Government of Pakistan

Drug Regulatory Authority of Pakistan

Ministry of National Health Services, Regulations & Coordination
***

MINUTES OF THE 6TH MEETING OF THE MEDICAL DEVICE BOARD (MDB)

HELD ON 20TH JULY, 2017

6th meeting of the Medical Device Board (MDB) was held in the Committee Room of
Drug Regulatory Authority of Pakistan, TF Complex, G-9/4, Islamabad on 20th July, 2017. The
meeting was chaired by Dr. Sheikh Akhter Hussain, Director Medical Devices & Medicated
Cosmetics, Drug Regulatory Authority of Pakistan. The meeting was attended by the following:-

Minutes of 6th Meeting of MDB Page 1 of 29

 S.No. Name and Designation / Department Position in the MDB

(i) Dr. Sheikh Akhter Hussain, Chairman

Director Medical Devices & Medicated Cosmetics,
DRAP,
The meeting Islamabad.
started with recitation of the Holy Quran by the Chairman MDB.
(ii) Dr. Mohammad Shoaib Akhtar, Ex-officio Member
Director Drug Testing Laboratory,
Rawalpindi.

(Nominee of Director General Health, Punjab)

(iii) Mr. M. Jalil Anwar, Ex-officio Member

Officer Incharge Government Medicine Coordinator
Cell, Health Department, Khyber Pakhtunkhwa,
Peshawar.
(Nominee of Director General Health, Khyber
Pakhtunkhwa)

(iv) Syed Abdul Saleem, Ex-officio Member

Chief Drug Inspector,
Health Department, Balochistan
(Nominee of Director General Health, Balochistan)

(v) Brig. (R) Dilshad Ahmed Khan, Member

Professor of Pathology & Director Research,
National University of Medical Sciences,
Rawalpindi.

(vi) Prof. Dr. Umar Hayat, Professor and Head of Member

Interventional Cardiology, Ayub Medical College,
Abbottabad.
(vii) Prof. Dr. Muhammad Nadeem Ahmad, Member
Department of Radiology, Aga Khan University
Hospital, Karachi.

(viii) Miss. Tazeen S. Bukhari, Member

TRF Technical Consultant for Medical Devices,
Technical Resource Facility, 16-BB, Defence
Housing Authority, Phase-IV, Lahore.

(ix) Mr. Luqman Ali, System Analyst, Pakistan Institute Member

of Medical Sciences, Islamabad.

(x) Mr. Muhammad Tahir Aziz Member

Chief Operating Officer,
Shaukat Khanum Memorial Cancer Hospital &
Research Centre, Peshawar.

(xi) Dr. Farhat Ullah, Assistant Professor, Department of Member

Pharmacy, University of Malakand.
Minutes of 6th Meeting of MDB Page 2 of 29
(xii) Dr. Ghazanfar Ali Khan, Member/Secretary
Deputy Director (MDMC),
Drug Regulatory Authority of Pakistan,
Islamabad.
Item No. I. CONFIRMATION OF MINUTES OF 5TH MEETING OF THE MEDICAL
DEVICE BOARD (MDB)

Decision: The Board confirmed the minutes of the 5th meeting of MDB.

Item No. II. UPDATE REGARDING THE PROVISIONAL ESTABLISHMENT

CERTIFICATE (PEC) AND PRODUCT REGISTRATION
ACKNOWLEDGEMENTS (PRA) ISSUED.

The Board was briefed regarding the Provisional Establishment Certificate (PEC) and
Product Registration Acknowledgements issued as follow:
On the directions of the Honorable Supreme Court of Pakistan on March 2, 2017 during
Human Rights Case No. 623-P/2017, Prime Minister’s office convened two extensive meetings
chaired by Secretary to the Prime Minister held on 6 th March and 10th March, 2017 involving all
the relevant stakeholders and as an outcome of these meetings, SRO. 167(I)/2017 was issued by
the Federal Government dated 15-03-2017 for regulation of medical devices including cardiac
stents. The salient features of the said SRO are as under:-

 The said SRO has a Schedule “A” of 134 life saving medical devices including
cardiac stents, legalizing the import, sale and usage of these medical devices, if these
were already approved for use and sale by regulatory authorities of USA, Japan,
Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy,
Netherland, Norway, Spain, Sweden, Switzerland, UK or CE Mark by notified
bodies of European Union.
 The said Notification empowered CEO, DRAP to amend the Schedule “A” from time
to time.
 Schedule “A” devices cannot be imported, sold or used in Pakistan except from
above sources.
 In addition, a firm has to submit provisional registration application along with
original Free Sale Certificate.
 The previous SROs declaring medical devices as drugs are repealed.
 Medical Devices Board shall issue Provisional Establishment Certificate for a period
of 06 months, within 07 working days, on submission of original valid authorized
agency agreement.
 The rest of the medical devices, not included in the Schedule “A”, have been
exempted from the operation of Medical Devices Rules, 2015 for six months.
Minutes of 6th Meeting of MDB Page 3 of 29
  All medical devices registered as drug and qualifying above said criteria shall be
deemed to be registered as medical device under the Medical Devices Rules, 2015.

Medical Device Board in its 4 th meeting convened on 24th March, 2017 approved
application forms for grant of Provisional Establishment Certificate, application form for
Provisional Registration of medical devices for import and Provisional Establishment Certificate.
So far, 68 Provisional Establishment Certificates under this SRO have been issued to the
applicant firms and 206 acknowledgements for Provisional Registration of medical devices have
also been issued.

Decision: The Board appreciated the efforts made so far by the Division of Medical Devices &
Medicated Cosmetics.

Item No.III. REVISION OF MEDICAL DEVICES RULES, 2015.

As an outcome of Prime Minister’s office meeting, a Committee including stakeholders
under the Chair of Additional Secretary, M/o National Health Services, Regulation and
Coordination has been constituted on 21 st March, 2017 to review the existing Medical Devices
Rules, 2015 in order to make them implementable.
In this regard 4 meetings of the committee were held and after thorough deliberations the
committee proposed and drafted amendments in Medical Devices Rules, 2015 namely Medical
Devices Rules, 2017 which were also placed before the MDB, in its 5th meeting. Each
amendment was discussed in length and the Board agreed with amendments with few valuable
suggestions which were taken care in the draft rules. They were approved by the Authority in its
48th meeting held on 21st June, 2017. The rules are under process for approval by the Federal
Government.
In this regard, Secretary MDB gave a detailed presentation on Steps taken in drafting
Medical Devices Rules, 2017 and salient features of the draft rules with special focus on
amendments done in existing rules.

Decision: The Board after thorough discussion endorsed the amendments proposed in Medical
Devices Rules, 2017.

