Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-110002

Dated' ~ i", f'''l?. 2. 4 tJ? c.n,To _/

\...--M/s Synthes Medical Pvt. Ltd.,118-P Sector-44,Gurgaon-122002, Haryana

SUBJECT: - Endorsement No. 02 to RC. No. MD- 188 of manufacturing site MisSynthes GmbH having factory premise at Eimattstrasse 3, 4436 Oberdorf,Switzerland under the provisions of Drugs & Cosmetics Rules for thepurpose of import of medical devices in India.

Sir, ©'\Please refer to your application no Nil date~"teceived by this office vide diary

no 27/07/2011 and reply received by this offic~t\iidiary no. 5898 dated 10/02/2012 onthe subject cited above. 1(\VRegistration Certificate in Form 41 u~ 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 / 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 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 The medical device will be required to be withdrawn from sale from the market incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage.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 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 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 b~ required to deposit inspection feeas stipulated under Clause (5) of RUI~~-A and enable inspection ofmanufacturing site by the officials Authori~for this purpose. Non-complianceto this condition as and when so di~ed would result in cancellation ofRegistration Certification. (Jt

8. This registration certificate is ~~ issued under the condition that you arerequired to submit the produ~~ls indicating the name and address of theimporter, import licence no., date of manufacturing and name and address ofthe manufacturer etc. as per Rules 96 of Drugs and Cosmetics Rule at thetime of submission of application for grant of Form 10.

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. G. N Singh)Drugs Controller General ndia)

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministry of Health & Familv WelfareFDABHAWAN,KolLA ROAD,NEWDElHI-llo 002 [INDlAJ

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

ENDORSEMENT NO. 02 DATED 2 -4 ;:j"R 2D1Z TO REGISTRATION

CERTIFICATE NO. MD-188 DATED 07-10-2009VALID UPTO 30-11-2012.

i~~ENDO.~~.." Name 0

RapidSorl1 ~esor~~ti(1) I!fa~b~~..f~2

New Delhi

Date: 2-;Sea Stamp

Dr G. t\J. SINGHDrugs C(nt'i)li;r General (India)Ote. G8lv:3alth Services

Ministry of i Family WelfareFD}'. Eli:' !3 Road, I.T.O.

1:0002

Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

2 ~ r' .'".t:.r l~f"{\ 201lTo. /

~s Johnson & Johnson Ltd.,AlI50, Room No.2, 100 Shed Area,G.I.D.C., Vapi, Tal. Pardi (Valsad) Gujarat

