Central Drugs Standard Control Organisation Directorate …cdsco.nic.in/Medical_div/RC_md/Medicla...

Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

1 2 JUN 20fZ

To~ /~. ~i~mer India Pvt. Ltd,

Plot No. B & B1, Vanijya Nikunj,7th Floor, Enkay Tower, Udyog Vihar,Phase-V, Gurgaon-122 016

SUB: -Registration of additional Medical Devices to RC No. MD-170, manufacturedby Mis Zimmer Inc., 1800 West Center Street, Warsaw, Indiana 46580, USAunder the provisions of Drugs & Cosmetics Rules for the purpose of importof medical devices in India.

Please refer to your application No. Z1/2012-005 dated 16/02/12 received by thisoffice vide dairy no.6749 dated 16/02/12 on the above noted 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.

1. The medical device(s) shall conform to the stand~"'ecifications mentioned inthe Second Schedule of the Drugs and Cos~~t~~ct; ISO / MDD / or such otherstandards or specifications approved ~~~'Oirectora~e.

2. Dispute, if any, in respect of the ~tent of fees and submission ofTR6 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 The medical device will be required to be withdrawn from sale from the market incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage.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 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.

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

6. Based on this registration, applications for the imPQrt of medical device(s)endorsed in -theenclosed Registration Certificate shall be considered for the issueof Form 10 Licence under the Rules.

7. This Registration Certificate is being issued under the condition that during thependency -of Registration, the applicant may be required to deposit inspection feeas stipulated under Clause (5) of Rule 24-A and enable inspection ofmanufacturing site by the officials Authorized for this purpose. Non-complianceto this condition as and when so directed would result in cancellation ofRegistration Certification.

8. This registration certificate is being issued under the condition that you arerequired to submit the following documents at ~he time of submission ofapplication for grant of Form 10 License,

I. Technical chart in respect of Product description, Mode of Action,Intended Use, Material of construction, Performance, Design between thethree model of Longevity® Highly Cross-linked Polyethylene ElevatedRim Liners.

a) Longevity IT Elevated Rim Linersb) Longevity IT DD22Elevated Rim Linersc) Longevity IT CC22 Elevated Rim Liners

II. Revised Labels in original duly printed in indelible ink for all proposeddevice having the Importer name and address, Import license No etc. asper Rule 96 of Drugs and Cosmetics Rules 1945 (as the same submitted byyou,above information has not been mentioned).

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 anyother condition that may be taken under the provisions of tpe Drugs & Cosmetics Act,1940 and the Rules thereunder.

(Dr. ~ Singh)Drugs Controller Gt;~(India)

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministry of Health & Family WelfareFDABHAWAN,KOllA ROU, NEW DELHI-110 OOZ [INDIAJ

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

ENDORSEMENT NO.07 DATED .il 2 JUN lOlZ TO REGISTRATION

CERTIFICATE NO. MD-170 DATED 04/08/2009 VALJD UPTO 31/7/2012.

:,\~~O,t\RDCO!Vr~0"S 0<

~ 01>Q<> ~'V ,~

~ \.f'~ EN NO.07 ~

1. Longevity® ~hly Cros yethylene<&levated Rim Lineru ITE ONLY Z

CDSCO CDSeC ~O~~!\ Ofli'\C~ Iy~.

~ ~~)- *lftlqq ~ &-

OJ:' ~Itt;ijLTH, GOVt.~~\'S'~

Date f1 2 JU N lOlZ



Food and Drug Administration BhawanKotla Road, N.ewDelhi-ll0002

11 2 JUN 201Z

To /~s ~?~nson & Johnson Ltd.,

Shed No. AlI50, 100 Shed Area,Degam Road, GIDC, Vapi - 396195,India.

SUB: - Registration of manufacturing site of Mis. Depuy (Ireland), having factory....._ _ - "" premises"at-.Lough beg, ,Ringakiddy,-.Co.· Gork" Ireland;-u nder the.p rovisions

of Drugs & Cosmetics Rules for the purpose of import of medical devices inIndia.

