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

Transcription

1 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi TO'L - \.,/MIs Zimmer India Pvt. Ltd., Plot B&B1, Vanijya Nikunj, 7 th Floor, Enkay Tower, Udyog Vihar, Phase..V, Gurgaon 1 6 fjov 2011 SUB: -Registration of MIs Zimmer Inc., 1800 West Center Street, Warsaw, IN 46580, USA' having a factory premises at MIs Zimmer Manufacturing B.V. Route #1, K.M , Mercedita 007is, Puerto Rico, 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 and received by this office vide diary no dated and reply received vide dairy no dated on the above noted subject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rilles is issued herewith for the manufacturing site alongwith the name(s) of medical device(s) imported under the said Certificate subject to the»ll0wing conditions.,, r.oy 1. The medical device(s) shall G.qp("~~ the standards / specifications mentioned in the Second Schedule qf,~s and Cosmetics Act! ISO / MDD / or such other standards or specificatieh~ approved by this Directorate. 2. Dispute, if any, in respect of the 'payment of fees and submission of TR6 cha1lan, shall be settled between the bank and the applicant. 3.The1TI~dical device will be required to be withdrawn from sale from the market in case any undesirable reactions due to failure of'the device or its accessories are brought to light at any stage. This Directorate shoilld be informed of adverse reports on the medical device, if any. 4. This registration in no way relieves you of the responsibility of complying with "'other- provisions of tlie Drugs"& Cosmetics Act and-rules thereunder, and any other provisions of any other Act and Rilles applicable in the matter concerned.

2 5. Each consignment of the medical device(s) to be imported by you shall be accompanieclby ate:st /analysisreports. 6. Based on this registration, applications for the import of medical device(s) endorsed in the enclosed Registration Certificate shall be considered for the issue of Form 10 Licence under the Rilles. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipillated under Clause (5) of Rille 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed woilld result in cancellation of Registration 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 any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rilles thereunder. 0,~~. (Dr. V.G. Somani) Drugs Controller General (India)

3 GO,ERMMElllf IMDIA Central Druus.Standard Control Organlsalion Mlnlstrlol Heallll & faldrviwerare FDABHAWIII, 1111A BIll, IEW DElBI...11I 1.2 litldw Form 41 (See rule 27-A) Registration CertifICate issued for import of devices into India Under Drugs and Cosmetics Rules, 1945 ReglstratlOnCertificateNo.:MD-905 Date:.1 0 NGVZIlll~-- _ MIs Zimmer Inc., 1800 West Center Street, Warsaw, IN 46580, USA having a factory premises at MIs Zimmer Manufacturing B.V. Route #1, K.M , Mercedita 00715, Puerto Rico, has been registered under rule 27-A as a manufacturer and i~her@9y,issued this~~gi~tion Certificate. ;~-«,!... ",..., " t",j/:, ~ i' I" ~:"'1v;l > Name(s) of devices(s), which may1'l>e imported und~r ~s RegistrationCel1ificate: Please refer to the enclosed Ii~{'.. '):,.,.;t. ~:::'V:d ''\0'' ~ ; ".C::: 0-;;' This Registration Certi~~~t: <~ror to ~TsS it is sooner suspended or cancelled under tlll=~"~'7 ("'X~ ;) This Registration Certificate MIs Zimmer India Pvt. :Ltd. Plot B& Phase-V, Gurgaon.Who -Will be responsi respects. <. 11:lisRegis!J:ation~ficate )' t",..,:'.{, VI ;' - is ~l1bt~9! to the conditions stated ove~lx«rwid to such other conditions as may.' "' '-. "" j'-,:,'".~,:,.. --,.,,'--' t".."«:'-"- '''; '~'., "". " ':./ -', be specified in the Act and the Rules, fi<5t1l.~p1~ J() ti!!t~,,( :;_"::-5>\' v : J , f~-ff'-tjt..) \J-:i...1: :' Place: New Delhi Date:. 1 trl\jo'v'lon /-:..,-"'...'\.. '.. f.\ CDSCO DSCO \- ~1 '%. - ~ O"'~LTH,G~ LICENSING' AUTHORITY.-..-"".,'''":"_--''"''-'.,--.."-~.--''--'''' ~ ~~~MANI Dru9.$C9111ro.lIl'r Genetal (India) Ole. Gen.erat of Health Services Ministry of.l"ieahh & Family Welfare FDA13tia"'jl:n.,Kotla Road, I.T.O. N.,w.Delh I

