Package testing for Medical devices

20. Mar.-Apr. 2017
20
1. Visit the website http://www.ingineering-brands.com
2. Along with many useful information about the E-Catalogues,
you will get the names of the industry, for which currently
the E-Catalogue registration is open,
a. Pumps & Valves,
b. Medical Devices,
c. Electrical Machineries, Equipment & Components
d. Textile Machinery & Accessories
3. Click on the link for the desired E-Catalogue.
4. The corresponding E-Catalogue home page is displayed. It
describes about the industry and some important statistics.
5. On the top banner, there is a button named “Get Listed”.
6. Click on that button, which will take you to the Manufacturer
Registration page for the corresponding catalogue.
7. Manufacturer Registration is a 3 step process.
a. In the first step, you need to mention details about your
company.
b. In the second step, enlist all the products that you want, to
be part of the E-Catalogue along with product certification
information. Please note, certification is mandatory, if you
do not have product certificate, then you will not be able to
list your products in the E-Catalogue.
c. You will also be able to upload maximum five product
images in a predefined format and size mentioned in the
E-Catalogue interface.
d. The third step is the optional questionnaire. After
responding to the questions, companies are requested to
accept the Terms & Conditions and submit their entry.
8. Once all the data entry validations are successfully passed,
your registration will be submitted.
9. Aftersubmission,theE-CatalogueAdminwillverifyyourentry
foraccuracyoranymissinginformation and yourapplication
will be either accepted or rejected. If your entry is approved,
your company and products gets listed in the E-Catalogue.
Reference : http://www.eepcindia.org/eepc-download/
96-Users-Guide.pdf
How to get listed in E-Catalogue

21. Contents
Vol. 25 No. 2 Mar. - Apr. 2017
Table of
24 Cover Story
• ASEAN Medical Devices & Plastics Sectors : Immense Market Potential
Medical manufacturing is one of the key growth areas in countries belonging to the Association of
Southeast Asian Nations (ASEAN). A rapidly expanding middle class is largely responsible for a
projected near doubling of the medical device market in these countries.
42 Events Calendar
• T-Plas, 2017: Sept. 20 – 23, 2017, Thailand, with “MEDICAL & HEALTHCARE PLASTIC PAVILION”
• Medicall 2017, 17th Edition: July 28 - 30, 2017, Chennai
• Medicall 2017, 18th Edition: Oct. 6 – 8, 2017, Mumbai
• MEDICAL FAIR INDIA 2017 Event Report
22 Did You Know?
• About Drug / Device Combination Products & ASEAN Markets
32 Industry News
• Med Devices Import up 16.8%, Export By 25.7% During 2012-16
• DCGI begins registration of notified bodies to carry out audit of mfg sites of Class A & Class B
medical devices
• 10% price hike cap on most medical devices
• CDSCO to go online for all services in six months
30 Global Trends
• Global Medical Disposables Market to Reach US$193.9 Bn by 2018
• Medical Polymers Market to exceed $24bn by 2024
• Asia-Pacific Reprocessed Medical Devices Market Will Hit at a CAGR of 15.7% by 2017 to
2027
34 Product Gallery
• Dilators and Introducer Sheaths
26 Manufacturing
• Developing Drug / Device Combination Products: Concept to Commissioning
Dr. Atul Sardana, Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi
A Drug Device combination products are emerging as innovative medical products due to their
contribution in advancing medical care and are thus expected to have an impact in coming years.
Development of Drug / Device combination entails the following steps…..
• Packaging Testing for Medical Devices
Mr. Bunty Kundnani, Business Manager, Life And Health Science,
UL India Pvt. Ltd., Mumbai.
Historically devices have been tested for degradation by accelerated aging
and other various material characteristics. Testing a new packaging design
before full scale manufacturing can save time and money.
Mar.-Apr. 2017 21

22. ?
Did
Know ?
You
In a
Nutshell....