Sir , ,t't)"'\~O~-Please refer to your letter No. JNJIRA40h!A~gust!RC-OI dated 29/07/2011

received by this office vide Diary N0.3.6J.?f.\W'e'f 01/0812011 and reply received vidediary No.1 1503 dated 20/03/201'1, rega~ Theabove 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.

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.

2. Dispute, if any, in respect of the payment of fees and submission ofTR6 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 I 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.

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

6. Based on this registration, applications for the import of medical device(s)endorsed in the enclosed Registi"ation Certificate shall be considered for the issueof Form 10 Licence under the Rules.

7. This Registration Certificate is being issued under the condition that during thependency of Registration, the applicant may be required to deposit inspection feeas stipulated under Clause (5) of Rule 24-A and enable inspection ofmanufacturing site by the officials Authorized for this purpose. Non-complianceto this condition as and when so directed would result in cancellation ofRegistration Certification.

8. This Registration Certificate is being issued under the condition that you arerequired to submit revised labels (in original), in respect of the proposedproduct, complying with Rule 96 of Drugs and Cosmetics Rule, bearing thename and address of the importer as per the Drug Sale Lice'nse, at the time ofsubmission of application for the grant of Form 10 License (as you hadsubmitted the photocopy of the labels with affixing the sticker bearing thename and address of the importer, import licence. No. etc.).

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 anyother condition that may be taken under the provisions of the Drugs & Cosmetics Act,1940 and the Rules thereunder.

Yours faithfully,

~"""~_'.'""'''"~''~ .••••"'_,._~"Dl'1Ig.oco_~~n:~~

GOVERNMENTOFINDIACentral Drugs Standard Control Organisation

Ministrv of Health & Familv WelfareFDABHAWAH, KOILAROAD, HEW OElHI-ll0 002 lINDIAl

Form 41(See rule 27-A)

Date: ~ 2 JU N lOl!I. MIs. Depuy (Ireland), having manufacturing premises at Loughbeg, Ringakiddy, Co. Cork, Ireland has

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

2. Name(s) of devices(s), which maype imported under this Registration Certificate:~APlease refer to the enclosed list •••>;~<".

~,\i)~)).",':t~~,_;',_,:

3. This Registration Certificate shall be in forgeff~~n522012 to 30-04-2015 unless it is sooner':if%·.··.· ···.4'\/./' ';;'

suspended or cancelled under the rules. ,()/')

4. This Registration Certificate is issued through tp.eoffiC~Qftb~11;}anufactureror his authorised agent in India

MIs Johnson & Johnson Ltd., Shed No. AlI~~,~ai~i"~QOltl~O. 1 to 9, 100 Shed Area, Degam Road,C.I.D.C., Vapi, Tal- Pardi (\-}alsad)- 39619S,lnc:liawno.wH{ be responsible for the business activities of

the manufacturer in India, in all re~pects.

This Registration Certificate is subject to the c(nlditiottssf3,tedbverleaf and to such other conditions as may be

specified in the Act and the Rules, from time to lime.S'\~"O OIvrl/a

Q"'.;§>sI~O1'\,# ~§ " ~

., .•.••....... ,,"-_....•. ,="., .... ~,- .. ,.,.."'".•·'..·r.··." ... "<:'0500' . eoSE(')·~~···,

Place: New Delhi \, . I~" ••••••- &~

Date: ~1 2. .n 1N ?012 OI'Iy<~(TH.GOV~~••••'-~


Ministry 01Health & Famil, WelfareFDABHAWAN,KOrLAROAD,NEW OElHI-ll0 002 [INOIAJ


REGISTRATION CERTIFICATE NO. MD-1003 DATED 01.05.2012 VALID UPTO

30.04.2015.

