01/09/2011 - central drugs standard control organization

Central Drugs Standard Control OrganisationDirectorate General of Health Services

-- - ---- -- -- --- -- --- - - - -- - --- -- MinIstryofHeaUIl ~ ~amilY WeIfare-- -

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

To ~Surgicon-Heajth-care -Pvt~Ltd.,611 Sakar 5, BIH. Natraj ,Cinema, Ashram Road,Ahmedabad-380 009

SUB: -Registration of MIs. Croma GmbH, Industriezeile 6, A~2100 Leobendorf,Austria, under the provisions of Drugs & Cosmetics Rules for the purpose ofimport of medical devices in India.

Please refer to your application dated Nil received by this office vide dairy no.38933 dated 06/08/2010 and replies received by this office vide diary no's. 8934 dated24/02/11,27718 dated 09/06/11 and 34579 dated 21107/11regarding the above mentionedsubject.

Registration Certificate in Form 41 under the Drugs and Cosmetics Rules isherewith for. the m~ufact~.g site al?n~ith.~aIl1.e~~)o~medical device(s) imported

-underthesaia-CertIficate subject to the fOllo~condltIOns.

1. The medical device(s) shall conf~ Yo the standards / specifications mentioned in

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

t:)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 The medical device will be required to be withdrawn from sale from the market incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage.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-Ad and Rules applicable in the inatterconcerried.

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

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

7. This Registration Certificate is being issued under the condition that during the:pendency 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 ofRegistrationCertificatioh~

8. This registration certificate is being issued under the condition that you arerequired to submit following documents at the time of submission ofapplication for grant of Form 10 License:

a. Duly notarized Free Sale Certificate from any of the GHTF countriesi.e. USA/Canada/Japan/ Australia or European Union (As you havestated, that the subject product is sold in the said countries)

b. Design verification and validation report of PMMA IOL (As the samehas not been submitted by you)

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. Su· er Singh)Drugs Controller General (India)

GOVERNMENT OF INDIA

~ ~_~__~ ~'PlralD'IJlS_Sl8ndarJl-CoDtrolllr.anisationMinist", of Health & Familv WenareFDA8HAWAN,KOru ROAD,NEWDEIHI-ll0 002l1NOIAJ

Form 41(See rtile 27;.A)

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

Date: ~p ZOl11. Mis. Croma GmbH, having factozy premises at Industriezeile 6, A-2100 Leobendorf, Austria has been

registered under rule 27-A as a manufacturerf~~j }l,~ t~tlj7\1 Registration Certificate.

rb _Name(s) of devices( s), which&~Ybeimportede,r;this Registnl.~~.,Certificate:Please refer to the enclosed list::::>"' \"'e:'-4 ~,

~ fr\

,Cr::' ~ vThis Registration CertifiC~hall b~,t:;Jce 0 14-08-2014 ~~ it is sooner suspended or

.~~c~I~~~Ull~~_th~~es~"L_--O~-_-,.-_-_- __ _ ._~___ .__ ~?: _('DS

4. This Registration Certificate is issued throu. .."".,;Mis. Sur Icon Healthcare PJ • Ltd. 611 Sa

009 who will be responsible rl~ business a

Ni'd""'"

("'+} .., - -'- ._>'"":\",

This Registration Certificate is sUbjectfo4P~ conditions stated ovel:\~t;.itnd to such other conditions as may bet;/.'<' ,/1 ~ "",*" .'. ",::: :',<,

specified in the Act and the Rules, from tinilKtiril¢;

Date: E1 SEP 2011

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

agent.---- --- --------

2. The m~~fuctureror his-aufuonsecfigcilfin -India snaIf comp1yWiffi-tliecon-dltlOllSof- - -- -- - - ---- -- - ---

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 witbdrawal, regtllatory 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

Auth~ritYof any other country, where the device is marketed/sold of 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

---------- --------submi-tt-ing-a-separate-application-along-With-the.registration.fee,asJ~p~.ci:ti~gjJl..f.I~.l!s~ _

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


immediately in writing in the event of any change in the constitution of the firm and

lor address of the registerM 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 Certifi~ate has been taken from the

Jicensing 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 INDIACentral Drugs Standard Contr,--IOrJl_8pj£ati_IO __

_ .._._--- .- --- - _._.- - - _._-"._--_. --~ - - - - ---- -_.- - - --- --- - ---_ ..- -_ .._-- ---"--"- -

Ministrv of Health & Familv WelfareFDAIHAWAN. KOrLA ROAD.NEW DELHI -110 00211NDIAJ

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

REGISTRATION CERTIFICATE NO. MD-831 DATED 15-08-2011

VALID UPTO 14-08-2014.