Sept.-Oct. 2004
Flashback
Mar.-Apr. 2017
22
About Drug / Device Combination Products & ASEAN Markets
Many of today’s most innovative medical devices are actually drug/device combination
products that generally include a medical device part and a drug part.
The growth of global drug device combination products market is attributed to the growing
incidence of chronic diseases such as prostate cancer, cardiovascular diseases, colorectal
cancer, diabetic neuropathy; increasing concerns related to obesity and diabetes; and
growing geriatric population.
As per a recent BCC Research Study , the overall global market for Drug-Device
Combinations is growing at a compound annual growth rate (CAGR) of 7.1% from 2014 to
2019, and thus sales are projected to reach $31 billion in 2019.
Western- type diseases have become increasingly prevalent in Asia. Increased lifespans
and growing incomes have led many to adopt Western habits—such as overeating,
consuming fast food, smoking, and engaging in little exercise—putting Asians at an
increasingly higher risk for lifestyle diseases. In particular, the growth rates of diabetes,
orthopedic problems, cardiovascular disease, and cancer are rising quickly. Western device
manufacturers already make products to diagnose and treat these diseases. Hence, the
ASEAN nations are attractive markets for Western device firms.
Although ASEAN countries have traditionally been known for low-end medical device
product manufacturing, such as simple catheters and drainage bags, this is no longer the
case. Some manufacturers inASEAN countries are now able to produce more sophisticated
Class II and, in some cases, Class III medical devices.
Besides selling their device products in ASEAN countries, an increasing number of Western
medical device companies are also manufacturing or sourcing their products there.
They are doing so for a variety of reasons, including Asia’s low overhead costs, low labor
costs, and improving technical capabilities. While labor costs have increased significantly
in China, they remain low in some of the ASEAN countries, including Vietnam.
“ The illiterate of the future
will not be the person
who cannot read,
it be the person who does not
know how to learn”
-Alvin Toffler
From Editor’s Desk
Dear Reader’s,
Importance of “Plastics” in medical grows more and more
with growth of medical technology. This is because of
excellent forming qualities, low weight and favourable
economics.
......As per Prof. Jurgen Fleischer, the chair of the Institute
For Production Technology at the University of Karlsruhe,
“Increasing miniaturization combined with simultaneous
integration of functions is a key theme of global product
development in the most diverse application fields”. In
particular, this applies to medical technology, which
receives major inspiration from ComPaMED. On one
hand, the focus is on materials that are prerequisites for
permanent system reduction and, on the other hand,
these innovative materials require that their
manufacturing and forming processes are
co-developed.
As per Mr. Horst Giesen, Project Director for MEDICA
and ComPaMED, “there can be no doubt: small and tiny
components, functional surfaces and innovative materials
will play an important role at ComPaMED 2004”.
........CBI, The Centre ForThe Promotion Of Imports From
Developing Countries, Under their export development
programme for medical devices which covered high-tech
products as well as less sophisticated ones, supported
26 companies including about 10 companies from India.
In the report by CBI Consultant Leendart Santema, “The
second and third time participants saw an overwhelming
increase of turnover”.......
CONTENTS
• Cover Story : Plastics Gain New Importance In
Medicine.
• Materials : Present Trends and Future Prospects of
Plastics in Medical Applications.
• Global Trends : CBI’s Export Development
Programme For Medical Devices
• Industry News :
- Indian Healthcare Federation (IHFC) To Launch
Country’s FirstAccreditation System For Healthcare
Institutions
- Asia’s Largest Healthcare City Soon In West Bengal
(India)
- Medical Insurance Set To Grow By 30 %
- Medical Tourism in India: Attracting 15 million

23. Editor’s
From the
Desk
Focused “Medical & Healthcare Plastics Pavilion “ @ T-Plas
2017, Thailand – A Unique Opportunity For Medical Plastics
Industry Suppliers to reach Asean Markets .
