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-ll0002 ps.bio-rad Laboratories(lndia )Pvt Ltd., Plot No.86-87,Udyog Vihar,Phase-IV, Gurgaon. SUB: - Registration of Mls.DiaMed GmbH,Pra Rond 23,1785 Cressier FR,Switzerland under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Sir, \~~ (,,,0\\ - Please refer to your application no. Nil dat~-lil.:>~ad~o10 received by this office vide dairy No.61507(FTS No.233) dated Jlfjfl~ and reply received by this office vide diary no.6047(fts No.10325) date~'?o2/2012 on the subject cited above. 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, ifany, in respect of the payment of fees and submission oftr6 challan, shall be settled between the bank and the applicant. 3. The medical device will be required to be withdrawn from sale from the market in case any undesirable reactions due to failure of the device or its accessories are brought to light at any stage.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. Each consignment of the medical device(s) to be imported by you shall be accompanied by a test / analysis reports.

2 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 Annexure-B of schedule D-II duly filled as per performa preceribed in the Drugs and Cosmetic Act & Rules thereunder at the time of submission of your application for the grant.&horm-lo License(As the same has not been submitted) (;~ C;O~-v Please note that Registration CePt1i~e issued is liable to be suspended I cancelled, if any of the condition stipula~~bove 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.~ingh) Drugs Controller General(India)

3 GOVERNMENloF INDIA Cenlral Drugs Siandard Conlrol organisalion Minisln of Heallb & Familv Welfare FDA BHAWAN, KOILA ROAD, NEW DELHI [INDIAJ Form 41 (See rule 27-A) Registration Certificate issuedfor import of devices into India Under Drugs and Cosmetics Rules, n r-r'" 7' 01'» Registration Certificate No.: CD-91 Date: /':',J'i'\ '" " Mls.DiaMed GmbH,Pra Rond 23,1785 Cressier FR,switzerland has been registered under rule 27-A as a manufacturer and is hereby issued this Reg~iA~JV Name(s)ofdevices(s), whichm~;:: ~erjjli Please refer to the enclosed hst<.). egis~:~~~b. ~\C ~ ~ lfj'\f. ~ ~ V' This Registration Certif~e shall be in for 12 to ~ unless it is sooner I..U 0 suspended or cancelled Wider the rules. Z This Registration Certificate i~g~c: MIs. Bio-Rad Laboratorie ndia Pvt Ltd responsible for the business ~ities of the, in all resp~ ~J-"""""""'''''''' This Registration Certificate is subje9,,(e the conditions stated overl~d specified in the Act and the Rules, from ti tp'pf; GO\lt.~~ ~ ej" to such other conditions as may be Date: Z LICEN OlJ;:AUTHORITY t;stamp Dr. G. N. SINGH Dru~;s Controller General (India) D'.c', Cen;::c: :l uf Health Servic,es Ministt"v of H: Jth &. Fami1;l \'J\f,;":~;re F.Ji... \<Oll3 Hoc'" LT.O. c ',hi

4 GOVERNMENT OF INDIA Cenlral Drugs Siandard Conlrol organisalion Minislrlol Health & FaUlII,Wellare FDAlHAWAN, KOILA ROAD,NEW DElHI-ll0 002l1NDIAJ NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO.CD..91 DATED VALID UPTO DiaClon Anti A(Tube and Plate method)(blood Grouping Sera) 2. DiaClon Anti B(Tube and Plate method) (Blood Grouping Sera) 3. DiaClon Anti AB(Tube and..t~~iiq);l)mlood Group~~~ Sera) 4. DiaClo.DAnti D(IgM+I~'tUbe,Plate add~~~4)i(»iood GroupIng Sera) ~ '~~'t7 t\i\rrc:, 5. DiaClon Anti A,B,ntplate an' ) (Bloo~Grouping Sera) 6. Anti D(Tube and ~d meth '\ ping S~ 7. Anti AI, Anti-H ~ctin(blood era) a 8. Rare Blood Grouping sera z CD~ ~ ~. ~ ~ ~r Bft4.yQ.~ & OJ'. ~"'\:t:;-. iie:/il TH, GO\l'tS\~~ t~~mp LICENSIN~ORITY ",neral (India) ':~i;h Services 'arnlly \/Veifare Ftoad, LT.O. il0002