Item No. IV. IT BASED NATIONAL REGISTRY FOR CARDIAC STENTS

Minutes of 6th Meeting of MDB Page 4 of 29

 Under SRO. 167(I)/2017, DRAP has launched and activated the first IT based National
Registry for cardiac stents which shall provide a mechanism for manufacturers / importers and
Cath Laboratories to compulsory enter the data of manufacturing / importation and utilization of
cardiac stents in National Registry. Under the aforesaid SRO, all Cath Labs are required to be
registered with the Pakistan Society of Interventional Cardiology (PSIC). Information of 21
importers of cardiac stents has been entered and verified by DRAP in the National Registry
while Cath Labs shall enter utilization data of cardiac stents after registration with PSIC.
Three meetings of DRAP have been held so far on 10 th April, 2017, 1st June, 2017 and 6th
July, 2017 with the representative of PSIC and stakeholders to update on the actions taken so far
by the PSIC regarding framing of rules, regulations and code of conduct for registration of Cath
Labs and to discuss the way forward. The salient features of the meetings are as follow:-
 A comprehensive document for Cath Labs has been prepared based on international
standards including requirements for Cath Labs, its equipments, personnel, pre-, inter-
and post-procedures.

 Three months time will be required for Cath Laboratories to be registered with the
PSIC.

 Capacity building of Cath Labs is required and type of training and experience
required by the interventional cardiologist/operators running Cath Labs shall be
defined.

 Regarding fixation of prices it was suggested that matter should be handled with care
so that the multinational companies should not quit from the market and shortages of
stents should not arise.

 Disciplinary Committee of PSIC shall make interventional cardiologist/Cath Labs

accountable if found violating the code of conduct.

 Misunderstandings in the minds of young doctors regarding registration of Cath Labs

has been removed.

 The heads of an institutes shall provide the list of their Cath Labs along with names of
operators, their skills, training, number of procedures carried out and no. of years of
relevant experience in Cath labs to the PSIC, which then be enlisted along with their
operators on the recommendations of the heads of an institutes making both the head
and the operator(s) responsible. The said list shall be provided to the DRAP at the
earliest.

 Disciplinary Committee to hold Cath Labs and operators accountable shall be

provided to the DRAP at the earliest.

Minutes of 6th Meeting of MDB Page 5 of 29

Decision: The Board discussed the matter in detail. Dr. Umer Hayat appreciated DRAP for
successfully launching the first IT based National Registry for cardiac stents which shall provide
a mechanism for manufacturers / importers and Cath Laboratories to compulsory enter the data
of manufacturing / importation and utilization of cardiac stents in National Registry. However,
he expressed his concerns regarding registration of Cath Labs with the Pakistan Society of
Interventional Cardiology. He said that Pakistan Society of Interventional Cardiology (PSIC) has
no legal standings for registering Cath Labs and Pakistan Society of Interventional Cardiology
would not be able to successfully complete the task without any Law/Act. He recommended that
the registration of Cath labs should be with the regulatory body like Provincial Health Care
Commissions.
Chairman MDB replied that during hearing in the Honorable Supreme Court of Pakistan
in Human Rights Case No. 623-P/2017 (In the matter of embedding sub-standard cardiac stents),
PSIC in the presence of stakeholders took this responsibility of registering Cath Labs. On the
directions of the Honorable Supreme Court of Pakistan on March 2, 2017, Prime Minister’s
office convened two extensive meetings chaired by Secretary to the Prime Minister held on 6 th
March and 10th March, 2017 involving all the relevant stakeholders including PSIC, Pakistan
Cardiac Society and their Lawyer. During the aforesaid meetings, PSIC and their Lawyer again
emphasized that Cath Labs should be registered with PSIC. As an outcome of these meetings,
SRO. 167(I)/2017 was issued by the Federal Government dated 15-03-2017 for regulation of
medical devices including cardiac stents wherein all Cath Labs are required to be registered with
the PSIC.
After thorough discussion, the Board appreciated the efforts so far made by DRAP
regarding first IT based National Registry for cardiac stents.

Item No. V. MEDICAL DEVICES ALREADY REGISTERED AS DRUGS

The erstwhile Ministry of Health, keeping in view the risks posed to the patient and in
exercise of the powers conferred by sub clause (vi) of the clause (g) of section 3 of the Drugs
Act, 1976, declared some medical devices to be drugs for the purpose of said Act. These devices
includes disposable syringes, disposable sets for collection or transfusion of blood or giving any
infusion, canula, catheter, stent, auto-disable syringes and butterfly needles. Since then many
devices have been registered.
The Federal Government issued SRO. 167(I)/2017 on 15-03-2017 for regulation of
medical devices. The said SRO has a Schedule “A” of 134 life saving medical devices legalizing
Minutes of 6th Meeting of MDB Page 6 of 29
the import, sale and usage of these medical devices, if these were already approved for use and
sale by regulatory authorities of USA, Japan, Australia, Canada, Austria, Belgium, Denmark,
France, Germany, Ireland, Italy, Netherland, Norway, Spain, Sweden, Switzerland, UK or CE
Mark by notified bodies of European Union. Schedule “A” devices cannot be imported, sold or
used in Pakistan except from above sources. In addition, a firm has to submit provisional
registration application along with original Free Sale Certificate. The previous SROs declaring
medical devices as drugs are repealed. Medical Devices Board shall issue Provisional
Establishment Certificate for a period of 06 months, within 07 working days, on submission of
original valid authorized agency agreement. The rest of the medical devices, not included in the
Schedule “A”, have been exempted from the operation of Medical Devices Rules, 2015 for six
months. All medical devices registered as drug and qualifying above said criteria shall be
deemed to be registered as medical device under the Medical Devices Rules, 2015.
Matter was discussed in length and the board members were of the view that the list
should be categorized in two categories as per SRO 167(I)/2017 and those medical devices
which do not fall under Schedule A but were previously registered as drugs should be listed out
and should be reviewed as per the Medical Devices Rules, 2017 upon their promulgation.

Decision: MDB thoroughly discussed the matter and recommended as follow:

(i) Those medical devices which fall under Schedule "A" of SRO 167(I)/2017 but
were previously registered as drugs shall be dealt as per the said SRO.
(ii) Those medical devices which do not fall under Schedule "A" but were previously
registered as drugs shall be listed out and shall be reviewed as per the
Medical Devices Rules. However, in the meantime validity of
registration of these devices shall be confirmed.

Item No. VI. MEDICAL DEVICES PROVIDED IN SCHEDULE-A AND ALREADY

REGISTERED AS DRUGS

MDB in its 5th meeting decided as follows:-

"For those Schedule "A" medical devices already registered as drug, having valid registration,
originating from reference countries mentioned in the SRO.167(I)/2017 and having Provisional
Establishment Certificate shall be treated as registered medical device under the Medical
Devices Rules, 2015. A list in this regard shall be issued by the MDMC Division."

Minutes of 6th Meeting of MDB Page 7 of 29

 In this regard, as decided by the MDB, a draft list of medical devices already registered
as drug, having valid registration, originating from reference countries mentioned in SRO.
167(I)/2017 and having Provisional Establishment Certificate has been prepared and placed at
Annex-I.