4 1. The Registration Certificate shall be displayed at a prominent place by the authorised agent. 2. The manufacturer or his authorised agent in India shall comply with the conditions of the import licence issued under the Drugs and Cosmetics Rules, The manufacturer or his authorised agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorisation, and/or not of standard quality report of any device pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the device is marke~ed/sold or distributed. In such cases, action equivalent to that taken with reference to the concerned device in the country of origin or in the country of marketing shall be followed in India also,, in consultation with and as per the directions of the licensing authority. The licensing. authority may, however, direct any further modification to this eourse of twtion, including the withdrawal of the device from Indian market. 4. The manufacturer or his authorised agent in India shall inform the licensing authority within 30 days in writing in the event of any change in manufacturing process, or in labelling or in testing, or in documentation of any of the device pertaining to this Registration Certificate. In such cases, where there shall be any major change/modification in manufacturing or in testing, or in documentation, as the case may be,. the manufacturer or his authorised agent in India shall obtain necessary approval within 30 days by submitting a separate application along with the registration fee, as specified in clause (ii) of sub rule (3) of rule 24-A. 5. The manufacturer or his authorised agent in India shall inform the licensing authority immediately in writing in the event of any change in the constitution of the firm and lor address of the registered office/ factory premises operating under this Registration Certificate. Whet"e any such cllange in the constitution of the firm and/or address takes place, the currentre~stratl0n Certificate-sliaII' be deemed to be valid for a maximum period of three months from the date on which the change has taken place unless, in the meantime, a fresh Registration Certificate has been taken from the licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premises.

5 GOVERNMENT OF INDIA Central DrUISStandard Control Oroanisadon Ministn of Health & Fallily Wenare FDAlIAWAN, 18TlI R81D, NEW DELHI DNDW NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD- 905 DATED VALID UPTO v{~ LICENSING~UTHORITY ~~~1e>MANI Drugs Controller General (India) Dte. General of Health Services Ministry of Health & Family Welfare FDA Bhawan"Kolia Road, I.T.O. New Delhi

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7 Annexure-I _NAME(S)OFMEDICAL DEYICES, wmcllmayjje IMPORT~D UNDER REGISTRATION CERTIFICATE NO. MD- 905 DATED VALID UPTO TOTAL KNEE REPLACEMENT PRODUCTS: a. NexGen System 1. NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component 2. NexGen Complete Knee Solution Taper Stem Plug 3. NexGen Complete Knee Solution All Poly Patella 4. NexGen Complete Knee Solution Stem Extension Straight 2. TOTAL HIP REPLACEMENT PRODUCTS: a. CPT System 1. CPT Hip System, Femoral Stem b. Versys System 1. Versys Heritage Hip Prosthesis,FelTloral'Stem 2. Versys Heritage Hip Prosthesis, Cemented Neck Taper 3. Versys Hip System Femoral Head c. Trilogy System 1. Trilogy Acetabular,System Liner 2. Trilogy Acetabular$ystem Shell /i\</' 3. Trilogy Acetabular System LongevityCros$Urtked Polyethyl~oe Liner 4. Trilogy AB Acetabular System d. Multipolar System 1. Multipolar Bipolar Cup Shell 2. Multipolar Bipolar Cup Liner 3. TOTAL FRACTURE CAREPRODUCTJF'" 1.;;;;/ J}'/% a. M/DN System " '. 1. M/DN Intramedullary Fixation'~e,trograde FemorallM'f;laii 2. MIDN Intramedullary Fixation He~~~e,f<WA.~~\ 3. M/DN Intramedullary FixationFemor~J~Ji'Nail 4. MIDN Intramedullary Fixation ~~i:screw 5. M/DN Intramedullary Fixati~ Tihial Nail 6. M/DN Intramedullary Fixatiorl Humeral Nail b. Zimmer Plates & Screw System 1. Magna Fx Cannulated Screw Fixation System Cannulated Bone Screw 2. HerlJert/Whipple Bone Screw Sy~tem,Cannulated Bone Screw 3. Versa- Fx Femoral Fixation System, Compression Lag Screw. 4., _Versa-Exll Femoral Fixation System, SupraconciyJarTubel Plate 5. Versa- Fx II Femoral Fixation System, Compression Tubel Plate 6. ECT Internal Fracture Fixation Cancellous Bone Screw 7. ECT Internal Fracture Fixation Self- Compression Plate 8. Periarticular Plating System Cortical Bone Screw 9. Periarticular Plating System Cancellous 'Bone Screw 10.Corti cell Screw 11.Cancellous Screw 12. Compression Plate 13. Bone Screw Place: New Delhi Date: i 1 6. tin~j 'UHf ~~V'~" '-Ui V qx: LICENSING AUTHORITY SeaVStamp Dr. V. G. SOMANI Drugs Controller General (India) Dte. General of Health Services Ministry of Health & Family Welfare FDA BhawCjn.,Kotla Road,I.T.C. New De1hi

