioli oc manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of ~2:_i~:_,":~~_~~;~~~~e~;~i~~~t!~~~-==~='~'.~;:_:E~"::-':t~i~~~~~1:tt::cti!;-~~~=c=~?:0;:=~-~~-c;J-~!=:~~ ~5>-. -l=j2~llc~jft--l'c"1'"om}l~-~i-cig"'l!rntnme'"tnrtt'- omjr -r1tht1ie".1imnoeo:rdtllct'ia'l11- ftde;:>,vj11i'lcep;]('<:s) - 3tno---bEile~:1imn:-U:pIl10;r;rti-Pe;{fd-hby~- -;y~o;u~-';s~ha;clitllb~e: a.ccompanied by a test / analysis reports. -==-:=:=~==:g-;- :-'f-bls:-cf'egistratioiiceifiliciite-ls-:belng~wstfea--uilder'-=ffie~c6riditf6tftl13t'yfu.-if;-: required to submit the specimen copies of labels bearing import licence no along with name and address of importer, IFU's and product broachers for the said medical device at the time of submission of application for grant of Form-lO. 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. Su nde-rsingh) Drugs Controller General (India)

3 GOVERNMENT OF INDIA Central Dr-ugsStandard ContralOrganisation Mitlislt18fHea.tllaFamilv Wel,are FDABHIWAN,IOTII ROil, NEWlnHI liniial - c--~-1~m-it:-41-- (See rule 27-A) Date: 2 0 SEP ZOll MIs Beijing Medical Target Technologies, Inc~,having factory premises at 3 rd Floor, Beikong Buildin No. lohanri nan Rd.Chaina'~lt~ oneberin P.R. China throu h Lepu MedicalTechnotogy(BejjiigyJ.~.L1d. h~'ts~ep.registeredunder rule 27-A as a manufacturerand is hereby issue4i iri~registrationc~rtifi~ate.' ~n.~"i,... Name(s)of devices(s),w~~~'may b~~~4~;;~~~~istration Please-refertOtheenc1o~o~i'~ ','.<ei.~'i,:?~.~' Certificate: This RegistrationC~rli~~t~~h~il'b~-i~-fb~~';fi~;~i~8:ioll to ls-os220i4unless it is sooner ' suspende(rorcance1red~und~~~~",;w<--c"'.':2--.'~:-"z,~.;;;-=,:.:==:-::;::: 7=C:;;:~::C::,;,... =:c:-, This Regist~atfon-Certfficate-ls~r;sU~dihio~~'the~~~e~f~liemanUlacturer"or'liis-aut!ioiised' agent in IndiaM/-sAdva-ncedlJfeSc-ieDces-Pvt~lJt\iJ.at ;~la.lndustrial.ar.ea_phase-l New Delhi who will be for ies of thel;ll8nufacturer in India, in all 5. This RegistrationCertificate is sllbjectto the conditionsstated overleaf and to such other conditions : ~ma~h-e=speelfred-;in-:ihe-~:ci~an:~{the;&1:li~~jt~iii~~!~-tiill~ ' c=~==place~newd~~~. ~'--~~---.c~-.c.----'d-.5 Dat~~'2-0- SEPZ01r.-,-----"-~\. cf l ~======cc=~~==lia TY q. r.of: ~ '-._-----_.-.-'------:tif.1z7'ij.oo;t#"'~ ~-- seai7sfiiii "--- :m-. W"'-"*' ~ Dr. SURINDER SINGH ' ~_... ~ ~ -~ '(-'ij«f)ionjgs-corrtrnlftr (Irda ,- ----, _ n----~'("!1.1~~'~~ J Dte, General of Health Services FDA Shawan, Kotls Road. New Delhl