For the first time ever in the Industry, “Medical Plastics Data Service” conceptualized
and successfully created a focused Pavilion during the Plastivision India 2017
event in Mumbai in Jan.2017 as a mission with multiple objectives :
- A knowledge Platform complete with Posters, Audio-Visuals, Models and
Samples.
- To help Medical Plastic Industry Suppliers To Reach Out To Medical Devices,
Pharmaceuticals & Diagnostic Industry.
- To help Non-Medical Plastics Industry To branch Out Into Medical Products.
- Enhance the value of “Brand Plastic”.
The experiment was extremely successful and very well received not only by the
existing Industry but also new entrepreneurs as well as those looking for expansions
and diversifications.
Extending same objective , “MPDS” has conceptualized similar Pavilion in
association with “T-Plas 2017” at Bangkok during Sept. 20 – 23, 2017, providing
global platform with an ASEAN perspective. Medical manufacturing is one of the
key growth areas in the ten member Asean countries led by Malaysia, Indonesia,
Thailand and Singapore. Unlike the past, these rapidly expanding countries are
not only projected to double the medical device industry markets, they are fast
moving from low-end medical device products to more critical and sophisticated
products manufacturing. Dedicated Pavilion in “T-Plas” show is a very good
opportunity for Medical Plastics Industry Suppliers to reach Asean Markets.
This issue covers two excellent and well researched articles by Dr Atul Sardana
and Mr Bunty Kundanani covering very important Medical Device manufacturing
issues. We are extremely grateful to them, particularly Dr Atul Sardana , for being
generous enough to share his valuable experience in developing Drug / Device
Combination products from concept to commissioning for the benefit of Indian
Industry.
Under Brand India Engineering campaign by Govt. of India, EEPC India has
developed Brand India Engineering E-Catalogue with an objective to bring out
360 degree change in perception of Indian products from a supplier of low value
added products to high value, technologically advanced and price competitive
supplier. “Medical Devices “ is one of the focus sectors as part of e-catalogue. We
appeal the Indian Medical Device Industry manufacturers to take benefit of this
golden opportunity by getting listed in this world class catalogue at the link :
http://ingineering-brands.com
EDITOR
D.L.PANDYA, B.E.(Chem), M.I.E.
ASSOCIATE EDITOR
Mr. Rutul Bhavsar
B.Tech (Biomedical & Instrumentation Eng.)
EDITORIAL ADVISORY BOARD
Dr. TARANG PATEL
M.B.B.S., M.Ch. (ONCO)
Cancer & Reconstructive Surgeon
Mr. C. BALAGOPAL
Director - Enter Technologies Pvt. Ltd.
Chairman - Mobilexion Technologies Pvt. Ltd.
Trivandrum
Dr. DILIPH. RAIKER
Ph.D., M.Sc., PGDBM,AMIE (Chem.Engg.)
Former Chief Manager(P), CIPET - Chennai
ING LOUIS C. SUHUURMAN
Formerly Sales Director
COLPITT B.V., Holland
Dr.A.V. RAMANI
Group Sr. Vice President (R&D), The TTK Group
Dr. Vinny Sastri
President, Winovia LLC, U.S.A.
Dr. C.S.B. NAIR
Director (R&D), Peninsula Polymers Ltd
Dr. BHARAT GADHAVI
CEO, Medisurge Hospitals
Mr.A.S.ATHALYE
ArvindAthalye TechnologyTransfer Pvt.Ltd, Mumbai
Dr. SUJOYK. GUHA
B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S.
IIT, Kharagpur
Dr. G. S. BHUVANESHWAR
Consultant, Medical Devices – Design, development,
testing and quality management.
Adjunct Professor, Dept. of Engineering Design, Indian
Institute of Technology, Madras.
PUBLISHED BY :
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E-mail: mpds00@vsnl.com
Website:www.medicalplasticsindia.com
Reg.No.GUJ-ENG-00446/23/ALL/TC/94 dt.3/8/94
DESIGNED AND PRINTED BY :
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Notice: Every precaution is taken to ensure accuracy of content.