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9 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare File No.: MD/2010-DC To, /" ~bbott Healthcare Pvt. Ltd.,. 4, Corporate Park, Sion Trambay Road, Mumbai , Maharashtra. Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 Dated:!1 b NCV 2011 SUB: - Endorsement No.1 to RoC. No. MD-867 to Manufacturing Site of MIs Abbott Laboratories, Abbott Vascular Inc., having Factory premises at 400 Saginaw Drive, Redwood City, Califol'nia 94063, 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 01/11/2010 and received by this office vide diary no dated 03/11/2010 and reply received vide dairy no dated 19/05/2011, dated 22/06t2011 and dated 19/07/2011 the above noted subject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is issued herewith for the manufacturing site alongwith the name(s) of medical device(s) imported under the said Certificate subject to the following conditions. 1. The medical device(s) shall confo~~~ standards 1 specifications mentioned in the Second Schedule of the p~m1d Cosmetics Act! ISO 1 MDD 1 or such other standards or specificat~1f5t"pproved O'~'fi: by this Directorate. 2. Dispute, if any, in respect of the payment of fees and submission of TR6 challan, shall be settled between the bank and the applicant.. 3. The medical device will be required to be withdrawn from sale from the market in case any undesirable reactions due to failure of the device Or its accessories are brought to light at any stage. This Directorate should be informed of adverse reports 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 Ru1es thereunder, and any other provisions of any other Act and Rules applicable in the matter concerned.

10 5. Each consignment of the medical device(s) to be imported by you shall be accompanied 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 issue of Fotm 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration 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 any other condition that may be taken under the prwisionsof the Drugs & Cosmetics Act, 1940 and the Rules thereunder. V(~~r. (Dr. V.G. Somani) Drugs Controller General (India)

11 GOVERNMENT OF INDIA Central Druls Standard Control Organisation Ministrv 01 Health & Familv Wellare FDAIHAWAN,KlrlA RIAD, NEWDElHI-lll 112 lindiaj NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER ENDORSEMENT - 1, DATED J 6 NOV loll! TO REGISTRATION CERTIFICATE NO. MD- 867 DATED VALID UPTO Date: 1 6 f,y \'.?011.. v. L Seal/Stamp Dr. V. G. SOMANI Drugs Controller General (India) Ole: General of Health Services Ministrv of HEalth & Family Welfare FDABI,c<"a', Ke'!a Road.!.T.O.