(

"'~_c:::;;)1. Intl:aocular LMQtl~ls: CP

~~. /:~-'

2.,Qlntraoc .Models: OOATRIX asW;.J

u ITE

/~,

es JIOL) 'iff<r.MMA.'.',M55B,~~PR

L) in Ht;JVIA 260/0ATRIX as~eric evolutive

".,,,}

_LY__.. ... Z

Date: ~ 1 SEP20nSeaJlStamp

:;sT - 'r~j~;

2963>~

"20, 0 b, ~O\

----------------Cenfral-Uru-gs-Sfandard-t-ontrol OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food andDrug Administration BhawanKotla Road, New Delhi-ll0002

- 1 SEP 2011

\~ Hansraj Nayyar Medical India,1416, Maker Chambers V, 14th Floor,Nariman Point Mumbai-400021, India.

SUB: - Registration of manufacturing site of MIs. Smiths Medical InternationalLimited., St Crispin Way, Haslingden, Rossendale, Lancashire, BB4 4PW,United Kingdom, having manufacturing premises at MIs. Smiths MedicalltaHa S.r.l., Via Della Stazione 2, Latina Scalo, Latina, Italy, under theprovisions of Drugs & Cosmetics Rules for the purpose of import of medicaldevices in India.

Please refer to your application no. Nil dated 28/06/2010 received QY_11li~_Qfiic~_____ _ __---------~----~d~~~~~ro~~~ci~-~~~~ryno. 29634

dated 20/06/2011 on the subject cited abo~

r9Registration Certificate in F~rm 1 'WIlder the Drugs and Cosmetics Rules isissued herewith for the manufi . . g site alongwith the name(s) of medicaldevice(s) imported under the5< ertificate subject to the following conditions.

1. The medical device(s) shalQonform to the standards I specifications mentioned inthe Second Schedule of the Drugs and Cosmetics Act! ISO I MDD 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 / 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

-- 6IFormTO 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, apartfrom any other condition that may be taken under the provisions of the Drugs &Cosmetics Act, 1940 and the Rules thereunder.

(Dr. Surinder Singh)-~~-- ------ ----- -----~--1)rugs-COntrot1eFGenera-.-{lndia)

GOVERNMENT OF INDIA

---.-----------CenlraIDIDJI-& St8o_daJJI J:O_QtroJ]rgBnl~~!i_on_. , ~

Ministry of Health & Familv WelfareFDABHAWAN, KOnA ROAD,NEW DElHI-ll0 002 lINDIAJ

_Form 41(See rule 27-A)

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

Date:~p lOll1. MIs. Smiths Medical International Limited., St Crispin Way, Haslingden, Rossendale, Lancashire, BB4

4PW, United Kingdom, having factory premi~F!l~trMIs."Smith~ Medical Italia S.d., Via Della Stazione 2,

Latina Scalo, Latina, Italy, has beel{r~glJti';~~( ~~d~;rul~~1'~{f~fl:lmanufacturer and is hereby issued this


9.4-2. Name(s) of devices(s), whiSh may be importFt,Q!rfthis.Jlegi.stration Certificat.e:

···-··--- ..-.-.-----P-lea-se-re-fer---t-o-the-@Close<lJis~-_~ \ .~~~.--.-_- ~_. _~~~.

( ~".

3. This Registration Certificate sh~. be in fon.~efrom15-08-2011to 14-08-2014 unless it is sooner

4. This Registration Certificate [sls~ued or his authorised agent in India

Mis. Hansraj Nayyar Medical In'dia, 1416, M~k~':;Chaffib~rs V, 14lhFloor, Nariman Point Mumbai-

400021, India. who will be responsib1~loPtbe business activities Qftheinanufacturer in India, in all respects.,.. '

This Registration Certificate is subjecUo the colli!itions stated overleaf and to such other conditions as may be~,,~~••o~ COl\'r~o(

specified in the Act and the Rules, from ti~ t' 0,I ~~ 6u :z

LICENSING AUTHORITY

:0;' Se~l/S;taJPP;h-~;"; • ,:-:,.~" r • .': ••.•>; ::~.;;..,:(:.;..:

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

agent.

·2. The manufacturer or his authorisedagent in India shall comply with the conditions.of

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


f(jrthwith inthe 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


In such cases, where there shall be any major change/modification in manufacturing

or in testing, or in documentation, as the case may be, th~ manufacturer or his

.. _~thorise.d__ageuL jn.JndiJLshall_Qb.ta.in _neg~s~(lI)'illJ..QrovaL~i!hin-.19_Q.ll)I~j>y_ . __ . _

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 constitution of the firm and

lor address of the registered office/ factory premises operating under this Registration

Certificate. Where any such change in the constitution of the firm and/or address

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

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 constitutio!1 of the firm

and/or changed address of the registered office or factory premises.