5 C9 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare Food and Drug Administration Bhawan Kotla Road, New Delhi ~S.Bio-Rad Laboratories(lndia )Pvt Ltd., Plot No.86-87,Udyog Vihar,Phase-IV, Gurgaon. SUB: -Registration of Mls.Bio-Rad Laboratories, 3, Boulevard Raymond Poincare, 92430, Marnes-La-Coquette, France having factory premises at M/s.Bio-Rad, Route De Cassel, Steenvoorde, 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 27/04/2011 received by this office vide dairy No.l9964(FTS No.28104) dated 28/04/2011 and reply received by this office vide diary no.56745(fts No.84235) dated 09/12/2011 o~ t~e~ub.e~~~above. Registration Certificate in Form 41 under the I$~\~~metics 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. I. 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 oftr6 challan, shall be settled between the bank and the applicant. 3. The medical device will be required to be withdrawn from sale from the market 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.

6 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 applica,nt 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. S. This Registration Certificate is being ~'s ~\nder the condition that you are required to submit Evaluation Report he following products at the time of submission of your application for t~ ant of Form-lO License(As the same has not been submitted)?~g /(~' S.No Product NAme 0"> No.of. Batches 1 Genscreen Ultra mv Ag- Ab(HIV Ag-Ab Elisa 4th generation) 2 Batches 2 Monolisa Anti-HBs Plus(Anti HBs Elisa) 1 Batches 3 Genscreen HIV Yz Version 2(HIV Yz Ab Elisa) 3 Batches 4 New Lav Blot I (HIV 1 Western Blot) 1 Batches 5 New Lav Blot II(HIV 2 Western Blot) 1 Batches 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. ~~gb) Drugs Controller Geneti(~~dia)

7 GOVERNMENT OF INDIA Cenlral Drugs Siandard Conlrol Organisalion Minislrv of Health & Familv Welfare FDABHAWAN,KOllA ROAD,NEW DElHI-ll0 002 IINBlAJ Form 41 (See rule 27-A) Registration Certificate isslledfor import of devices into India Under Drllgs and Cosmetics Rilles, 1945 Date: -_2~4"._/,,.- lolz Mis. Mls.Bio-Rad Laboratories, 3, Boulevard Raymond Poincare, 92430, Marnes-La-Coguette, France havin facto remises at Mls.Bio- t Cassel Steenvoorde France has been registered under rule 27-~~anufacturer and is e~lssued this Registration Certificate. ~G O~~+....'1 Name(s) of devices(s), which!!!p be importe,rati~~;g~~i~~ <' Please refer to the enclosed 1J~ (.~ \j ~ 1.\ \J" Q;:'"' v 'y R ::,..I, < - This RegistrationCertiGte shall be in for 012 to ~unless it is sooner suspendedor cancelledund~f1.5~ This Registration Certificat~ issued throu ufacturer or ~ authorised agent in India Mis. Bio-Rad Laboratorie:" ia Pvt Ltd. 0 Vihar P ~-IV Gur aon who will be responsible for the business acti~~ of the m~;~dia, in all r~cts. ()~ x,~' This Registration Certificate is subject to'y{~tm,o~~\6,~af and to such other conditions as may be specified in the Act and the Rules, from time to time. fl CDSCO. CDSCO \. I '~q.. r<!<!f Date: '2 Iye.L1H. G()'ll.""'" /-...\ LICENSI~THORITY Seal/Stamp Dr. G. N. SINGH Drugs Controller General (india) Ote General vf Heah'h Servic2s ~lijnjc/r,! of He3lth & Fi:'i\ ~-h::;\\l0"1, f<cu: ] :s:hi-"li

8 GOVERNMENTOFINDIA Central Drugs Standard Control Organisation Ministn of Health & Familv Welfare FDABHAWAN;KOllA ROD, NEW DRHI-110 OOUINOW NAME(S) OF MEDICAL DEVICES, WHICH MAYBE IMPORTED UNDER REGISTRATION CERTIFICATE NO.CD-94 DATED VALID UPTO Genscreen Ultra HIV Ag Ab(HIV Ag-Ab Elisa 4 th generation) 2.Monolisa HBs Ag Ultra(HBs_~~~~a 4 th Generation) 3.Monolisa HCV Ag Ab Us~~~~~R Elisa4 th Generation) 4.Monolisa Anti-~Bs ~~\Anti HBs,ElisaY.(?~ 5.Genscreen HIV Y2 ~rslon 2,.,b Ebs~.'0;'(' \Q)'~!( 6.New Lav BI.ot I (!*IV 1 W '1r. ~C~ (~~ c\ 7.New Lav Blot II. thiv2 W (; ~ 8.Monolisa Anti ItCv Plus V CV Ab Elia) CD5 bot0 Place: New Delhi Date: 6') l~, r:r 'j 1Z '- ''( t ~l '!~ LoU LICENstrnORlTY Seal/Stamp Dr G. ~I. S!NGH Drugs General (India) D:e. Ccr,c:, Health Services rv1inis"j" ;"amily Welfare F,),i\ i:1 r~oad. /.T.O.,110002