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13 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-ll0002 To, '-.A-./S. Boston Scientific International B.V., 100A, The Capital Court, Olof Plame Marg, Murirka, New Delhi SUB: - Endorsement No. 4 to R.C. No. MD-41A to Registration of MIs Boston Scientific Corporation, Boston ScielltificPlace, Natick, Massachusetts '- 1537, USA having factory premises at MIs Boston Scientific Ireland Limited, Ballybrit Business Park, Galway, Ireland under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application no. BSCIF40101 dated 18104/2010 and received by this office vide diary no dated 20105/2010 and reply received vide dairy no dated 24/06/2011 on the above noted subject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is issued herewith for the manufacturing site alongwith the name(s) of medical device(s) imported tinder the said Certificate subject to the following conditions. 1. The medical device(s) shall conform to ~~dards 1 specifications mentioned in the Second Schedule of the Dru~d b d1etics Act! ISO 1 MDD 1 or such other standards or specificatio,ns,.a,}fpt:covedby this Directorate. 2. Dispute, if any, in respect of the payment of fees and submission of TR6 challan, shall be settled between the bank and the applicant. 3. The medical device will be required to be withdrawn from sale from the market in case any undesirable reactions due to failure of the device or its accessories are brought to light at any stage. This Directorate should be informed of adverse reports 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 any other provisions of any other Act and Rules applicable in the matter concerned.,

14 5. Each consignment of the medical device(s) to be imported by you shall be accompanied 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 issue of Form 10 license under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration Certification. 8. This registration Certificate is being issued under the condition that you are required to submit the Duly Notarized and Valid copy of EC Full Quality Assurance Certificate, indicating the name and address of the legal as wen as actual manufacturer at the time of submission of application for grant of Form 10 Licence. (As the same submitted by you has been expired). Please note that Registration Certificate issued is liable to be suspended / cancelled, if any of the condition stipulated above is not complied with, apart from any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. ~-Iq~ (Dr. V.G. Somani) Drugs Controller General (India)

15 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministry of Health & Familv Welfare FDAIHAWAN, KOllA ROAD, NEW DELHI-ll0 002 IINDII) NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER ENDORSEMENT NO.4 DATED II 6 NG\j 2011 TO REGISTRATION CERTIFICATE NO. MD-41A DATED VALID UPTO Place: New Delhi Date: )1 6 NO\! 2an \fc9~~ ~ LlCENSING AUTHORITY Seal/Stamp Dr.V. G. SOMANI Drugs Controller Geneta. (India)..ole. General of Health Services MinIstry of Heilllh & Family Welfare FDA Shawan, Kotla.Road, I.T.O. '" I'.:;.?".'L(i"1,~11C (102

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17 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan KotIa Road, New Delhi-ll0002 F. No.: 6-4/FF/50/03-DC (Re registration 2009) END. 2 Dated.1 6 NOV 20llr TOil / \..~!s B. Braun Medical (I) Pvt. Ltd, 5 th Floor, East Quadrant, The IL & FS Financial Centre, Bandra Kurla Complex, Bandra (East), Mumbai SUB: -Endorsement No.2 to R.C. No. FF-202 to Manufacturing Site of Mis B. Braun Surgical S.A. Spain having a factory premises at Carretera DE Terrassa, Rubi (Bercelona), Spain under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application no. BBRA/END-202-FFI and BBRA/END-202-FF/ dated and received by this office vide diary no dated and dated and replies received vide dairy nos dated , dated and dated on the above noted subject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is issued herewith for the manufacturing site alongwith the name(s) of medical device(s) imported under the said Certificate subjectto the following conditions. ~'''w'\ 1. The medical device(s) shal.l~..oo~n:~tlr rr@.~ standards! specifications mentioned in the Second Schedule of th~~and Cosmetics Act! ISO I MDD I or such other standards or specifica~~"p))roved by this Directorate. 2. Dispute, if any~in respect of the pay'mentof fees and submission of TR6 challan, shall be settled between the bank and the applicant. 3. The medical device will be required to be withdrawn from sale from the market in case any undesirable reactions due to failure of the device or its accessories are brought to light at any stage. This Directorate should be informed of adverse reports 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 any other provisions of any other Act and Rules applicable in the matter concerned.