4 .. _.'.. n.,'._.".,', _ ",_""_"._,,.. _, ' ''. ".... '_.. _..,._ _ " _' ".. _.....,_.. _ 1. The Registration Certificate shall be displayed at a prominent place by the authorised agent. 2. 'Th-e maniifucturer or his iuthorlsed agerrt In India 'shall comply with the conditi~~~ of...the-impottlicence.issued'uilderthedrugs 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. _m._n.~:=:::~~~~~~~icti~~~~n~~~~~-=.... :Of~(l~gtJ.~iiJY~~!~I!1>t'tQ.tiW-YjfeVif~-:R~~ItlfngCiQJffis._ R:eglstrafio:n~E.ertificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authont)' of any other country, where the device is marketed/sold or distributed. --_.. _. -','- -..._..,_...~ ''''c In such cases, action equivalent to that taken with reference to the concerned device... in,th &Q~~"E)[,ig!Ti;Orij:itJie:QGllIDtiiQ iliar~etid3''ihdt~ io.l~mjildia.alse,-... _"... ' -.:.~_~:_,~-,.,- ~,... _._-_~"_,;::~.._~_~..,". ~. ~_'"_,...::...,.-+,.~.e~~~-'--:..;..: "--:.... -;:.-.:~.,._,_...:"-""'.--,._-_.~,,,-:--'''c~._~.e._.,_~._:, ~._.-_ _-~-----in-ccl1tsultationwithrridaspertlurdtreciiorisi>flhe'1fcenslilg aumority:-the1icerising~ autl:1ority 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 Illrulufacfufingprocess, or in labellingor- in testing~6r.in dociliiientati(jd '()fany~ofthe -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 Iridiasnall obtain necessary appro:val within 36. days by suomittingaseparafeapplicatiodalongwitliilie iegistriitiorifee;as speeifie,fin21ause 5.. The manufacturer or hiscauthorisedagenrijjindi~csliall inf6rmlhtnicenslng authorit)' - iillmediatelyjo_writingjn..the..eyenlofmty.change in the constitution of the -firm.and lor address of the registered office/ factory premises operating under this Registration _~~i!i~!1~.wh.~!~_~ys~~~2p:ap:.@1i!j:h~. ~cqjimtij.t1qii. Qf ]:li~_tiijii-aiidlqr=addres.s takes place, the current Registration Certificate shall be deemed to be valid for a maximum period ofthre~mo.qth~f[()!11~!tl~-~!~qliwljl.9pjlift:~hafig~ Jja~~e.ripJace ~'- +.. '-... '_ ~..._-_... '--. --_., ,_.~-_. _-. _... _ _'--:::-.:_. _. -".~. ~'~:_.. _" ~ --' '.'-~ ".:..._... -:... '-' ~._ '.' _~.. _ un!ess,in, thecmeantime,ccacfr-esnccr-egistration- -ertificatecnas oeerrtid<erffrtffllctlle. c...:: ' _0 -...: -.,, -:cc:_, _....c"".,.. "':c-=-:.::"'_ c-:--::: -,...:,_c... '-.:"'::...,.::::.::c:...=::::.::.:."==:::'==-::--o,"=--=."':=~..:=:_-:o-_c_=::~:,-..:-.',.:-:-.:::-c-=-~:::-=-..co. -'-..".:.o ~:.::::_.~..: ~=,,.-: =:-:..::_-c:,_, :.-_...:: :::-:..:::.:_'-O'~ :::--.:.C =-::.:.":~~:-:... liceiising..authority jnjhename.() lhe4~w.ith~the_chang~d_coostitutien()f thefll11l. and/or changed address of the register~4oflice.or factory premises.

5 GOVERNMENT OF INDIA OenlraIDrUDsStandardOontrol"Organisalion MillistrvolH8allb &Jamilv Welfare FDABRAWAN. KOnA ROAD.NEW DElRI lindial..,~-name(sl,..qe,medicat DEVICES, WHICH-MAY' BE' IMPORTED.. trnl>er REGISTRATION CERTIFICATE NO. MD-878 DATED '2 Os VALID FROM 1- no'h\l' l'.. 'T'O'15 'no"",n'1';fc... fp."ll".'_.-,-"~"'ue,,,~ ".-,.. ":- :.~~7J.'::~..::.,:,._..",,,,.c.._c""".e'CCo...,,,.c--_'".. c.c...;. _,.... _.. ~..._ ". - ~;'!#,:..... coseo - c ---==Ne~Mn-=~-~c'-~ , "",..~_==_===c~- -~= ~,; _ -Qate:Jt-O--SE-~ ZO.lL ~~q."'~k~"'~~d'_~_~,!'!c_en S _ Seal/Stamp' gr. W't~ ~ " -..~ ,-..._-..--~ _._.-..- Dr. SURINDER SINGH ' ~~_(1Imf}tflr'JgS'eontmJ8T1.jrdal - ~~~~~ Dte. General of Health Sarvicell FDA Shawano KotlaRoad, lliew 0eIhi 1100fJ2 _