However, the publishers cannot accept responsibility for the
correctness of the information supplied or advertised or for
any opinion expressed herein.
Mar.-Apr. 2017 23

24. Cover Story
Mar.-Apr. 2017
24
ASEAN (Association of Southeast Asian Nation). Economy
The ten member states making up ASEAN include Indonesia,
Malaysia, Philippines, Singapore, Thailand, Brunei, Vietnam,
Laos, Myanmar and Cambodia. ASEAN’s fertile consumer base
with a combined population of over 600 million and a combined
GDP of US$ 2.6 trillion, as well as presence in the global market,
enables the region to tap the right opportunities, hinging on the
region’s rising middle class sector and substantial consumer
base. One of ASEAN’s top export sectors by value is plastics
and plastic products earning US$ 39.3 billion in export revenues
in 2013, the International Trade Statistics reported.
The sector’s production rates have witnessed a steady average
growth over the recent years, especially in the ASEAN-6:
Indonesia, Malaysia, the Philippines, Singapore, Thailand, and
Vietnam, which account for more than 95 % of regional GDP,
according to McKinsey & Company. Countries like Cambodia
and Myanmar are growing strongly, with increased economic
liberalisation and development, but will still contribute only a
ASEAN Medical Devices & Plastics Sectors : Immense Market Potential
ASEAN’s Plastics Industry
ASEAN’s plastics industry is anticipated to expand in the coming
years .
In the ASEAN Business Outlook Survey , by the American
Chamber of Commerce Singapore and US Chamber of
Commerce, it was revealed that 19 % of ASEAN businesses
themselves plan to shift investment or business from China into
their own region. Respondents also identified Indonesia as the
most attractive country for new business expansion, followed
by Vietnam, Thailand, and Myanmar. The availability of low-cost
labour in countries such as Cambodia, Indonesia, Laos,
Myanmar, and Vietnam could be a competitive advantage.
With the growth of ASEAN countries’ consumer bases,
broadening of plastic import and export markets, and expanding
foreign trading powers, ASEAN’s plastics industry offers
significant opportunities.
ASEAN Medical Devices Industry : Immense Market
Potential
Medical manufacturing is one of the key growth areas in countries
belonging to the Association of Southeast Asian Nations
(ASEAN).A rapidly expanding middle class is largely responsible
for a projected near doubling of the medical device market in
these countries, from $4.6 billion in 2013 to $9 billion by 2019.
Three ASEAN countries—Malaysia, Indonesia, and Thailand—
account for approximately 65% of the current medical device
market among the 10 member countries, according to Matthew
Zito, Benedict Lynn, and Emily Liu of business intelligence firm
Dezan Shira & Associates. The other seven are Singapore, the
Phillipines, Brunei, Vietnam, Laos, Myanmar, and Cambodia.
Medical device markets within the region have been charting
double digit growth rates in recent years, and will likely continue
to do so. “With the increased demand for better healthcare,
encouraged by governmental focus on healthcare as a priority
sector for trade and service liberalization . . . the upside market
potential for medical devices in the region is immense,”.
small percentage of manufacturing foreign direct investment
(FDI) in the coming years.
The individual medical device markets across ASEAN’s 10
member countries are in various stages of development. Those
with the greatest presence in the medtech market can be broken
down as follows:
• Malaysia and Indonesia, which are rich in rubber, lead global
production in latex products such as surgical gloves and
syringes. Malaysian exports in diagnostic imaging have
expanded in recent years, according to research by Espicom,
which estimates the country is likely to see compound annual
growth of 16.1% to 2018, with growth for consumables as
high as 24.8%.
• Singapore, the region’s medical and technological hub, has a
thriving biomedical research and development industry, and
a competitive advantage in advanced manufacturing. It is
home to the manufacturing operations of more than 30 medical
technology firms.
