CentralDrugsStandardCo · PDF fileCentralDrugsStandardControlOrganisation ... Mediquip Sdn.Bhd. POBox 2501700 Kangar, ... case any undesirable reactions due to failure of

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Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

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

~TYCO Healthcare India Pvt. Ltd.,"DOSHI TOWERs" 6TH FLOOR, Doshi Towers,Poonamallee High Road, Chennai - 600010

SUB: -Registration of Mis. Mediquip Sdn. Bhd. PO Box 2501700 Kangar, PerlisMalaysia under the provisions of Drugs & Cosmetics Rules for the purposeof import of medical devices in India.

Please refer to your application no. THCIIIRA/Re-Reg MD-333 dated 09106/2010received by this office vide dairy no. 27364 dated 09106/2010 and reply received by thisoffice vide diary no. 56536 dated 2/1212010 on the subject cited above.

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

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

3. The medical device will be required to be withdrawn from sale from the market incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage. This Directorate should be informed of adversereports on the medical device, if any.

4. This registration in no way relieves you of the responsibility of complying withother provisions of the Drugs & Cosmetics Act and Rules thereunder, and anyother provisions of any other Act and Rules applicable in the matter concerned.

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

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

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

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

(Dr. S rinder Singh)Drugs Controller eneral (India)

----------------------~-

GOVERNMENT OF INDIA

Central Drugs Standard Control OrganisationMinistry of Health & Familv WelfareFDA8ftAWAN, KorLA ROAD,NEWOElHI-llo OOZUNDIAJ

Form 41(See rule 27-A)

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

Date: 1 9 Ji~iN2011Mis. Mediguip Sdn. Bhd. PO Box 2501700 Kangar, Perlis, Malaysia has been registered under rule 27-A

as a manufacturer and is hereby issued this Re8i,$P-iiPjql1rC$e.rtijiYl,lt~.1).\1~:--",+LJ .~'"", J-.,." -~'",,"'\",,/ l\X l"i,;>,,~~

}.".-,....~,».;:" -"'~//./

": ,A,«f' ''''•.,.. /,.;'\

Name(s) of devices(s), which m~~'r)-fmported underth!~JZegistration CettJ.!i~ate:Please refer to the enclosed list {':f . .~':<:1'-'><, .~,:; ~~-~

This Registration Certifi~~: hOE t; 0 31-12-;6]:3 unless it is sooner• ' ...•..cw".,

{ ~0:J :,_'

suspended or cancelled iu~derthe rules. ;:'.

This Registration Certificate is issued throug~:t-

Mis T co Healthcare IndiaMvt. Ltd. "DJ/.

High Road, Chennai -600011l~ho will be r""'>C-

"..-

FLOOR m~hi Towers Poonamallee~~<./

usiness acti"t¥les of the manufacturer in

"-" ';~'"'v...._--:~~/"t---- , ',. ,\<,'i:\\:, -.

This Registration Certificate is subject to ~~~'~bJdtttpiisGt'li~a1e~~;1:~fand to such other conditions as may be

specified in the Act and the Rules, from time to ~Une.s",i>JlO ON/;?o(

sf 0."

{~<l \

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1 9 Jft,N l011 LICENSING AUTHORITY

Seal/Stamp

1. The Registration Certificate shall be displayed at a prominent place by the authorised

agent.

2. The manufactw:er or his authorised agent in India shall comply with the conditions of

the import licence issued under the Drugs and Cosmetics Rules, 1945.

3. 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.


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.


immediately in writing in the event of any change in the constitutiOIi 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

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.

GOVERNMENT OF INDIA

Central Drugs Standard Control OrganisationMinistrv of Health & Familv WenareFDA8HAWAN, KOTLAROAD,NEW DElHI-ll0 002l1NOIAJ

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

REGISTRATION CERTIFICATE NO. MD..333 DATED 01.01.2011 VALID UPTO

31.12.2013

New Delhi

Date: 1 9 Jf~.N 2011Jv'\J

LICENSING AUTHORITY

St3\1b --\' \')..~'2,,'




DatedFile No.: 31-22-MD2006-DC(Re-registration 2009)ENDIII 1 9 JAN 2011

~ St. Jude Medical India Private Limited,A&B, 2nd Floor," Brij Tarang"Greenlands, Begumpet, Hyderabad 500016

SUB: -Registration of additional products under Endorsement No. 03 to R.C. No.MD-22 of Manufacturing Site Mis St. Jude Medical Inc. 14901 De Veau PlaceMinnetonka, MN 55345-2126 USA under the provisions of Drugs &Cosmetics Rules for the purpose of import of medical devices in India.

Registration Certificate in Form 41 under the Drugs and Cosmetics Rules is issuedherewith for the manufacturing site alongwith the name(s) of medical device(s) importedunder the said Certificate subject to the following conditions.

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

2. Dispute, if any, in respect of the payinent of fees and submission of TR6 challan,shall be settled between the bank and the applicant.