GOVERNMENT OF INDIA

Central Drugs Standard Control QrganisationMinistry of Health & Familv WelfareFDA BHAWAN. KOTLI ROAD. NEW DElHI-ll0 002 UNDlAJ

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

REGISTRATION CERTIFICATE NO. MD-815 DATED 15.08.2011 VALID UPTO

14.08.2014.

I.V. CathetersOptiva®2 I.V. Catheter Radiopaque (Codes 1014, 1016, 1018, 1019,1020, 1022);,pptiva®W tV. Catheter RaC!j\<?~~:a-qutP(!C:Q~i~!~,1114,1116, 1118, 1119,1120, 1122, 1124); (, ":5'" ('<.',

Jelco® I.V. Catheter (CQdes 4010, 4,H1~,4013, 4014, 4016, 4018);~elco® I.V. CatheterRadiop~que«e~cJ@$ 4030,4032, 4033, 4034,4035, 4036, 4038, 4q39);,'i .•G<'t· " ' ,~:;~~~~~~.5~:~~~8~:~~~a~~s- 5060,Sfi6-1,-5062, -50&3, - ..

Jelco® 2 I.V. CatheterKRa4MPaql.lelCodes MR14, MR16,MR18,Mfl19, MR20, MR22); .,"•..•.•.•, ",.··~,..".;:;.<'.'!-i ' /Protectiv®Acuvanc~ 21.V. sal,f~"[~~'!!~!;~~1~~flrRadi0l'.aque (co~es1714,1716, 1718, 17t~" 1720, t~~~l;i::;_!~':' \Jelco® Plus I.V. Cathete't,Radio,:Jaq'ue'(Cbdes 70.60, 7061, 7062, 7063,7064, 7065, 7068, 7069). <." . "'.

ITEM§!j(9J'~ElPNUV

Date: _ 1 SEP lOl1.:,:;-,Se8;¥S~.Wp,,~..!"~:'

"',. ~;':"";()~::~:~"r"3i.;H'::'~""~~:' ~ ':.--";1 .t:-·:~::;/r:(:q:· ('.t):~:(,~,;h~,!!n(n~·:

';'-: x:rc·~!:::-'~:'~:?l~·r~r"'.r<:~,_ I·';('.:.'f-.~;:'_; c::' r!';=:~~lt~: E;6i",./jCk~::'

r~~"'\ \<~i::::-; t?,~.':;~{~t~i()~X!.!:

Central Drugs -Sfa-Ii(Jarcf Confro[OrganisatioDDirectorate General of Health Services---Ministry-ofHealth-&-Eamily_Welf3fJL _

Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

- 1 SEP ZOl1

To • ./v.M:/s DePuy Medical Pvt. Ltd. ,

64-66, Senapati Bapat Marg,Mahim, Mumbai400016, India.

SUB: - Endorsement No. 02 to RC. No. MD-287 of Manufacturing Site Mis DePuySpine SARL, having manufacturing premises at Chemin-Blanc 36, CH-2400Le Lode, Switzerland, under the provisions of Drugs & Cosmetics Rules forthe purpose of import of medical devices in India.

,. /i- -'. - -- '\Please refer to your letter No. DePuylRA1201O/AugustlRC-13 dated 13/08/2010

received by this office vide Diary No. 39810 dated 20108/2010 and reply received vide- --------~------diary_Nu;-3+68{;) -dated{)+!-B9f2-0H,regar-e-ing-the-above-cit-ed-subject.-------______ _ _

Registration Certificate in Form 41 under the Drugs and Cosmetics Rules isherewith for the manufacturing site alongwith the~me(s) of medical device(s) importedunder thesaidCertificate subject to the followiaJ)onditions.(~,.

1. The medical device(s) shall confl to the standards I specifications mentioned inthe Second Schedule of the Dand Cosmetics Act! ISO / MDD / or such otherstandards or specifications roved by this Directorate.

r2. 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. ~gacl:rc;()n.signnrent-oftl:I~medic;aldevice(s) to be imported byyollshal1 beaccompanied by a test / analysis reports.

6. Based on this registration, applications for the import of medical device(s)--endorsed-in-the enclose&'l&gistrationGertiflcateshaHbeconsidered .for the issue

of Form 10 Licence under the Rules.

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

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

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

GOVERNMENT OF INDIA...C.entrJlI Drugs.Standard.ControI.Organisation

Ministrv of Health & Familv WelfareFDAIHAWAN, KOllA ROAD,NEW DElHI-ll0 002 (lNDlAJ

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

ENDORSEMENT NO.2 DATED - 1 SEP lOll TO REGISTRATIONCERTIFICATE NO. MD-287 DATED 23-07-2010, VALID UPTO 30-06-2013.

EN DO RSEI\II E:NI NO. 2

Date: ~ 1 SEP lOtiSealiStam~1"'§IT - \~i.·~~~;;:'\.?t·~~

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01/09/2011 - central drugs standard control organization

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