Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

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

2 7 SfP lOll1To, /V MIs NexusNovus Tech ConBultancy Services Pvt. Ltd.,

No. 52/2, Site No. A-2, Ground Floor, Nova Residency,Chikkanna, Layout, Maheshwari Tample Road, Mahadevpura,Bangalore-560048

SUB: -Registration of MIs Polyganics B.V., having Factory premises atRozenburglaan 15A, 9727 DL, Groningen, The Netherlands and its medical devicesunder the provisions of Drugs & Cosmetics Rules for the p1!rpose of import ofmedical devices in India.

Please refer to your application no. Poly-OOldated 23/06/2010 and received bythis office vide diary no. 29455 dated 23/0612010 and replies received vide dairy nos.19742 dated 27/04/2011, 22759 dated 13/05/2011 and 32878 dated 11/07/2011 on theabove noted subject.

Registration Certificate in Form 41 4e Drugs and Cosmetics Rules isissued herewith for the manufacturing site tli the name(s) of medical device(s)imported under the said Certificate sub) e following conditions .

•••• f"'~~

1. The medical device(s) s('a(i.~\'torm to the standards / specifications mentioned inthe Second Schedule o~Drugs and Cosmetics Act! ISO / MDD / or such otherstandards or specifications·approvedby 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 The medical device will be required to be withdrawn from sale from the market incase any undesirable reactions due to failure of the device or its accessories arebrought to light at any stage.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 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 from anyother condition that may be taken under the provisions of the Drugs & Cosmetics Act,1940 and the Rules thereunder.

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

GOVERNMENT OF INDIA

Central Drugs Standard Control OrganisationMinistrv of Health & Familv WenareFDABHAWAN.KOllA ROAD.NEWDELHI-110 002 lINDIAl

Form 41(See rule 27-A)

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

Date: 2 7 s~p lOllI" MIs Polyganics B.V., having Factory premises at Rozenhurglaan 15A, 9727 DL, Groningen, The

Netherlands has been registered under rule 27--A~,~~_aJPanufacturer and is hereby issued this RegistrationCertificate. jA,j-I"U CON!'?

;r bj/~,,,

~. ~~/,:~x,

..."»>~Y',

to 31-08-2014 UJ5,lessit is sooner suspendedoZ"

~~;J~ ("::;~5. This Registration Certificate is ~~~:~/<;tto the conditions stated ove{~~~'K~dto such other conditions as may

be specified in the Act "andthe Rule;, fr~€",p:1~tc! t,:;S\\>,';·(,..i H

2 t

2 7 SEP ZOtl

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

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

the import licence issued under the Drugs and Cosmetics Rules, 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 marketeqisold 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 ofthe device from Indian market.

4. The manufacturer or his authorised agent in India shall inform the licensing authority

within 30 days in writing in the event of any change in manufacturing process, or in

labelling or in testing, or in documentation of any of the device pertaining to this

Registration Certificate.

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

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

authorised agent in India shall obtain necessary approval within 30 days by

submitting a separate application along with the registration fee, as specified in clause

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

5. ,The manufacturer or his authorised agent in India shall inform the licensing authority

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

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

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

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

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 prem,ises.

GOVERNMENT OF INDIACentral Drugs StandardCootrol Organisation

Ministry of Health & Familv WenareFDABHAWAN, KOYlA ROAD,NEW OElHI-110 002 [INOIII

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

REGISTRATION CERTIFICATE NO. MD- 810 DATED 01-09-2011 VALID UPTO

31-08-2014.

~~, vS~¥W~ ~i1?. )EF SlrJGH

,>lY' "d} ID'uy& Conlll'iler (!ro<1~:~~ qg~mr<1-:cr

r'" ~~Heral of hedlth Selvic96fT.'1\ 8hawan. K:l~!3 RU<ld.

f',;aw Dolhi.11UuO:i

Date: 2 7 SEP 20"

15818~ ~_~__~ ~ ~__~ ~ ._~_~ ~ ~ ~ ~~ Q4.Q4.11 ..~

Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry ofHealth & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

2 i SEP ZOtl1To,

~~dward Life Sciences (India) Pvt. Ltd,Plot No.-70,A-23, Ground Floor,Rama Road Industrial Area,NewDelhi-ll0015

SUB:- Registration of Mis Edward Lifesciences LLC having manufacturingpremises at 12050, Lone Peak parkway, Draper, Utah 84020 USA and itsmedical Devices under the provisions of Drugs & Cosmetics Rules for thepurpose of import of medical devices in India.