9 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 Dated 2. 4 /.1 1\ lol2, To ~Apex Diagnostics., 0 th FIoor,Malhotra Chambers, 31/33,Police Court Lane,Fort Mumbai ,Maharashtra. SUB: -Registration of Mls.INn Diagnostic Inc,1629,Fosters Way"Delta British Columbia, Canada V3M 687 and under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application no. ADIDCGIIRJd)\ dated 09109/2011 received by this office vide dairy No.42822(FiS~.62616) dated 14/09/2011 and reply received by this office vide FTS No.l~~ 'difted 15/03/2012 on the subject cited above. \~~~~ -:f",~ I("\\ \~ Registration Certificate in Form 4~nder 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 1 specifications mentioned in the Second Schedule of the Drugs and Cosmetics ActJ ISO 1 MDD 1 or such other standards or specifications approved by this Directorate. 2. Dispute, ifany, in respect of the payment of fees and submission oftr6 challan, shall be settled between the bank and the applicant. 3. The medical device will be required to be withdrawn from sale from the market 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.

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 foir he import of medical device(s) endorsed in the enclosed Registration Certificate s be considered for the issue of Form 10 license under the Rules This Registration Certificate is!!bi ~ssued under the condition that during the pendency of Registration, the appl' may be required to deposit inspection fee as stipulated under Clause (5) Of~.U. -A and enable inspection of manufacturing site by the officials Authorized for t urpose. Non-compliance to this condition as and when so directed would result' ncellation of Registration Certification. 8. This Registration Certificate is being 'issued under the condition that you are required to submit revised product inserts of all the proposed products mentioning the specificity(%) and sensitivity(%) in corelation with specificity(%) and sensitivity(%) criteria issued by National Institute of Biologicals,Noida at the time of submission of your application for the grant of Form-tO License(As the same has not been submitted) 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. G~ingb) Drugs Controller General(lndia)

11 GOVERNMENT OF INDIA Cenlral Druls Siandard Conlrol Organlsalion MlnlslnI 01Health & Famllv Wellafe FDAIOWAN, KOllA ROAD,NEW DElHI lindw Form 41 (See rule 27-A) Registration Certificate issued for import of devices into India Under Drugs and Cosmetics Rules, 1945 Date: 2 4 /... \.; J,,( ~ 1-.:.." ' Mis. IND Diagnostic Inc,1629,Fosters Way,,Delta British Columbia,Canada V3M 6S7 has been registered under rule 27-A as a manufacturn~'tiooqed r.. this Registration Cert!!!~ate. :\~. rlr,o.. A.f'\\.. 't:) ", S~ ~. r>">l~'l S' Name(s) ofdevices(s), whichm~mported under. 'sregistratio~~~: ~ Please refer to the enclosed li~ 0t \f ~-1:: ~ ~ This Registration Certif~ shall be in fo 12 to ~ unless it is sooner. W 0 suspended or cancelled U1tderthe rules. Z This Registration Certificate iscg~c Mis. A ex Dia nostics 5 th or Malhotra Fort Mumbai Maharashtra who will be re::z.-~siblefor th fthe manuf1. er in India, in all respects. "'~ 5<." 1>;-. -~~-~-l5i ~ 0' This Registration Certificate is subj~ &e conditions stated overl~d to such other conditions as may be specified in the Act and the Rules, from tilfe4t.t)tjlf; GO\lf\\\'\~ Place: New Delhi Date: 2 4 ~\,;.~2012" LICENSING~HORITY Seal/Stamp Dr. G. N. SINGH Drugs Controller General (India) Ole. CpneraJ uf Health Services Mlnic,try of Health & Family V/c;ifare FDA Bi;-'v'Cl, I<otla R02d, I.T.O. '.':21hi

