Central Drugs Standard Control Organisation Directorate General of Health Services

Transcription

1 Central Drugs Standard Control Organisation Directorate General of Health Services To _/ \...--M/s Synthes Medical Pvt. Ltd., 118-P Sector-44, Gurgaon , Haryana Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi Dated' ~ i", f'''l? tj? c.n, SUBJECT: - Endorsement No. 02 to RC. No. MD- 188 of manufacturing site Mis Synthes GmbH having factory premise at Eimattstrasse 3, 4436 Oberdorf, Switzerland under the provisions of Drugs & Cosmetics Rules for the purpose 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 dated 10/02/2012 on the subject cited above. 1(\V Registration Certificate in Form 41 u~ the Drugs and Cosmetics Rules is 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 in the Second Schedule of the Drugs and Cosmetics Act! ISO / MDD / or such other standards 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 The medical device will be required to be withdrawn from sale from the market in case any undesirable reactions due to failure of the device or its accessories are brought to light at any stage.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.

2 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 b~ required to deposit inspection fee as stipulated under Clause (5) of RUI~~-A and enable inspection of manufacturing site by the officials Authori~for this purpose. Non-compliance to this condition as and when so di~ed would result in cancellation of Registration Certification. (Jt 8. This registration certificate is ~~ issued under the condition that you are required to submit the produ~~ls indicating the name and address of the importer, import licence no., date of manufacturing and name and address of the manufacturer etc. as per Rules 96 of Drugs and Cosmetics Rule at the time of submission of application for grant of Form 10. 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. G. N Singh) Drugs Controller General ndia)

3 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministry of Health & Familv Welfare FDABHAWAN,KolLA ROAD,NEW DElHI-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 VALID UPTO i~~endo.~~.." Name 0 RapidSorl1 ~esor~~ti (1) I!fa~b~~..f~2 New Delhi Date: 2-; Sea Stamp Dr G. t\j. SINGH Drugs C(nt'i)li;r General (India) Ote. G8lv:3alth Services Ministry of i Family Welfare FD}'. Eli:'!3 Road, I.T.O. 1:0002

4 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare To. / ~s Johnson & Johnson Ltd., AlI50, Room No.2, 100 Shed Area, G.I.D.C., Vapi, Tal. Pardi (Valsad) Gujarat Food and Drug Administration Bhawan Kotla Road, New Delhi-ll ~ r'.'".t:.r l~f"{\ 201l SUB.:Registration of manufacturing site of Mis DePuy (Ireland), Loughbeg, Ringaskiddy, Co. Cork, Ireland is having manufacturing premises at Mis Johnson & Johnson Medical (Suzhou) Ltd., 29~ Chang Yang Street, Suzhou Industrial Park, Suzhou, China under th~$p\iljsions of Drugs & Cosmetics Rules 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/ received by this office vide Diary dated 03/08/2011 and reply received by this office vide diary no dated 02/03/2012 regarding the cited subject above. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is 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 I specifications mentioned in the Second Schedule of the Drugs and Cosmetics Act! ISO I MDD I or such other standards 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 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, ifany. 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.

5 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. 8. This registration certificate is being issued under the condition that you are required to submit the original product labels printed in indelible ink indicating the name and address of the importer, import licence no., date of manufacturing, name and address of the manufacturer etc. as per Rule 96 of Drugs and Cosmetics Rules 1945 at the time of submission of app-iication for grant 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, 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. G. N. Singh) Drugs Controller Gene al (India)

6 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministrv of Health & Farnilv Welfare FDABHAWAN, KOlLA ROAD,NEW DElHI lindial Form 41 (See rule 27-A) Registration Certificate issuedfor import of devices into India Under Drugs and Cosmetics Rules, 1945 Registration Certificate No.: MD-999 Date: 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 Suzhou , China has been register~d"u~g,et)r4hr~~7,-alis a manufacturer and is hereby issued this Registration Certificate. ~,~,/ f,)\\ ~;!=\,I::'~ 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! 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 in India 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<?:, Park, 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 '

