Ministry ofHealth &Family Welfare - Central Drugs … final Md 29.02.12.pdf · Central Drugs...

Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-110002

TJ6/s Covidien Healthcare India Pvt Ltd.,Doshi Towers, 6th Floor, # 156,Poonamallee High Road, Kilpauk,Chennai - 600010, India.

SUB: -Registration of additional medical device(s) under the registration Certificateno. MD-948 of Mis Covidien IIc.1S Hampshire Street, Mansfield, 'MA 02048,USA., having manufacturing premises at Mis Covidien Zona Franca De SanIsidro Santo Domingo Dominican Republic, uIl:der the provisions of Drugs &Cosmetics Rules for the purpose of import. ~)ihedical devices in India.

%.:>K]\>,-y \~~:::)\~;;

Sir, If~\~,f&

(c~'~r-?f '~Please refer to your letter ~~)\tHIL/lRA/FF-256-(END)12011 dated 29/03/2011

received by this office vide Diary No.14786 dated 29/03/2011 and reply received vidediary No. 48227, 57954 and 1372 dated 14/10/2011, 19/12/2011 and 10101/2012respectively regarding the above cited subject.

Registration Certificate in Form 41 under the Drugs and Cosmetics Rules isherewith for the manufacturing site alongwith the name(s) of medical device(s) importedunder the said Certificate subject to the following conditions.

__________._____ L Th~ medkaLde-Yic!~.csJ.shaILcQnfo1ID_to_the.-standar.dsLspecificati.ons-mentionedin-the Second Schedule of the Drugs and Cosmetics Act! ISO / MDD I or such otherstandards or specifications approved by this Directorate.

2. Dispute, if any, in respect of the payment of fees and submission of TR6 challan,s.hallbe~ettledbetween the hank and the applicant.

3. The medical device "willbe required to be withdrawn from sale from the market in-.-- -~--ease-any-unclesirablereactions-d ueto failureof--thedeviee-or-its-accessori es-are

brought to light at any stage. This Directorate should be informed of adversereports on the medical device, if any..

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministrv of Health & Familv WelfareFDA BHAWAN, KOlLA ROAD, NEW DElHl-110 002 (INDlAl

NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER

ENDORSEMENT NO.1 DATED .... TO REGISTRATION~:.,.,...-

CERTIFICATE NO. MD-948 DATED 05-05-2011, VALID VPTO 14-04-2014.

ENDORSEMENT NO.11. Surgipro ™ II Monofilament Polypropylene/Polypropylene

Nonabsorbable Suture.2. Biosyn ™ Monofilal1l.ent AbsorbaIJJ~::Suture/Synthetic Absorbable

Suture. .'....(":"0.:)"3. Caprosyn ™ MonofilamEt.~I:,:~,A'bsorbable Suture/ Synthetic

Absorbable Suture.. ,>,,;," : . ".

4. Maxon™ Monofilamerit~~sg;~iJable Suture/ PolyglyconateSynttletic A6so-rb~bJeiSijtl.lr~·~/;<i.

5. Sofsilk™ Silksing.leistitch.t~t<?~~6. Surgidac ™ Polyester singlestitc:ll'-reload7. Bralon ™ Nylon single stitc~ •.~1;9~~8. Surgitie ™ Autosuture:M Liga1:il1~l.;'()opwith delivery system ..____.__. .__.. . -_,--~-_-.ITE~M(.5l_EiQh-lQNL~Y_.-------~_~~--c




? 0 ,...""' -' , '-.. ,,, "..

No.: 31-383 MD/2007-DC (Re-Registration 2011) (End.01)

To /~. Amardeep Enterprise,

No.5-6, 3rd Floor, Nr. Income tax Building,AshramRoad, Ahmedabad, Pin: 380009

SUB: - Registration of additional Medical Devices to RC No. MD-383, manufacturedby M/s.Solco Bio-Medical Co. Ltd., having manufacturing address at 34-6,Keumam-ri, Seotan-myeon,' Pyengtaek, Gyeonggi-do, 451-852, The Republicof Korea under the provisions of Drugs & Cosmetics Rules for the purpose ofimport of medical devices in India.

Please refer to your application No. Nil dated 27/08/2010 received by tl1is officevide dairy no.420 13 dated 06109/2010, replies received by this office vide dairy no no.17976 dated 18/04/11 and 30778 dared 27/06/11 and agditional documents received bythis office vide dairy No.55344 dated 30111111.~;~~)

.,~'"J'()l ','

Registration Certificate in Fonn 4L\~~hf'the Drugs and Cosmetics Rules isherewith for the manufacturing site alQng~t6 'ihe name(s) of medical device(s) importedunder the said Certificate subject to:th~folJowing conditions.

1. The medical device(s) shall conform to the standards 1 specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Actl ISO 1MDDI or such otherstandards or specifi.cations approved by this Directorate.

_______ __2 DispUre,-i-t=-any;·-in~1'eSpect"Ofthe--p'aymenror-tee-sancrsuDmlssiori(;fTR6 challan,shall be settled between the bank and the applicant.

3. The medical device will be required to be withdrawn from sale from theinarket incase any undesirable reactions due to failure of the device or its aC9~~sQdes arebrought to light at any stage. ·····TliisDirecforate should be informed'of adversereports on the medical device, if any.

---- -------4:-This-registration'u1-no way relieves you of the responsibility of complying withother provisions of the Drug~ & Cosmetics Act and Rulesthereunder, and anyother provisions of any other Act and Rules applicable in the matter concerned.


Ministry of Health & Familv WelfareFDABHAWAN, KOTLAROAD, NEW DELHI-11000Z lINDIAJ


ENDORSEMENT NO.Ol DATED .. .',. 5",:;? TO REGISTRATION••••• ;.> l. ~_.~ :.,,:::.J."~~

CERTIFICATE NO. MD-383 DATED 18-08-2011 VALID UPTO 31-07-2014.