Decision: The Board thoroughly reviewed and discussed Medical Devices mentioned in Annex-
I. As these Medical Devices are fulfilling the criteria prescribed in the SRO,
therefore, the Board approved these devices as registered medical devices under
Medical Devices Rules, 2015 and accordingly a list of these medical devices shall be
issued by the MDMC Division. New registration numbers shall be allotted to these
registered devices.

Item No. VII. FEE FOR INCLUSION OF ADDITIONAL MANUFACTURERS IN

PROVISIONAL ESTABLISHMENT CERTIFICATE .

It is submitted the Medical Device Board is issuing provisional establishment certificates.

The importers are applying for additional manufacturers for provisional establishment
certificates without any fee. Rule 138 (8) of Medical Devices Rules, 2015 states that fee for any
other activity having commercial significance shall be treated as miscellaneous and will be
charged Rs.5000/-. It is proposed that we may charge Rs.5000/- (per application) for inclusion
of additional manufacturers in Form-3.

Decision: The Board discussed the matter in length and decided that fee of Rs.5000/- shall be
charged for each further application regarding inclusion of additional manufacturers in Form-3
(Provisional Establishment Certificate).

Item No.VIII. FORMAT OF LETTER OF AUTHORIZATION FROM THE

MANUFACTURER ABROAD.

There is no specific format for the letter of Authorization for Agency Agreement. In
some cases the product is manufactured in one country, it is owned by some person in another
country and authorization is passed on to some other distributor and then the authorized agent in
Pakistan.
Minutes of 6th Meeting of MDB Page 8 of 29
 The case is placed before the MDB for consideration to standardize the Letter of
Authorization for Agency Agreement.

Decision: The Board decided as follow:

i. Letter of Authorization or agreement shall only be considered if issued by
manufacturer (legal) / owner or Marketing Authorization Holder or its own
Distribution Center being authorized to issue authorization for Pakistan or this
region.
ii. Letter of Authorization or agreement shall be original, signed & stamped, having
validity, names and addresses of both manufacturer and importer and having
name or category of medical devices.

Item No. IX. MEDICAL DEVICES WHICH ARE NEITHER DEFINED NOR
DECLARED AS DRUG.

It is submitted that medical devices like Blood bags, Hyaluronic acid injection, Incise
Drapes, Surgical dressing, Surgical tapes etc are neither defined nor declared as drug under the
Drugs Act, 1976. Moreover, internationally these are regulated as medical devices. However,
these devices are being registered as drug under the Drug Act, 1976. DRAP Act, 2012 was
promulgated on 13th November, 2012 where drugs and medical devices were separately defined.
For this purpose, Medical Devices Rules, 2015 were notified on 9 th March, 2015 wherein all
medical devices has to be regulated under these rules except those defined as drug. Fate of these
subject devices neither defined nor declared as drug has to be decided.

Decision: The Board discussed the matter at length. As the medical devices like Blood bags,
Hyaluronic acid injection, Incise Drapes, Surgical dressing, Surgical tapes and like devices are
being regulated as medical devices internationally and the DRAP Act, 2012 has also separately
defined drugs and medical devices, therefore, the Board decided that these devices shall be
regulated under the Medical Devices Rules. Division of PE&R shall be asked to transfer their
files to Division of MDMC for further processing in compliance to new medical devices rules.

Item No.X. POST-FACTO APPROVAL FOR ISSUANCE NOC FOR MITRAL VALVE
CLIP PROCEDURE ITEMS FOR PERSONAL USE.

Minutes of 6th Meeting of MDB Page 9 of 29

 A request was made by Maj.Gen. ® Prof. Dr. Azhar Kayani, ED, RIC, Rawalpindi for the
issuance of NOC for Mitral Valve Clip Procedure items for the first ever procedure in patient at
Rawalpindi Institute of Cardiology, Rawalpindi. The said items are said to be imported as same
are not available in Pakistan and therefore NOC was requested. The said items are to be imported
through M/s Digital Imaging System.

Keeping in view the need of the said items, an NOC was issued with the approval of
Director MDMC / Chairman MDB as provision for import of medical devices for personal use is
given in Rule 100 (c) of Medical Devices Rules, 2015.

Decision: The Board approved the case and also authorized Chairman MDB for future
approval for issuance of NOC for import of medical devices for personal use under the
prescribed rules.

Item No.XI. SCHEDULE "A" MEDICAL DEVICES ALREADY REGISTERED AS

DRUG, AND THE FIRMS NOT APPLIED FOR PROVISIONAL
ESTABLISHMENT CERTIFICATE.

As per SRO.167(I)/2017, dated 15th March, 2017, the previous SROs declaring medical
devices as drugs are repealed and all products registered under the provisions of previous SROs,
if qualify the prescribed criteria in the said SRO, shall be deemed to be registered as medical
devices under the Medical Devices Rules, 2015. For those Schedule "A" medical devices already
registered as drug, having valid registration, originating from reference countries mentioned in
the SRO.167(I)/2017 and having Provisional Establishment Certificate shall be deemed to be
registered as medical devices under the Medical Devices Rules, 2015. However, some of the
firms have not applied for PEC having Schedule "A" medical devices. Medical Device Board in
its 5th meeting held on 25th May, 2017 decided as under:-
"For those Schedule "A" medical devices already registered as drug, having valid
registration, originating from reference countries mentioned in the SRO.167(I)/2017 but
the firms have still not applied for Provisional Establishment Certificate, these firms
shall be asked to apply for Provisional Establishment Certificate within 7 days otherwise
further necessary action shall be taken by the MDB."

The following firms have not applied for Provisional Establishment Certificate and they
were issued letters on 10-07-2017 with directions to apply for Provisional Establishment

Minutes of 6th Meeting of MDB Page 10 of 29

Certificate within 7 days otherwise further necessary action shall be taken by the MDB which
may lead to cancellation of registration of their product(s).

1. M/s Johnson & Johnson Pakistan (Pvt) Limited, Karachi.

2. M/s Universal Trades, Quetta.
3. M/s. SES Associate, Lahore.
4. M/s. Nabiqasim Industries (Private) Limited, Karachi.
5. M/s. Trans Angio System, Karachi.
6. M/s Radiant Devices Biomedical Pvt. Ltd, Lahore.