7 Central Drugs Standard Control Organisation Ministrv 01 Health & Familv Wellare FDABHAWAN.KOILAROAD.NEW DElHI-ll0 002 [INDlAJ NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD-999 DATED VALID UP TO Date: 2.,:\, \ i~.mz ~ LICENSING tuthority Sea Stampr. G. N. SINGH Drugs Controller General (India) D~e. General vf Health Services Ministry of Health & Family Welfare FDA BhawaQ, Kolla Road, I.T.O. New Oelhi

8 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare 0) Food and Drug Administration Bhawan Kotla Road, New Delhi To, ~ \,/;~~~~hnson & Johnson Ltd., 30 Forjett Street Mumbai , India. SUB: - Registration of MIs DePuy (Ireland), Loughbeg, Ringaskiddy,, Co. Cork, Ireland having factory premises at MIs CeramTec GmbH, Medical Products Division, CeramTec-Platz 1-9, 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 received by this office vide dairy no dated 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 said Certificate 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 other standards 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 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. 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.

9 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 these documents at the time of submission of application for grant of Form 10 License. Revised Labels of proposed products having import licence no. and the address of the importer etc as per Rule 96 of Drugs and Cosmetic Rules ~~~\ Duly notarized copy of Full Quality A~~c~ indicating both legal and actual manufacturer address (as the ~IMsubmitted by you reflecting only legal 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 that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder. (Dr. ~~ingh) Drugs Controller Gen~~ (;ndia)

10 GOVERNMENT OF INDIA Central Brugs Standard Control Organisation Minist" of Health & Familv Welfare FDA BHAWAH, KOILA ROAD, NEW DELHI-ll0 002 lindiaj Form 41 (See rule 27-A) Regi~ tration Certificate issued/or import 0/ devices into India Under Drugs and Cosmetics Rules, Mis DePuy (Ireland), Loughbeg, Ringaskiddy,, Co. Cork, Ireland having factory premises at Mis CeramTec GmbH Medical Products Di.. r -Platz Plochin en German has been registered under rule 27-A ~ ufacturer and is hereby ~ed this Registration Certificate. is. ~ 01>Q 2. Name(s) of devices(s), wh~may be im egistration~ tificate: :'r', ~ Please refer to the enclos~st 1<~ ~ ~ ~ () 0 3. This Registration Certific~ shall be in force fr to unl ~ it is sooner suspended or cancelled under the rules. LICENSING ~TY Seal/Stamp Dr. G. N. SINGH D~'j(Js Controller General (India) ["'Ic General vf Health Services of Health & Fsmily Welfare!(Jtla RUNI, I.TO.

11 GOVERNMENT OF INDIA Oentral DrugS Standard Control Organisation Mlnislrv of Health & Familv Welfare FDA 8HAWAN, KolLA ROAD, NEW DELHI-llo ooz IINDIAI NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD-I044 DATED VALID UP TO New Delhi Date: 2. i\;' ~JJ1Z Seal Stamp Cr G. N. SINGH DrUGS controller General (India) c.:-.' vf Health Services M'n",\!v ()[ipalth & Family Welfare r u/\. Kotla Road

12 Central Drugs Standard Control Organization Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Kotla Road, New Delhi-ll0002 Date: Bhawan 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 of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. 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 the above 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) imported under the said Certificate subject to the following conditions. 1. The medical device(s) shall conform to the standards I specifications mentioned in the Second Schedule of the Drugs and Cosmetics Actl ISO I MDD I or such other standards 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 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. 5. Each consignment of the medical device(s) to be imported by you shall be accompanied by a test I analysis reports.

13 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. 8. This registration certificate is being issued under the condition that you are requin~d to submit following documents at the time of submission of application 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 by the firm).",>c~ Clarification from the manufactur~_~garding Shelf life for the proposed product (as the Schedl!JA..<&m mentions the shelf life as 1825 days, 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 and Cosmetics Rules (as you have submitted photocopy of the labels with a stickel' mentioning import lie. no., name and address of the importer and fu rthel" address of the importer mentioned does not correlate with address 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 any other condition that may be taken under the provisions of the Drugs & Cosmetics Act, 1940 and the J\ u1es thereunder. (Dr. G.~ngh) Drugs Controller Gene~~ (~~dia)