Please refer to your application no. NIL dated 04.04.11 received by this officevide dairy 15818 dated 04.04.11 on the above noted subject.

f

'\Registration Certificate in Form 4l.-~r the Drugs and Cosmetics Rules is

issued herewith for the manufacturing sfj,eYongwith the name(s) of medical device(s)imported under the said Certificate ~f~t1o the following conditions.

. <.'\;.1. The medical device( s) sQi'" conform to the standards / specifications mentioned in

the Second Schedule of the Drugs and Cosmetics Aqt/ ISO / MDD / 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.

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 thereU11der,.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 eonsidered 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.

8.. -ThisRegistration Certificate is being isstiedunder the-eonditionthat you are.required to submit a following, at the time of submission of application forthe grant of Fo'rm 10 License. '

• Duly Notarized Certificate of Analysis of all the products.• Duly Notarized Domestic prices all the proposed products.• Original labels of the proposed products.

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. Surinder Singh)Drugs Controller General (India)

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Minist" of Health & Famil, WelfareFDA8NAWAN, KOrlA ROU, NEW DElHI-no 002 [INDIAJ

Form 41(See rule 27-A)

REGISTRATION CERTlEICATE

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

• Date: 2 7 SEP lOti1. MIs Edward Life Sciences LLC h~ving manufacturing premises at 12050 Lone Peak parkway, Draper,

Utah 84020 USA has been registered under rule 27-A as a manufacturer and is hereby issued thisRegistration Certificate.

o((~2. Name(s) of devices(s), which may be ~(Junderthis Registration Certificate:

Please refer to the enclosed liO«'«~3. This Registration Certificate shall be in force from 01.09.2011 to 31.08.2014 unless it is sooner suspended or

cancelled under the rules.

4. This Registration Certificate is issued through the office of the manufacturer or his authorised agent in IndiaMIs Edward Life Sciences (India) Pvt. Ltd, Plot No.-70, A-23, Ground Floor, Rama Road IndustrialArea, New Delhi-HOOl5 who will be responsible for the business activities of themanufacturer in India, inall respects.

5. This Registration Certificate is subject to the conditions stated overleaf and to such other conditions as maybe specified in the Act and the Rules, from time to time.

Place: Nir Delhi

Date: ~ 7 SEP ZtJJ1LICENSING AUTHORITY

Seal/Stamp:sT. ~ r~~

,'IDER SINGH~.. • lofPcr)/Dr~gsComro!IH(lndia)

. ~ ~TRi7.f...;>nf.:ral of Hf'alth Servi~es

H.:P SI-'::lWar" Kolle Rc.ad.New Delni-110C02

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

agent.

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

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

4. The manufacturer or his authorised agent in India shall inform the licensing authority

within 30 days in writing in the event of any change in manufacturing process, or in

labelling or in testing, or in documentation of any of the device pertaining to this

Registration Certificate.

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

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

authorised agent in India shall obtain necessary approval within 30 days by

submitting a separate application along with the registration fee, as specified in clause

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

5. The manufacturer or his authorised agent in India shall inform the licensing authority

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

lor address of the registered offic~ 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 INDIACentral Drugs Standard Control Organisation

Ministry of Heanh & Family WelfareFDABHAWAI, KOllA ROIO, HEW 01181- no 002 [IHOIAl

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

REGISTRATION CERTIFICATE -NO. MD-944 DATED 01.09.2011 valid upto

31.08.2014

:\~~OARB~/~0'-;') C~ C Q( 0~::O~~~""~ ~Q

<), ~,~ y:;,1.C;a'J\eters-Ve ~2. tinheters-Antoot Cathetefi.\3,,~theters-Left re Catheters04.iStenousCannul Z:::~?:=t;a7. RetrogradeCa

~TEM(SE~ \1\:A ".

1J)- *lftlGq

0;('. ~t:A

New Delhi

Date: 2 7 SEP Z01J S~St~ ~. ,DER SINGH

",,0/ \ 'W~Ii)lDrtlg~ Conk oller (India~

~'~-'L.aoeral of Health Ser/ices

,,"D~rhawan, !',olla Road,New Delhi.11 0002

Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

2 7 SEP lOllTo, /V MIs Biora~ Medisys Private Limited,

#394, Khata No. 660 1st Floor, Eshwari Industiral Estate,Banneraghatta Road, Bangalore-560076

SUB: -Registration of MIs Alvimedica Tibbi Urunler San Ve Dis. Tic A.S. IstabulTrakya Serbest, Bolgesi Ferhatpasa Mahallesi Ataturk Bulvari Manolya, Sokak No.7, Catalca, Istanbul, Turkey and its medical devices under the prov~ions bfDrugs& Cosmetics Rules for the purpose of import of medical devices in India ..