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7 CentralDrugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare ""C~'':':'=''"~'C'~~=-''''-'=",,:_c=c=':,,='=ccc::::.''C-'"C-' =:~~":= ~~.-'~":="'"'-'C-::-=~: -:::FOQ(fa.~g:AdjffiffiStiiitiOii'.fniaw..i-.n=:-:~~:._ 'J<{jJ:I~~I{(nrd~N~jy~~elbl::1jD]J12. Dateo. No.: 'MD/2010-DC - cce--']i.=~~.~~;7 c"'_~~_-c'~ _~==~CC_ Prerna Complex, AnjurPhata, DapodaRoad, At Val Village Bhiwandi , Maharashtra, India....SUB :-Registrati(}u-of.. manufacturing-. site~- ()fl\fls;... -B;Braun.Avi1lIm AG, SchwarzentiergerWeg 73-79, 34212'Melsungen, Germany,' having manufacturing premises.. at Mis. RBraun Avitum ItalyS.p.A,via XXV Luglio 11,41037 Mirandola(MO), Italy and its Medical Devices under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. ':~~~~~~!JEI2;;;f~~~!;r:~rr~;. Regi&tration CertificQlJ.n Form 41 under the Drugs and Cosmetics Rules is..._her~with::forlhe manufacturing.site-aiongwith.the. name(s) of medical-devk-eesj-imported ---uf1defthe=said- ~reate=stlbjeettrrth-e"fo1towtngcorrd'iti,()tl~t ' '--"~--' ~~=_~---,~~":-~=-=-~c_--~"_~-,-~ " '... ThemediGaldevice(s)shaH conform to the standards lspecifications mentionedin ==the~e~fl-a.'scfledule.{)f.the Dru~s MiO-tOSIlietics ActJ. I-S0.-7-MD~-l.Qr~sJ!~ij:-()11j~t.... : =:~-~=~J!gm:m~]1.n<:atloi1~ipprQYictl) t1lls:djrecto:rate~==-.. '... -~~~~~~~~'.~.'.'. 2. Dispute, if any, in respect of the payment of fees and submission of TR6challan, shall be settled between the bank and the applicant. 3. The medical device will be requited to bewithdfawn ffom sale from the market in -case-any-undesirable'-reactlons-clife lofail1:rre ottneaevice-oritsaccessories-a-re brought to light at any stage. This Directorate should be informed of adverse reports on the medical device, if any.

8 4. TlJ.isregis~ratio? in no. way relieves. you of the responsibilityiofcomplying with OtherproVislons of the Drugs &- Cosmetics -A-a and Rules thereunder, and any other provisions of any other Act and Rules applicable in the matter concerned. 5. Each consignment of the medical device(s} to be imported by you shall be._._~~o="-~:hy=ates~~~~_:~==~_:.'::: :'~::=~=~~~~:',===-:~::=--,,-'=-~::::~.~:==:== 6: 13aselron-tbWreglsfratlori,'appllcafi()ns. foiiheiiriporr'or meciicaf devi~e{s) "enocersooiiftheei1c!()sed c -RegiStl:atiortCertificaleshall.Off'OtIIIIO Ueenceunder me Kules. be'cortsidetedfortheissue 7. This Registration CertifIcate is being issued under the condition that during the...' =i'. '~ ~ "~"~'"" F " - _ ' _ _' _=" =c. = ~" =.. _,,~ =. -.,.-_.=-",.,... ".=,~,_..~..-.===~,=..---."'~'-". ".'..:-,~;.~~"'{),t-]~,:eglstr~twll;'-{he~ieant~,-he;fequii"-ed4(i)"depqsit,inspeet1on;-fee --~SIipiirate0--liUder- -.1jlaiise--(5T=or;~fure=~:Q4::-.\-=:in&=:enibl~=-tnip~ Qll-=-Qt '-n:lal1yra~tar.in,gsitel)ythe-'officiais-auth6ilze~::.fqf=this:il~i>s h-n'qll;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 require~to submit detailed Stability data, Biocompatibility dat~ and -St~iJ~tjqIl,y~lidatio:ndata~inrespeclofth,e.proposedpro<luctat the tinieof submissi()d()fapplicationforthe grantoffornt 10 Liccl1se.. Please note that Registration Certificate issued is liable to be suspended / cancelled, ifany 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, 194() ariui:he Rul'es iherel1rider:.... Please acknowledge the receipt ~. --~ =-:-~;-,--::.=.-~-~~-,~~,.-o-,-.-.-_:.~-:..;l-,,-,,".,=--_.. --=:--.,_,:~_-"- o,,--_-,-- _.--~ -_- --;=~-_. -_ --=-;:-=--=--:-::::~-==-~':::-~;;:'--~:"'<C'0~::"'~~: --'.~------:;-~-::;;:-.,;;::-'~--::':";:~~~-==-----""--""-----'--,--,--c=-:-,--:-:~~-._ -.-., '-::--:--:-:-'~-~::;::~:,:-~ , ~.._... _....._.. - ~_~._= (.Ilr.~...surjnderSjngh) '...-, ~Brttgs -ontroller~-eneraiiindia1- -,