12 GOVERNMENT OFINDIA Central Drugs Standard Control Organisation Ministrv 01Health & Famllv Welfare FDABHAWAN, KOlU ROAD, NEW DElHI IINDIAl NAM:E;(S)OF MEDICAL DEVICES, wmch MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO.CD-51 DATED VALID UPTO Date: 2. 1\ P",J., 7,;D1Z " r'd 1\ 11.. LICENSING~UTHORITY :t~'i'1j'1\singh Druos Controiler General (India) Dte- Ger'.>rai vf Health Services Minis":'!,)',,,\,:)th & FarnilyWelfare F 'JP : :<oua Road, 11.0, '01:"

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-ll l' DR "01",1. ~. L' '- To ABioMerieux India Pvt Ltd., A-32,Mohan Co-operative Industrial Area, New Delhi-ll0044. SUB: -Registration of MIs.BioMerieux S.A chemin de I'Orme,69280 Marcy L' Etoile,France under the provisions of Drugs & Cosmetics Rules for the purpose of import of medical devices in India. Please refer to your application no.bmx/34111 dated 01/07/2g~~eceived by this office vide dairy No (FTS No,44659) dated 0 1/05/20 ll,~ re'ply received by this office vide diary no.8879(fts No.14250) dated O!L~2'M2 on the subject cited above."~\\<~v:;>. ""V,:,~ (n\:f) Registration Certificate in Form 41 under the '!:frugs 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. I. The medical device(s) shall conform to the standards / specifications mentioned in the Second Schedule of the Drugs and Cosmetics Act! ISO / MOD / or such other standards or specifications approved by this Directorate. 2. Dispute, ifany, in respect of the payment of fees and submission oftr6 challan, shall be settled between the bank and the applicant. 3. The medical device will be required to be withdrawn from sale from the market 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 andenable~.n.s ~ion of manufacturing site by the officials Authorized for this purpose. Non-~~ in~e to this condition as and when so directed would result in cancellati\~~~ ation Certification. 8. This Registration Certificate is b0itsued under the condition that you are required to submit colored labels of all the proposed products as per Rule 96 of Drugs and Cosmetic Act & Rules thereunder at the time of submission of your application for the grant of Form-tO License(As the same has not been submitted) 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 Gen al(lndia)

15 GOVERNMENT OF INDIA Cenlral Drugs Siandard Conlrol Organisalion Minisl" 01Health & Famllv Wellare FDAIOWAN, KolLA ROAD,NEW DRHI l1NDIAJ Form 41 (See rule 27-A) Registration Certificate issuedfor import of devices into India Under Drugs and Cosmetics Rules, 1945 Date: 2. 4 t.::n 201Z Mls.BioMerieux S.A chemin de I'Orme,69280 Marcy L' Etoile,France has been registered under rule 27-A as a manufacturer and is hereby issue~~t~certificate. S"\~ fro _,: Name(s) ofdevices(s), which m~~ported under. Registration~l\~ ct~'«please refer to the enclosed list<:) (J;f '\f '~"t: ~. ~ ~ 7' This Registration Certif~e shall be in fo 12 to :Sunless it is sooner ~ 0 suspendedor cancelled iutder the rules. Z This Registration Certificate iscqsr~ is authorised agent in India MIs. BioMerieux India Pv' td. A-32 Moh w Delhi-l10044 who will be responsible for the busine~ "tivities ofth dia, in all re~cts. ~ [,"-?Jj... -~~flol""'4-~ 0' This Registration Certificate is subjjd.,,(ethe conditions stated OVer1Rt~d to such other conditions as may be specified in the Act and the Rules, from ~~tjtpf; GO\lt.~\'\~ ! LICENJ:;:uTHORITY SeaVStamp Dr. G. N. SINGH Drugs Controller General (India) Dte General uf Health Services Ministry of Health & Family Weifare FDA Bri3waD. Kalla Road, I.T.O. ILw belhi

16 GOVERNMENTOFINDIA Central Drogs Standard Control Organisation Minist" of Health & Familv Welfare FDA BHAWAN, KOrLA ROAD, HEW DELHI HDIAJ NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO.CD-14 DATED VALID UPTO VIDAS HIV P24 II 2. VIDASHIV P24 II Confirmation 3. VIDAS HBs Ag Ultra 4. VIDAS,:U~~... Ultra Confirmation 5. V~~~fVI.JD'i1l)~a 6.$ID~SHI~,UO QU~,..,(~(:}p<1 J?Nucb~.. ', HIV~2~.~C\~ '~5) i!. HepaD' g Ultr~f 3]9. Virono g/ab 5 u 10. VIDAS Total Quiek(HBST) (jj)loc~ {J)5C 'L!12. ~ VID -HBe ::.::: ~. ~. VIDA: Total I~ fft.~epan i-hbc ~fili-form OJ' :<"S~ ITEMS (V~m~b~t~~ Place: New Delhi Date: 2 4 i\; n ZOlZ LICENS~ORITY Seal/Stamp Or. G. N. SINGH Drugs Contr('\ier General (India) DIe Genp,r2' 'ij Health Servlce: s t of & :=amily Wellare M IniS ry 0 FDA ehs'/ ",\ia Road, L~,:<i