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

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

7. This Registration Certificate is being issued under the condition that the youare required to submit 'detailed PMS data duly attested by manufactureralong with corrective action in respect of complaints received' at the time ofsubmission of application for grant of Form 10 licence. (as you havesubmitted a summary of the same without corrective action and the same hasnot been attested by the manufacturer)

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

(Dr. S rinder Singh)Drugs Controller General (India)

GOVERNMENT Of 'ND'IICentral Drugs Standard Control Organisation

Ministry of Health & Familv WelfareFDA BHAWAN, KOrlA ROAD, NEW DELHI :"'110 002 [lNDIAl


ENDORSEMENT NO.3 DATED TO REGISTRATION

CERTIFICATE NO. MD-22 DATED 08-09-2009 VALID UPTO 30-06-2012.

Place: New Delhi

Date: ~19 JAN ZOI1

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I



Food and Drug Administration BhawanKotla Road, New Delhi-110002

1 9 JAN lOll

~ Baxter (India) Private Limited,2nd Floor, Tower C, Building 8,DLF Cyber City, DLF Phase II, Gurgaon 122002

SUB: -Registration of Mis. Baxter Healthcare Corporation 1900 N. Highway 201Mountain Home, AR 72653-2497 under the provisions of Drugs & CosmeticsRules for the purpose of import of medical devices in India.

Please refer to your application dated lO/Feb/2010 received by this office videdairy no. 6433 dated 10/02/2010 and reply received by this office vide diary no.54004dated 18/11/2010 on the subject ci

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

2. Dispute, if any, inrespect of the payment of fees and submission of TR6 challan,shall be settled between the bank and the applicant.



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



8. This registration certificate is being issued under the condition that you arerequired to submit the 'Detailed Biocompatibility study report and RiskManagement Report in respect of the proposed product at the time ofsubmission of application for the grant of Form 10 License. (as you havesubmitted only summary of the same)

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

(Dr. S rinder Singh)Drugs Controller General (India)

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministrv of Health & Familv WelfareFDASHAWAN, KOrlA ROAD,NEW DELHI-110 002 UNDIAl


REGISTRATION CERTIFICATE


Date) 1 9 JAM 20111. Mis. Baxter Healthcare Corporation having factory premises at 1900 N. IDghway 201 Mountain Home,

AR 72653-2497 has been registered under ru~e(41'3:-4\ilIS. ~0tp~1.!facturerand is hereby issued this Registrationf\",t~'<tt....J" '1("\''''''/ ~~-'\'_..,//\/ '/"'j

Certificate. ....") v.' • f fyi.) i

...gFFICE/.C;QPY «2. Name(s)ofdevices(s),whichrri;~'beimporte . .•.. . n

~<··",,/'/4

Please refer to the enclosed lii' .'~-"''';'''''~

r'o",,:-

3. This Registration Certif"tt:gateshall be in for

fP@ .~ ;/" f·······suspended or cancelled unde,[Jt~it!r!4:M

V'"

anufacturer~;his authorised agent in India

8 BD Cyber City ,DLF Phase II

Gurgaon 122002

respects.

,~c,~,_,

oDthe manufacturer in India, in all

This Registration Certificate is subject to the com!Wons stated overleaf and to such other conditions as may beb';<'~""O "1lIo(

specified in the Act and the Rules, from tw~ t' 0..\" ~~ '6u z

Place: New Delhi

Date: "1 9 JAN 2011 LICENSING AUTHORITY

Seal/Stamp


agent.

2. The manufacturer or his authorised agent in India shall comply with the conditions of






















5. The manufacturer or his authori~edagent 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


takes place, the current Registration Certificate shall be deemed to be valid for a





GOVERNMENT OF INDIA,

Central Drugs Standard Control OrganisationMinistry of Health & Familv WelfareFDI IHIWIN, KOILAROAD,NEWDELHI-ll0 OOZlINDIAJ


REGISTRATION CERTIFICATE NO. MD-730 DATED 01.01.2011VALID UPTO

31.12.2013.

New Delhi

Date: .1 9 J.4N 2011 LICENSJG AUTHORITY

,\<t:" S ~\S, \b \'l0\1:



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

Dated '1 9 J.AN Z011

~s Becton Dickinson India Pvt. Ltd.,5th Floor, Signature Towers II, South City-lGurgaon-122001 Haryana

SUB.:- Registration of manufacturing site of Mis Becton Dickinson and Company,BD Medical Diabetes Care, 1 Becton Drive, Franklin Lakes, New Jersey 07417,having factory premises at Mis BD Medical Diabetes Care, 1329 West Highway # 6,Holdrege, Nebraska, 68949, USA, under the provisions of Drugs & Cosmetics Rulesfor the purpose of import of medical devices in India.

Please refer to your lett r@~~~~~<\i~112/2009 received by thisoffice vide Diary No.5' '11f2'/2M~ rlpl es received by this officevide diary no. 25711 dated 31/05/2010, 32876 ate 14/07/2010, 40206 dated25/08/2010 and 48755 dated 15110/2010 regarding the cited subject above.

Registration Certificate in Form 41 under the Drugs and Cosmetics Rilles isherewith f()r-tne maIJ:ufa.cturing 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 1specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Act! ISO 1MDD lor such otherstandards or specifications approved by this Directorate.