14 GOVERNMENTOFINDIA Central Drugs Standard Control Organisation Ministrv of Health & Familv Welfare FDASHAWAN, KOlLA ROAD,NEW DElHI-ll0 002 (lndlaj Form 41 (See rule 27-A) Registration Cert(ficate issuedfor import of devices into India Under Drugs and Cosmetics Rules, 1945 Date: 2 4.' I! 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 Gujarat who will be responsible f6rtb~ businessach~ifies.f.i'~'"t"i;!~ 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, ~ ~ $ 6 u z LICENSING ~ORITY Seal/Stamp Dr. G. N. SINGH Druos C~\ntroller General (India) Dt'1 (ocnergi uf Health Services, Lk :.:'"/ of Health & Family Welfare fl, Kolla Road, I.T.O..\cll1i

15 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministrv of Health & Familv Welfare FDABHAWAN, KOlLA ROAD,NEW DELHI-ll0 002l1NDlAJ NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD-I068 DATED VALID UPTO CORAIL AMT Cementless Femoral Stems ITEM (S) ONE ONLY Date: tl, '. L1CENS rg ~UTHORJTY A Seal/Stamp Dr. G. N. SINGH Drugs Controller General (Ind'la) ['t8. Generaluf Health S[;[v:ces of Health & Farpi!y V'!eif2r~ KOl\8 r-{c~ :.':!, T.O. 0C",.\2

16 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, _/ \-.MIs Hitech Equipment N System, 53, Shahkar Society, 25 S.ector, Gandhinagar, Gujarat SUB: -Registration of MIs Dedienne- Sante, Mas Des, Cavaliers- 217, Rue Nungesser.F-34130, Mauguio, France 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 , dated ,"~~\dated , dated , dated and~~ed on the above noted subject..' ~\~\V~ O~~ 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 conform to the standards / specifications mentioned in the Second Schedule of the Drugs and Cosmetics Act! ISO / MDD / or such other standards 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 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.

17 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. G.~ingh) Drugs Controller GeneIi tindi3)

18 IIUUtOnllltn. ur.nuih Central Drugs Standard Control Organisation Minlstrv 01Health & Familv Wellare FDA BHAWAN, KoYLA ROAD, NEW DElHI-110 oo2l1hdiaj Form 41 (See rule 27-A) Registratioll Certificate issuedfor import of devices illto Illdia Ullder Drugs alld Cosmetics Rules, Mis Dedienne- Sante. having Factory premises at Mas Des. Cavaliers Rue Nungesser.F Mauguio. France has been register~.~jlltd~~l}l.1~27-aas a manufacturer and is hereby issued this Registration Certificate. '> >.. >, 2. Name(s) of devices(s), which ~~;'15e Please refer to the enclosed list ?\( \\~ /~. \'-;...") \). U\) '\ tf.>\~~>. 3. This Registration Certifi 'l;l.teshall be in fore to uij1ess it is sooner suspended " ~ 5. This Registration Certificate i; ~9.bject to the~ijh<fftr'bnsl'lsikfud overle~r@a be specified in the Act and the RUl~~(:f~9Jll time to time.:> ::'[' to such other conditions as may " Ii '- 'i' i. Dr. G. N. SINGH, Drugs Controller General (India) Ole. General of He~lth ~ervlcl';~. t of Health &,-am,ly \f\!e,ue M InIS ry, I l' 0 FDA Bilawan, Kolla 1'\080, ".. New Oelhi-l10002

19 GOVERNMENT OFINDIA Central Drugs Standard Control Organisation Ministry of Health & Familv Welfare FDA BHAWAN, KOYLAROAD, NEW DELHI UNDIAJ NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD- 628 DATED VALID UPTO {,;~,i~sis:_trlt,cc mobile bearing on Prosthes12 TRICCC ~J9 t.b~sis:shiva t""~1:: i&, Date. 2' 1 f LIC~G AUTHORITY Seal/Stamp Dr G. N. SINGH..troller General (IndIa) Drugs Con \,'Health Services Dte Genera ul..,\th &!=arll\\y 'j\1,(';,,"'- ""rr' "'nistry of Hea., 'T C' Iv,l _, \'o"\a R02C1, I,', J, FDA Bh8W<:',', '. I,,' r,') \". ",,;,<,11'1'-',(Jc.",,.