17 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 lolz ~s.johnson & Johnson Limited., 32/33 A,GR.Floor,Deonar Village Rd., Deonar,Mumbai Maharashtra SUB: - Registration of Mls.CSL Limited,ABN ,45 Poplar Road,Parkville, Victoria,3052, Austraila 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 01/0612g.11i,~~e~',~,Jl by this office vide dairy No (FTS No.42326) dated 22/06/20 I}<zattg. reply received by this office vide diary no.7834(fts No ) dated 2~~~Yon the subject cited above. 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 1 specifications mentioned in the Second Schedule of the Drugs and Cosmetics ActJ ISO 1 MDD 1 or such other standards or specifications approved by this Directorate. 2. Dispute, ifany, in respect of the payment of fees and submission oftr6 challan, shall be settled between the bank and the applicant. 3. The medical device will be required to be withdrawn from sale from the market 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 1analysis reports.

18 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 Performance Evaluation _~~~or all the proposed products from National Institutte of biologic!ls,~ '\tt vthe time of submission of your application for the grant of F0rP\-o~icense(As the same has not been submitted) O'f"t~ 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. G.~~ngh) Drugs Controller Genti~~dia)

19 GOVERNMENT OF INDIA Central Drugs Standard Control Organisation Ministn 01Health & Familv Wellare FDAIHAWAN,lOlU ROAD,NEWDElHI-ll0 002l1NDIAJ Form 41 (See rule 27-A) Registration Certificate i~suedfor import of devices into India Under Drugs and Cosmetics Rules, 1945 Date: 2 4 f?fllz c. ~ ' 'H. ""'.u MIs. CSL Limited,ABN ,45 Poplar Road,Parkville, Victoria,3052,Austraiia has been registered under rule 27-A as a manufactur~'t5~hl:fwned this Registration Ce~~~~late. S'\~!RO~{~,:f? '-,', ",p.~s ~ ig"j' Name(s) of devices(s), which m~~.mported under!his ~egistrat~~ ;.1{f~"V?": '~- Please refer to the enclosed list().<~ cor \S ~A 'I Y 'v;. ~ ~ ~7 This Registration Certif~e shall be in for 012 to :Sunless it is sooner ~ 0 suspended'or cancelled under the rules. Z This Registration Certificate iscg~c MIs. Johnson & Johnson ited. 32/33 A Maharashtra who will be re~9jlsible for th fthe manuf~ rer in India, in all respects. ~ /~ "Y}- -~("q--il-61 ~ Cf 5.. This Registration Certificate is subje'9 A e&e conditions stated overl~d to such other conditions as may be specified in the Act and the Rules, from ti~f1lpf; GO\lt.~~~ Place: New Delhi Date: ,\ LICENi'AUTHORITY Seal/Stamp Dr. G. N. SINGH Drugs Controller General (India) ii' ':J. General uf Hec:lth SerJices,'itly of Health & F",'T,ik V""ifare '!\ 8haw"n, Kotl,: :. 1.,J. NewOelhic!

20 GOVERNMENT OF INDIA Central Druus Siandard Conlrol Organisalion Minisln of Health & Familv Welfare FDABUWAN, KOTLAROAD,NEW DELHI NDIII NAME(S) OF MEDICAL DEVICES, WHICH MAY BE IMPORTED UNDER REGISTRATION CERTIFICATE NO.CD-25 DATED VALID UPTO RhESOLVE Anti-B(Blood Grouping Sera) 2. RhESOLVE ~\\~~9d Grouping Sera) 3. RhES<?!,~~Xnti-A(BloOd ~~ping S~~ 4. RhESO~'VE Anti-. (Bloo~~o~ Sera) '".... e'~~ ITsMs (FO ".,. ((j\r~~ ~ ~ 0 u z Date: "4 i\ L ~ r; s J::l LICENSI ~~ i"uthority Dr. G. N S!NGH Drugs Co,." ell,, Ceneral (India) Dte, Gene c>!lthservices Ministry of ':amily Welfare FDA 8h.... F<oad, I.T.O, K:.,. ','\'10002