;fi·· ••',.·'.i.i .. 'f

. ." ENDORS~M~~t~>01 •.•..•.• .1. 4CIS SpInal C~geSystemJ1~.~~~?n Cage S~st~mJ[Nonsterile]

2. 4CIS T•.~!!!ila'§yst~I!!INonsterile]ITEM(S) TWO!ONI.i¥

New Delhi

Date

Central Drugs Standard, Control OrganisationDirectorate General of Health Services



""'.:I::/~.t

~- .- c f.,

Tov>1/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 421302Maharashtra

SUBJECT: - Endorsement No. 01 to R.C. No. MD- 431 of manufacturing site MisSmith & Nephew Inc., Endoscopy Division, 150 Minuteman Rd., Andover MA01810, USA having factory premises at Mis Smith & Nephew Inc, 130 ForbesBoulevard, 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/58/2012 dated 05.01.2012 and receivedby this office vide Diary No.777 (FTS No.1811) dated 06.01.2012 on the subject citedabove.

.- ~Registration Certificate in Form 41 under ~'brugs and Cosmetics Rules is

herewith for the manufacturing site alongwithJhet~"tfie(s) of medical device(s) importedunder the said Certificate subject to the fC)Jkw~ conditions.

, .. jJ \~::..-? \),

/(,\ 'Zt ,\1. The medical device(s) shall c~(orm to the standards I specifications mentioned in

the Second Schedule of the Drugs and Cosmetics Actl ISO I MDD I or such otherstandards 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 incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage. This Directorate should be informed of adverserepolis on the medical device, if any.

4. This registration in no way relieves you of the responsibility of complying withother provisions of the Drugs & Cosmetics Act and Rules thereunder, and anyother provisions of any other Act and Rules applicable in the matter concerned.

GOVERNMENT OF INDIACentral Drugs Standard CuntrolOrganisation

Ministry of Health & Fa.Dlllv WelfareFDABHAWAN, KOllA ROAD, NEW DELHI ....110 002 [INDlAJ


ENDORSEMENT NO. 01 DATED ? C:.; rp1 TO REGISTRATIONc.. .,i "" "" * •• ,

CERTIFICATE NO. MD-431 DATED 25.11.2011 VALID UPTO 31.12.2014.

:\p..~OA.RD Cotvrfi,

"if''''' 0"

~::Del~ f~ ~D~ LICENSI~ORiTVi:c ~., c.. ,.. o~Iy€~LrH.Gov<~"'''''''~

_. ._..__ .~_. ._._._._._. . . .__~. ~-----.-~-~~. . ._. __~_S_ea.~.ll_S_ta~m_p.~. .. .__. __.. _Dr.G.N.SINGH

Dru\l$Cpntfon~rGeneral(lndia)Dte. Generalof.Mea:t:. Serv,ces

Ministr'l6fHe.?:lth & F2~""!ii)VV-};;:i-;creFD/-\ E}ti3:"/Z:ib:'i/ t.OZ-.D.


Ministry of Health 8tFamily Welfare

Food and Drug AdministratiOll BhawanKotla Road, New Delhi,. 110002

? c~ ..#

To ./ '~/s. Hanstronics Medical Equipment Pvt. Ltd.,

2001, Outram Line, Kingsway Camp, Delhi-110009

SUB: - Registration of MIs. Hydrofera LLC., having factory premises at 332 MainStreet, Willimantic, Connecticut, 06226 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 16/05/2011 received by this officevide dairy no.25238 (FTS 34818/2011) dated 27/0512011 and reply received by thisoffice vide diary no.59453 dated28/12/11 on the above noted suject.

Registration Certificate in Form 41 ,undet:'~6 Drugs and Cosmetics Rules isherewith for the manufacturing site along'Ytt11\w.~1i'ame(s) of medical device(s) importedunder the said Certificate subject to the.i~U'~~ngconditions: .

",";> \\\ ';-' 'I> ''':::J

1. The medical device(s) shall conform to the standards / specifications mentioned int41:':.~econd.Schedule of the Drugs and CQsmetics Act! ISO / MDD lor ,such otherstandards or specifications approved by this Directorate.

2. Dispute, if any, in respect of the payment of fees and submission of.TR6challan,shall be settled between the bank and the applicant. '

.-...

'-~-~~~, ,'~~---~--c3·.-ccThe1Iltxiiccrhtevi-c-e-wt1tiJerequiredto715e-w1thafawn-from -sarefiOlt1~Ij¢fnafKet m --'~----c--case any undesirable reactions due to failure' of the device or its acc~ssories arebrought to light at any stage. This Directorate should be informed of adversereports on the medical ~evice, if any.

4.' Thisfeglstrati6riiri-rioway relieves' youofihe responsibility of coiJ)ply[rig'WIthother provisions of the Drugs & Cosmetics Act and Rules thereunder, and any

_ oth~LprQ.visiOjJ]~tanY__Qth,er..AcLafid.Rii1esapp1icablejh-the-l1l.attei~<iriied.----- -,,,-,--

5. Each consignment of the medical device(s) to be imported by you shall beaccompanied by a test / analysis reports.

GOVERNMENT OF INDIACentral Drugs Standard Control OIVaoisalion

Ministry 01 Heallh & FandlvWeliareFDABBAWAH,IOTlARDAD, NEWDElHI.;..11.'02 (INDIA)

Form 41(See rule 27-A)

Registration Certificate issuedfor import of devices into IndiaUnder Drugs and Cosmetics Rules, 1945

1. MIs. Hydrofera LLC., having factory premises at 3~2 Main Street, Willimantic, Connecticut, 06226 USA.,

has been registered under rule 27-A as a manufacturer and is hereby issued this Registration Certificate .