Please refer to your application no. NIL dated 23/12/2010 received by this officevide diary no. 60327 dated 24/12/2010 and subsequent submission received vide diaryno. 37875 dated 12/08/2011 and. 34644 dated 22/07/2011 on the above noted subject.

Registration Certificate in Form 41 under the Drugs and Cosmetics Rules isissued herewith for the manufacturing site a!,o~.th the name(s) of medical device(s)imported under the said Certificate subject to ~ol1owing conditions.

V1. The medical device( s) shall c~~ to the standards / specifications mentioned in

the Second Schedule of t~ .•~Ngs and Cosmetics Act! ISO / MDD / or such otherstandards or specificati~~pproved 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 af 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 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 dep'osit 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.

8. This registration Certificate is being issued under the condition that you arerequired to submit the following documents at the time of submission ofapplication for grant of Form 10 Licence.(a) Duly notarized EC Design Examination certificate (no. 547 F DE) in

respect the proposed product-Ephesos II Coronary Stent DeliverySystem.

(b) Essential Principle Checklist and Domestic Prices of the devices in thecurrency followed in the country of origin in respect the all proposedproducts.

(c) Duly Notarized Post Marketing Surveillance report along with correctiveand preventive action taken in respect the all proposed products.

(d) Bank Verification w.r.t TR6 Challan no. 02 dated 30/07/2009.

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)

G01(ERNMENT OF INDIA

Central DrugsStalulard ControlOrganisadonMinistrv of Health & Familv WeUareFDABHAWAN, KOllA ROAD.HEW DELHI-110 002 lINDIAJ

Form 41(See rule 27-A)

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

2 7 SEP lOll

Name(s) of devices(s), which l11aybe imported

~~i ~,,'i'\

This Registration Certifis~te Sh~~~'rt1"orcefi,••,rPll1' ...,.:~ (:''0

or cancelled under the rUl'e~~",

4. This Registration Certificat:"is ftsued :trr~tlg~i,fhJ{qrr~~;'8~titrJi~~fac ~ or his authorised agent in IndiaMIs Biorad Medisys Private Limited, #594,KI1:IL ',rII",\! ((f) 1st Fl or 'CcEshwari Industiral EstateBanneraghatta Road, Bilngalore-560076~~h onsible f<!lrAhebusiness activities of themanufacturer in India, in all::f'espects. "jL'j' ,:'

/,'"

Registratiori'€e~ificate.:'.:1

C'··_,v·'

to 15-08-2014 titiless it is sooner suspendedr.\.,,,,,,;

5. This Registration Certificate is subject to the conditions stated ove~I1(~:~tl to such other conditions as may

be specified in the Act and the Rules, fro~ .•time (0 time.

Place: New Delhi

Date: 2 7 SEP Z01l~~l/~~ ftj~

.x::r Sltle;·!,*<'. , ..(J) /DeJYS Con" .~. ",~

W~l %~:t1i<Tf7.~',; .",eral of Healtr. :::;",''';r:<36

'" ~1;~. 8h~.Nan. !<.~t:JRead.New Delhi-1i0002

I

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

-agent.

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

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

3. The manufucturer 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.

m~ket withdrawal, regulatory restrictions, or cancellation of author. isat ion, 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 Qf 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 coullitry of origin or in the country of marketing shall be followed in India also,

in consultation with and as per the directions of the licensing authority. The licensing

authority may, however, direct any further modification to this course of action,

including the withdrawal of the device from Indian market.

4. The manufliCturer.or his authorised agent in India shall inform the licensing autho~ity

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 mdY he, the manufacturer or his

authorised agent in india shall obtain necessary approval within 30 days by

submitting a separate application along with the registration fee, as specified in clause

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

5. The manufacturer or his authorised agent in India shall inform the licensing authority

immediate~y 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 constituc :()n of the firm and/or address

takes place, the current Registration Cei\ificate shall bc deemed to be valid for a

maximum period of three months from the date on \\1:icL 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 ch<\IIged constitution of the firm

and/or changed address of the registered office or facl"·\ "remises.

GOVERNMENT OF INDIA------------·'·-1:entraI1lrugs-Staodard1:ootroI1lruanisation----···-

Ministrv 01Health & Familv Wenare

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

REGISTRATION CERTIFICATE.NO. MD- 889 DATED 16-09-2011 VALID UPTO

15-08-2014.