9 --,_., _ GOVERNMENT OF INDIA CentralD, sslandardc Ir ~'_''';'''''''~ ''''''_''''~.",_,_'_'_"'._" ~_... _.'._,_~ :....._...., ".,,"_,_,, 'w_,,_,_,' <",-"-_' ".._ -MinislrvoIHeallb'&~FamilVWelfare fdaihawan~iollaroad, NEWDElHI-ll0 002 lindiaj ~::'::~I-=~~~.~ (Seecrule.~7-A). REGISTRA:TION' CERTIFICATE ~=~Jleg,,$~J::eitiJi:caitliiuei1fiir..iinii()ii'oftkviciii.ilito India.~:=;:.... Under 7lriigsandCosmetics Riiles,19'1S.. ~o":,_~..:~:;.:_.:,;:~~:;-.;,~--,,;;,,,;~:';:;''':'::~~::'',~,-_:~~ ~_::.:c;:~::;_,2,,_:,z;;-:7';':'::-;:~~~_"';;':::;:;'::"'; - - ""~---,'-'- Date:-2JLSE loll MIs. B.Braun Avitum AG, Schwarzenberger Weg 73-79, Melsungen, Germany, having manufacturing premises at Mis. B.Braun, JA.:Vitunl, Italy S.p.A, via XXV Luglio 11, Mirandola(MO), Italy, has be-en re~~ ~r~dhqql:lrrule47-a~syi,9i~nufactlireland is hereby issued this Registration Certificate., f :-'\." ','" Name(s) of devices(s), whicli'thay be import~dund~r.thi Please refer to the ertc1ose4 jist ''''This::Registration{jertmc ate:..;gnah. g......c;~ L suspended or cancelled under the rules. '- L~; ":'.-':;.~);, ~.~.O~~.{:, Ci;ij; ";,,.'t:~tioncertificate:. ~tromcl'5~8t;.2ljt~10"'~f4~~iol~"uitless --:.':> ----'->'f~)?'~~'-i..<--~t ;;:c, -_''O'''':-<j'' 'r-.":'t- -..._._._.'-_._. _'::',.~-;,":':";,:;:'.~.'-'~ - :=-;.'_',.,c-",' _,._',:;;_._"; _ '.",_":. '_. ifissooner 4. This.Registration Certificate' i~i suedthrouglfitheqffic~kq;jil'tjje manufacturei.oi' hi a.~thor!sed agent in. India. MIS~B~~Braun=Mediealiindii'tPrt-=Eid~r ~d~n()~eb:,~~aia~ o~<t.~)o; Pl"~rnll-.G~!lIP!~~,.AnJ!!t. -. -'--,----,.-.-',, --,----'c: , c-= ~,""-~_,_...,._,:, _~==_-_~"'".;:~=,~"'_""'""=="'''"=,._=~==_=.---=c- =_~=._=_:=., ~_-~ ,"' _=%;,0.-' - _",.., ',-"'C'--" Ph'ata,Dapoda lfoad, At Val'}y:mage Bhiwandi ,.~aharashtra, India who will be responsible for the busin.essactivitie;60h((.~anufacturer in~~a~~alfrespects " ~-_ _~ _.-. -_... _._.,. ~,-:;;"'-:.~. -'.",. <;--...,.....~._~--_..._.._.~.._..~-~~~~_.~--_.--.~_. -~ --~~~._--._- ~--~~.- '~.~.._-~'"_ ~ ea1/~Stamp-~~. 'e'f. '!!~""* ~ Or. SURINDEr<, SINGH ~ ~t'~ (~)ldrugscoolfoller(l/1(j,l~ (-'!Il~ ~ i(!if.!\allm14 Ow. General of Health Sel'Vicea FDA Bhawan, Kotia Road. Ne"'i DeI/'I