SUB.:Registration of manufacturing site of Mis DePuy (Ireland), Loughbeg,Ringaskiddy, Co. Cork, Ireland is having manufacturing premises at MisJohnson & Johnson Medical (Suzhou) Ltd., 29~ Chang Yang Street, SuzhouIndustrial Park, Suzhou, China under th~$p\iljsions of Drugs & CosmeticsRules for the purpose of import of med.i~Mvices in India.

~~~-9 \f' \'V¥Sir, "o;\,;,,\r

1'\ \\~'.;.d

Please refer to your letter no. No. JNJ/RA/2011/August!RC-02 dated 03/0812011received by this office vide Diary 36410 dated 03/08/2011 and reply received by thisoffice vide diary no. 9005 dated 02/03/2012 regarding the cited subject 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.

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 adversereports on the medical device, ifany.

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 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 original product labels printed in indelible inkindicating the name and address of the importer, import licence no., date ofmanufacturing, name and address of the manufacturer etc. as per Rule 96 ofDrugs and Cosmetics Rules 1945 at the time of submission of app-Iication forgrant of Form 10 (as the same submitted by you is photo cu1{s of labels,Further it reveals that the sticker has been affixed 'for im~Q'tic. no., name& address of importer, moreover the addrej:\~mporter cannot be

'correlated with the wholesale address). 01(~'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 othercondition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940and the Rules thereunder.

(Dr. G. N. Singh)Drugs Controller Gene al (India)

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministrv of Health & Farnilv WelfareFDABHAWAN,KOlLA ROAD,NEW DElHI-110 002 lINDIAl

Form 41(See rule 27-A)

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

Registration Certificate No.: MD-999 Date: 2. 4- PH 201Z

1. MIs DePuy areland), Loughbeg, Ringaskiddy, Co. Cork, Ireland having manufacturing premises at

Mis Johnson & Johnson Medical (Suzhou) Ltd., No. 299, ChangYang Street, Suzhou Industrial Park,

Suzhou 215126, China has been register~d"u~g,et)r4hr~~7,-AliS a manufacturer and is hereby issued this

Registration Certificate. ~;!=\,I::'~~,~,/f,)\\

2. Name(s) of devices(s), whichll1ay be importeq un~enQ~~~tration Certificate:

Please refer to the enclosed list. .,'S~)~~,,<:~~~\)( ,

,y

3. This Registration Certificate shall be in force!fto,!iJ.,ol-IT42~O!2to 31-03-2015 unless it is sooner suspended

or cancelled under the rules.

This Registration Certificate,ts,i§stiedthroug~J~2.~fficr;;!o~the(ma:Iiufacturer or his authorised agent inIndia Mis Johnson & Johnson Ltd. Alrl~O~,·',ifJd'iif~~~100 Shed Area·G.I.D.C. Va i Tal. Pardi

'~

(Valsad) Gujarat, India':wj).? will be res mess activiti(;l~bfthe manufacturer in India,

in all respects.">:.,,,

This Registration Certificate is ~ubjeFtto the conditions state~"~,,erIeaf and to such other conditions as

may be specified in the Act and the R~les,!rrQ~,ti~~stQ\titn<?:,

Date: 2 201l LICENSI,,\~ORITY~al/Stamp

Dr. G, N, SINGH!Jeugs Controller General (India)')18 General vf Health Services

,t'J of Health 8, Family VVelfare. )\ HI13w,:n, ;'(0'[3 Roe"j, 1.1.0,

I '

Central Drugs Standard Control OrganisationMinistrv 01Health & Familv WellareFDABHAWAN.KOILAROAD.NEWDElHI-ll0 002 [INDlAJ

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

REGISTRATION CERTIFICATE NO. MD-999 DATED ·01-04-2012

VALID UP TO 31-03-2015.

~LICENSING tUTHORITY

Sea Stamp-r. G. N. SINGH

Drugs Controller General (India)D~e. General vf Health Services

Ministry of Health & Family WelfareFDA BhawaQ, Kolla Road, I.T.O.

New Oelhi-11 0002

Date: 2. ,:\, \ i~.mZ

®0)Central Drugs Standard Control Organisation

Directorate General of Health ServicesMinistry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-11 0002

To, ~\,/;~~~~hnson & Johnson Ltd.,

30 Forjett Street Mumbai-400036,India.

SUB: - Registration of MIs DePuy (Ireland), Loughbeg, Ringaskiddy, , Co. Cork, Irelandhaving factory premises at MIs CeramTec GmbH, Medical Products Division,CeramTec-Platz 1-9, 73207 Plochingen, Germany under the provisions of Drugs& Cosmetics Rules for the purpose of import of medical devices in India.