• " .••• II!!

Name(s) of devices(s), which may be imported und.er~~ Registration Certificate:'-' ''')J

Please refer to the enclosed list ..' ,r>\'&, ':~ ,~"_",. 'i\,'.,,,7

~\'-?"\~""'= •••

". ""'\\

This Registration Certificate shall be i~i~~e fromJ6-02-2012 to 15-02-2015 unless itis sooner suspended or

cancelled under the rules.

4. This Registration Certificate is issued through the office of the manufacturer or his authorised agent India

MIs. Hanstronics-MedicalEquipmentcPvt Ltd., 2001•.outramLine, Kingsway Ca,tnp.Delhi-ll0009 who-- _. --- - . --'--, "-','-'-'-""'-- .... __.. --- ... -.. --- --__._.·· ··_··._.'v __ -,--._-_..._-' ... --'"-- ..•. ,', _.... " .:. ._. .,' '. '. ,',_0"_._ : __;.

wi11 be responsible for the business activities of the manufacturer in India, in all respects.

,~,.\jAAO cOt<ir~",sS o.r

'J~ 99",tf\~ 0u ~

eDse oseoNew Delhi . "\ --1

~J- octr, ".~"..-:\. ~_'-'.' O..e-;,." ft-v."'.

---- ..--------[)ate ..----£-~'.-:::::,~Z£J~l ~ALT"GD"t::~ . , .c ,eallStamp. ~.1lLSJNGi-J_~ ._··OrugsController General (India)ote,Seneral of Health Services

MiniSIrYOfHeallh & Family WeliareFDAShawan, Kotla R.oad, 1.7.0.

New Delhi-11 0002


Ministrv of Heallb & famjIVWelfaremA 8HAWAN, KOILA ROAD, NEW DELHI~ DU 002 lINDIAJ


REGISTRATION CERTIFICATE NO. MD-970 DATED 16-02-2012 VALID UPTO

15-02-2015.

Name of the ProductsHydrofera Blue Bacteriostatic wound Dressings

HB 2214 . 2x2Wo~nd Dressing22-662214"4)(2. WoundDrf3ssingHB6614 6x6 Wound Dressing..22-666614 6x6 Wo~nd DressingHBFR4414 4~4W9~89D(~ssing w/fi1rn22-664414F 4~4\A1~4P(j;Q~~:~singw/fi1rnHBRF2258 2.1g§~§.;i~~~d Dressingwl~ilm~~~~~~~_~~1.#dD~~:~~~~gwlfilm24_..§§~9~Q.~ (~~mhl_Ostcirri'YDfes~ing"\HBHD4450' . . Heavy.Drgin?g¢Dressing22~6£445D ..He...'.·..··.~.\I.y.",[J.).,:~ln.•••.;·a.·9.•••·••.e.•••.'··...•.••Qf§.§§iflg.·~~.

.. RSRD6575 f-f~~XY-gfafncige:Dressing.22-666675 He?\lYQraip~geDressingHBT0906 9mmTunnelWound Dressing22660906 ~rTlm'Tunnelvypund Dressing

.. HBER441..5 . .. - .1slar-idVrcessing..22;;.664475 IslandDressingHB3300 J,OtJccoWQundDressingcr .~22-663300 .!3 o\nd Dressing

~. ··.···0

11E ~QNLY~ ;$';. ~"'~ ..• ~(/

Op~ 'if.:~f4LTff.G®""'"

~."V~L. ':~i~~...

LICENSIrIGA~Y

Seal/Stamp

Dr. G. N. SiNGMDrugs Controller General (:nd;a:'

.Die, OCilcrfJ of HCaJih ~VViv~jfV~~~~I~:'?~::~~~;~:ggi'~~~;~:~



Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

To, /~s ~!ovatec Surgical Systems Pvt. Ltd.,

T-A/I71/I, Tughlakabad Extension,New Delhi- 110019

SUB: - Registration of M/s Allergan, Marlow International Parkway Marlow Bucks,SL7 1YL GBR having a factory premises at M/s Allergan, Global Park Free ZoneLa Aurora de Heredia 900 Parkway Costa Rica under the provisions of Drugs &Cosmetics Rules for the purpose of import of medical devices in India.

Please refer to your application no. MS/Drug/2010-11/515 dated 25.03.2011 andreceived by this office vide diary no.14697 dated 29.03.22011 and reply received vidediary no. 59826 dated 30.12.2011 on the above noted subject.

Registration Certificate in Form 41 under the Drugs and Cosmetics Rules isissued herewith for the manufacturing site alongwithtQ~fiil.me(s) of medical device(s)imported under the said Certificate subject to the f~ll~~' conditions .

.~ --I. The medical device(s) shall conf9rm~iti~e;~tandards / specifications mentioned in

the Second Schedule of the Dru~SilnCi Cosmetics Act! ISO / MDD / or such otherstandards or specifications approved by this Directorate.


3. The medical device will b~requiredto .Qewithdrllwnfrom salefrQmthe marketin-~----~--_·_--~--caseany ·ul1desirabteleaCtimrg-due~ttr-fai1ure--of-me-device or its accessones-are------~---·~·

brought to light at any stage. This Directorate should be informed of adversereports on the medical device, if any.