The above firms have still not applied for PEC and have been issued letters on 18-07-
2017 for personal hearing before the MDB on 20th July, 2017 to explain their position in the
subject matter along with details of all of their imported medical devices. The following firms
appeared before the Board and the Board decided as mentioned against each:

Decision:
1. Miss Ayesha Zaman, Manager Regulatory affairs M/s Johnson & Johnson
Pakistan (Pvt) Limited, Karachi appeared before the Board and informed the reason for
not applying for Provisional Establishment Certificate (PEC) in writing. She submitted
that due to relocation of their office, issuance of drug sale license is awaited and the firm
will apply PEC as soon as they secure Drug Sale License. Furthermore she also informed
that they are now only dealing with registered products from Codman Portfolio namely
Prowler Micro Catheters (Reg No. 074692). Their registered products from Cordis
portfolio have been globally transferred from Johnson & Johnson to Cardinal Health.
These products will be imported by Cardinal Health's appointed authorized agent M/s
Global Marketing Services, 111, Hali Road,Westridge I, Rawalpindi, Pakistan who have
already secured Provisional Establishment Certificate for the said products. Therefore
Johnson & Johnson will not be importing the following Cordis products namely:
(i) Cordis catheters (Diagnostic Catheter and Guiding Catheter) (Reg No. 071628)
 Infiniti
 Super Torque
 Super Torque Plus
 Tempo
 High Flow
 Nylex
 Vista Brite
(ii) Empira RX PTCA Dilatation Catheter (Reg No. 074705)
(iii) Empira NC RX PTCA Dilatation Catheter (Reg No. 074706)
(iv)Palmaz Genesis Stent (Reg No. 071629)
(v) SES Precise RX stent (Reg No. 071630)
Minutes of 6th Meeting of MDB Page 11 of 29
 (vi)S.M.A.R.T. Control Nitinol Stent System (Reg No. 074662)

(i) The Board cancelled the registrations of above mentioned Cordis products already
registered in the name of M/s Johnson & Johnson Pakistan (Pvt) Limited, Karachi due to
reasons as submitted above by M/s Johnson & Johnson Pakistan (Pvt) Limited.

(ii) For Codman Portfolio product namely Prowler Micro Catheters (Reg No.
074692), the Board again directed the firm to apply for Provisional Establishment
Certificate within 15 days otherwise further necessary action shall be taken by the MDB
which may lead to cancellation of registration of their product.

2. Mr. Mubashir Iqbal representing M/s SES Associates, Lahore appeared before the
Board and submitted written reply that Mr. Shahid Ikram,(Chief Executive) of the firm is
out of country and he will come back next week and shall appear in person in DRAP in
next week on Tuesday.
The Board directed Mr. Mubashir Iqbal to inform Mr. Shahid Ikram to personally
appear in DRAP on upcoming Tuesday to clarify his position regarding the subject matter
for not applying for Provisional Establishment Certificate despite the written directions of
the MDB. The Board further directed the firm to apply for Provisional Establishment
Certificate within 15 days otherwise further necessary action shall be taken by the MDB
which may lead to cancellation of registration of their product(s).

3. Mr. Munawar, Liason Manager of M/s Nabiqasim Industries (Private) Limited,

Karachi appeared before the Board and submitted written reply of the firm that on receipt
of original agency agreement from principal abroad, they will apply for Provisional
Establishment Certificate within 15 days.
The Board directed the firm to apply for Provisional Establishment Certificate
within 15 days otherwise further necessary action shall be taken by the MDB which may
lead to cancellation of registration of their product(s).

4. Mr. Asghar Khattak, Regional Sales Coordinator (North) of M/s Trans Angio
Systems, Karachi appeared before the Board and submitted written reply of the firm
wherein the firm requested the Board to allow them to submit their application of
Provisional Establishment Certificate by 30th August, 2017 due to the reason that

Minutes of 6th Meeting of MDB Page 12 of 29

 documents are pending at their end of their principal in Germany.
The Board directed the firm to apply for Provisional Establishment Certificate
within 15 days otherwise further necessary action shall be taken by the MDB which may
lead to cancellation of registration of their product(s). The representative agreed and
submitted written statement in writing.

5. M/s Radiant Devices Biomedical Pvt. Limited, Lahore did not appear before the
Board, however, Mr. Rashid Ahmed, Director, Radiant Devices Biomedical Pvt. Limited
sent a letter wherein he has informed that they have discontinued their services and do not
wish to apply for Provisional Establishment Certificate.
The Board cancelled the registrations of the products namely PTA Self
Expandable Stent System “Resistant” (Reg No. 074671) and PTCA Coronary Drug
Eluting Stent System “euca TAX” (Reg No. 074672) already registered in the name of
M/s Radiant Devices Biomedical Private Limited, Lahore due to the reason that the firm
has informed in writing that they have discontinued their services and do not wish to apply
for Provisional Establishment Certificate.

6. M/s Universal Trades, Quetta did not appear before the Board, however, Mr.
Javed, Managing Director, Universal Trades, Quetta informed telephonically that he is
unable to come due to his personal issues.
The Board again directed the firm to apply for Provisional Establishment
Certificate within 15 days otherwise further necessary action shall be taken by the MDB
which may lead to cancellation of registration of its product(s).

Meeting ended with vote of thanks to and from the Chair.

==========

Minutes of 6th Meeting of MDB Page 13 of 29

 ANNEX-I

LIST OF MEDICAL DEVICES DEEMED TO BE REGISTERED

UNDER MEDICAL DEVICES RULES, 2015 UNDER SRO. 167(I)/2017
(AS PER INITIAL REGISTRATION LETTER)

CATHETERS

S.No Name of Firm/ Name of Manufacturer Reg.No. Name of Medical Device Date of
Importer. Registration
1. M/s Iqbal & M/s. Arrow International, 074635 Arrow Central Venous 21-2-2013
Company, Inc (subsidiary of Teleflex, Catheterization Set.
Islamabad. Incorporated) 2400 Bernville
Road, Reading PA 19605,
USA)

2. -do- -do- 074636 Arrow Intra Aortic 21-2-2013

Balloon Catheters.
3. -do- -do- 074637 Arrow Two Lumen 21-2-2013
Haemodialysis
Catheterization Set.
4. -do- -do- 074638 Arrow Balloon Wedge 21-2-2013
Pressure Catheters
5. -do- -do- 074639 Arrow Arterial 21-2-2013
Catheterization Set.
6. -do- -do- 074640 Arrow Berman 21-2-2013
Angiographic Balloon
Catheters.
7. -do- -do- 074641 Arrow Multi Lumen 21-2-2013
Access Catheters.
8. M/s Digital Imaging Responsible Manufacturer: 074648 Trek RX Coronary 12-4-2013
Systems, Lahore. M/s. Abbott Vascular Dilatation Catheter
Lakeside Drive, California,
USA.
Manufacturing Site: M/s.
Abbott Vascular Cashel
Road, Clonmel, County
Tipperary, Ireland).

9. -do- -do- 074649 Mini Trek RX Coronary -do-

Dilatation Catheter

10. -do- -do- 074650 NC Trek RX Coronary -do-

Dilatation Catheter.

Minutes of 6th Meeting of MDB Page 14 of 29

11. M/s Intek M/s. OrbusNeich Medical 074673 Scoreflex Coronary 1-1-2014
Corporation, B.V. Drs, W. Van Dilatation Catheter.
Rawalpindi Royenstraat, AN
Hoevelaken, The
Netherlands.