Please refer to your application no. JNJ/RA/2011/Nov/RC-02 dated 04.11.2011received by this office vide dairy no.51104 dated 04.11.11 on the above noted suject.

1"'\""Registration Certificate in Form 41 under the Drugs awM.~metics Rules is herewith

for the manufacturing site alongwith the name(s) ofmed~Mce(s) imported under the saidCertificate subject to the following conditions. /?' ~~~

O~1. The medical device(s) shall conform to the standards / specifications mentioned in the

Second Schedule of the Drugs and Cosmetics Act! ISO / MDD / or such otherstandards or specifications approved by this Directorate.

2. Dispute, if any, in respect of the payment of fees and submission of TR6 challan, shallbe settled between the bank and the applicant.

3. The medical device will be required to be withdrawn from sale from the market in caseany undesirable reactions due to failure of the device or its accessories are brought tolight at any stage. This Directorate should be informed of adverse reports on themedical device, if any.

4. This registration in no way relieves you of the responsibility of complying with otherprovisions of the Drugs & Cosmetics Act and Rules thereunder, and any otherprovisions 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 inthe enclosed Registration Certificate shall be considered for the issue of Form 10Licence 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 fee asstipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing siteby the officials Authorized for this purpose. Non-compliance to this condition as andwhen so directed would result in cancellation of Registration Certification.

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

• Revised Labels of proposed products having import licence no. and theaddress of the importer etc as per Rule 96 of Drugs and Cosmetic Rules1945. ~~~\

• Duly notarized copy of Full Quality A~~c~ indicating both legal andactual manufacturer address (as the ~IMsubmitted by you reflecting onlylegal manufacturer address). ~(;~

O~~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 thatmay be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rulesthereunder.

(Dr. ~~ingh)Drugs Controller Gen~~ (;ndia)

GOVERNMENT OF INDIACentral Brugs Standard Control Organisation

Minist" of Health & Familv WelfareFDABHAWAH, KOILAROAD, NEW DELHI-ll0 002 lINDIAJ

Form 41(See rule 27-A)

Regi~·tration Certificate issued/or import 0/ devices into IndiaUnder Drugs and Cosmetics Rules, 1945

1. Mis DePuy (Ireland), Loughbeg, Ringaskiddy, , Co. Cork, Ireland having factory premises at Mis

CeramTec GmbH Medical Products Di . . r -Platz 1-9 73207 Plochin en German

has been registered under rule 27-A ~ ufacturer and is hereby ~ed this Registration Certificate.is . ~ 01>Q2. Name(s) of devices(s), wh~may be im egistration~·tificate:

:'r', ~Please refer to the enclos~st 1<~ ~ ~

~ () 03. This Registration Certific~ shall be in force fr to 15-03-2015 unl€~ it is sooner suspended or

cancelled under the rules.

LICENSING ~TY

Seal/StampDr. G. N. SINGH

D~'j(Js Controller General (India)["'Ic General vf Health Services

of Health & Fsmily Welfare!(Jtla RUNI, I.TO.

GOVERNMENT OF INDIAOentral DrugS Standard Control Organisation

Mlnislrv of Health & Familv WelfareFDA8HAWAN, KolLA ROAD,NEW DELHI-llo ooZ IINDIAI

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

REGISTRATION CERTIFICATE NO. MD-I044 DATED 16.03.2012 VALID UPTO

15.03.2015.

Seal StampCr G. N. SINGH

DrUGS controller General (India)c.:- .' vf Health Services

M'n",\!v ()[ipalth & Family Welfarer u/\ . Kotla Road. 1.1.0.

0002

New Delhi

Date: 2. i\;' ~JJ1Z

Central Drugs Standard Control OrganizationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

Date:

To. ~\,/MIs. Johnson & Johnson Ltd.,

A-l/50, Room No.2,100 Shed Area, G.I.D.C., Vapi,Tal: Pardi (Valsad),Gujarat.