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

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

8. This registration certificate is being issued under the condition that you arerequired to submit the revised labels clearly specifying the storage conditionsof the proposed product at the time of submission of application for grant ofForm 10 License.

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

(Dr. Su inder Singh)Drugs Controller General (India)


Ministry of Health & Family WelfareFDAINAWAN,KOTlAROAD,NEWDElNI-ll0 002 [INDIAJ



Date:) 9 J"N- 2011re 1 Becton Drive Franklin

e ical Diabetes Care 1329 West

registered under rule 27-A as a

2. Name(s) of devices(s), which may be

Please refer to the enclosed list

4. This Registration Certificate is.issued through the office of the manufacturer or his authorised agentin India MIs. Becton Dickinson India Pvt. Ltd., 5th Floor , Signature Towers II, South City-1Gurgaon-122001 Baryana who will be responsible for the business activities of the manufacturer inIndia, in all respects.

5. This Registration Certificate is sUbjeC~p~~eDc"O~ons stated overleaf and to such other conditions

as may be specified in the Act and tht$"'Rul ti~e to time.u z

CDSCO DSCO\, ~

':J'~)- ~....m d-~Cl< .f

"'<~LlH.GrYJt~"''''

1 9 JAN 2D11Seal/Stamp

::gT. \~f{;::s:r ~DI. 3URINDER SINGH

~ ~~ (~\~COntrollerfindio)~-' 'mn ~~

Ute. Genefi" [If Hea/!+' S","\"c'.aF,FI;lA ""'<aIMil", K;:'ltii' R<;i.\i~i,

/l4iS~'~>iJlflk 1,00"2


agent.


the import licence issued.under-the Drugs and Cosmetics Rules, 1945.

3; The manufacturer or his authorised agent in India shall inform the licensing authority



















(ii) of sub rule (3) of rule 24-A











Ministrv 01 Health & Familv WellareFDABHAWAN,KOTIAROAD;NEW DELHI-110002 [INDIAJ


REGISTRATION CERTIFICATE NO. MD 825 DATED '1 9 JAM 2.{1f~IDFROM

15-12-2010 TO 14-12-2013.

Date: 1 9 JAN 2011Seal/Stamp

m.~.,...~~j\ " D~. SUf{INOER SINGHA~,~~ {~rt'l"),'1)"JgsConlrcUer (India)

. r4R:>..:I1 Bar '1f>lf-1e::m~'-T'tte. General of Heallt, Services

::OA B.haw.·.e. n;,.Kotla Rpad.",.>"" jj~~n'-11Mtl?

~ \..\,Cl <' '-\'":1-'l ,0q \.'2-0\ <:



Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

1 9 JAN 2011

~ Labindia Healthcare Pvt. Ltd.,372 Udyog Vihar, Phase 2,Gurgaon, 122016, Haryana.

SUB: - Registration of Mis KCI USA Inc, 4958 Stout Drive, San Antonio, TX 78219USA, having factory premises at Mis Polymedics BVBA, 1031 Ambachtslaan,Peer, Belgium 3990, under the provisions of Drugs & Cosmetics Rules for thepurpose of import of medical devices in India.

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

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


3. The medical device will be required to be withdrawn from sale from the market incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage. This Directorate should be informed of adversereports on the medical device, ifany.


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


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

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

(Dr. Su inder Singh)Drugs Controller Gtmeral(lndia)


Ministrv of Health & Family WelfareFDAIHAWAN, KOrlA ROAD,NEW DE1HI-ll0 002 lINDIAJ


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

1 r. J A 1\1 ~/unl1Registration Certificate No.: MD-792 Date: '::; fWll _

1. Mis KCI USA Ine, 4958 Stout Drive, San Antonio, TX 78219 USA having factory premises at Mis

Polymedies BVBA, 1031 Ambaehtslaan,Peer,",B:elaium,c3990, has been registered under rule 27-A as a:~\.) .,. ·~f·-',.~ -S'."Ie,,"''' ,,.. '"_w./'-'f-'-l---"''',

manufacturer and is hereby issued .' '.'

2. Name(s) of devices(s), which

Please refer to the endosed'1ist,-"'·'"L •

.,.~.,.o-·'

4. This Registration Certificat~;;is issued throu

Mis. Labindia Healtheare PW.,Ltd. 372

responsible for the business acti~ities of the m~iitif~bthre~;iiflndia, in

5. This Registration Certificate is subject to thecbitditigJ1s'stated' overleaf and to such other conditions as may

be specified in the Act and the Rules, from tims'Rb<2time.s~~~"o o"'r~o(

Q",~(j 01'<;;,

I ~~~ 0u z

Date: 11 9 L-1~' 'alloJ /'i i'j •.•LICENSING AUTHORITY

Seal/Stamp

,gr. ~~Dr. 3U~IN['IER SINGH

..[).) P-1~ ('llm'1\/r)nl\l6 Conl""ilr IlNlio)~Tff'7{ ~ l4t>if~1.SfiP:?iQ

Ott. Gerl6fa! 01 H"'8tff;.3~rvi06>SF=QA Bhaw",..., i'(c,tla Ro.a<'1,

tll_ C"'lfil- 1'0OO;Ji


agent.













including the withdrawal of the device from Indian market








subrilittirig a separate applicatiollaloiigwith the registration fee, as specified in clause












Minist." 01Health & Familv WellareFDAIHAWAN, KOILA ROAD, NEW DElHI-ll0 002 lINDIAl


REGISTRATION CERTIFICATE NO. MD-792 DATED 01.01.2011 VALID UPTO

31.12.2013.