18 5. Each consignment of the medical device(s) to be imported by you shall be accompanied 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 issue of Form 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration 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 any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. ~,~.~. (Dr. V.G. Somani) Drugs Controller General (India)

19 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Minish IIHealth & FamilYWellare FDAIIIWIN, KOTlA ROD, NEW DELHI [INDIAl NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER ENDORSEMENT - 2, DATED ',1 5 r.~ovl0111 TO REGISTRATION CERTIFICATE NO. FF- 202 DATED VALID UPTO , ')'l «j;~endo_&irf;no. 2.. ~*~~:~t;~:";-;:7:"«1.~onor.pax~~s~~~~'hydroxybj(~rate ) ~rnonofilamerlt.!-;~~~~~pible surgical::,~uture 2. N~~~~~O~1'''):~Q &~~J~.Qqli9~~:T:g:>~dactide), braided, co'ated;'absofl)~}:)i~~y[9:iccil'stjtufe ITE~~:J' "'»'"~enl y <;:;<:~;: ','".::;~:e -;~""2:; ::"~;:~ :';' ::'",';,.:);;>>.,;;" Place: New Delhi Date: "1 (; rjov 2011 LICENSING AUTHORITY StiW~ OMANI Drugs Controller Genefa' (India),Dte. General of Health Services Ministry of Health & Family Wel'are FDA Bhawan"Kotla Road, I.T.O. New Oelhj

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21 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi-I ~o, /" ~M/s Confident Sales India Pvt. Ltd., No.47, 2 nd Floor, Pete Chennappa Industrial Estate,. Magadi Main Road, Kamakshipalya Bangalore- 79. SUB: - Registration of Mis Biomatlante, having a factory premises at ZA Les Quatre Nations, 5 Rue, Edouard Belin, F-44360, Vigneux de Bretagne, France under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to application No. NIL dated received by this office vide dairy no,1514 dated and Subsequent submission vide dairy no dated 30106/2010 and replies received by this office vide diary nos dated , dated and dated on the above noted subject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is issued herewith for the manufacturing site alongwith the name(s) of medical device(s) imported under the said Certificate subject to the following conditions. 1. The medical device( s) shall confo}l? fj',q~t~dards 1 specifications mentioned in the Second Schedule of the P~\OOdCosmetics Act! ISO 1 MDD 1 or such other standards or specificati~~foved 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....~.. IJ:J.~_m~(licC!Ld~yjc~wilLb~.r_eq]Jir.ed-tQ-b.e--wi1hdrawn..fmill.sale_fromthemarketin. case any undesirable reactions due to failure of the device or its accessories are brought to light at any stage. This Directorate should be informed of adverse reports 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 any other provisions of any other Act and Rules applicable in the matter concerned.

22 5. Each consignment of the medical device(s) to be imported by you shall be accompanied 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 issue of Form 10 Licence under the Rules. 7. This Registration Certificate is being issued under the condition that during the pendency of Registration, the applicant may be required to deposit inspection fee as stipulated under Clause (5) of Rule 24-A and enable inspection of manufacturing site by the officials Authorized for this purpose. Non-compliance to this condition as and when so directed would result in cancellation of Registration Certification. Please note that Registration Certificate issued is liable to be suspended I cancelled, if any of the condition stipulated above is not complied with, apart from any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. ~/~.~. (Dr. V.G. Somani) Drugs Controller General (India)

23 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministry of Health & Familv Welfare FDABHAWAN, KOTIA ROAD,NEW DELHI-ll NDiAJ Form 41 (See rule 27-A) Registration Certificate issued for import of devices into India Under Drugs and Cosmetics Rules, Mis Biomatlante, having a factory premises at ZA Les Ouatre Nations, 5 Rue, Edouard Belin, F-44360, Vigneux de Bretagne, France has been registered under rule 27-A as a manufacturer and is hereby issued this Registration Certificate. 2. Name(s) of devices(s), which may be imported under this Registration Certificate: Please refer to the enclosed list.,4:",.:o{~ 3. This Registration Certificae,E)\fb! in force from to unless it is sooner suspended or carmq~der.'\jfc~ the rules. 4. This Registration Certificate is issued through the office of the manufacturer or his authorised agent in India MIs Confident Sales IndiaPvt. Ltd., No.47, 2 nd Floor, Pete Chennappa Industrial Estate, Magadi Main Road, KamakshipalyaBangalore- manufacturer in India, iril:il1respects: 79, who will be responsible for the business activities of the 5. This Registration Certificate is subject to th~~~itions stated overleaf and to such other conditions as may ':11.",. 'Ila. be specified in the Act and the Rules, fr~" f ici'r\ f ~ v z Place: New Delhi.Date:.1 6 NOV 2011 LICENSING AUTHORITY Seal/Stamp Dr. V. G. SOMANI Drugs Controller General (India) Dte. General of Health Services Ministry of Healtt', & Family Welfare FDA Bhawa", 'alia R03d, Lr.C. Ne,~ UE d l_ l' ',~J2