MinistrvolHealth&FamilvWellareFDABHAWAM; KOTLAROAD~NEwnnHI= llU-00211NDIAJ



Mis Allergan, Marlow International Parkway Marlow Bucks, SL7 t YL GBR having a factory premisesat Mis Allergan, Global- Park Free Zone La Aurora de Heredia 900 Parkway Costa Rica has beenregistered 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 listI

.•....·'.,.1

This Registration Certificate shall be in forcefrom16-02-~t.V~(t~~02-20t5 unless it is soonersuspended,t. i>,J)

...,.>\\('>.~'~?\\,p~~()'fi;\';

This Registration Gertificate is issued through the office ofthe manllfacturer or his autl10rised agent in IndiaMis Myovatec Surgical Systems Pvt. Ltd., T~A/1711J;Tughlakabad Extension, New Delhi-ltOOt9.Whowi11 be resR()rJsibl~fQr the husiness activities-ofthelTIantlfa£t~rerin lndia,in:'lll:respects.

This Registration Certificate is supject to the conditions stated overleaf and to such other conditions as may

be specified in the Act and the Rules, from time to time.

~\I-",O"'RO COtvrJ.l,G'>S o(

0«" 01'"

}' \-~ 0

u

CDSCZ EPlace: New Delhi ~;:;

~",?;. ~W!1Rl - &#

Date: Z S :-._ _ ~~"f:~Go,,'-~:"-t:- ~ICEN~~: fS:~:HO~~~Y- _- --------_._----,._-----~--- -

Dr. G: N. SINGHDrugs Controller General (India)Ote. General of Health Services

Ministr/ of He811h & Family V\ie!fars~- ~, 1<,".' •.::' ~>,,:_,~.1.',''J.


Ministrv 01Health & FamUv WellareFDA-BHAWAN;KOTlAlnrAD,NEWlfnIU~ 110002 [iNDIAl


REGISTRATION CERTIFICATE NO. MD- 934 DATED 16-02-2012 VALID UPTO

15-02-2015.

Name of the products1. Breast Implants:

• Single Lumen(;eb,~~l1ledBreast Implants• DoubleLul1l~pGeli Saline Filled Breast

Implan,~~\~~~Jv>• Saline~'FinedBreast Implants

2. Tis.sue.Expallders:" "• CUI Tissue Expanders

- ·--.·Nat-retle==Rss8e-=ExpandersITEMS (TWO) ONLY

S S"\,,,~OA.RD COlVi110(

~(j 0-9.

~o'" ~

_~::NO;Delhi ~-------~-::<";'~----~~~~;S~:~RIT~-__________ ~ ~"__ .__-.----------~---- ~17Stamp

. -·--Dr.G. N_ SINGH" Drugs Controller General (India)

D~e.General of Health ServicesMInistry of Health & Family Welfare

FDA8ha\~~n.'!~9tlaRoad;I.T.O.f"JP\M De!hi~110;'102

Central Drugs Standard Control OrganizationDirectorate General of Health Services


Food and])rug Administration Bhawan- -Kotla Road, New Delhi~110002

Date: -. _..~'''-~.: ,T

- d;.e

To /~s.Globe Bio-Medicals,

Room C/2, Juhu Apartment,Near SNDT College,Juhu, Mumbai - 400049.

SUB: -Registration of MIs. Starway Medical Technology Inc., having factorypremises at Suite 1007, Huijingge,No. 2, Chang Wa Haidian Beijing, 100089,China under the provisions of Drugs & Cosmetics Rules for the purpose ofimport of medical devices in India.

Please refer to your application no. Nil dated 28/1112011 received by this officevide dairy no. 55098 dated 29/11/2011 on the above noted suject.

Registration Certificate in Form 41 under thepr~gs and Cosmetics Rules isherewith for the manufacturing site alongwith the n~f 01medical device(s) importedunder the said Certificate subject to the_f~;~~~~ofiditions.

1. The medical device(s) shall cont$)~\>to the standards I specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Act! ISO / MDD / or such otherstandards or specifications approved by this Directorate.

2,Di~Qule,_ if@y,jn respect of the payment of fees and submission of TR6 challan,sha.ll be settled between the bank and the applicant

3. The medical device will be required to be withdrawn from sale from the market incase any undesirable reactions ~ue to failure of the device or its accessories arebrought to light at any stage. This Directorate should be informed of adverse

.~-~._-._,-.~----------,--~-- repofts'--o-n--ure-medical--deviee,#any. --~...-~-. -. -.--- _


5. Each consignment of the medical device(s) to be imported by you shall be------- ----.,___----- ....:.a..cc.Q.illp-aniedbya test /analysis reports. --

, '" ~---'----'--"----~--_.~-.----_ .._-----~~--. __ .~--_._~-------_.~._------

GOVERNMENT OF INDIACentralDrugs Standard Control Organisation

MinistrvofHealth& FamilVWeUare·IDABHAWAN~IOTlIllID,NEWlJELHI::.:n0002l1NDIAl


Registration Certificate issued.for import of devices into IndiaUnder Drugs and Cosmetics Rules, 1945

1. Mis. Starway Medical Technology Inc., having factory premises at Suite 1007, Huiiingge, No.2

Chang Wa Haidian Beijing, 100089, China has been registered under rule 27-A as a manufacturer and is

hereby issued this Registration Certificate.

,I<'1,,\

2. Name(s) of devices(s), which may be imported under ~hi~~~i'~tration Certificate:, ."'# f~1

Please refer to the enclosed list iF"'> '~:, ~.

-;',»~,,',.,.-? Vf9"~,'. ,\(\;.,

3. This Registration Certificate shall be in for&'~r'Om 16-02-2012 to 15-02-2015 unless it is sooner suspended or

cancelled under the rules .

.4. ..ThisRegi~trati()I1~(;~rtifi()l;l.t~ds~!s§ued. th~()ugh!he~()ffip~·:qf __thC;:'111a.nufactureror:~his·au:th()riSed'agent irlltidia

Mis. Globe Rio-Medicals, C/2, Juhu Apartments, Near SNDT College, Juhu, Mumbai - 400 049 who will

be responsible for the business activities of the manufacturer in India, in all respects.