S.No.1.2.

Descri ptio'1::,VAC WhiteE:cam Sn1'tl

}'"%""'c -',

VAC Whit~oam Larg::':' ITEM"

Cij,t~logue No.M6Zis033/10M62~~034/1 0

-"'M'/"

Date: 1 9 JAN 2011




To_~/s.RFCL Limited

A-3, Okhla Industrial Area,Phase-I, New Delhi

Dated 1 (\ ,f, M ?n'1:J •..:'1111 L L I

SUB: -Endorsement No.1 to R.C. No. CD-31 of Manufacturing Site Mis. BIOKITS.A Can Male sin, 08186, Llica d Amunt, Barcelona, Spain under theprovisions of Drugs & Cosmetics Rules for the purpose of import of medicaldevices in India.

Please refer to your application dated 04/11/2009 received by this office vidediary no. 45692 dated 04/11/2009 and reply received by this office vide diary no.38883 dated 16/08/2010 and 51034 dated 28/1012010 on the above noted subject.

Registration ~cate in ~ mefilli.1Cosmetics Rules isIssued hereWith for the m l@eaG~trf' lIe name(s) of medIcaldevice(s) imported under the ~ ~ '*"':i ~t to tire fU lowing conditions.








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

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

"r·( t'.,. 1 , ..•

"Pi! "1" "« '~.:J # " ;'::1" 1'{.J- t I" '.1 0'

f I -r.',' , : ;;'4, •

GOVERNMENT OF INDIACentrallrugs Standard Control Organisation

Ministrv of Health & Familv WelfareFDABHAWAII,KOTlAROU. NEWDELHI-110 012 IINDIAl


REGISTRATION CERTIFICATE NO. CD-31 DATED 05.11.2009 Endorsement No.1

Dated1 9 JAN ZDJ1VALID UPTO 31.05.2012.

CDS

Date: :'1 9 JAN lO',

GOVERNMENT Of INDIA

Central Drugs Standard Control OrganisationMinistrv of Health,:&familv Welfare

'J

FDAIRAWAN, KOllA ROAD,NEVIDElHI-ll0102 UNDIAI



Date: 1 9 JIJ, ~J.ZOff1. Mis. Aaren Scientific, having factory premises at 4290 E. Brickell Street, Building A, Ontario,

California 91761 USA, has been regist~~~g,ff~;~f)1lt'f1i}:s a manufacturer and is hereby issued this"'., \ -'>, loyc'· " , "'.>,-,,- :fV f ._{-~i

Registration Certificate. M .,i"'~ ,

0"-'-,.,';;;;'

busines~.~fivities of the manufacturer in

2. Name(s) of devices(s), which

Please refer to the enclosed

3. This Registration Certif&;ateshall be in for( __ .J

4. This Registration Certificate;is issued throug

Mis. E silon E e Care Pri~te Limited 6"pJ'~

Kandivali East, Mumbai-400U!'P;,hO willIndia, in all respects. . >

5. This Registration Certificate is subject to the

specified in the Act and the Rules, from tim.~JQlttiftlEw~o,oQ"'" '9",

I' \.~ "6u z

Place: New Delhi

Date: 1 9 JAN ZOu


agent.

































Ministrv of Health & Familv WelfareFDAIHAWAN, KOTU ROAD,NEWDElHI-ll0 002l1NDIAJ



30.06.2012.

S--\bO~J.D\\\,LolC

Central Drugs Standard Control Organisation ~.Directorate General of Health Services



1 9 JAN 2011

To~ Abbott Medical Optics Private Limited,

No. 91, G.N.T. Road, Madhavaram,Chennai-600110

SUB: -Registration of Mis ABBOTT MEDICAL OPTICS INC. (formerly known asAdvanced Medical Optics Inc.) 1700E St. Andrew Place, Santa Ana,California 92705, USA having factory premises at Mis AMOMAUFACTURING SPAIN, S.L, Crta. Fuencarral A, KM 15.4, 28100Alcobendas (Madrid), Spain under the provisions of Drugs & CosmeticsRules for the purpose of import of medical devices in India.

Sir,

vided~ea:r~~;;~~~:da?s~~l€.:~ya r;:j~~~:~~~°d~;;no.290 14 dated 18/06/2010, 44113 dated 17/09/2010 and 51603 dated 20/11/2010 on thesubject cited above.

Registration Certificate in- Form 41 under the Drugs and Cosmetics Rules isherewith 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 otherstandards or specifications approved by this Directorate.