LIST O,FPRODUCTS1. Pinnacle Hip System - M-Spec Heads & Acetabular Insert

2. ModularF:mO~~f~?ft~ - Ultamet

ITE~.~~~,f"L y

eallStamp ~.;s'l. w:j<; ~ fu6

1161 3frqf<:l ~ ("1ffil)~ ~m r:BIN~~IIc1l:l

~~~~I"T~

~.~.<;11<A,<T~&lT <R;, ~t\.w"'T~ RC"<~-11 0002,

Date: 1 2. JUN ZOll



Food and Drug Administration BhawanKotla Road, New Delhi-110002

::Ai:eNO: 31-~~Mb/2011-DC

\ Is B.L. Lifesciences Pvt. Ltd.,\. A-245 Okhla Industrial Area, Phase-I,

New Delhi-110020

1 2 JUN ZOlZ

SUB: - Registration of MIs Oscor Inc., having factory premises at 3816 DeSoto Boulevard,Palm Harbor, FL 34683 United States of America 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 14.06.11 received by this officevide dairy no. 29136 dated 16.06.2011 and reply received by this office vide diary no.10289 dated 12.03.2012 on the above noted 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 condi~~.

1. The medical device(s) shall conform~o e ~ ...~rds I specifications mentioned inthe Second Schedule of the Drugs metics Act! ISO I MDD I or such otherstandards or specifications appo~ Bythis: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.



5. Each consignment of the medical device(s) to be imported by you shall beaccompanied by a test I 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 issueof Form 10 Licence under the Rules.


8. This registration certificate is being issued under the condition that you arerequired to submit these documents at the time of submission of applicationfor grant of Form 10 License. ~.

• Revised Labels of proposed products ha!ttg import licence no. andthe address of the importer etc as per R~ 96 of Drugs and CosmeticRules 1945. CJ .

f-y/Please note that Registration Certificate ~d ~ liable to be suspended /

cancelled, if any of the condition stipulated abov~ not complied with, apart from anyother condition that may be taken under the pr~ons of the Drugs & Cosmetics Act,1940 and the Rules thereunder.

(Dr.$:;:SinghlDrugs Controller General (India)


Ministry of Health & Familv WelfareFDABHAWAN, KOYLAROAD,NEW DElHI-ll0 002l1NDIAJ


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

Date:_1 Z_JU_N 201Z1. MIs Oscor Inc., having factory premises at 3816 Desoto Boulevard, Palm Harbor, FL 34683 United States

of America has been registered under rule 27-A as a manufacturer and is hereby issued this RegistrationCertificate.

/( \X~Dp..RD COIV~2. Name(s) of devices(s), which maY~e:iMported under this R~Gt!ation Certificate:

.'"'' 0Please refer to the enclosed IistR'Y ~,......,o v~y ~

3. This Registration Certifica~hall be in forc,~2015~S it is sooner suspended or

cancelled under the rules. f5 '0u z

4. This Registration Certificate is @ go-€~<8€Os allthorised agent India

MIs B.L. Lifesciences Pvt. Ltd., having w A-2450khla Industrial Area, Phase-I,

New Delhi-ll0020and havi,*,;nanufacturin Site-IV Kas~ Sura' ur Greater noida

(U.Pl (For non-Sterile prOd~~()nIY) who .' . for the bUS~ activities of the manufacturerin India, in all respects. ..p)- flt"'i4QQ ~ ~O

OA'ft. ...~~~

This Registration Certificate is subject to t~1b~tt()6S~~~~rleaf aridtosllch other conditions as may be

specified in the Act and the Rules, from time to time. co~~~o""~ "r~o,I'~ ~,

~ ';"~ ~e: ~

CDSC DSCO

" . J'\. --' ,/0.. #'"'E~L1lI. Ga<'tWl'

L1CENS~HORITYSeal/Stamp

;g'1 w:j~"11'1.l res>rr:l3i~f) ~ (~Tffij)"f'Tf{-2l1 ;R'T{ ''';lf~

~iX:.o:r ~ t:rf:-:::rf\ ;(::r,~~~iVll--j-;lld<Oltr-i}.~t1..;_-~d;l _~:1~Jl~:1 ;/:-,~. Jrr~.€r.:2':{I..

\::";lJ2

New Delhi

Date: . 1 2. JUNZ01Z