5. This Registration. Certificate is subject tQtlle copditions statedQverleaLan.dA~~RG#iefl5~a5-emay~be---· --

specified in the Act and the Rules, from time to JJm~o .""s'~ 'Vrf/qa

<f, ~~, ~

g ~u z

Place:,:w~~e~h~c'~>,~~~ ~ -\>,,~-'1- _~__~1CJ>N~I~:~~~IT~ _·_-·~----Vate:-'L > "';...J' ':,:.J i:t. Seal/Stamp

'" "'" . . - ~Dr. G. N, SINGH

Drugs Controller Genera! (india)r\,~;j~~:f~~721"21':Jf Health Se:vices


Ministrv of Health & Familv WelfareFDA BHAWAH, KOTlA ROAD, NEW DELHI~ 110002 lINDIAl



15-02-2015.

NAME OF THE PRO,UCTS:1. Cardi-O-Fi.x ·.•.••..A·.•.SJlr.,. ' -'CCLUDER SYSTEM2~iCardi-~~~I~ti:1t.~QCCLUDI:R SYSTEM3~Cardi~~l!Y~n ..•··......••.O....CCLUDER SYSTEM

\..··1} :""",,,,,<--,,,,;::,',,,,,,,', , , ', ,"

ITEM (S)tliliREE ONLY

UL G.N ..~t_I\!GnDrugs Controller General (India)Dte. General of Health Services

Ministry of Health & Family WelfarefTJ:~~DhaV>/an, Katie Roed. tT.O.

-,-""",..,:-;..,




TO~ .• Zimmer India Private Limited,

lot No B & BI, Vanijya Nikunj, 7th Floor,Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016

SUB: -Registration of Mis. Zimmer GmbH Sulzer Allee 8,CH-8404 Winterthur,Switzerland under the provisions of Drugs & Cosmetics Rules for thepurpose of import of medical devices in India

Please refer to your application no. Nil dated 18.10.2011 received by this officevide dairy no. 48844 dated 18-10-2011 on the above noted spject.

~O~1Registration Certificate in Form 4~~ er~brugs and Cosmetics Rules is

herewith for the manufacturing site alon~ ame(s) of medical device(s) importedunder the said Certificate subject to tht)<f' .ng conditions.

1. The medical device(s) shall conform to the standards / specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Act! ISO / MDD / or such others~5i~gsor sl?~cifications approv~d.pythisQiI"~ct()rate.


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 arebrought to light at any stage. This Directorate should be informed of adverserepQrtsonthe medical device, ifany.

4. This registration in no way reli~Y§_~3-QuofJhe..-responsibility_oLcomplyingwith-----other provIsions-'ofthe-Drugs & Cosmetics Act and Ru1es thereunder, and any

other provisions of any other Act and Rules appli~a.1Jlein theIl1.a.tt~rc;QIlcerned.- ~- _~--_~-~-._-"~--_._~--_._-----'-------_._---_ ..__ ._-------~-----_._--_._----_.-_._.__ .._._._-_ .... -

5. Each consignment of the medical device(s) to be imported by you shall beaccompanied by a test / analysis reportS'.

GOVERNMENT OF INDIA,Central Drugs Standard Control Organisation

MinistrvofHeallh&FamilvWeUareJOABRAWII.KDlllIDAD. NEWDELHI-111ID211Nnlll


Registration Certificate issued for import of devices into IndiaUnder Drugs and Cosmetics Rules, 1945

1. Mis. Zimmer GmbH having factory premises at Sulzer Allee 8, CH-8404 Winterthur, Switzerland

has been registered under rule 27-A as a manufacturer and is hereby issued this Registration Certificate.

2. Name(s) of devices(s), which ~ay be imported und~r,this Registration Certificate:

4. This Registration Certificate is issued through tl1eg:ffl<;eo{.t:he.manufacturer or his authorised agent in India

MIs. Zimmer.lndia Privat~'Limited. Plot ~6{~~~r~ti.;'~~iiyaNikuni,7th;FloorEnkaY Tower, Udyog

Vih-~;,Ph~~tl..V:G~;~~;=i2Z01-6~h~~ill~;~;§~·6ri~i~I¢!i~+·the business activities of the manufacturer in

India,' in all respects.

This Registration Certificate is subject to the conditions stated overleaf and to such other conditions ~ill.--a~.b~ ~_~_

specified in the Act and the Rules, from time to time ..~~o~cOrvr""

<t<f>~ .•.• ,

_.1 - ._\§ ~

DSCO

=1:E:~I:~~:RlTY----~~~---- -.------ -----~-=------~t~arz------ -.... ~~~, SINGH

Drugs Controller General (India)Dte. General of Realth Servic<'>s

Ministry of Health 8. Fzn-::!y WelfareFDi\ BhawBn, KoBe Road, I.T.O.

t,lp;,'" ;-",-,,::'-i


Ministrv of Health & Familv WelfareFDABHAWAN.KOllA ROAD.NEW DElHI-110 002 lINDIAl



15-02-2015

1. Allergretto Knee Replacement Products2. Total Hip Replacement Products

Containing the following family of products namelya) Bipolar Cup & Liner

i~~:ON'R5{o~,~ MS-30 S'e ' . !izer.~. G;1.

~)Muller . ..~,~ h)CLS St ~.<' i) SL Revisi ...;

UI.J..J j) MeduJt~r#:; ~"\.', -

3. Fra6~S~e® 0'(0C"ohlffiinlnQtlie y of ffie proaucts namely

"?a) Sirus ~~) Anatomi , §

~GSB 11\ .'~-9)- -fl("q-~-q ~ &.