12. -do- -do- 074674 Sapphire NC Coronary 1-1-2014

Dilatation Catheter

13. -do- -do- 074675 “Sapphire II (Rx)” 1-1-2014

Coronary Dilatation
Catheter

14. -do- -do- 074677 Sapphire Coronary 1-1-2014

Dilatation Catheter

15. M/s Cor-Med, M/s. IHT, Iberhospitex S.A, 074689 Fairway Rapid Exchange 25-4-2014
Rawalpindi. Barcelona, Spain) Dilatation Catheter for
PTCA

16. M/s. B.Braun Legal Manufacturer: M/s. 080168 Angiodyn” Angiographic 10-02-2016
Pakistan (Pvt) Ltd., PendraCare International Catheter.
Karachi. B.V., Van der Waalspark-
22, VC Leek, Netherland.
Marketing Authorization
Holder & Central
Distributors: M/s. B.Braun
Melsungen AG, Vascular
System, Sieversufer 8, D-
12359, Berlin, Germany).

17. -do- Legal Manufacturer: M/s. 080169 SeQuent Neo Rapid 10-02-2016
B.Braun Melsungen AG, Exchange Coronary
Carl-Braun-Strasse 1, 34212 (PTCA) Balloon Catheter.
Melsungen, Germany.
Manufacturing Site: B.
Braun Melsungen AG,
Vascular Systems,
Sieversufer 8, 12359 Berlin,
Germany.

18. M/s Healthtec, (Manufacturer: Blue 080409 Force NC Balloon 08-03-2016

Rawalpindi. Medical Device B.V, Dilatation Catheter
Steenovemweg 19, 5708 NH
Helmond, The
Netherlands.
Production plant:
Panovenweg 7, 5708 HR
Helmond, The Netherlands).

19. -do- -do- 080410 Everest SC Balloon 08-03-2016

Dilatation Catheter

Minutes of 6th Meeting of MDB Page 15 of 29

20. -do- -do- 080411 Summit CTO Balloon 08-03-2016
Dilation Catheter

21. M/s Healthtec, Manufacturer: Blue 082017 Protégé DEB Dilatation 30-9-2016
Rawalpindi. Medical Device B.V, Catheter
Steenovemweg 19, 5708 NH
Helmond, The (Paclitaxel Eluting
Netherlands Balloon Dilatation
Production plant: Catheter)
Panovenweg 7, 5708 HR
Helmond, The Netherlands).

22. M/s Intek, Legal Manufacturer: M/s 083119 Progreat 09-02-2017

Rawalpindi. Terumo Corporation-1,2- (Micro Catheter System)
chome, Hatagaya, Shibuya-
ku, Tokyo, Japan.
Manufacturing Site: M/s
Ashitaka Factory of Terumo
Corporation, 150, Maimaigi-
cho, Fujinomiya city,
Shizuoka Prefecture, Japan.

23. -do- -do- 083120 Heartrail II PTCA 09-02-2017

Guiding Catheter.
24. -do- Manufactured by: M/s 083121 Sapphire II NC Coronary 09-02-2017
OrbusNeich Medical B.V. Dilatation Catheter
Drs. W.Van Royenstraat 5,
3871 AN Hoevelaken, The
Netherlands.
25. -do- -do- 083122 Sapphire II PRO 09-02-2017
Coronary Dilatation
Catheter

26. M/s Healthtec, Manufacturer: M/s 083123 Primum Hydrophilic 07-03-2017

Rawalpindi. PendraCAre International Guiding Catheter
B.V. Vander Waals Park 22,
9351 VC Leek,
The Netherlands.
27. M/s Intek, Legal Manufacturer:M/s 083127 Radifocus Optitorque 06-3-2017
Rawalpindi. Terumo Corporation, 44-1,2- (Angiographic Catheter)
chome, Hatagaya, Shibuya-
ku, Tokyo, Japan.
Manufacturing Site: M/s
Ashitaka Factory of Terumo
Corporation, 150, Maimaigi-
cho, Fujinomiya city,
Shizuoka Prefecture, Japan.
28. -do- -do- 083128 Ryujin Plus PTCA 06-3-2017
Dilatation Catheter

Minutes of 6th Meeting of MDB Page 16 of 29

29. M/s ACP System. Legal Manufacturer: M/s 083130 Euphora Rapid Exchange 07-03-2017
Karachi. Medtronic, Inc, 710 Balloon Dilatation
Medtronic Parkway N.E., Catheter
Minneapolis, 55432,US.
Manufacturing Facility:
M/s Medtronic Mexico S. de
R.L. de CV, Av. Paseo
Cucapah, 10510 El
Lago, C.P.22210 Tijuana,
Baja California, Mexico.

30. M/s Intek, Manufactured By: 083134 Hoper PTCA Balloon 06-03-2017
Rawalpindi. M/s Lepu Medical Dilatation Catheter
Technology (Beijing) Co.,
Ltd., no 37 Chaoqian Rd,
Changping district, Beijing,
China.

(Free sale certificate from

regulatory authority of
Netherlands also provided)

31. M/s Ferozsons Legal Manufacturer: M/s. 083135 Emerge Over-The-Wire 08-03-2017
Laboratories Limited, Boston Scientific PTCA Dilatation Catheter
Nowshera. Corporation, 300 Boston
Scientific Way, Marlborough
MA 01752, USA.
Manufacturing Site: M/s.
Boston Scientific
Corporation, Two Scimed
Place, Maple Grove, MN
55311, USA.

32. -do- -do- 083136 Emerge MONORAIL TM 08-03-2017

PTCA Dilatation Catheter

33. -do- -do- 083137 NC Quantum Apex TM 08-03-2017

Monorail TM PTCA
Dilatation Catheter

34. -do- -do- 083138 Maverick 2TM Monorail 08-03-2017

TM
PTCA Dilatation
Catheter

Minutes of 6th Meeting of MDB Page 17 of 29

35. -do- Legal Manufacturer: M/s. 083390 Flextome TM Cutting 09-03-2017
Boston Scientific Balloon TM Monorail TM
Corporation, 300 Boston Microsurgical Dilatation
Scientific Way, Device
Marlbnorough,
Massachusetts 01752, USA.
Manufacturing Site: M/s.
Boston Scientific Ltd,
Ballybrit Business Park,
Galway, Ireland.