GOVERNMENT OF INDIAcentral Drugs Standard Control Organisation

Ministry of Health & Familv WelfareDA BHAWAN, KOILA ROAD,NEW DELHI-110 00211NDlAJ

New Delhi

Date ~12. JUN l01l.

List of Products

1. OcclusionBW\~p~ter.• VeJ1~~'e'lusion'W&cf~catheter

2.TM~0'?(emporary MYOCardi~~Heartwires Unipolar,

3. ~da~::e~ua,9ri '" CO ".~1:::i\ Adelan ntroduce~et. (Non- Sterile)<:. Adelant Long Intr~ucer Set (Non -tJ Sterile) Z

t~~~ et1SW~:;~~~~~~terile)-.;'. Adelant eliverySh~th (Non-Sterile~ s

4. ~..F9ios- A theter (tt.@- Sterile)~~ fl(''24¥h:w ~ &-"-

l1WY1S(FOUR) ONL v..x,~ItEALTH, GOVt.~~~



'Food and Drug Administration Bhawan,Kotla Road, New Delhi-110002

1 2 JUN ZOlZTo, L

~/s 3M India Limited,No. 60/16, Hoskur Road, Electronic City,Bangalore-560100, India

SUB:- Amendment in Registration CertifICate No. MD-873 issued on 14.03.2012valid from 16.02.2012up to 15.02.2015-reg.

Please refer to your letter no. NIL dated 30.03.2012 received by this office vide diary no.13201 (FTS 21511) dated 30.03.2012 on the subject matter. ~~,

O·This is with reference to the Registration Certiftc"~, MD-873 dated 14.03.2012 valid

from 16.02.2012 up to 15.02.2015 issued by this4~~e validity period of RC No. MD-873indicated on page NO.5 is hereby amended as ~:":'

In place of:"01.03.2012 Valid upto 28.02.2015".

Read as:"16.02.2012Valid upto 15.02.2015".

(Dr~ingh)Drugs Controller G~~r:1 ~India)

Central Drugs Standard ~ontrol OrganisationDirectorate General of Health Services



File No: 31-857-MD/2010-DC (End. 01)

To /\,MIs Boston Scientific International B.V.

100A, The Capital Court, Olof Plame Marg,Munirka, New Delhi-110067

Dated 1 2 J UN ZOlZ

SUBJECT: - Endorsement No. 01 to R.C. No. MD- 857 of manufacturing site MIs.Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760 -1537, USA having factory premise at MIs. Boston Scientific Corporation TwoScimed Place Maple Grove, MN 55311-1566 USA under the provisions of Drugs &Cosmetics Rules for the purpose of import of medi~evices in India.

cf;)·'Sir, ~c-~

Please refer to your applica~~'irnC/F40/11/11 dated 07/09/2011 received bythis office vide diary no 47427 dadd'0/10/2011 and reply received by this office vidediary no. 13381 dated 02/04/2012 on the subject cited above.

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

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




5. Each consignment of the medical devioe(s) to be imported by you shall beaccompanied 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 issueof Form 10 Licence under the Rules.

7. This Registration Certificate is being issued under the conDition that during thependency of Registration, the applicant may be required to deposit inspection feeas stipulated under Clause (5) of Rule 24-A and enable inspection ofmanufacturing site by the officials Authorized for this purpose. Non-complianceto this condition as and when so directed would result in cancellation ofRegistration Certification.

8. This Registration Certificate is being issued under the condition that you arerequired to submit the following documents at the time of submission ofapplication for grant of Form 10.

a. The original labels printed in indelible ink indicating the name andaddress of the importer, import licence no., date of manufacturing, nameand address of the legal as well as actual manufacturers etc. as per Rule96 of Drugs and Cosmetics Rules 1945 (as the same has been submittedby you doesn't reflect the name & address of the actual manufacturer).