,.'4. Spinar ~boapedic Implant: Dyn~1s

'.~:~~:~ Mi~a1dijRGO\ft.~~~7. Trofix Trochanteric Fixation Plating System8. Metasul Taper Lin!~,...oARDco,o,~O(9. Biolox Delta Tap~, 0-9'\10.Ceramic Femo~1 H . ' \11.Metal (CoCr) Fe . ~o12.Metasul Head \~ _. I13. NCB® Polyaxial l~~mg.,.ptate System

..1":';',' '-;',',- ,',

LICENSIN~t;:;HORITYSe~=~:HDrugs Controller General (India)Dte G·.•t,-~· ~t t:·"),-!"~. Sennc.es

Mil'>','FC·.'

New DelhiDate .Z ('



Food and Drug Administration BhawanKotla Road, New Delhi-ll0002Dated

To

~epuy Medical Pvt. Ltd,64-66, Senapati Bapat Marg, Mahim, Mumbai-400016

SUB: -Endorsement No. 01 to R.C. No. MD-127 of Manufacturing Site MIs. DePuyOrthopaedics, PO Box 988,700 Orthopaedic Drive, Warsaw, Indiana 46581-0988 under the provisions of Drugs & Cosmetics Rules for the purpose ofimport of medical devices in India.

t',':.. • , '·::t-'1';~>:;Please refer -to,·your application no.. DepuylRA/2011/Sept/RC-O1 dated 01-09-

2Qll received by this office vide diary no.-40906 dated 01-09-2011 on the above notedsubject.

()<:Registration Certificate in Form 41, wn'te; 'W~"/Drugs and Cosmetics Rules is

issued herewith for the manufacturing~i~;;',~~~~ with the name(s) of medical device(s)imported under the said Certificate subJ~afto the following conditions.

1. The medical device(s) shall conform to the standards / specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Act! ISO / MDD / or such otherstandards or specifications approved by this Directorate.


3. The medical device will be required to be withdrawn from sale from the market incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage. This Directorate should be informed of adversereports on the medical device, if any.

4. This registration in no way relieves you of the responsibility of complying withother provisions of the Drugs & Cosmetics Act and Rules. thereunder, and anyother provisions of any other Act and Rules applicable in the matter concerned.

GOVERNMENT Of INDIA

Central DrUgSStandard Control OrganisationMinistrv 01Health & familv WellareFDABHAWAN, KOIU ROAD,NEW DEIHI-110 00211NDIAJ

NAME(S) OF MEDICAL DEVICES,

REGISTRATION CERTIFICATE

ENDORSEMENT NO.1 DATED 2 S

WHICH MAY BE IMPORTED UNDER

NO. MD-127 DATED 09-08-2010

"' 2D1f ALID UPTO 30-11-2012

LICENS.9::;HORlTYSeal/Stamp

Dr. G. N. SINGHDnJgs Controller General (IntJio)Dte. General of Healt~ Services

Ministry of Health & Family WelfareFDA Bhawan. Kalla Road, I.TO.

New Delhi-11 0002

Date: .2... ; - ";




2 ,~.,:;;" '

To~ Covidien Healthcare India Pvt. Ltd.,

"Doshi Towers", 6th Floor, # 156, Poonamallee High Road,Kilpauk, Chennai- 600 010.

SUB: - Registration of MIs Kendall-Gammatron Co. Ltd., 117 Moo 2, PetchkasemRoad, Sampran, Nakron athom 73110, Thiland under the provisions ofDrugs & Cosmetics Rules for the purpose of import of medical devices inIndia.

" -Please refer to youi~:application ngi~1t/IRA/REB-MD-748/2011 dated

28/02/2011 ·received by this office vide ~~o. 9627 dated 28/02/2011 and repliesreceived by this office vide di~J1\~\~0101 dated 28/04/2011 and 55423 dated30/11/2011 on the above noted s~t}

Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewithfor the manufacturing site alongwith the name(s) of medical device(s) imported under thesaid Certificate subject to the following conditions.

I. The medical device(s) shall conform to the standards / specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Act! ISO / MDD / or such otherstandards or specifications approved by this Directorate.


3. The medical device will be required to be withdrawn from sale from the market incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage. This Directorate should be informed of adversereports on the medical device, if any.


GOVERNMENT OF INDIACentral Druls Standard Control OraanisaUon

Ministrl of Health & Famil, WenareFDA••• WAII,.8U 101D, IIEWIUI-"O 112 (IIIIIAI



Date: 2 C !:.:: :-~,:/-

1. MIs Kendall-Gammatron Co. Ltd., having factory premises at 117 Moo 2, Petchkasem Road,

Sampran, Nakron athom 73110. Thila~~ ~~~ under rule 27-A as a manufacturer and is

hereby issued this Registration ceffl~' ''0''<\ J?O.(,~G (~' ~\) O...po-','! ,. '

Name(s) of devices(s), whichm~ be impo tion Certifi9.ate: ..~ ~ '_.~Please refer to the enclosed~ ,- 'X ~ U'I..::. (~ ~

~, a"This Registration Certificate shall be in for 012 to 15-02-201:5 unless it is sooner

suspended or cancelled und'OQSC 04. This Registration Certificat~SSUed throu

MIs. Covidien Healthcare I~ Pvt. Ltd.

Kilpauk, Cbennai- 600 010 Wb~~be responslb e or t e usiness ~~es of the manufacturer in India, in

all respects. ~ It£. ~x..~4LiH, GO\/£'\\\'\

This Registration Certificate is subject to the .;~~ stated overleaf and to such other conditions as may be

specified in the Act and the Rules, from ti~ tl "f \~ z

CDSCO DSCOto I'\. -- do

~~7H.GCNf!I"'#'

allStampDr. G. N. SINGH

Drugs Controller General (India)Ole. General of Heal'h Serv'M' , "IcesInlslry of Health & Family WelfareFDA B~awan, Kalla Road, I.T.O.