• Thailand also has a relatively robust medical device market,
worth approximately $1 billion and growing 15% annually,

25. Cover Story
South East Asian Pharma Industry
The South East Asian pharma industry has been growing at an
average of 6-10 percent in the past 10 years. The governments
across the ASEAN region are introducing universal healthcare
programmes, with the consequential rising demand for all
categories of medicines, especially generic drugs.
Comprising almost 40 per cent of the SEA economic output,
Indonesia is now the largest pharma market in the Southeast
Asia/Asia Pacific region (SEA/AP), experiencing an impressive
85 per cent growth in between 2007-2013. The country has the
biggest and fastest growing economy in the SEA region and a
pharma economy consisting of approximately 200
pharmaceutical companies.
There are already 25-30 generic domestic companies with
access to the international market and equally, there are
approximately 35 multinational companies, such as Sanofi,ACG
and Novo Nordisk, established in the area. Most significantly
however, are the remaining domestic manufacturers, who are
increasingly targeting international sales in neighbouring
countries.
according to Ames Gross, President of Pacific Bridge Medical
(Bethesda, MD).
On the regulatory front, ASEAN member countries have made
significant strides toward developing a mature regulatory
framework for medical devices, both individually and regionally.
ASEAN countries currently remain reliant on imports to satisfy
demand for medical devices: for example, as much as 97% of
devices consumed in Indonesia in 2013 were imported, mainly
from the United States, Japan, and Europe. Nevertheless,
momentum is building for local manufacturing to transition toward
more advanced products, as foreign companies move into the
region to take advantage of lower costs and rising demand.
T-PLAS 2017 - A Global Platform with an ASEAN
Perspective on the Buoyant Opportunities in the region.
Bringing together industry leaders from the best local and
international brand names from the plastic and rubber sectors,
T-PLAS 2017 to be held in Bangkok offers a full spectrum
of specialised equipment, high-precision machinery, semi-
finished products, raw materials, applications and solutions
serving the plastic and rubber value chain. Gain special
insights on growing markets such as manufacturing of plastics
for the medical, packaging, and automotive sectors.
A synergistic platform with Focused Medical & Healthcare
Plastic Pavilion
- Global Innovations , Strategic Presence
A dedicated “Medical & Healthcare Plastic Pavilion” is
conceptualized by “T-PLAS 2017 “ in association with “MEDICAL
PLASTICS DATA SERVICE” which will be participated by
Exporters and Manufacturers of Materials , Machinery and
Products to the Medical Plastics, Medical Devices and
Pharmaceuticals Industries.
The Pavilion will showcase latest
developments by regional and international
exporters And manufacturers Of Medical
Plastics Processing Machinery,
Pharmaceuticals / Medical Products
Packaging Machinery, Medical
Polymers, Components / Tubings /
Adhessives, Packaging
Films / Pouches etc.
Driven by the nation’s various burgeoning sectors such as
Medical, Pharmaceuticals, Packaging as well as Lifestyle,
Thailand is well positioned to become Southeast Asia’s very own
hub for its plastics and rubber industries. These areas of interests
have seen significant growth in recent years, and are projected
to expand to new heights in years to come.
Concept & Contents By :
Special Visitor Campaign for Medical
Device and Pharmaceutical Industries
Calling all Exhibitors
specialising in :
Clean Room Products
Medical Plastic - Components, Sub-assemblies
Medical Plastic Tubings and Extruded Products
Medical Plastic Resins, Chemicals & Additives
Medical Plastic Processing Machinery
Medical Plastic Devices
Medical Packaging Films and Pouches
Medical & Pharmaceutical Packaging Supplies
& Machinery
Sept. 20 – 23 , 2017
Mar.-Apr. 2017 25

26. Manufacturing
Mar.-Apr. 2017
26
Definition of Drug/ Device Combination
• A Drug Device combination is a product comprising of active
pharmaceutical ingredient(s) and a medical device that are
physically or chemically combined to produce a single product.