(Dr. rin r Singh)Drugs Controller General (India)

GOVERNMENT OF INDIA,Central Drugs Standard Control Organisation

Ministrv 01Health & Familv WellareFDABHAWAN,10Yli ROD, NEWDElHI-110 002 [INDIAl


1. MIs Abbott Medical Optics Inc., (Formerly known as Advanced Medical Optics Inc.) 1700E St. Andrew

Place, Santa Ana, California 92705, USA~¥~~r:(apt9ffF premises at MIs AMO MAUFACTURING~' ,-~'j,_1_,f ;:_h'~_; ", Lf' 'c'<w, \ __ ,.Ff~t>;<' :]-'"

SPAIN S.L Crta. Fuencarral A h,o •. d , ' .j . "}" , • S ain has been registered under

rule 27-A as a manufacturer and e~~t1CQlt1l:) #.;":i-:'-,j~-:'-""::;;kj, ..:, :,,: " "

suspended or cancelled ullger the rules.:-,,"'°'::1';-~:~<';',

~~~i~

ion Certific~{¢:2. Name(s) of devices(s), whiG1l~ay be impo,,>'''4<_

Please refer to the enclosefList-",,'<0

3. This Registration Certificate1'S"1: 8':L.•.t~2'013 unless it is sooner"I ,..,•...:".••l;

4. This Registration Certificate i(J~ued through anufacturer ot'JIis authorised agent in India

MIs. MIs Abbott Medical Opti{~Pi"ivate LinliltlJ'Iii'. 9;1;i<;~!N.T.Road;',~dhavaram,Chennai-600110

who will be responsible for the busi~e~~a~tiyities of the manufact4r¢r;T~India, in all respects.c· ,-,. ;.,- -'.-. "N, ". "";,-:,-.,,,

5. This Registration Certificate is subject to the cooo~tions stated overleaf and to such other conditions as may be~s~~"o 0"'7>10(

specified in the Act and the Rules, from ti~-:gt' 0s>G;.'1< •

ff %is "5u z

Place: New Delhi

Date: i l' 9" ~p\ M 2011..Jrin LICENSING AUTHORITY

Seal/Stamp51". ~~ ~Dr. SURINOE:R. SINGH

2$,citt~ l~~ C~!lnlh!~n ~i q~;fZ1iE;~i

Ole. Genera! ~ i-le@lth ~>B:vi09!>F~F.Bha_", koG~,,~;

I'Iililit 9."Ili~-<,~~


agent.













including the withdrawal of the device from Indian market




















Ministrv 01Health & Family WellareFDABHAWAN,KOllA ROAD,NEWDElHI-no 002 UNDIAJ



31.12.2013.

Date: 1 9 JAN 2011

5s'::).-.~'-'\~~,\\,lo\0




1 9 JAN ZOl1

To /'V"M/s. B.Braun Medical (India) Pvt. Ltd.,

5th Floor, East Quadrant,The IL & FS Financial Centre,Bandra Kurla Complex, Bandra (East),Mumbai-400051, India.

SUB: -Registration of Mis. B. Braun Medical, 204 Avenue du Marechal Juin - BP331,92107 Boulogne, Cedex, France, having factory premises at Mis. B.Braun Medical Industries Sdn. Bhd., Bayan Lepas Free Industrial Zone,11900 Penang, Malaysia, under the provisions of Drugs & Cosmetics Rulesfor the purpose of import of medical devices in India.

Please refer to your letter N~.eFiiii:l&G9Re't1 by this office videDiary No.8965 dated 24/02/2010 a-ct ••ply •••• i¥e<l ¥ide diM, N' .44972 and 55234dated 23/09/2010 and 25/11/201 0 respectively, regarding the above cited subject.

Registration Certificate in Form 41 under the Drugs and Cosmetics Rules isherewith for the manufacturing site aJongwith 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 1 specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Actl ISO / MOD / or such otherstandards or specifications approved by this Directorate.







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

(Dr. S ·rinder Singh)Drugs Controller General (India)

GOVERNMENT Of INDIACentral Drugs Standard Control Organisation

Ministrv 01Health & Familv WelfareFDABRAWIN, KOllA ROAD,NEWDElHI- no 002 IINDIAl



Date: 1 9 JAN. 20111. MIs. B. Braun Medical, 204 Avenue du Marechal Juin - BP 331,92107 Boulogne, Cedex, France, having

factory premises at MIs. B. Braun Medicallnd-ustries--5dn. Bhd., Bayan Lepas Free Industrial Zone,~J) ,~~\,~L,,:ii1'"'1,,, ~ ~r""..,. \«,.,il\[ i\,>:,:,

11900 Penang, Malaysia, has been r d-_~~_ nufacturer and is hereby issued this

Registration Certificate. FF IG.E.\C 0 Py::: ;)~"~.~- )

2. Name(s) of devices(s), whic;l{:;fiiaybe~",'~,

Please refer to the enclose&Jist"'"""'"""'«

3. This Registration Certificat~'Sh¢~ l1!:ef

'.~ ,.","," .'\.\;;'1;',,-""

4. This Registration Certificate is'.ss,ued through authorised agent in India

MIs. B.Braun Medical India Pvt:Ltd., 5th FIJ~~;~'E~t QiJia~ant, The_IL~& FS Financial Centre, Bandra

Kurla Complex, Bandra (East), Muinhai.,,400051 who will be re~pCtnsible for the business activities of the:'-,~,'\\'- ... ?'~ -- - '," .. ~._-- •• " ~