',J,:,w r',,,,lh; ~"""I"\')')

Place: New DelhiI"; l'

Date: l. .',

GOVEINMENT OF INDIACentral Druls Standard Control Organisation

Mlnlstrv 01Health & Famil, WeRarenA BIAWAI, IIIlA RIU, IEWDELHI-111'.2 [INDIAI


REGISTRATION CERTIFICATE NO. MD-748 DATED 16.02.2012 VALID UP TO

15.02.2015.

New DelWif "Date: .0- ". L1CENSj::UTHORITY

SeaVStampDr. G. N SIt-.Grl

Drugs Controller General (India)Dte. General of Health Services

Ministry of Health & Family WelfareFDA Bhawan, Kotla Road, ITO.

N~"" O",lhi-11 0002

\"~. j,--_ -.•• ~ It Ok\)



Food and Drug Administration BhawanKotla Road, New Delhi-ll0002Date:

TO~. MI. eleflex Medical Pvt. Ltd.,ld No: 10, No: 19, 1st Floor and Ground Floor,

Harrington Road, Chetpet,Chennai - 600031.

SUB: -Registration of Mis. Teleflex Medical, IDA Business and Technology Park,Athlone, Ireland having factory premises at Mis. Arrow InternationalC.R.A.S. Jamska 2359/47, Zdar Nad Sazavou, Czech Republic 591 01 underthe provisions of Drugs & Cosmetics Rules for the purpose of import ofmedical devices in India.

Please refer to your application no. Nil dated 17/03/2011 received by this officev~de.d~iry no. 14077 dated,25103/20 11 and subsequent r~ply received,-'by"this office vide ."d~YJao. 51746 dated 09/11/2011 on the above<n6(~h~~t.. ,'"

Registration Certificate in Form 41 ,~er the Drugs and' Cosmetics Rules isherewith for the manufacturing site alon~flename(s) of medical device(s) importedunder the said Certificate subject to t~~:Ib~ng conditions.

1. The medical device( s) shall conform to the standards I specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Act! ISO / MDD I or such otherstandards 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 incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage. This Directorate should he informed of adversereports on the medical device, if any.


5. Each consignment of the medical device(s) to be imported by you shall beaccompanied by a test I analysis reports.

Central Drugs Standard Control OrganisationMinistry of Health & Familv WelfareFDA8HAWAH, KOlLA ROAD,HEW DELHI-ll0 002l1HDIAJ



1. Mis. Teleflex Medical, IDA Business and Technology Park, Athlone, Ireland having factory

premises at Mis. Arrow International CoR.A.S. Jamska 2359/47, Zdar Nad Sazavou, Czech

Republic 591 01 has been registered under rule 27-A as a manufacturer and is hereby issued this Registration

Certificate. <t)~~'.If"'C'::'

"" \~?2. Name(s) of devices(s), which may be imP9~l~der this Registration Certificate:

t1":"\.'~? <'.:>

Please refer to the enclosed list . ,'" ~f'~\) "

3. This Registration Certificate shall be in force from 16-02-2012 to 15-02-2015 unless it is sooner suspended or

cancelled under the rules.

4. This Registration Certificate is issued through the office of the manufacturer or his authorised agent in India

Mis. Teleflex Medical Pvt. Ltd., Old No. 10, No: 19, 1st Floor and Ground Floor, Harrington Road,

Chetpet, Chennai - 600031 who will be responsible for the business activities of the manufacturer in India, in

all respects.

S '7~",~Op..RDcOtyr09o(

5. This Kegistration Certificate is subject to tb€ c s°-S>§tptedoverleaf and to such other conditions as may be! ~specified in the Act and the Rules, from ti11t<t>~~ ~

LICENSING ~y

Seal/StampDr. G, N. SINGH

Drugs Controller General (India)Ole. General of Heal:h SeNices

Minlstryof Health & Family WelfareFDA BhCiwan Kotla Road, I.T.O,

r-. ,it,; ..,1 ('!"'or-.')

Place: New Delhi

Date: "? ~

t,~"


Ministrv of Health & Familv WelfareFDAHHAWAN,KOrlA ROAD,NEWDElHI-ll0 002 UNDIAl

,...~?i,~

l-LICENSINP AUTHORITY

Seal/StampDr. G. N. SINGH

Drugs Controller General (India)Dte. General of Health Services

Ministry of Health & Family WelfareFDA Bhawan. Kotla Road. I.T.O

New Dplhi-11 O()02




To /.~~~ptimus Pharma Consulting,

# 1319,First Floor 24th A Main, 9th BlockJayanagar, Bangalaore-560069

SUB: -Registration of Manufacturing site MIs. Cappella Medical Device Limited,Unit 3, Ballybrit Business Park, Ballybrit, Galway, Ireland under theprovisions of Drugs & Cosmetics Rules for the purpose of import of medicaldevices in India.

Sir,_ .. 1.. , '- ,{.)",

. ,-.,Please refer to your 'applications no'. nil ~ 16/08/2011 received by this officevide dairy no.39141 dated-23/08/2011 and?~~ti'~t~d 08/11/2011 and·reply received bythis office vide diary no. 1588 dated 1!I;~l~2 on the subject cited above.

",,' \\\~''-....j

Registration Certificate in Form. 41 under the Drugs and Cosmetics Rules isherewith for the manufacturing site alongwith the name(s) of medical device(s) importedundcr the said Certificate subject to the following conditions.

1. The medical device(s) shall conform.to the standards 1 specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Act! ISO 1 MDD 1 or such otherstandards or specifications approved by this Directorate.


3, The medical device will be required to be withdrawn from sale from the market incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage. This Directorate should be informed of adversereports on the medical device, if any.