20 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, ~ ~~~Intra ocular care Pvt. Ltd., 26 Gandhi Oil Mill Compound, Near BIDC, Gorwa, Vadodara SUB: - Registration of Manufacturing site MIs Hanita lenses, Kibutz Hanita, Israel and its Medical Devices under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India.. ~lease refer to your application ~~l. aated ~7/04/20 1~ received. by t~is office vide dairy no dated 20/04/2.~.~lJA~"rephes received by this office vide diary no's 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) imported under the said Certificate subject to the following conditions. ~l 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 other standards 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 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. 5. Each consignment of the medical device(s) to be imported by you shall be accompanied by a test / analysis reports.

21 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 thec~ndition that during the pendency of Registration, the applicant may be requir<::~~ deposit inspection fee as stipulated under Clause (5) of Rule enable inspection of manufacturing site by the officials Authorized for tfi!$~purpose. Non-compliance to this condition as and when so directed~ld result in cancellation of Registration Certification. '!<~~ 8. This registration Certificate is being iqed under the condition that you are required to submit duly notarized and valid Drugs Sales License in form of Form 20B/21B as the same submitted by you was nearer to expiry, at the time 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, apart from 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)

22 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministry of Health & Familv Welfare FDA IHAWAN. KOILA ROAD. NEW DELHI llndiaj Form 41 (See rule 27-A) Registration Certificate issuedfor import of devices into India Under Drugs and Cosmetics Rules, 1945 Date: 2 4- L.'.\ lolz Mis. 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:./,.,",, /j\~'..j-'''''._'''' 0,'../ Please refer to the enclosed list.;,,/(j}f-<>" '"{;~.,' "",/;;.-,,\v? '\'<""::'/ _.\\? \::, This Registration Certi@Q">shallbein ti.' 'dm~n4~ to 31-0$.'2015 unless it is sooner "-"- _',.. _,y). v) j' ' ' T~ '~j\;'<' 4. This Registration Certificate is issued throug Mis. Intra ocular care Pvt.:I:..td. 26 Gandh manufacturer or his authorised agent in India d Near BIDEt Gorwa Vadodara '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. '., Date: 2. I' i 1 SeallStamp Dr. G. N. SINGH Drugs Controller General (India) Die. General uf Health Services r\1illistry of Health & Family Welfare f'di\ BhawC1l).KOlla Road New Delhi,

23 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministrv of Health & Familv Welfare FDASHAWAN, KOILA ROAD,NEW DELHI-ll0 002 [INDlAJ NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD-I084 DATED VALID UPTO /;-."""" 1. Hydropn'ilic Intra '," (ITE es (ModeIF~ISeeLens AF) NLY) New Delhi Date: 2 4 Ai ~~201l L1CENS~UTHORITY SeallStamo rk G. I\t SINGH Drugs Controller General (India) Dte. Ceneral uf Health Services M;'- '.try of Health & Family Welfare I J,D.. Ijh3W311. Kolla Road, I.T.O. i'hew belhi

24 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device & Diagnostics Division) To vmis India Medtronic Pvt. Ltd. 1241, Solitaire Corporate Park, Building Number 12, 4 th Floor, Andheri-Ghatkopar Link Road, Andheri (D), Mumbai , Maharashtra. Food and Drug Administration Bhawan, Kotla Road, New Delhi Dated 2 4 /.::: 201Z SUB:- Amendment in Registration Certificate No. MD-769 (A) dated valid from up to and Form 10 License No. MD-769A-1250 dated valid up to reg. Please refer to your letter No. NIL d~e.a1i1 received by this office vide diary No (FTS 59214) dated anq~received by this office vide diary no (FTS 12530) dated on.th~~t matter. This is with referena~~~he Registration Certificate No. MD- 769(A) dated valid from ~10 up to and Form 10 license No. MD-769A dated valid up to issued by this office. The name of product is hereby amended as follows:- In place of: "PTCA Guidewire". Read as: "Catheter Guidewire". Yours faithfully, (Dr. G~nghJ Drugs Controller Gen~rtl ~~dia)