ss~~••oI\ROCONrol'o(

5. Th is Registration Certificate is subject to th--e c . . n~<itated overleaf and to such other conditions as may be~ tspecified in the Act and the Rules, from time t ~

CDSCO "

LICENSING AUTHORITY

:t~al'4§~ ~rh. SURl"~·.tr)rf? S~HG;....t

"'~E~3;?§J~~~~f:'

GOVERNMENT OF INDIACentral Drugs Standard comrol Organisation

Ministrv 01Health & Familv WenareFDABHAWAN,II'lA RIAD,NEWDElll-lll 112 [lNDIAl



31.12.2013.

" O~Et~,~''''''';''

Needles for i."'-0,."

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Date: i1 Q 1}. N t.~O11. J ..fA:

{!rf. 'fl1~ ~;r_, Dr. surrf;-.JDEP. Sii'~'~-;:~

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[~:~~~8~~f ~~;!;:~.,.-:c~,,~s~ :=DA 8haw8:;, ~<0~1r~~:,~-.:.

N<)w Delhi-1', 0002

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~.Braun Medical India Pvt. Ltd.,5thFloor, East Quadrant,The IL & FS Financial Centre,Bandra Kurla Complex, Bandra (E),Mumbai-400051, India.

SUB: -Endorsement No. 01 to R.c. No. MD-146 of Manufacturing Site MIs. B.BraunMelsungen AG, having factory premises at Carl-Braun-Strasse 1, 34212Melsungen, Germany, under the provisions of Drugs & Cosmetics Rules forthe purpose of import of medical devices in India.

Please refer to your aptIOFF.~I!i>GOP\'2~ 10 received by this officevide dairy no. 7807 dated 18 :wnOJQ aud '"Ply ",coi"". b} this office vide diary no.57203 dated 07/12/2010 on the subject cited above.


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

2. Dispute, if any, in respect of the payment of fees and submission of TR6 Challan,shall be settled between the bank and the applicant.







(Dr. 'S inder Singh)Drugs Controller General (India)


Ministrv of Health & Familv WelfareFIA BUWAN, 10lIA ROAI, IIEWDELHI-l10 002 IIIIIIAl


ENDORSEMENT NO.1 DATED .1 9 J'~IN 2011 TO REGISTRATION

CERTIFICATE NO. MD-146 DATED 07-10-2009, VALID UPTO 30-11-2012.

OFE~"ENDO

Intrafix® -IV Infus~on admini~;'ID~-"'""",,,-

.'WH"I'g.ra~jUP·:l.>c~<:W~,:~ rt,t,~",f:;'cw;"""fii

. 1:~~,tsvented ~r pressure and

q~itp,sr'""! ..k_

}%-:jij\t"',;;~i ~c i

Date: i1 9 1" ~V..Jf.\t 2011

~. ~i~~Dr. 3URIND!::R SINGH

,,1'!tflr frltl~ ~'/Olllgt c~\"t.ilwIl'~:fr.l)~<'iT~-<::j ~ r .~'f.i~'1ff<:'T'1

ate. Gtit(1';:!ial ot n~a!tti :3i-;i"J;GdS

FDi). ~l'!~~i;I!JI. ~l.lJ':£1000.NBw Dalhi-11 0002

L\ b l 1'12',01,2.0\ 0




.1 9 Jp.fJ 2011

£So Edward Lifesciences (India) Pvt. Ltd.,E.F. 201-204, Remi Biz Court, Plot No.9,OffVeera Desai Road, Andheri West, Mumbai - 400058

SUB: - Endorsement No. 01 to RC. No. MD-93 of Manufacturing Site Mis. EdwardLifesciences LLC, One Edwards Way, Irvine CA, USA 92614-5686, underthe provisions of Drugs & Cosmetics Rules for the purpose of import ofmedical devices in India.

Sir,

Please refer to your apPlicat1oOl!Jr iGEi<GQlii'v'lG ~y this office vidediary no. 47285 dated 13/11/2009 and replies received by this office vIde diary no. 32239dated 09/07/2010,38004 dated 10/08/2010 and 46174 dated 29/09/10 on the above notedsubject.


1. The medical device(s) shall conform to the standards / specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Act! ISO / MDD / or such other' ' ..•..

"t':;,.~standards or specifications approved by this Directorate.




S.C 60Lj?-b,( o,}-ol




1 9 JAN 2011

~ Boston Scientific International B.V.,100A, The Capital Court, Olof Plame Marg,Murirka, New Delhi -110067

SUB: - Registration of Mis Boston Scientific Corporation, Boston Scientific Place,Natick, Massachusetts 01760 -1537, USA having factory premises at MisBoston Scientific Ireland Limited, Ballybrit Business Park, Galway, Irelandunder the provisions of Drugs & Cosmetics Rules for the purpose of importof medical devices in India.

Sir, Please refer to your appli aQ~r~~~t~Q/~~10 and received by thisoffice vide diary no. 19383 dated 23/04/2010 and reply received vide dairy no. 50604dated 26/10/2010 on the above noted subject.