b. The original IFU's indicating name & address of the legal as well asactual manufacturer (as the same submitted by you photo copies of thesame and doesn't reflect the name & address of the actual manufacturer).

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 conditionthat may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and theRules thereunder.

(Dr. ~ingh)Drugs Controller Gen1r~i (~ndia)


Ministry of Health & Familv WelfareFDA8HAWAN. KOlLA ROAD.NEW DElHI-110 002 [INDlAJ


ENDORSEMENT NO. 01 DATED 1 2 JUN 201Z TO REGISTRATION

CERTIFICATE NO. MD-857 DATED 18-08-2011 VALID UPTO 31-07-2014.

SS\:'00-

~NDOR""-.Ill.NC Quantu~pex M --2.NC Quantu.@ Apex Ove3. Quantum ~verick Mon4. Quantum Ma~r~~9;v,5. Coyote Monor'ail,.p-rk '6. Coyote Ove~he Wire:.....-

~ ITE0"~

1}-

Date: f1 2. JU N Z01Z


Ministry of Health & Family Welfare(Medical Device & Diagnostics Division)

Food and Drug Administration Bhawan,Kotla Road, New Delhi-11 0002

Dated .1 2 JUN 201lTo L

~/s Advanced Life Sciences Pvt. ltd.,0-22, Okhla Industrial Area, Phase-1New Oelhi-110020

SUB:-Amendment in Registration CertifICate No. MO-1001dated 08.12.2011 validupto 15.11.2014 & Form-10 Lic No. MO-1001-1514dated 14.03.2012 validupto to 15.11.2014-reg.

,~

Please refer to your letter no. NIL dated 17.04.293~ceived by this office vidediary no. 15854 (FTS 25812) dated 17.04.2012 on ~Ubfect matter.'"~~ .This is with reference to the Re~?ation Certificate No. MD-1001 dated08.12.2011 valid up to 15.11.2014 and Form-10 Lic. No. MD-1001-1514 dated14.03.2012 valid upto 15.11.2014 issued by this office. The name of the Manufacturer ishereby amended as follows:-

In place of:"MIs Qualimed GmbH".

Read as:"MIs Qualimed Innovative Medizinprodukte GmbH".

Yours faithfully,

(Dr.O\ Singh)

Drugs Controller Getr:1 (India)



Food and Drug Administration BhawanKotla Road, New Delhi-110002

~12 JUN lOlZTo,_ /

\;HfJs Covidien Healthcare India Pvt. Ltd.,"Doshi Tower" 6th Floor, # 156, Poonamallee High Road,Kilpauk, Chennai- 600 010

SUB: -Endorsement No. 2 to R.C. No. MD- 948 to Manufacturing Site of MIsCovidien IIc, 15 Hamsphire Street, Mansfield, MA 02048 USA havingfactory premises at MIs Covidien Zone Franca de San Isidro Santo Domingo,Dominican Republic under the provisions of Drugs & Cosmetics Rules forthe purpose of import of medical devices in India.

S~ ~~.",~..

. Please refer to your application no. CHIL/I~d -01 (MD-948)/20 11 dated04.11.2011 received by this office vide diary I1p~3 6.dated 04.11.2011 on the abovenoted subject. G~~ /'0' /'

Registration Certificate in Form 41 under the Drugs and Cosmetics Rules isissued herewith for the manufacturing site alongwith the name(s) of medical device(s)imported under the said Certificate suhject to 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.


5. Each consignment of the medi<:aldevice(s) to be imported by you shall beaccompanied by a test / analysis reports.


7. This Registration Certificate is being issued under the condition that during thependency of Registration, the applkant may be required to deposit inspection feeas stipulated under Clause (5) of Rule 24-A and enable inspection ofmanufacturing site by the officials Authorized for this purpose. Non-complianceto this condition as and when so directed would result in cancellation ofRegistration Certification.

8. This registration Certificate is being issued under the condition that you arerequired to submit the following documents at the time of submission ofapplication for grant of Form 10Licence:

a. Duly Notarized detailed stability study report, device designvalidation report (as you have submitted the same in summary).