SUB: - Registration of MIs. DePuy France SAS, 7 Allee Irene Joliot Curie, BP 256,69801, Saint Priest Cedex, France having factory premises at MIs. DePuy(Ireland) Loughbeg, Ringaskiddy, Co. Cork, Ireland under the provisions ofDrugs & Cosmetics Rules for the purpose of import of medical devices inIndia.

Sir, ..,,,,~~Please refer to your application_ Jt.'jNJ/RA/2011/Dec/RC-03 dated

23/12/2011 received by this office vide dail- ~~9316 dated 27/12/201 1regarding theabove subject. 4J'(,::'~~f:.J

t\~~\\Registration Certificate in ~orm 41 under 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 I specifications mentioned inthe 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 adversereports on the medical device, if any.

4. This registration in no way relieves you of the responsibility of complying with /other provisions of the Drugs & Cosmetics Act and Rules thereunder, and 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 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.

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 arerequin~d to submit following documents at the time of submission ofapplication for grant of Form 10 License:• Produd specifications and Batch Release Report or Certificate of

Analysis for the proposed product (as the sam~s not been submitted bythe firm).",>C~

• Clarification from the manufactur~_~garding Shelf life for theproposed product (as the Schedl!JA..<&m mentions the shelf life as 1825days, whereas shelf report on~~aging design concept depicts the shelf

. life to he 10 years).02 Q'"• Revised Labels in original for the proposed product with import lie. no.

and name and address of the importer as per Rule 96 of the Drugs andCosmetics Rules (as you have submitted photocopy of the labels with astickel' mentioning import lie. no., name and address of the importer andfu rthel" address of the importer mentioned does not correlate withaddress mentioned in Drug Sale License).

Please note that Registration Certificate issued is liable to be suspended /cancelled, if any of the condition stipulated above is not complied with, apart from anyother condition that may be taken under the provisions of the Drugs & Cosmetics Act,1940 and the J\ u 1es thereunder.

(Dr. G.~ngh)Drugs Controller Gene~~ (~~dia)

GOVERNMENTOFINDIACentral Drugs Standard Control Organisation

Ministrv of Health & Familv WelfareFDASHAWAN,KOlLA ROAD,NEWDElHI-ll0 002 (lNDlAJ

Form 41(See rule 27-A)

Registration Cert(ficate issuedfor import of devices into IndiaUnder Drugs and Cosmetics Rules, 1945

2 I!4.'Date: t

1. Mis. DePuy France SAS,. 7 Allee Irene Joliot Curie, BP 256, 69801, Saint Priest Cedex, France

having factory prem ises at Mis. DePuy (Irelalldt)f'LOoghbeg, Ringaskiddy, Co. Cork, Ireland has,been registered under rule 27-A as a manUfacturer and is hereb;issJed·ithis Registration Certificate.

2. Name(s) of devices(s), whicb'J1~ay be imp~tted' .

Please refer to the encIosedtlist

~il:\)J " ..\egistration Ce,ttificate:

:>':(, ,:>

3. This Registration Certificateishall be in force

cancelled under the rules.

4. This Registration Certificate

M/s. Johnson & Johnson Ltd/A-1/50.f .i'~'"T"i;!~

Gujarat who will be responsible f6rtb~ businessacH~ifies

anufacturer 9r;his authorised agent in India,"~"'~i>,}

manufactb~er in India, in all respects.

't,,-';:'$;<"':"';"

5. This Registration Certificate is subject to the6J~Md9n·s.,~t~t~~:~~~~I~afand to such other conditions as may be

specified in the Act and the Rules, from time to 1Jm'to<,,,\,,,,,, NrRo

~.;:J~s , (:'0-9<;-

~QJ:-. '1't,~ ~$ 6u z

LICENSING ~ORITY

Seal/StampDr. G. N. SINGH

Druos C~\ntroller General (India)Dt'1 (ocnerGI uf Health Services,

Lk :.:'"/ of Health & Family Welfarefl, Kolla Road, I.T.O .

. \cll1i-11 0002

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministrv of Health & Familv WelfareFDABHAWAN,KOlLA ROAD,NEW DELHI-ll0 002l1NDlAJ

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

REGISTRATION CERTIFICATE NO. MD-I068 DATED 01-04-2012 VALID UPTO

31-03-2015.

CORAIL AMT Cementless Femoral StemsITEM (S) ONE ONLY

L1CENS ~UTHORJTYrGA Seal/Stamp

Dr. G. N. SINGHDrugs Controller General (Ind'la)['t8. Generaluf Health S[;[v:ces

of Health & Farpi!y V'!eif2r~KOl\8 r-{c~·:.':!, T.O.

0C",.\2

Date: tl, '.

Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-110002

To, _/\-.MIs Hitech Equipment N System,

53, Shahkar Society, 25 S.ector,Gandhinagar, Gujarat

SUB: -Registration of MIs Dedienne- Sante, Mas Des, Cavaliers- 217, RueNungesser.F-34130, Mauguio, France under the provisions of Drugs & CosmeticsRules for the purpose of import of medical devices in India.

Please refer to your application no. NIL dated 19.02.2009 and received by thisoffice vide diary no. 6486 dated 19.02.2009 and reply received vide dairy no. 30814dated 31.07.2009, 46680 dated 11.11.2009,"~~\dated 05.02.2010, 56635 dated03.12.2010, 43454 dated 19.09.2011 and~~ed 05.03.2012 on the above notedsubject. .' ~\~\V~O~~

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 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 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 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 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.

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.

(Dr. G.~ingh)Drugs Controller GeneIi tIndi3)

IIUUtOnllltn. ur .nUIH

Central Drugs Standard Control OrganisationMinlstrv 01Health & Familv WellareFDABHAWAN, KoYLA ROAD, NEW DElHI-110 oo2l1HDIAJ

Form 41(See rule 27-A)

Registratioll Certificate issuedfor import of devices illto IlldiaUllder Drugs alld Cosmetics Rules, 1945

1. Mis Dedienne- Sante. having Factory premises at Mas Des. Cavaliers- 217. Rue Nungesser.F-34130. Mauguio. France has been register~.~Jlltd~~l}l.1~27-Aas a manufacturer and is hereby issued thisRegistration Certificate. '> >. .•> ,

to 31-03-2015 uij1ess it is sooner suspended" ~

2. Name(s) of devices(s), which ~~;'15e

Please refer to the enclosed list......•. '\ tf.>\~~>.•.-?\(¢\\~

/~. \'-;...") \).U\)3. This Registration Certifi¢'l;l.teshall be in fore

5. This Registration Certificate i;·~9.bject to the~ijH<fftr'bnSl'lsiKfudoverle~r@a to such other conditions as may

be specified in the Act and the RUl~~(:f~9Jlltime to time.:>::'['

" Ii'- 'i' i.

Dr. G. N. SINGH ,Drugs Controller General (India)Ole. General of He~lth ~ervlcl';~

M· . t of Health & ,-am,ly \f\!e,ueInIS ry , I l' 0FDA Bilawan, Kolla 1'\080, " . .

New Oelhi-l10002

GOVERNMENT OFINDIACentral Drugs Standard Control Organisation

Ministry of Health & Familv WelfareFDABHAWAN, KOYLAROAD, NEW DELHI-110 002 UNDIAJ

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

REGISTRATION CERTIFICATE NO. MD- 628 DATED 01-04-2012 VALID UPTO

31-03-2015.

{,;~,i~sis:_TRlt,CC mobile bearing

·on Prosthes12 TRICCC~J9§t.b~sis:Shivat""~1:: i&,

LIC~G AUTHORITYSeal/Stamp

Dr G. N. SINGH .. troller General (IndIa)

Drugs Con \ ,'Health ServicesDte Genera ul . 'j\1 ""rr'. ,\th & !=arll\\Y ,(';,,"'-

"'nistry of Hea . , 'T C'Iv,l _, \'o"\a R02C1, I,', J,

FDA Bh8W<:',', '. I,,' r,')\".•",,;,<,11'1'-' ,(Jc.",,.

Date· 2' f. ·1

Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

To, ~~~~Intra ocular care Pvt. Ltd.,

26 Gandhi Oil Mill Compound,Near BIDC, Gorwa,Vadodara 390016

SUB: - Registration of Manufacturing site MIs Hanita lenses, Kibutz Hanita, Israel22885 and its Medical Devices under the provisions of Drugs & CosmeticsRules for the purpose of import of medical devices in India.

~l. ~lease refer to your application ~~l. aated ~7/04/20 1~ received. by t~is office

vIde daIry no.18529 dated 20/04/2.~.~lJA~~"rephes receIved by thISoffice vIde dIary no's.58743 dated 23/12/2011 and 8727 ~ 29/02/2012 on the subject cited above.

- /(~\\;Registration Certifi~ in Form 41 under 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 / 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 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 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 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 thec~ndition that during thependency of Registration, the applicant may be requir<::~~ deposit inspection feeas stipulated under Clause (5) of Rule 24-A. @,'}1l enable inspection ofmanufacturing site by the officials Authorized for tfi!$~purpose. Non-complianceto this condition as and when so directed~ld result in cancellation ofRegistration Certification. '!<~~