5. Each consignment of the medical device(s) to be imported by you shall beaccompanied by a test 1 analysis reports.

GUIIINMINT Uf INDIACenlral Drugs Standard Control Organisation

Ministrlol Health & Familv WenareFlABHAWAI,.IU RIAl, NEW1101-111112 [INIIAl


Registration Certificate issued for import of devices into IndiaUnder Drugs and Cosmetics Rules, 1945

MIs. Cappella Medical Device Limited, having factory premises at Unit 3, Ballybrit Business Park,

Ball~bri~ GaIW~y, Ireland has been regist~~~NA. as a manufacturer and is hereby issued thisRegistratIOn Certificate. L S'i.~<,\i IRO(

~;§SJ :':::.}, 0.' ~. ~~"

Name( s) of devices( s), which ~ be impo,11 " tion Certi . e: ' ".~ ~. ~

Please refer to the enclose~t <":c, ' " \.j\, 't...:::. {~'\,'; ~< \'::3,1 ~

This Registration Certi~ate shall be in 2.2012 to 15-0~015 unless it is sooner

suspended or cancelled und(L~ 0This Registration Certificat\ issued throu

MIs 0 timus Pharma Cons' # 1319

560069 who will be responsible ~.J4l!e busines I I es e manuf~~r in India, in all respects.01." 0~

This Registration Certificate is subject to~~1&r~~~~f and to such other conditions as may be

specified in the Act and the Rules, from time to,_t~.$'/~I'--~\~ au z

CDSCO CDSCO

" i~ -- ,fq. .•~"€4t.Jli.GO'It"" •••. LICE NSIt:uTHORITY

Seal/StampDr. G. N, SINGH

Drugs Controller General (India)Ole General of Heai:h Services

Ministry of Health & Family WelfareFDA Bhawan, Kotla Road, I.TG.

New Deihi-l1 0002

GOVERNMENT OF INDIACenlral Druls Standard Clntrol Organisatiln

Ministrv II Health & Fallilv WenareFDABIAWAI, ana ROAD,NEWDEUI-111112 lIIDIAJ


REGISTRATION CERTIFICATE NO. MD-I0ll DATED 16.02.2012 VALID UPTO

15.02.2015.

::\~~OJ\RDCON/~0SS o(

. is "f~'\~ 0-9(;,,.:'_ '·,,~ame .."ts: 11~

1."'SideGuard C~onary,,:l "ent an~elivery·System"(Products codes: P230~ , ,,2, SG023S@p2, SG0233513,

U SG ' Z

C~

New Delhi

Date: ..",i.,..• - LICENS~UTHORITY

Sea VStampDr. G, N. SINGH

Drugs Controller General (India)Dte. Generill of Heal:h Services

Ministry of Health & Family WelfareFDA 8hawan, KOlla Road, LTO.

New Delhi-110002



Food and Drug Administration BhawanKotla Road, New Delhi-l10002

F. No.: 31-274-MD/2007-DC (Re registration 2010) (End. 1) Dated •••.1 iviAH lD12To /

~. Sahajanand MedicalTechnologies Pvt. Ltd.,Sahajanand House, Parsi Street,Saiyedpura, Surat- 395003

SUB: - Endorsement No. 1 to R.C. No. MD- 274 to Manufacturing Site of MIsArthesys, 20 rue Traversiere 92230 Gennevilliers, France under theprovisions of Drugs & Cosmetics Rules for the purpose of import of medicaldevices in India.

Please refer to your application dated 01.02.2011 and 15.07.2011 received by thisoffice vide diary nos. 4965 dated 01.02.2011, 33633 dated 15.07.2011 and repliesreceived vide Diary no. 50017 dated 27.10.2011 and 58647 dated 22.12.2011 on theabove noted subject.

_.":,, "(-" ',' "'1

Registration CertificaW'"\\~ '·~~iID~.j1Crttre/ t~e Drugs and Cosmetics Rules isissued herewith for the manu\f~Hu~ing 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 intl1~:S~_cQndSChedule of the Drugs and Cosmetics Act/ ISO / MDD / or such otherstandards or specifications approved by this Directorate.

2. Dispute, ifany, in respect of the payment of fees and submission ~f 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 incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any' stage. This Directorate should be informed of adverse

-~--TeP9:rtSlJIl:1h~medicat:devlce, if any.

4. This registration in no way relieves you of the responsibility of complying withother provisioriSbf the Drugs & Cosmetics Ad arid Rules therell119~r, and anyotherprovisiollsofany other Acfa.ndRu}es'appHcable in the matter concerned.


Ministry of Health & Familv WelfareFDABHAWAN, KoYLA ROAD,NEW DELHI-11o 002 [lNDIAJ

NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDERENDORSEMENT - 1, DATED r;.. 11;'\?;.H Lull. TO REGISTRATION

~"

CERTIFICATE NO. MD- 274 DATED 17.09.2010 VALID UPTO 14.09.2013.c:

ENDORSEMENTN~. 11. CYGNUS II C~- cr9rS?.rf~~tY\i'5Tent~ystem (Non Ste.rile)2. PEGASEAsp~'~tffeter(Stenle and Non Stenle)3. LYNX PTA Catlieter (Sterile andNon- sterile)

ITEMSITHREEYONL Y

S""OARO Corvr-\b(>s "0

--------~a-ce~~ew-~-e-l-h-i------~---:·~--o~••.(~H'G::,o:~-------L-I-C-~E-N-SIN-QnJ_ -A-U--T-H.--O-----R--I--T---Y---------------

Date: -~ 1 lAt,.f1, 101t "'<0, v. o"'~" Ip AUT1----:Sea1fStam p

Dr. G. N, SINGHDrugs Controller General (India'~~e,General of Hes!lh Service;

MInistry of Health 8. F~milyWelfareFDABhawan. Kotla Road, I.T.O.

New Delhi.iiCJ002

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