b. A revised label indicates the name and address of the legal as well asactual manufacturer, import licence number, name and address of theImporter as per the Rule 96 of Drugs &Cosmetics Rules 1945 inrespect the proposed product (as the same has~ submitted by you,indicates the name and address of the legal ~facturer only).

Please note that Registration Certificate issued~ Cfiable to be suspended /cancelled, if any of the condition stipulated above is ~om'plied with, apart from anyother condition that may be taken under the provis~ of die Drugs & Cosmetics Act,1940 and the Rules thereunder. 0

(Dr. G~ingh)Drugs Controller General (India)


Ministry of Health & Familv WelfareFDA8HAWAN, KOTlA ROAD,NEW DELHI-110 002 lINDIAJ


ENDORSEMENT - 2, DATED 1 2 JUN 20tl TO REGISTRATION

CERTIFICATE NO. MD- 948 DATED 05.05.2011 VALID UPTO 14.04.2014.

LICENSlt:uTHORlTY

SeaVStamp;g'j w-i~'1T'Il ~

"W 3i1tl~ ~ ('lffiCl)~ <'fen Tffi1~

~ ~ Lfftm q;c;mur ~l:(tP:t'l.1{.~.qi'rCi:'llxts. 3lTttr.:>Tr ..

.,J fi:C'V1T-110002

Date: 1 2 Ii' 1\1 ?n12




-1 2 JUN lOlZ

TO~• s. Vascular Concepts Ltd.,7C, Doddaballapur Industrial Estate,Doddaballapur, Bangalore-561203.

SUB: -Endorsement to R.C. No. MD-03 of manufacturing site MIs Eucatech AG,having factory premises at Gottlieb-Daimler-STR-2, D-79618. Rheinfelden,Germany under the provisions of Drugs & Cosmetics Rules for the purposeof import of medical devices in India.

>1,('\ '

Please refer to your application no. nil dated 15/03/~6l~)\~~ceived by this officevide dairy no.11174 dated 16/03/2012 on the subject ~~~\~ov~.

~~\}Registration Certificate in Form 41 ~? the Drugs and Cosmetics Rules is

herewith for the manufacturing site alongwith the name( s) of medical device( s) importedunder 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 1MDD 1or such otherstandards or specifications approved by this Directorate.




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



8. This registration Certificate is being issued under the condition that you arerequired to submit duly notarized and valid copy o( Free Sales Certificatefrom National Drug Regulatory Authority of the c~ry of origin or any ofthe following c~uD;triesi.e. I!SA, EU, Japan, Can~'Or Australia, in respectof "Pronova-Slrobmus Eluting stent system-staWCss steel" & "Pronova-XRSirolimus Eluting stent system" (as the s~ has not been submitted inrespect of these products by you) at the ~f submission of application forgrant of Form 10 license. . <t.,'O~

Please note that Registration Certificate issued is liable to be suspended Icancelled, if any of the condition stipulated above is not complied with, apartfrom any other condition that may be taken under the provisions of the Drugs &Cosmetics Act, 1940 and the Rules thereunder.

(Dr.~ingh)Drugs Controller General (India)

GOVERNMENT OF INDIACentral Druls Standard Control Organisation

Ministrv of Health & Familv WelfareFDABHAWAN,KInA RIU, NEWDElHI-ll1 102l1NDIAI


ENDORSEMENT NO.1 DATED .1 2 JUN lOlZ TO REGISTRATION

CERTIFICATE NO. MD-03DATED14.03.2012VALIDUPTO 28.02.2015.

.n{~I!

Nameof the~ibt~:..,,~ ..•.. -

, ON1.Prolink-LP-n~t~ Stent systel&~o~-Sterile)2. Prol!nk - ~~nary Stent ~n- Sterile~~ .3. Prohnk-~: Corona n-Sterd~z4. Prolin~V - Cor (Non-~ile)5. Spee~TCA Catti de) ~6. PropaJs- Platinum t (Non-Steri@7. Propa8s- Platinum nt system(Now;.Sterile)8. Pronov~"lP\mrt\1 . less steel (Non-Sterile)9. Pronova~slr\rlhtlJ on-Sterile)10.Proz~ -Cobalt C (Non-Ster~)II.Prozeft,;PS- Coba ent (Non:§l'Crile)12.Resista~elf Expa 01Stent ~n-Sterile)