36. M/s B.Braun Manufacturer: 083393 Sequent Please Neo 10-03-2017

Pakistan (Pvt) B.Braun Melsungen AG Paclitaxel Releasing
Limited, Carl-Braun –Stabe 1 34212 Rapid Exchange PTCA
Karachi. Melsungen, Germany. Balloon Catheter
Manufacturing Site:
B.Braun Melsungen AG
Vascular Systems
Sieversufer 8, 12359 Berlin,
Germany.
37. M/s Hashir Surgical Manufactured By: M/s 083396 Trilucath Central Venous 10-03-2017
Services, Intra Special Catheter Catheter-3 Lumen
Peshawar. GmbH, Oststrasse 2, 66780
Rehlingen-Siersburg,
Germany
38. -do- -do- 083397 Venoseld Central Venus 10-03-2017
Catheter-I Lumen.
39. -do- -do- 083398 Duocath Central Venus 10-03-2017
Catheter 2-Lumen.
40. -do- -do- 083399 Duocath Hemodialysis 10-03-2017
Catheter 2-Lumen.
41. -do- -do- 083400 Quadrocath Central Venus 10-03-2017
Catheter 4-Lumen

42. -do- -do- 083401 Trilucath Hemodialysis 10-03-2017

Catheter 3-Lumen
43. M/s Digital Imaging Name of Owner Operator 083407 Eagle Eye Platinum & ST- 10-03-2017
Systems, Lahore. and manufacturing IVUS Catheter.
Facility:
M/s Volcano Corporation
2870 Kilgore rd, Rancho
cordova, CA USA 95670

Minutes of 6th Meeting of MDB Page 18 of 29

44. M/s ACP System. Legal Manufacturer: M/s 083410 Export Advance 10-03-2017
Karachi. Medtronic, Inc. 710 Aspiration Catheter
Medtronic Parkway
Minneapolis, MN 55432,
USA.
Manufacturing Site: M/s
Medtronic Vascular, 37A
Cherry Hill Drive, Danvers,
MA 01923, USA.
45. M/s Ferozsons Legal Manufacturer: M/s. 083413 CRE Pulmonary Balloon 10-03-2017
Laboratories Limited, Boston Scientific Dilatation Catheter
Nowshera Corporation, 300 Boston
Scientific Way,
Marlborough MA 01752,
USA.

Manufacturing Site: M/s.

Boston Scientific Limited,
Business and Technology
Park, Model Farm Road
CORK, Ireland.
46. M/s Ferozsons Legal Manufacturer: M/s. 083414 Coyote TM Monorail TM 10-03-2017
Laboratories Limited, Boston Scientific PTA Balloon Dilatation
Nowshera Corporation, 300 Boston Catheter
Scientific Way, Marlborough
MA 01752, USA.
Manufacturing Site: M/s.
Boston Scientific
Corporation, Two Scimed
Place, Maple Grove, MN,
USA
47. M/s Ferozsons Legal Manufacturer: M/s. 083415 Coyote TM ES Monorail 10-03-2017
Laboratories Limited, Boston Scientific TM PTA Balloon
Nowshera Corporation, 300 Boston Dilatation Catheter
Scientific Way, Marlborough
MA 01752, USA.
Manufacturing Site: M/s.
Boston Scientific
Corporation, Two Scimed
Place, Maple Grove, MN,
USA

Minutes of 6th Meeting of MDB Page 19 of 29

48. M/s Ferozsons Legal Manufacturer: M/s. 083416 Coyote TM Over-The- 10-03-2017
Laboratories Limited, Boston Scientific Wite PTA Balloon
Nowshera Corporation, 300 Boston Dilatation Catheter
Scientific Way, Marlborough
MA 01752, USA.
Manufacturing Site: M/s.
Boston Scientific
Corporation, Two Scimed
Place, Maple Grove, MN,
USA
49. M/s Ferozsons Legal Manufacturer: M/s. 083417 Coyote TM ES Over- 10-03-2017
Laboratories Limited, Boston Scientific The-Wire PTA Balloon
Nowshera Corporation, 300 Boston Dilatation Catheter
Scientific Way, Marlborough
MA 01752, USA.
Manufacturing Site: M/s.
Boston Scientific
Corporation, Two Scimed
Place, Maple Grove, MN,
USA
50. M/s Ferozsons Legal Manufacturer: M/s. 083418 Sterling TM Monorail TM 10-03-2017
Laboratories Limited, Boston Scientific PTA Balloon Dilatation
Nowshera Corporation, 300 Boston Catheter
Scientific Way, Marlborough
MA 01752, USA.
Manufacturing Site: M/s.
Boston Scientific
Corporation, Two Scimed
Place, Maple Grove, MN,
USA
51. M/s Ferozsons Legal Manufacturer: M/s. 083419 Mustang TM Over-The- 10-03-2017
Laboratories Limited, Boston Scientific Wire PTA Balloon
Nowshera Corporation, 300 Boston Dilatation Catheter
Scientific Way, Marlborough
MA 01752, USA.
Manufacturing Site: M/s.
Boston Scientific
Corporation, Two Scimed
Place, Maple Grove, MN,
USA

Minutes of 6th Meeting of MDB Page 20 of 29

 52. M/s. Promed Legal Manufacturer: M/s 083420 Powerline TM PTCA 14-03-2017
International, Biosensors Interventional Catheter
Rawalpindi. Technologies Pte Ltd, 36
Jalan Tukang, Singapore
619266, Singapore.
Manufacturing Site: M/s
Biosensors Interventional
Technologies Pte Ltd, 36
Jalan Tukang, Singapore
619266, Singapore.

(Free sale certificate from

regulatory authority of
Switzerland provided)

53. M/s Genus, Karachi. Manufactured by: M/s 083421 Hawk TM-SC- PTCA 15-03-2017
Umbra Medical Products, Balloon Catheter Semi-
Inc, 8930 East Roan Lane, Compliant
Inverness, Florida, 34450
USA.
54. -do- -do- 083422 Falcon Guiding Catheter 15-03-2017

55. -do- -do- 083423 Hawk TM NC- PTCA 15-03-2017

Balloon Catheter Non-
Compliant
56. M/s Hakimsons (Pvt) Manufactured by: M/s 083430 Ivascular Xperience 15-03-2017
Limited, Karachi. Life Vascular Devices Cateter Balon De
Biotech, S.L., C.I.F. B- Dilatacion Coronario
65405169, Cami de (Coronary Dilatation
Can’Ubach, 11 (pol. IND. Balloon Catheter )
Les Fallulles), 08620 SANT
VICENC, DELS HORTS,
Barcelona, Spain.

57. -do- -do- 083431 Ivascular Oceanus 35 15-03-2017

Cateter balon de
predilatacion periferico
para guia de alambre de
0.014 (PTA Balloon
Dilatation Catheter )

58. -do- -do- 083432 Oceanus 14 Peripheral 15-03-2017

Balloon Dilatation
Catheter

STENTS

S.No Name of Firm/ Name of Manufacturer Reg.No. Name of Medical Device Date of
Importer. Registration