24 1. The Re''gistration Certificate shall be displayed at a prominent place by the authorised agent. 2. The manufacturer or his authorised agent in India shall comply with the conditions of the import licence issued under the Drugs and Cosmetics Rules, The manufacturer or his authorised agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorisation, and/or not of standard quality report of any device pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the device is marketed/sold or distributed. In such cases, action equivalent to that taken with reference to the concerned device in the country of origin or in the country of marketing shall be followed in India also, in consultation with and as per the directions of the licensing authority. The licensing authority may, however, direct any further modification to this course of action, including the withdrawal of the device from Indian market. 4. The manufacturer or his authorised agent in India shall inform the licensing authority within 30 days in writing in the event of any change in manufacturing process, or in labelling or in testing, or in documentation of any of the device pertaining to this Registration Certificate. In such cases, where there shall be any major change/modification in manufacturing or in testing, or in documentation, as the case may be, the manufacturer or his authorised agent in India shall obtain necessary approval within 30 days by submitting a separate application along with the registration fee, as specified in clause, (ii) of sub rule (3) of rule 24-A. 5. The manufacturer or his authorised agent in India shall inform the licensing authority immediately in writing in the event of any change in the constitution of the firm and lor address of the registered office/ factory premises operating under this Registration Certificate. Where any such change in the constitution of the firm and/or address takes place, the current Registration Certificate shall be deemed to be valid for a c---maximum-period-of-thfee-month8-fmm-the-da1e-on_wmch_tbj~j~_b.ng~_has _~K~~pJace unless, in the meantime, a fresh Registration Certificate has been taken from the licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premises. _

25 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministry of Health & Familv Welfare FDA BHAWAN, KOrLA ROAD, NEW DELHI l1NDlAJ NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD DAtED VALID UPTO 31, New Delhi Date:, -'1 6 I'~U pry!' V L?011 ~'~'~. LICENSING AUTHORITY Seal/Stamp Dr. V. G. SOMANI Drugs Controller Genefal (India) Dte. General of Health ServIces Ministry of Health & Family Welfare FDA Bhawan"Kotia Road, I.T.O. N_ Delhi

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27 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan, Kotla Road, New Delhi To, ~s. Carl Zeiss India (Bangalore) Private Limited 22, Kensington Road, Ulsoor, Bangalore SUB:-Amendment in Registration Certificate No. MD-769 valid from 01/02/2010 up to 31/01/2013 and Form 10 Licence No. MD in the brand names of the approved products-reg. Please refer to your letter No. NIL dated 06/09/2011 received by this office vide diary no (Fts No ) dated 07/09/2011 on the subject matter. This is with reference to the Registration Certificate No. MD-148 issued on 18/02/2010 valid from 01/02/2010 up to 31/01/2013 issued by this office. The site of the manufacturer is hereby amended as follows: - In place of: "M~s. Carl Zeiss Meditec SAS, ~venue ~1..langevin-I3P' 5, La' Rochelle Cedex 9, France having manufacwri(g(i}emlses at MIS Carl Zeiss Meditec SAS, 10 Avenue Paul Langevin, 1z,1:00,P'engny, France" 1"".\>('~, Read as: "MIs. Carl Zeiss Meditec SAS, Avenue Paul langevin-bp 5, La Rochelle Cedex 9, France having manufacturing premises at MIS Carl Zeiss Meditec SAS, 27 Avenue Paul Langevin, Perigny, France". Copy to:- Asstt. Drugs Controller Mumbai \Iv..... \j~ (Dr. V G Somani) Drugs Controller General (India) (I), New Custom House Annexe, Ballard Estate, Fort,

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