(lTENts TWEI.; N ~ 0" .O~ . f<..~

ftE/4L THtGO\lt~\'\~

Date: "1 2 JU N l01Z



Food and Drug Administration BhawanKotla Road, New Delhi-I 10002

Dated 1 r;. I i\ ~\I lOlZL J U!;J

To /~s Elder Pharmaceuticals Limited,

"Elder House" C-9, Dalia Industrial Estate,Off Veera Desai Road, Taluka-Andheri,Andheri (W) Mumbai-400 058 India

SUB.:Registration of manufacturing site of MIs PFM Medical Titanium GmbH,having manufacturing premises at Hoefener Strasse 45, D-90431, Nuremberg,Germany under the provisions of Drugs & Cosmetics Rules for the purpose ofimport of medical devices in India.

Please refer to your letter no. No. SK/RP/250/2011 date~r07/03/2011 received bythis office vide Diary 11711 dated 11/0312011 and reply r~~ by this office vide diaryno. 55665 dated 02/12/2012 and diary no. 18088 9flt~~f05/2012 regarding the citedsubject above. . ' .\ C~'Registration Certificate in Form 41 underQ't~rugs and Cosmetics Rules is herewith forthe manufacturing site alongwith the name(s) of medical device(s) imported under thesaid Certificate subject to the following conditions.

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




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



8. This registration certificate is being issued under the condition that you arerequired to submit duly notarizedl attested by gazetted office and valid copyof wholesale licence in Form 20B and Form 21B or its renewal in Form 21Cissued by concerned State Licensing Authority (as the same submitted by youis not notarized) and also duly notarized and va~ copy of ISO 13485Certificate (as the same submitted by you has tlteildy been expired on04/03/2012) at the time of submission of applicati~r grant of Form 10.

Please note that Registration Certificate issued is l.~·ab, be suspended 1 cancelled, ifany of the condition stipulated above is not co . d with, apart from any othercondition that may be taken under the provisions~ e /Drugs & Cosmetics Act, 1940and the Rules thereunder. 0

(Dr.Drugs Controller G


Ministry of Health & Familv WelfareFDA8HAWAN, KOllA ROAD,NEW DELHI-110 002 UNDIAl


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

1 2 JUN 20121. M/s PFM Medical Titanium GmbH, having manufacturing premises at Hoefener Strasse 45, D-90431,

Nuremberg, Germany has been registered under rule 27-A as a manufacturer and is hereby issued this

Registration Certificate. ," ", (O!V7/~J{)

2. Name(s) of devices(s), which m~1imported under this Registr~ti~Ir(}xrtificate:~ c" ~.~

Please refer to the enclosed ,Hit:' ',""\':JG';;,1' ~ , : (,,',,'\ \\/ ,.,~" *#1

"''',i :)" :/ " "f:;3. This Registration Certifi~t~'shall be in 0 15-05-2015~less it is sooner suspended

",-,."".,or cancelled under the rul~s. .-w 0G ZThis Registration Certifica{€:i f t@£aJ@@"er or his authorised agent in

India MIs Elder Pharmaceuticals Limi ' C-9 Dalia Industrial Estate Off Veera~""'I'''

Desai Road Taluka - A11tlheri Andhe 058 India ~i> will be responsible for the~. *_~:r,L-

business activities of the nlah)facturer in I ~,'-'~'O·

This Registration Certificate i?;~~ct to the conditions stated ~v~!leaf and to such other conditions as

may be specified in the Act and th; R<lt~4foPlJim,e,a,0,tj~~ ~\(",R..- 11 ~ Gp -\I t:~f-\

~ ~t-';; "\

LICENklITHORITYSeal/Stamp;gj "lr.'i~'11'1:1 f*T6

"'® 3Wl!?l f.j<T'Of'" ('l1ffij)~'l WIT Tffi1i7ri;:~

m~ 'i'i c~ ""...err"!,q-.;rfCTl:!~,£l,~,'l1'T'l. q~CC11,'Fs, 3JT:ii1Z-i'r"

'1J \~:«r..:.iJ-110002

Date: '1 2 JUN 201l


Ministry of Health & Familv WelfareFDABHAWAN, KOrlA ROAD,NEW DELHI-110 002 lINDIAJ