Minutes of 6th Meeting of MDB Page 21 of 29

1. M/s Digital Imaging Responsible 074642 Xience V Everolimus 12-4-2013
Systems, Lahore. Manufacturer: M/s. Eluting Coronary Stent
Abbott Vascular System.
Lakeside Drive,
California, USA.
Manufacturing Site:
M/s. Abbott Vascular
Cashel Road, Clonmel,
County Tipperary,
Ireland.
1. -do- -do- 074643 Xience Prime Everolimus -do-
Eluting Coronary Stent
System
2. -do- -do- 074644 Omnilink Elite Peripheral -do-
Stent System.
3. -do- -do- 074645 Multi-Link Vision -do-
Coronary Stent System
4. -do- -do- 074646 Multi-Link Minivision -do-
Coronary Stent System
5. -do- -do- 074647 Multi-Link Zeta Coronary -do-
Stent System
6. -do- Responsible 074651 RX Acculink Carotid -do-
Manufacturer and Stent System
Manufacturing Site:
M/s. Abbott Vascular
Lakeside Drive,
California, USA
7. -do- -do- 074652 RX Herculink Elite -do-
Peripheral Stent System.
8. M/s Intek Corporation, M/s. OrbusNeich 074676 Genous Bioengineered 1-1-2014
Rawalpindi Medical B.V. Drs, W. Cobalt Chromium
Van Royenstraat, AN Stent Delivery System.
Hoevelaken, The
Netherlands.
9. -do- -do- 074678 Azule CoCr Alloy 1-1-2014
Coronary Stent Delivery
System
10. M/s Cor-Med, M/s. IHT, Iberhospitex 074690 Bionert Inert Coronary 25-4-2014
Rawalpindi. S.A, Barcelona, Spain Stent (Bare Metal Stent)

11. -do- -do- 074691 Active Paclitaxel Eluting 25-4-2014

Coronary Stent

Minutes of 6th Meeting of MDB Page 22 of 29

12. M/s Ferozsons Legal Manufacturer : 074716 Promus ® Element-Plus 8-4-2015
Laboratories Limited, M/s. Boston Scientific Monorail TM
Nowshera. Corporation, USA
Manufacturing Site : (Everolimus-Eluting
M/s Boston Scientific Coronary Artery Stent)
Ireland Ltd, Ireland.
13. M/s Intek Corporation, M/s. OrbusNeich 080003 Combo Bio-Engineered 26-1-2016
Rawalpindi. Medical B.V. Drs, W. Sirolimus Eluting Stent.
Van Royenstraat, AN (Combo Dual Therapy
Hoevelaken, The Stent)
Netherland.
14. -do- Legal Manufacturer: 080004 Nobori Drug Eluting 26-1-2016
M/s Terumo Europe Stent System
N.V., Interleuvenlaan
40, 3001 Leuven, (Biolimus A-9 Eluting
Belgium. Stent)
Manufacturing Site:
Ashitaka Factory of
Terumo Corporation,
150, Maimaigi-cho,
Fujinomiya
15. -do- Legal Manufacturer: 080005 Ultimaster Sirolimus 26-1-2016
M/s Terumo Europe Eluting Coronary Stent
N.V., Interleuvenlaan System
40, 3001 Leuven,
Belgium.
Manufacturing Site:
Ashitaka Factory of
Terumo Corporation,
150, Maimaigi-cho,
Fujinomiya City,
Shizuoka Prefecture
418-0015, Japan.
Design Site: Terumo
Corporation, R&D
Centre, 1500, Inokuchi,
Nakai-Machi,
Ashigarakami-gun,
Kanagawa, Perfecture,
Japan.
16. M/s. B.Braun Pakistan Legal Manufacturer: 080170 Coroflex ISAR 10-02-2016
(Pvt) Ltd., Karachi. M/s. B.Braun
Melsungen AG, Carl- (Sirolimus Eluting
Braun-Strasse 1, 34212 Polymer-Free Coronary
Melsungen, Germany. Stent System)
Manufacturing Site: B.
Braun Melsungen AG,
Vascular Systems,
Sieversufer 8, 12359
Berlin, Germany.
Minutes of 6th Meeting of MDB Page 23 of 29
17. M/s Healthtec, Manufacturer: Blue 080412 Track CoCr Coronary 08-03-2016
Rawalpindi. Medical Device B.V, Stent System
Steenovemweg 19, 5708 (Bare Metal)
NH Helmond, The
Netherlands.
Production plant:
Panovenweg 7, 5708
HR Helmond, The
Netherlands.

18. M/s Ferozsons Owner Operator: M/s. 080719 Promus Premier TM 10-5-2016
Laboratories Limited, Boston Scientific Monorail TM Everolimus-
Nowshera. Corporation, 300 Boston Eluting Platinum
Scientific Way, Chromium Coronary
Marlborough, MA Stent System
01752, USA.

Manufacturing Site: M/s

Boston Scientific
Limited, Ballybrit
Business Park, Galway,
Ireland

19. M/s. Promed Legal Manufacturer : 081522 BioMatrix Flex TM Drug 19-8-2016
International, M/s Biosensor Europe Eluting Coronary Stent
Rawalpindi. SA,. Rue de Lausanne System
29, 1110 Morges,
Switzerland. (Biolimus A9)

Manufacturing Site:
Biosensor Interventional
Technologies Pte Ltd,
36 Jalan Tukang,
Singapore 619266.

Sterilization Sites: BGS

Beta-Gamma-Service
GmbH & Co KG. Fritz-
Kotz-Strasse 16, 51674
Wiehi, Germany.

Electron Beam Sdn,

Bhd, Lot 7, Jalan Sungai
Pinang 4/3, Taman
Perindustrian Pulau
Indah (Fasa 2), 42920
Port Kalang, Selangor,
Malaysia.
20. -do- -do- 081523 Biofreedom Drug Coated 19-8-2016
Coronary Stent System

(Biolimus A9)

Minutes of 6th Meeting of MDB Page 24 of 29

21. M/s Cardiovascular Owner/Legal 082105 ITRIX Rapamycin 30-9-2016
Medical System, Manufacturer: M/s Eluting Coronary Stent
Lahore. amg International Implantation System
GmbH Lohnfeld 26, D-
21423 Winsen-Luhe,
Germany.
Manufactured by: M/s
QualiMed Innovative
Medizinprodukte
GmbH, BoschstraBe 16,
21423, Winsen- Luhe,
Germany.
22. -do- -do- 082016 ARTHOS Pico Stent 30-9-2016
Implantation System
23. M/s Healthtec, Manufacturer: Blue 082020 Pioneer 09-02-2017
Rawalpindi. Medical Device
B.V,Steenovenweg 19, (Cobalt Chromium Stent
5708 HN Helmand mounted on Paclitaxel
Netherlands Eluting Balloon Catheter)
Production plant:
Panoverweg 7 5708 HR
Helmond, Netherlands.
24. M/s. Intek Legal Manufacturer: 082021 Kaname Cobalt 09-02-2017
Corporation, M/s Terumo Europe Chromium Coronary
Rawalpindi. N.V. Interleuvenlaan 40, Stent System
3001 Leuven, Belgium.
Manufacturing Site:
M/s Terumo
Corporation Ashitaka
Plant, 150, Maimaigi-
cho, Fujinomiya city,
Shizuoka Prefecture
418-0015, Japan.
25. M/s Digital Imaging Legal Manufacturer: 083124 Xience Xpedition 06-03-2017
Systems, M/s Abbott Vascular, Everolimus Eluting
Lahore. 3200 Lakeside Drive, Coronary Stent System
Santa Clara, California
95054, USA.
Manufacturing Site:
M/s Abbott Vascular,
Cashel Road, Clonmel,
County Tipperary,
Ireland.