Registration Certificate in Form 41 under the Drugs and Cosmetics Rules isissued herewith for the manufacturing site alon'gwith 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 inthe Second Schedule of the Drugs and Cosmetics Act! ISO I MDD I or such otherstandards or specifications approved by this Directorate.







8. This registration Certificate is being issued under the condition that you arerequired to submit the Revised Form 40 duly signed and stamped by theapplicant, indicating the name of the product as given in the Power ofAttorney (i.e. Wall Flex Enteral Colonic / Duodenal Stent System) at the timeof submission of application for grant of Form 10 Licence.

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

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

GOVERNMENT OF INDIACentral Druls Standard Control Organisation

Ministry of Health & Familv WelfareFDA8HAWAN, KOrLA ROAD,NEW DElHI-110 002 lINDIAI


ENDORSEMENT NO.2 DATED .1 9 JAN l011 TO REGISTRATION

CERTIFICATE NO. MD-41A DATED 13-04-2010 VALID UPTO 31-03-2013.

Place: New Delhi

Date: 1 OJ I fl. !l,'oJ ••;f"~J~ 2D J1

G l?'~ G0\ \\L \"2...0\ I



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

Dated It 7 ~ lilll\1\,/"

vMJs VSY Ophthalmic India Pvt. Ltd.,860/1-B, GIDC Estate, Nr. ABB Goods Gate,Makarpura, Vadodara-390010, Gujarat, India

SUB: -Registration of MIs. VSY Biotechnology-VSY Biyoteknoloji ve Hac San. A.S.of Ataturk Mah., Sulun c., Kamilbey Sok No.4, Atasehir, Istanbul, Turkeyunder the provisions of Drugs & Cosmetics Rules for the purpose of importof medical devices in India.

Please refer to yO~ ~~ tVI-~\}~.201O received by tbis officevide dairy no. 34294 date ~.\l'lN~ ~~eJl.,; by this office vide diary no.61386 dated 31.12.20100 die sUDJectcIted above.




3. The medical device will be required to be withdrawn from sale from tpe market incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage. This Directorate should be informed of adversereports on the medical device, if any .

. 4. This registration in no way relieves you of the responsibility of complying withother provisions of the Drugs & Cosmetics Act and Rules thereunder, and anyother provisions of any other Act and Rules applicable in the matter concerned.

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



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

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

GOVERNMENT OF INDIA

Central Drugs Standard Control OrganisationMinistry of Health & Familv WelfareFDAIHAWAN,KOlU ROAD,NEWOElHI-ll0 002l1NOIAJ



1 7 JAN Lv'

1. MIs VSY Biotechnology-VSY Biyoteknoloji ve Hac San. A.S. of Ataturk Mah., Sulun c., Kamilbey Sok

No.4, Atasehir, Istanbul, Turkey has bee~s)?bt~~t9l\~f~l~27-A as a manufacturer and is hereby issued

this Registration Certificate. ..,'-~, .':< . r:.~O.' :OFi:~CE''J fF

.~ A '1.\

2. Name(s) of devices(s), which ma;y b tJ:"ationCertifi:~e:" '{/"

Please refer to the enclosed:@tl1'~~:/,,<,%w~ "'Y;7

<:3. This Registration Certitt4te shall be in for

e manufact~ or his authorised agent inGillC Estiit:i Nr. ABB Goods Gate

responsible:f'or the business activities of the.t--·"*'-'.,~"'"

LICENSING AUTHORITY

Seal/Stamp


agent.








Authority of any other countIy,where the device is l1!carketed/soldor distributed.



















takes place, the c~ent Registration Certificate shall be deemed to be valid for a





GOVERNMENTOFINDIA

Central Drugs Standard Control OrganisationMinistrv of Health & Familv WelfareFDASHAWAN, KOILA ROAD,NEW DELHI-110 002 IINDIAJ



31.12.2013.

New Delhi

Date:)~":i "OoJ

i

LICENSING AUTHORITY




f1 9 JAN 2011

~ndia Medtronic Pvt. Ltd.,1241, Solitaire Corporate Park, Building Number 12,4th Floor, Andheri-Ghatkopar Link Road,Andheri (E), Mumbai - 400093

SUB: -Registration of MIs. Medtronic Inc., 710 Medtronic Parkway N. E.Minneapolis MN 55432 USA having manufacturing premises at MIsMedtronic ATS Medical Inc., 3905 Annapolis Lane, Suite 105 Minneapolis,MN-5547, USA under the provisions of Drugs & Cosmetics Rules for thepurpose of import of medical devices in India.


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

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