• Such combination products are emerging as innovative medical
products due to their contribution in advancing medical care and
are thus expected have an impact in the coming years.
• These offer several advantages including reduced adverse/side
effects, improved patient compliance, controlled release of drugs
and targeted drug delivery, overall reduction in healthcare
expenses and augmented performance.
Developing Drug / Device Combination
Products : Concept to Commissioning
Classification of Drug/ Device Combination
• “Single Entity” or “Integral” product comprises of two
or more different regulated components (drug/device) that
are physically, chemically, or otherwise combined or mixed.
• “Co-packaged” or “Kitted” unit in a single package
comprising of drug(s) and device(s).
• “Cross-Labelled” comprise of drug(s) or device(s)
packaged separately that according to its investigational
plan or proposed labelling is intended for use only with
another individually and where both are required to
achieve the intended use, indication, or effect.
Dr. Atul Sardana, Chairman,
Alfa Corpuscles Pvt. Ltd., New Delhi.
“Single Entity” or “Integral”
• Prefilled Drug Delivery Systems
- Prefilled syringes
- Prefilled autoinjectors
- Prefilled pen injectors
- Prefilled on-body delivery systems
- Dry-powder inhalers
- Metered dose inhalers
- Prefilled nasal sprayers
- Transdermal patches
- Oral Vaccine Delivery Devices
• Medicated Devices
- Drug-coated stents
- Drug-coated catheters
- Drug-coated pacemaker leads
- Antimicrobial surgical scrubs
- Antimicrobial wound dressings
- Antimicrobial Sutures
- Drug impregnated surgical mesh
- Antibiotic bone cements
- Spermicidal condoms
Examples of Drug/ Device
Combination
“Co-packaged” or “Kitted”
• Convenience kits
- Surgical trays with anaesthetic
and/or surgical scrub
- Vial and syringe packs
- Injector pen with user-loaded
prefilled cartridge
- Liquid medication with dose-
dispenser
Examples of Drug/ Device Combinations
• Other
- Collagen sponge with bone
morphogenic protein
“Cross-Labelled”
• Companion diagnostics
• Photodynamic therapy (laser
activated drug)
• Contrast agent and diagnostic
imaging
• Iontophoretic delivery systems
The Development of Drug/ Device Combination entails the
following steps :
1.Unmet Need Identification
• A Device may require a drug to
• Improve its Safety especially over long term implantation or
when being placed in pathological conditions or challenging
environments within the body.
• To augment the function of the device by providing synergy
• To enhance the efficacy of the device by suitably modifying
the local or systemic conditions
To reduce device associated co-morbidities and complications.
• A Drug may need a Device in order to :
• Ensure or regulate proper dosing
• To provide a constant rate of drug elution and sustained release
• To monitor drug release and concentration levels as in a loop
feedback
• Improve patient compliance
• To ease administration and make self administration possible.
• To enhance the shelf life of the drug
• To reduce filling and administration losses and drug
contamination
• To improve drug safety
• To provide targeted drug delivery
2.Design Development
Design development of a drug device combination needs in depth
understanding and critical analysis of the following :
• Understanding the drug device Interphase with the body
• Understanding the interactions between the drug and the
device throughout the product life cycle
Raw Material Selection for the device is based on the following
criterion that need to be evaluated in all phases of the product
development and use.
• Leachable interaction with the body and the drug
• Extractable interaction with the body and the drug
• Additives and Coatings to be used on the device and their
interactions with the drug.
• Barrier Properties of the Material and effects of oxygen,
moisture and other gases on the drug.
• Stability Testing of Drugs in the drug device combination
• The effect on drug(s) on Polymer(s) properties and function
• DMPK (Drug Metabolism and Phamacokinetics) Study
• Shelf life study and accelerated ageing of the drug device
combination
• Method of sterilization to be used for the combination with

27. Manufacturing
respect to drug stability.