Minutes of 6th Meeting of MDB Page 25 of 29

26. M/s Digital Imaging Responsible 083125 Absorb GT1 06-03-2017
Systems, Manufacturer: M/s Bioresorbable Vascular
Lahore. Abbott Vascular, 3200 Scaffold System
Lakeside Drive, Santa
Clara, California 95054,
USA.
Manufacturing Site:
M/s Abbott Vascular,
26531 Ynez Road,
Temecula, CA 92591,
USA.
27. M/s B.Braun Pakistan Responsible 083129 Coroflex Blue Neo 07-03-2017
(Pvt) Limited, Manufacturer: M/s Coronary Stent System
Karachi/ B.Braun Melsungen
AG, Caril-Braun-StraBe
1, 34212 Melsungen,
Germany.
Manufacturing Site:
M/s B.Braun Melsungen
AG Vascular System
Sieversufer 8, 12359
Berlin Germany.
28. M/s ACP System. Legal Manufacturer: 083131 Resolute Onyx 07-03-2017
Karachi. M/s Medtronic, Inc, 710 Zotarolimus-Eluting
Medtronic Parkway, Coronary Stent System
Minneapolis, Minnesota
55432, USA.
Manufacturing Site:
M/s Medtronic Ireland,
Parkmore Business Park
West, Galway, Ireland.
29. M/s Promed Legal Manufacturer: 083132 BioMatrix Neoflex TM 07-03-2017
International, M/s Biosensors Europe Drug Eluting Coronary
Rawalpindi. SA, Rue De Lausanne Stent System.
29, 1110 Morges,
Switzerland.
Manufacturing Site:
M/s Biosensors
Interventional
Technologies Pte Ltd,
36 Jalan Tukang,
Singapore 619266,
Singapore.

Minutes of 6th Meeting of MDB Page 26 of 29

30. M/s Intek Corp. Manufactured By: 083133 Partner Sirolimus-Eluting 06-03-2017
Rawalpindi. M/s Lepu Medical Coronary Stent System
Technology (Beijing)
Co., Ltd., no 37
Chaoqian Rd,
Changping district,
Beijing, China.

(Free sale certificate

from regulatory
authority of Netherlands
also provided)
31. M/s Ferozsons Legal Manufacturer: 083389 Synergy TM Monorail TM 09-03-2017
Laboratories Limited, M/s. Boston Scientific Everolius Eluting
Nowshera. Corporation, 300 Boston Platinum Chromium
Scientific Way, Coronary Stent System
Marlbnorough,
Massachusetts 01752,
USA.
Manufacturing Site:
M/s. Boston Scientific
Ltd, Ballybrit Business
Park, Galway, Ireland.

32. M/s B.Braun Pakistan Manufacturer: 083394 Coroflex ISAR NEO 10-03-2017
(Pvt) Limited, B.Braun Melsungen AG Sirolimus-eluting
Karachi. Carl-Braun –Stabe 1 Coronary Stent System
34212 Melsungen,
Germany.
Manufacturing Site:
B.Braun Melsungen AG
Vascular Systems
Sieversufer 8, 12359
Berlin, Germany.

33. M/s Promed Legal Manufacturer: 083402 BioMatrix Alpha TM Drug 10-03-2017
International, M/s Biosnsor Europe Eluting Coronary Stent
Rawalpindi. SA, Rue De Lausanne System
29, 1110 Morges,
Switzerland. (Biolimus A9)
Manufacturing Site:
M/s Biosensors
Interventional
Technologies Pte Ltd,
36 Jalan Tukang,
Singapore 619266,
Singapore.

Minutes of 6th Meeting of MDB Page 27 of 29

34. M/s Digital Imaging Legal Manufacturer: 083404 Xience Alpine 10-03-2017
Systems, Lahore. M/s Abbott Vascular, Everolimus Eluting
3200 Lakeside Drive, Coronary Stent System
Santa Clara, California
95054, USA.
Manufacturing Site:
M/s Abbott Vascular,
Cashel Road, Clonmel,
County Tipperary,
Ireland.

35. -do- -do- 083405 Graft Master RX 10-03-2017

Coronary Stent Graft
System

36. M/s Digital Imaging Manufactured By: 083406 Multi link 8 Coronary 10-03-2017
Systems, M/s Abbott Vascular, Stent System
Lahore. Cashel Road, Clonmel,
County Tipperary, (Cobalt Chromium)
Ireland.
Legal Manufacturer :
M/s Abbott Vascular,
3200 Lakeside Drive,
Santa Clara, California
95054, USA.

37. M/s ACP System. Legal Manufacturer: 083411 Driver Sprint Rapid 10-03-2017
13 &23,Naval Fleet M/s Medtronic, Inc.710 Exchange Coronary Stent
Club, Iqbal (S.J) Medtronic Parkway NE System
Shaheed Road, Minneapolis, MN
Karachi. 55432, USA.
Manufacturing Site:
M/s Medtronic Ireland,
Parkmore Business Park
West Galway, Ireland.

38. M/s Ferozsons Legal Manufacturer: 083412 RebelTM MonorailTM PtCr 10-03-2017
Laboratories Limited, M/s. Boston Scientific Coronary Stent System
P.O.Ferozsons, Corporation, 300 Boston
Amangarh, Scientific Way,
Nowshera Marlborough MA
01752, USA.
Manufacturing Site:
M/s. Boston Scientific
Corporation, Two
Scimed Place, Maple
Grove, MN 55311,
USA.
39. F.W Distributors, M/s Coloplast A/S, 083425 Biosoft Duo Mujolti 15-03-2017
Rawalpindi. Holtedam 1, 3050 Length Hydro-Coated
Humlebaek, Denmark. Urethral Stent Kit (long
term)

Minutes of 6th Meeting of MDB Page 28 of 29

40. -do- -do- 083426 Double Loop Urethral 15-03-2017
Stent in PA OR PU (Short
Term)
41. Hakimsons (Pvt) Manufactured by: 083429 IVASCULAR 15-03-2017
Limited, Karachi M/s Life Vascular ARCHITECT
Devices Biotech, S.L.,
C.I.F. B-65405169, Sistema de Stent
Cami de Ca n’Ubach, Coronario CoCr (CoCr
11 (pol. IND. Les Coronary Stent System)
Fallulles), 08620 SANT
VICENC, DELS
HORTS, Barcelona,
Spain.
42. M/s Genus, Karachi. Manufactured by: 083408 Silver Stent-CC Cobalt 15-03-2017
M/s Umbra Medical Chromium Drug Eluting
Products, Inc, 8930 East Stent
Roan Lane, Inverness,
Florida 34450 USA.

43. -do- -do- 083409 Affinity CC Cobalt 15-03-2017

Chromium Sirolimus
Eluting Stent.

============

Minutes of 6th Meeting of MDB Page 29 of 29