. .1. Alvision Cardiova~yj1J1'a:r!'-\iil)9i-&tgf~~lf1icCatheter2. Alviguide Car~t~~a'scularGuiding'Uaj!leter3. Commander :~oronary ...~ livery Sr:.~tem

v" ...::" ~~ Y., '"4. Constant C,?J'onary' SysteJiJ;5. Ephesos 1~:Soronary ry Syst~!l6. Invader cit> Corona sty BaUoOfiiCatheter

" 1 '''7'7. Invader PT-CABalloo Catheter 4~,

#~0" " ~ tact.""'"--'-8-.-T-u'rquois'ePfvA'Efa .nr~i:ltfleter"'%:;;*'~(%#~ ~~'::1«"1'*«if.;i

ITEM NLY

2 7 SEP lD1J~I/~~ ffi1'f~, .1' !f!OER SINGH

~';1f''(if',tr) IJIU~~~troUer(Imia),'; r-rerr q~~T~

DIG, G<~neral·)t Health 'ServicesFDA 13hawan. Kotla Road.

New Dellli-110002

Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

2 7 SEP 2011To

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

SUB: - EndorsemenfNo. 01 to RC. No. MD-240 of Manufacturing Site of Mis SmithsMedical International Limited, Boundary Road, Hythe Kent, CT21 6JL, U.K.,having manufacturing premises at MIs. Smiths Healthcare Manufacturing, S.A. deC.V., Ave Calidad No.4, Parque Industrial International Tijuana, Tijuana, B.C.22427, Mexico under the provisions of Drugs & Cosmetics Rules for thepurpose of import of medical devices in India.

Please refer to your application No. NIL dated 01.04.2011 received by this officevide Diary No.15394 dated 01.04.2011, regarding the above cited subject ..

Registration Certificate in Form 41 under the Dr~ftd Cosmetics Rules is issuedherewith for the manufacturing site alongwith.~~ ~s) of medical device(s) importedunder the said Certificate subject to the fOI~~~onditions.

I. The medical device(s) shall c00~ to the standards / specifications mentioned inthe Second Schedule ofthe Drugs and Cosmetics Act! ISO / MDD / 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.

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 concern,ed.

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 issueof Form 10 license 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 qause (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 Certification.

8. This Registration Certificate is being issued under the con'dition that you arerequired to submit the following documents/data in respect of the proposedproduct at the time of submission of application for the grant of Form 10License:

a. Revised labels as per the provisions of Rule 96 of Drugs andCosmetics Act and Rules thereunder bearing the name and address ofthe manufacturer, Import Licence. No. and Name and Address of theImporter. .

b. Revised IFU's bearing the name and address of the actual as well aslegal Manufacturer.

c. Device Design and Validation data.d. Essential Principles Check List.

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. S n Singh)Drugs Controller General (India)

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministry of Health & Familv WelfareFDAIHAWAN. KOllA ROAD.NEW DELHI-ll0 002 lINDIAJ

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

ENDORSEMENT NO.1 DATED 2 7 SEP lOtI TO REGISTRATION

.CERTIFICATE NO. MD-240 DATED 24-06-2011, VALID UPTO 14-06-2014.

ENDORSEMENT NO.11. Tracheal Tubes

100/105/025-090 PorteX(ID)rracheal Tube100/111/020-090 PO,rteX®Tracheal Tube100/141/025-095 Poftex® Trash13.~I·"'7100/179/050-090.8ortex® Trachea <e100/190/050 Portex® Blue LirnJ:i'l'tibe Microlaryngeal100/199/050-100 Portex® Tra::..100/11 0/050-0~5 Portex® ReinI~.~6~:'.?;ir~~;~ealTube100/113/030-050 PQ~13~@I3:!Qf~,rq~@;~~a~h13~L!LJbe100/132/030-070 F'()[;t13X@~p~l~rTMi.pref~·rrBed[nacl1ealTube100/133/060-080 Portex® pol~~~.~;J3r;~.twrm~?Tracheal Tube100/134/030-075iPortex® Pol~Iill~:::? Tracheal T,I,Jbe100/136/050-090P ..•...o.rtex® Polar[M.;.. ". i'ied Tracheal Tube100/189/060-0805 Blue Line®)§~~g:TT~~~Suctioo Above the Cuff197-28R-197-41R, 1981t~~(~:~~~l::ine® EndobronchialTube

Date: 2 7 SEP 2011 LICENSING AUTHORITY

~~I/~~ 8'5r'1. :,URlt .DER SIN(;!-l

~.'.if'i~ ('lIT~)/Drug& c~:_.,,' "",'~;a~ W.rr ~~""llr,

[it", General of Health Sf,:"",:esFDA Shawano Kolle: Road.