• Prototyping challenges for drug device combination usually
preclude 3D printing as the combination needs to be tested
with actual polymer proposed. Though it may be used for
mechanical and dimensional validation.
• A thorough understanding by the
devices manufacturer is
required with regards to the drug
filling lines and due consideration
should be given to the
environmental challenges of the
aseptic conditions to be
maintained.
The Current Challenges faced
During the Development and
Marketing of Drug / Device
Combination can be summarized
as below :
1.During Manufacturing of the
Drug Device combination the
following challenges may be
encountered
• Large Scale Manufacturing
• Device Filling in Aseptic Lines
with Drugs
• Replication of the Drug
Impregnation / Coating process
on commercial scale
• Combipack Development
• Integration of Automation
• From Production to Filling/ Coating
• Validation Protocols to be used
• Clinical Trials requirements for Novel Devices
• Packaging Requirements (Intermediate and Final)
• Filling Lines
• Sterility of Ready to Fill Systems
in Aseptic Lines
• Labeling for Regulators and
Users
• Choice of Sterilization Methods
• Standardization of Exchange of
Data amongst Device and Drug
Manufacturers
2.Affixing Responsibility
• Post Market Clinical Feedback
• Post Market Surveillance
• Vigilance and Incident Reporting
• Complaints
• Corrective and Preventive
Actions
3.Classification of Drug/Device
combinations in the currently
prevailing law in India.
4.Regulatory Approvals
5.Legal and Intellectual Property
Right Issues amongst the parties involved in collaborative
development (drug manufacturer and device
manufacturer)
Mar.-Apr. 2017 27

28. Manufacturing
Mar.-Apr. 2017
28
Mr. Bunty Kundnani, Business Manager
Life and Health Science, UL India Pvt. Ltd.
Mumbai.
Packaging Testing for Medical Devices
Introduction
Medical Device Packaging is highly regulated and must meet the
standard requirement. Historically devices have been tested for
degradation by accelerated aging and other various material char-
acteristics. Packaging testing is measuring the characteristics
and property of packing material. Most precarious factor is the
sterility which should be maintained through the distribution and
storage. Packaging must comply with ISO 11607 and EN 868-1,
in order to satisfy European regulations and obtain a CE Mark.
Testing a new packaging design before full scale manufacturing
can save time and money. Many manufacture conduct packag-
ing testing in-house or through third party lab (ISO/IEC 17025
accredited) which is accredited and certified (ISTA certified, ISO
17025). The testing is vital to ensure integrity of the package's
seal. The general factors that influence the product stability are
physical, chemical, microbiological and toxicological.Most of the
Figure 1 : Package validation testing with Standard Reference
Package Integrity Test
Depending on package design, a variety of packageintegrity test-
ing methods may be employed. Thisis to ensure the integrity of
package seal and system.Visual inspection, peel strength, burst
strength, creeps and bubble emission test are some of the pack-
age integrity test. During the study conduct deformities break or
crack, blister can be observed(Figure 2).
Figure 2 : Deformities from visual
inspection
Seal strength test is conducted through a simple burst and / or
creep test where packages are pressurized and evaluated for
the rupture pressure points and time of failure. It is conducted to
measure the ability of package seal to resist separation. Burst
and creep testing entails pressurizing theinside of the package
and measuring the pressurerequired to either cause seals to sepa-
rate or packaging materials to rupture. Some packages use po-
rous materials,allowing the contents to be gas sterilized throughthe
porous package walls after the package has beensealed; burst
testing of these packages can require higher inflow capability in
order to achieve sufficientpressure to challenge the package.