REGISTRATION CERTIFICATE NO. MD-323 DATED 16-05-2012

VALID UP TO 15-05-2015.

LICEN~ORITY

Se~V.S~~~1rl\iC'1fus~l ~.frqfil f.'"i,*n ('{I'm)~ i':cn'iFlf;Ii;mcn:l

. ~ J:;ii ~ ",e:mur T0rRT!l1:['l':~1t~.'l1<A,'!i1Cc<n ,];g, 3~.ti.:;h,

~ fci~-11ooo2

Date: l1 2 J UN lOlZ




Dated !1 2. JUN 2m2

T~t. Jude Medical India Pvt. Ltd.,D.No.8-3-168/B/l, Plot No.18 &19,Laxmi Nagar, Behind T.B Hospital,MCH CIRCLE-5 Mandai, Hyderabad Dist.

SUB: - Registration of Mis. St. Jude Medical Atrial Fibrillation Inc., having factorypremises at 14901 DeVeau Place, Minnetonka, MN 55345-2126, USA underthe provisions of Drugs & Cosmetics Rules for the purpose of import ofmedical devices in India.

'~

Please refer to your application No. Nil dated 28/09/~~<received by this officevide dairy no.46000 dated 30109/2011 and reply recei'leQ ~lhis office vide diary no.10891 dated 15/03/2012 on the above noted suject.. ~\(j~

Registration Certificate in Form 41 u~~ 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.

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




S. Each consignment of the medical devi<:e(s) to be imported by you shall beaccompanied by a test / analysis reports.


7. This Registration Certificate is being issued under the condition that during thependency of Registration, the applicant may be required to deposit inspection feeas stipulated under Clause (5) of Rule 24-A and enable inspection ofmanufacturing site by the officials Authorized for this purpose. Non-complianceto this condition as and when so directed would resu~ in cancellation ofRegistration Certification. ~t

~.

?~/

'~9Please note that Registration Certificate issued .i~iable to be suspended /

cancelled, if any of the condition stipulated above is not,~plied with, apart from anyother condition that may be taken under the provisions~ the Drugs & Cosmetics Act,1940 and the Rules thereunder. ~

Please acknowledge the receipt.

(Dr. . N Singh)Drugs Controller Ge eral (India)


Ministrv of Health & Familv WelfareFDA8HAWAN,KOllA ROAD,NEWDElHI-ll0 002 UNDIAl


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

Date!1 2 j UN- 201Z1. MIs. St. Jude Medical Atrial Fibrillation Inc., having factory premises at 14901 DeVeau Place,

Minnetonka, MN 55345-2126, USA has ~~~\\~fP!ftce:.~(t'V~1v;r:~le27-A as a manufacturer and is herebyissued this Registration Certificate." frO/

f< i,y''',

i);'~,.,~,

eg!strati~~rtificate:~, t;:;:v'~~o

o 30,.06-2015 unl~ it is sooner suspended or

',,:~h,.

Name(s) of devices(s), whi~~=hIaybe imR~\\;"';iT"'" ,',~,,¥<'

Please refer to the enclosed;&ist

;:::llJ

This Registration Certificatt'l shall be in force,;',J' '.

cancelled under the rules.

4. This Registration Certificat;~issued throug ufacturer or{h~~authorised agent India Mis.·,~t· ,',-

St. Jude Medical India Pvt. eia~D.No.8-3-1 &19 Laxmi~a ar Behind T.B Hos ital

MCH CIRCLE-5 MandaI, HyUtbad Dist wifb.~I!Sbe~StJ~nsible fo~~1)usiness activities of the

manufacturer in India, in all respects.O,.ti;ll~'''~ ."to>, '\'~ ,,~~:~ '

'" oVcr,\5. This Registration Certificate is subject to the conditions stCl-tedoverleaf and to such other conditions as may be

::':.pr..l'\O"RO co",.,.//,specified in the Act and the Rules, from ti~'to' O{o~'"

ff \~ -0u z


Ministry of Health & Famil, WelfareFDAIHAWAN, KOTlAROAD,NEWDElHI-ll0 002l1NDIAJ


REGISTRATION CERTIFICATE NO. MD-22 DATED 01-07-2012 VALID UPTO

30-06-2015.

3.4.5.6.7.8.9.10.11.

S.No.1.

Date: '-1 2. y, N 201t

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