10 .._---_._.,. 1. The Registration Certificate shall be displayed at a prominent place by the authorised. _~~[lt._ 2. I he manufacturer or his autfionsedagent In India shall comply with the conditions of - "..,,---.,- --;:--~ tlie~1mporthce~ce-tss~ued: tirid~r--the~d~r~gs and Costnetics Rules, The manufacturer or hisauthorisedagent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. - ~~~~~c==':oo=c,==c--miir~atxegmaiory restrictions;oic~~i~n OI~lllli?f~i~~ci,I()r.ri~t:-~=~-:~~~-~~=~-~ " _~ ~.._..,.~. ~. '._ -:-".~-=.:. ==~~--::'._=~':::::" ~_~., ~_._._._.,..~ ~._...._..._..._.~.._,.._._~_... _._~_~.'_..~_...._. _._~..._.._M...,. authorisedagent in India shall obtain necess~l)'_approval within 30 days by submitting a separate application along with the registration fee, as specified in clause ~i':;;::;;:c;:-~(iirof~lili~~m131-6ff~f~r~;:c.:.;:;c-:;;.~"".o.'''''~'''--..;;:~c:;-;;;:;;;;~""';:;;::;;:~;;:;;~~c;,..~~~;;,~-;;;.;;;;';;;~;~;..o.,'- cc.; 5. The manufacturer or his authorised agent in India shall inform the licensing authority immediately in wtitingihtheeveflt ofariycbarigeiri-theconstitijfion ortheflrm and -~----'-"'---'-""'---'-'-"----.-'-,._--- '_._-.. -_.._------_._., _."..,..._-_._.-_._--_.._._- '--'"--'~-'----'--"""._----~._ " I()r a<iclr~s_s_qfth~re.gi~tel'e<l9ffi~~lfa~1qiypiemi ses _operating tinder th is Registration..._..,._-_.-., ~. --ertifieate;---wher-e~any--sttehc-change~cin the..c(mstitution--of'ihe-fmn~andfprau:dress -.. takes place, the current Registration Certificate shall be deemed to be valid for a.-.c-.::=fd~inl:t!m::p_eriodofthreef110t1ths. LOm:therlate-nn:which._ihe~dlange-_has_:takenlJiace ~c;~:uille~~clu-1he-fu~1~iij~ ~.:~:t:~sll -cor~~~~t1()ri:~cert1fi~~~-h.a~.. b~~~ ~{~ken:ffo;~the... - llcel1singayt11qtit)'ill Jheilall1eQffhFifi1T(wlt6Ifle=chan~ged-consm~Ho no1' iliefirm and/or changed address orlhe registered office or factory premises.

11 GOVERNMENT OF INDIA CenlralDru s Slandard Oonlrl r MinisllYofHeallll & FamilvWelfare FDABHAWAN,KOrlA ROAD.NEW DElHI-ll0 002 [lndial REGISTRATION CERTIFICATE NO. MD-856-DATED VALID UPTO., ,,2014. ~O': Date: r2 0 sep ~g11 ~~ \.O~'~A~" A.,~ -.. ~--~~--~ ~-~ -- - olrhgov<"" ~ l. ~~~_~~!~G.~~T~Q~TY. Seal/Stamp ~.~~ NAME(Sl ne----medical --t:'!lkv1ces, WHJ~ BE--:~IMP9R='flID---~-{JNDE-R-~-....~---.-_..-._---~._.-... _~- -_.-.~.._.._-~_..._... _-~._.~.~._.._------~---_... ~~~--_.~_._~~~~f~:&;~~(~) ~ ~ "lgi~~;tii~>.:f Dt~. General of Health Services FDA Bllawan. Kotla Road. New Delhi

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