/'Jew Delhi-11 0002

Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare

Food and Drug Administration BhawanKotla Road, New Delhi-ll0002

2 7 SEP 2011To _L

\~s. Meril Life Sciences India Pvt. Ltd.512-513, "Midas", Sahar ~laza Complex,J.B. Nagar, Andheri (East) Mumbai,Tal: Andheri East (Mumbai-Zone6)

SUB: Registration of MIs Maxx Orthopedics Inc., 2260 Butler Pike, Suite 100,Plymouth Meeting Pennsylvania 19462, USA under the provisions of Drugs& Cosmetics Rules for the purpose of import of medical devices in India.

Please refer to your application no. MLSIPLlREG/1112/002 dated21.06.2011 received by this office vide dairy no.30176 dated 22.06.2011 andreply received vide dairy no.36658 dated 04.08.2011 on the above noted subject.

Registration Certificate in Form 41 under the Drugs and Cosmetics Rulesis herewith for the manufacturing site alongwith the name(s) of medical device(s)imported under the said Certificate subject to t.8eibllowing conditions.

0" ~1. The medical device(s) shall conform t~JhMtandards I specifications mentioned in

the Second Schedule of the Drug~d'd.~osmetics Act! ISO I MDD I or such otherstandards or specifications ap~~bY this Directorate.

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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 I analysis reports.

6. Bas~4 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, apartfrom any other condition that may be taken under the provisions of the Drugs &Cosmetics Act, 1940 and the Rules thereunder.

GOVERNMENT OF INDIACentral Drugs Standard Control Organisation

Ministnr of Health & Familv WelfareFDA8HAWAN, KOrlA ROAD,NEW DELHI-110 002 [INDIAJ

Form 41(See rule 27-A)

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

Date: 2. 7. S L P lOllMIs Maxx Orthopedics Inc., having factory premises .at 2260 Butler Pike, Suite 100, Plymouth Meeting

Pennsylvania 19462, USA has been registeredund~rruleXl~A as a manufacturer and is hereby issued this

Registration Certificate.

This Registration Certificateisissued thrOUg~;t~0'g¥~\,~t';~e:~~ufacturer orijis authorised agent in India

MIs. Merit Life Sciences IndiaPvt Ltd., 5l2~13",".iti~s~~:S~har Plaza Complex, J.B. Nagar, Andheri~;~;-;:,~;.:.,; , , c._ ,<: ;'"

(East) Mumbai, Tal: Andheri East (Mumbai;Zone6) who Willbe responsible for the business activities of

the manufacturer in India, in all respects.

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

specified in the Act and the Rnles. fromf::I~~\, ,I~.•. _ .••• ,f

Place: New Delhi ~"<~(1H.G~""#

2 7 LICENSING AUTHORITY

~~S~~WJi·~ ~. ""jr:F:Jl~JC;H

\~~r;-- ! ~:' :j-'IOru~s Con\101:~ i1nd'l.t:,1w.r !1i'>n;;~n~

• i" • ,Hral of He"llth Services, 'l...\ Fthawar., kotla ~oad,

[,<IW Oeihi.1i0002

lon

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

agent.

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

the import licence issued under the Drugs and Cosmetics Rules, 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 ftpther modification to this course of action,

including the withdrawal of the device from Indian market.

4. The manufacturer or his authorised agent in India shall inform the licensing authority

within 30 days in writing in the event of any change in manufacturing process, or in

labelling or in testing, or in documentation of any of the device pertaining to this

Registration Certificate.

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

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

authorised agent in India shall obtain necessary approval within 30 days by

submitting a separate application along with the registration fee, as specified in clause

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

5. The manufacturer or his authorised agent in India shall inform the licensing authority

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

, lor address of the registered office/ factory premises operating u.nderthis 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 INDIACentral Drugs Standard Control Organisation

Ministrv of Health & Familv WelfareFDA8HAWAN, KOllA ROAD,NEW DELHI-110 002 [INDIAl

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

REGISTRATION CERTIFICATE NO. MD-635 DATED 01.07.2009 VALID UPTO

30.06.2012.

Place: New Delhi

Date: 2 7 ~LO zon~~~~s~ fti~'J' . ;-~i,p.JL.f;511JGi-i

.. ~"t:f',,;.':':. \ ,;,J)/DruJsCE!llfO:Iw(I,1d'131, i,-c'i:! ~1 ~mw:r

8i.c. G.•..'!.'f~ra:l of Health -Servicest'-;:;.~P-hawan, Kotla Road.

t~t;~ Delhi-11 0002