8. This Registration Certificate is being issued under the condition that you arerequested to submit the 'revised Form 40 indicating the name of the productsalong with the model No's as per the Certificate to Foreign Govt submittedby you', at the time of submission of your application for the grant of Form10 License.


(Dr. S rintler Singh)Drugs Controller General (India)

GOVERNMENT Of INDIA

Central Drugs Standard Control OrganisationMinistrv of Health & familv WelfareFDABHAWAN,KOllA ROAD,NEWDELHI-110 002 lINDIAl



Registration Certificate No.: MD-892 Date: 1 9 JAN l a111. Mis. Medtronic Inc., 710 Medtronic Parkway N. E. Minneapolis MN 55432 USA having manufacturing

premises at Mis Medtronic ATS Medi~~~\i~t~i'~~2;t~~~ejt~i~Lane, Suite 105 Minneapolis, MN-5547,USA has been registered under tulet2''7~A as a manufac't1irfn(/Uld is hereby issued this Registration-- ~"":; ••.. """f.

'"'" ."'"2. Name(s) ofdevices(s), whiqiPTIaybe Impo ,-or::::

Please refer to the enc1osed::11st">.,~,.",

J ~~<.~.,.,;".,,~

2. This Registration Certificat~tsh~'t*,,,,,,.;

or cancelled under the rules."""."'::."

A'::m~/-",.,_.

':::<>;tThis Registration Certificate i§1's,suedthroug authorised agent in India

Mis India Medtronic Pvt. Lt~::1:~41, Solitaire~.ora~:~rk, BUildin~'Number 12, 4th Floor, Andheri-

Ghatkopar Link Road, Andheri '(}3~,j'Mumbai- 400093who will qC;:i'~~~onsiblefor the business activities of, r:f["

the manufacturer in India, in all respects. -'!.

,~OARO Cotv~

This Registration Certificate is subject to :~''cI'ti01t~ated overleaf and to such other conditions as may be

specified in the Act and the Rules, from tine t '\IJ Z

CDSCO --- : cosco\.. I

~ ~1IIIftt &-0". #

""L7H, Gov<~I4'"


agent.







declared by the Regulatory Authority of-the country of origin or by any Regulatory



in the ,country of origin or in the country of marketing shall be followed in India also,






















GOVERNMENT OF INDIACentral Drugs·Standard Control Organisation

Ministrv of Health & Familv WelfareFDABHAWAN,KOILAROAD,NEWDELHI-ll0 002l1NDIAl



31.12.2013.

Date: 1 9 JAN ZDn

Annexure-l

List of products registered under RC No. MD-892 valid from 01.01.2011 to31.12.2013 :-

Model No. Description500DM25 Valve Standard Series (Mitral)500DM27 Valve Standard Series (Mitral)500DM29 Valve Standard Series (Mitral)500DM31 Valve Standard Series (Mitral)500DM33 Valve Standard Series (Mitral)500FAl9 Valve Standard Series (Aortic)500FA21 Valve Standard Series (Aortic)500FA23 Valve Standard Series (Aortic)500FA25 Valve Standard Series (Aortic)500FA27 Valve Standard Series (Aortic)500FA29 Valve Standard Series (Aortic)50lDAl6 Valve AP Series (Aortic)50lDAl8 (]r'r:,,~g-~ T , nQ ries (Aortic)""'" '",-, ~ ~ '.,'U" ". F'-,501DA20

-.-. iWtml] ~~c!!AplSq ries (Aortic)501DA22 Valve AP Series (Aortic)501DA24 Valve AP Series (Aortic)501DA26 Valve AP Series (Aortic)501DM22 Valve AP Series (Mitral)501DM24 Valve AP Series (Mitral)50lDM26 Valve AP Series (Mitral)50lDM28 Valve AP Series (Mitral)503DAl6 Valve A Pex Series (Aortic)503DAl8 Valve A Pex Series (Aortic)503DA20 Valve A Pex Series (Aortic)503DA22 Valve A Pex Series (Aortic)503DA24 Valve A Pex Series (Aortic)503DA26 Valve A Pex Series (Aortic)503DA28 Valve A Pex Series (Aortic)505DAl6 Valve AP360 Series (Aortic)505DAl8 Valve AP360 Series (Aortic)505DA20 Valve AP360 Series (Aortic)505DA22 Valve AP360 Series (Aortic)505DA24 Valve AP360 Series (Aortic)505DA26 Valve AP360 Series (Aortic)505DA28 Valve AP360 Series (Aortic)

Model No. Description502AG21 Aortic Valved Graft (AVG)502AG23 Aortic Valved Graft (AVG)502AG25 Aortic Valved Graft (AVG)502AG27 Aortic Valved Graft (AVG)502AG29 Aortic Valved Graft (AVG)

Date:~1 9 .J4N 2011 I OFr':UCE r:;()PY LICENS

Model No. Description502AG2l Aortic Valved Graft (AVG)502AG23 Aortic Valved Graft (AVG)502A025 Aortic Valved Graft (AVO)502AG27 Aortic Valved Graft (AVG)502A029 Aortic Valved Graft (AVG)

Date: ~19 J~N 2011

Documents

CentralDrugsStandardCo · PDF fileCentralDrugsStandardControlOrganisation ... Mediquip Sdn.Bhd. POBox 2501700 Kangar, ... case any undesirable reactions due to failure of