25 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device & Diagnostics Division) Food and Drug Administration Bhawan, Kotla Road, New Delhi No MD/2006-DC(Re-Registration 2009) Dated 2. 4!\FH 201Z.L; To v:~~~ndia Medtronic Pvt. Ltd. 1241,Solitaire Corporate Park, Building Number 12, 4 th Floor, Andheri-Ghatkopar Link Road, Andheri (E), Mumbai , Maharashtra. SUB:- Amendment in Registration Ctwtificate No. MD-63 dated valid from up 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 and received by this office vide diary no dated on the subject matter. This is with reference to the Registration Certificate No. MD-63 dated valid from up to issued by this office. The name of product is hereby amended as follows:- In place of: "PTCA Guidewire". Read as: "Catheter Guidewire". (Dr.~ Singh) Drugs Controller General (India)

26 Central Drugs Standard Control Organization Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Kotla Road, New Delhi Date: 2 4 /.rn 201l Bhawan TO~ Is. Narang Enterprises, l' " Floor, A-31, Kailash Colony, New Delhi SUB: - Registration. of Medical Devices manufactured by Mis., OPHTEC BV, having manufacturing site at Schweitzerlaan 15, 9728 NR Groningen, The Netherlands under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. S.",~ II',.f:')' '~ Please refer to your application~ it91\'nil dated 04/05/2011 received by this office vide dairy no date~~.~~~~%2of1 and subsequent reply received vide diary no dated 07/03/20 12 re~~i~~ffi'e above subject. Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is herewith for the manufacturing site alongwith the name(s) of medical device(s) imported under the said Celiificate subject to the following conditions. 1. The medical device(s) shall conform to the standards I specifications mentioned in the Second Schedule of the Drugs and Cosmetics Act! ISO I MDD I or such other standards 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 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. 5. Each consignment of the medical device(s) to be imported by you shall be accompanied by a test I analysis reports.

27 6. Rased on this registration, applications for the import of medical device(s) endorsed in the enclosed Registration Celtificate 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 can~ation of Registration Certification..;::> (f:)~ \',.;:> \~ 8. This registration certificate is being issued under th~.,~~ion that you are required to submit following documents at th~lfrfte of submission of application for grant of Form 10 License:. () Revised Labels in original for the proposed product bearing import lie. no. and name and address of the importer etc. as per Rule 96 of the Drugs and Cosmetics Rules 1945 (as the same has not been mentioned 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 any other 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)

28 GOVERNMENTOFINDIA Central Drugs Standard Control Organisation Ministry of Health & Familv Welfare FDABHAJ,VAN,KOILA ROAD, NEW DElHI-ll0 002 lindiaj Form 41 (See rule 27-A) Registration Certlficate issuedfor import of devices into India Under Drugs and Cosmetics Rules, /945 Date:~2 tifh 201l 1. 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. >,;';j,( " r--:\_i, /-;;'"/,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,~o e,1.~ Iyr~o.(~ ~o 0«" '9«;, i' \. Date: ') c,.,dj) ".f'1-» L. l' f"\\ 1\ 1..iJ {", $ 0 u z LlCENst;THORITY Seal/Stamp Ur. N. SINGH Drugs Co ' General (I~dia) Ole. Gee Health ServIces Ministrv Co' & FamilyWelfare FDA; ilia Road, I.T.O.,

29 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministrv 01 Health & Familv Wellare FDABHAWAN, KOILA ROAD,NEW DELHI UNDIAJ NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO. MD-436 DATED VALID UPTO NAME OF THE PRODUCTS: 1. Hydrophilic Acrylic Intraocular Lens (Foldable Intraocular Lens inclusive of Dualtec Kit & Cartridge). 2. PM MA Intraocular Lens. ITEM(S}l~NLY Off~\C ~,!J New Delhi Date: 2,4 1" L1CEN~AUTHORITY Seal/~ta[Jlll. SINGH. Drugs Co:'r General (In.dlC Dt ~ (':'0 '-lealth Service t;.. 7~., W If Mlnis!:'y & Family e cnj\ - 't1a Road, l.t.l I - :