8. This registration Certificate is being iQed under the condition that you arerequired to submit duly notarized and valid Drugs Sales License in form ofForm 20B/21B as the same submitted by you was nearer to expiry, at thetime of submission of application for grant of Form 10 license.

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

Yours faithfully,

(Dr. ~Singh)Drugs Controller Ge~r~i !India)

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministry of Health & Familv WelfareFDAIHAWAN. KOILAROAD.NEW DELHI-110 002 llNDIAJ

Form 41(See rule 27-A)

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

Date: 2 4- L .'.\ lOlZMis. Hanita lenses, having factory premises at Kibutz Hanita, Israel 22885, has been registered under rule

27-A as a manufacturer and is hereby issued tN~R;~~~~~tion\<;~rtificate.

(.-~~ft,.:,_ """Name(s) of devices(s), which may.be:import;~Ql~er·this Registration Ce~if!cate:

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Please refer to the enclosed list .;,,/(j}f-<>" '"{;~.,'"",/;;.-,,\v? '\'<""::'/_.\\? \::, '·'·T~

This Registration Certi@Q">shallbein ti.' 'dm~n4~04.2012to 31-0$.'2015 unless it is sooner"-"- _',.. _,y) .•v) j'

'~j\;'<'

manufacturer or his authorised agent in India

d Near BIDEt Gorwa Vadodara 390016

4. This Registration Certificate is issued throug

Mis. Intra ocular care Pvt.:I:..td. 26 Gandh

'5. This Registration Certificate is sUbjeetih~ithe~o~ditions stated oVe~~aNind to such other conditions as may be

specified in the Act and the Rules, from time'td·tfrfie. ' .,

SeallStampDr. G. N. SINGH

Drugs Controller General (India)Die. General uf Health Services

r\1illistry of Health & Family Welfaref'Di\ BhawC1l).KOlla Road. 11.0.

New Delhi, 110002

Date: 2. I' i 1

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministrv of Health & Familv WelfareFDASHAWAN, KOILA ROAD,NEW DELHI-ll0 002 [INDlAJ

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

REGISTRATION CERTIFICATE NO. MD-I084 DATED 01.04.2012 VALID UPTO

31.03.2015.

/;-.""""

1. Hydropn'ilic Intra'," (ITE

es (ModeIF~ISeeLens AF)NLY)

New Delhi

Date: 2 4 Ai ~~201l L1CENS~UTHORITY

SeallStamork G. I\t SINGHDrugs Controller General (India)Dte. Ceneral uf Health Services

M;'-·'.try of Health & Family WelfareI J,D.. Ijh3W311. Kolla Road, I.T.O.

i'heW belhi-11 0002

Central Drugs Standard Control OrganisationDirectorate General of Health Services

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

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

Dated 2 4 /.::: 201ZTo

vMIs India Medtronic Pvt. Ltd.1241, Solitaire Corporate Park,Building Number 12, 4th Floor,Andheri-Ghatkopar Link Road, Andheri (D),Mumbai-400093, Maharashtra.

SUB:- Amendment in Registration Certificate No. MD-769 (A) dated03.03.2011 valid from 15.08.2010 up to 14.08.2013 and Form 10 LicenseNo. MD-769A-1250 dated 03.03.2011 valid up to 14.08.2013 -reg.

Please refer to your letter No. NIL d~e.a1i1 received by this office vide diary No.40390 (FTS 59214) dated 30.08.2011 anq~received by this office vide diary no. 7540(FTS 12530) dated 22.02.2012 on.th~~t matter.

This is with referenA~~~he Registration Certificate No. MD- 769(A) dated03.03.2011 valid from 15.08.~10 up to 14.08.2013 and Form 10 license No. MD-769A-1250 dated 03.03.2011 valid up to 14.08.2013 issued by this office. The name of productis hereby amended as follows:-

In place of:"PTCA Guidewire".

Read as:"Catheter Guidewire".

Yours faithfully,

(Dr. G~nghJDrugs Controller Gen~rtl ~~dia)

Central Drugs Standard Control OrganisationDirectorate General of Health Services

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

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

No. 31-63-MD/2006-DC(Re-Registration 2009) Dated 2. 4 !\FH 201Z

To .L;v:~~~ndia Medtronic Pvt. Ltd.

1241,Solitaire Corporate Park,Building Number 12,4th Floor,Andheri-Ghatkopar Link Road, Andheri (E),Mumbai-400093, Maharashtra.

SUB:-Amendment in Registration Ctwtificate No. MD-63 dated 22.02.2011valid from 01.09.2009up t9:-~'fi':2012 -reg.

-,:,\:j, \\-ji\\ (I '0>-;e;,1?\':J.~O'i~

Please refer to your letter No.SH/SMNAS-MD-63-QR-NF-1/0212 dated 21.02.2012and received by this office vide diary no. 7539 dated 22.02.2012 on the subject matter.

This is with reference to the Registration Certificate No. MD-63 dated 22.02.2011valid from 01.09.2009 up to 31.08.2012 issued by this office. The name of product ishereby amended as follows:-

In place of:"PTCA Guidewire".

Read as:"Catheter Guidewire".

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

Central Drugs Standard Control OrganizationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-110002

Date: 2 4 /.rn 201l

TO~ Is. Narang Enterprises,"l' Floor, A-31,

Kailash Colony,New Delhi -110048.

SUB: - Registration. of Medical Devices manufactured by Mis., OPHTEC BV, havingmanufacturing site at Schweitzerlaan 15, 9728 NR Groningen, TheNetherlands under the provisions of Drugs & Cosmetics Rules for thepurpose of import of medical devices in India.

S· .",~II', .f:')'·'~

Please refer to your application~·it91\'NIL dated 04/05/2011 received by thisoffice vide dairy no. 21329 date~~.~~~~%2Of1 and subsequent reply received vide diaryno. 9659 dated 07/03/20 12 re~~i~~ffi'e above 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 Celiificate 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.

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. 'l'he 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 I analysis reports.

6. Rased on this registration, applications for the import of medical device(s)endorsed in the enclosed Registration Celtificate 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 can~ation ofRegistration Certification. .;::> (f:)~ \'

,.;:> \~

8. This registration certificate is being issued under th~.,~~ion that you arerequired to submit following documents at th~lfrfte of submission ofapplication for grant of Form 10 License: . ()

• Revised Labels in original for the proposed product bearing importlie. no. and name and address of the importer etc. as per Rule 96 ofthe Drugs and Cosmetics Rules 1945 (as the same has not beenmentioned in labels submitted earlier).

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.

Please acknowledge the receipt.

(Dr. a~Singh)Drugs Controller Genf;~(India)

GOVERNMENTOFINDIACentral Drugs Standard Control Organisation

Ministry of Health & Familv WelfareFDABHAJ,VAN,KOILAROAD, NEW DElHI-ll0 002 lINDIAJ

Form 41(See rule 27-A)

Registration Certlficate issuedfor import of devices into IndiaUnder Drugs and Cosmetics Rules, /945

Date:~2 tiFH 201l1. Mis. OPHTEC BV having factory premises at Schweitzerlaan 15, 9728 NR Groningen, The

Net~erlands has been registered unde:ru~~,;.~f~~~·~:Yr(;ar)~~:::;r and is hereby issued this Registration

Certificate. '" "'e>''C \~ 'j/

'. ·ec:.' "\ (C4'~?. '."'-c '\t '\"'tV

2. Name(s) of devices(s), whicbJ~;be

Please refer to the encIose(rli~t

3. This Registration Certificate/shall be in force fr

cancelled under the rules.

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/-;;'"/,l--,-,"~ .. " _/'_~ ~•.,\\>_;,>"C'

This Registration Certificate is subject to tl;~'~Vnlitt1(;)J(sl~tAt~a~'bV;~ieafand to such other conditions as may be

specified in the Act and the Rules, from time to tim,~oe,1.~ Iyr~o

.(~ ~o0«" '9«;,i' \.

$ 0u z

LlCENst;THORITYSeal/Stamp

Ur.· N. SINGHDrugs Co ' General (I~dia)Ole. Gee Health ServIces

Ministrv Co' & FamilyWelfareFDA; ilia Road, I.T.O.

,-110002

Date: ') c ,.,Dj) ".f'1-»L. l' f"\\ 1\ 1..iJ {",

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministrv 01Health & Familv WellareFDABHAWAN, KOILA ROAD,NEW DELHI-110 002UNDIAJ

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

REGISTRATION CERTIFICATE NO. MD-436 DATED 01-04-2012 VALID UPTO

31-03-2015.

NAME OF THE PRODUCTS:

1. Hydrophilic Acrylic Intraocular Lens (Foldable Intraocular Lensinclusive of Dualtec Kit & Cartridge).

2. PM MA Intraocular Lens.ITEM(S}l~NLY

Off~\C ~,!J

L1CEN~AUTHORITY

Seal/~ta[Jlll. SINGH .Drugs Co:'r General (In.dlCDt~ (':'0 '-lealth Service

t; .. 7~. , W IfMlnis!:'y & Family e

cnj\ - 't1a Road, l.T.lI - • :-110002

New Delhi

Date: 2,4 1"