Regulations and Standards
Package Validation Testing
Test Procedures :
• Seal Intefrity
- Visual inspection (ASTM F1929)
• Seal Strength
- Peel Test (ASTM F18)
- Burst Test (ASTM F 1140)
- Bubble Test (ASTM F 2066)
• Microblel Challenge
- ASTM F1603
Test Procedures :
• Atmosphere Conditioning (ASTM D4332)
• Drop Test (ASTM D5276)
• Vibration Test (ASTM D4728)
• Compression Test (ASTM D642)
• Low Pressure (ASTM D6653)
Test Procedures :
• Accelerated Aging (ASTM F 1980)
Package Integrity Testing Distribution Simulation Testing Stability Testing
manufacturer conducts the testing at different phases of product
life cycle like product design stage, product launch, and new pack-
age design, resolve package damage issue and sometimes based
on client requirement.
Regulations and Standards for Packaging Testing
Packaging testing guidelines are listed in ISO 11607 describing
the available ASTM packaging tests. The key aspects of packag-
ing validation are material qualification, seal validation process
and whole package seal integrity. Physical tests like burst, peal,
creep and leak tests are performed as per ASTM standards. ISO
11607 require both accelerated and real time aging to be per-
formed simultaneously. The key areas to be focused in the pack-
aging are stability, performance, package integrity and strength
testing(Figure 1).
Figure 3 : Burst test (ASTM F1140)
Dye penetration test is conductedto detect the presence of any
leakage in the seal, (Figure 4). This test method is limited to porus
material which can retain the dye penetrant solution and prevent

29. Manufacturing
Figure 4 : Dye penetration
Bubble test as per ASTM F2096 standard is conducted by visu-
ally inspecting for bubble streams caused due to affect in the
packaging while it is submerged in water.This destructive testing
provides a practical way to examine packages for gross leaks,
which may render the product non-sterile. This test may apply to
very large or long packages, which do not fit into any other
package integrity test method apparatus.
Figure 5 : Bubble Test
Peel Testing is performed in accordance with
ASTM F88 and EN 868-5Standard Method
for Seal Strength of Flexible Barrier
Materials.The test results are not only related
to package integrity, but also to measuring
the packaging processes' ability to produce
consistent seals. Given that seal strength is
a necessary requirement for packaging, Peel
Tests are ubiquitous for all types of
packaging.
Transport Simulation
The medical packages encounter many variables during the transit
from the manufacturing site to the sterilization facility, distribution
center, health care facility, etc.
Distribution Simulation is large and quintessential component that
complies with the standard and are of three types (Figure 4);Drop
test, Vibration test and Compression test. It is necessary to ex-
pose the packages and products to atmospheric conditioning in
order to simulate particular field conditions that a packaged prod-
uct or component may encounter during its expected life cycle.
Figure 6 : Transport Simulation
Compression Vibration Drop
Drop test study is used to determine the package ruggedness
nature and interior cushioning effectiveness when the products/
packages systems are exposed to bumpy situation during
material handling operations.
Vibration study as per ASTM D999 & ASTM D4728is used to
determine the package withstand to the stresses, shock and vi-
bration that will be encountered during the transit and package's
ability to function and protect in real world conditions.
Compression study as per ASTM D642 is to determine the maxi-
mum resistance of compression and lock term stacking strength
of the packages (Figure 7). For example, foam is compressed to
determine how well it maintains its cushioning properties.
Figure 7 : Study results
Drop Test Compact Test
Shock Test
Stability Testing/ Shelf Life Testing
Accelerated Aging is a testing method used to estimate the prod-
uct lifespan when actual data is unavailable or have not gone
through the entire product lifespan cycle. A product can be re-
leased to market based upon successful Accelerated Aging of
the package/product that simulates the period claimed for prod-
uct expiration (1 year, 2 years, etc). Accelerated Aging data is
recognized by regulatory bodies as an acceptable means to gen-
erate data quickly, but is only accepted until those tests can be
repeated on "real time" samples.
Accelerated Aging test is carried out by subjecting the product to
unusually high levels of stress (rapid, but controlled, changes in
temperature, humidity, pressure, strain, etc.) designed to mimic
the effects of normal use.
Real-Time Aging provides the actual data to determine shelf life
and the effects of aging on materials.
Conclusion
In packaging medical products that impact lives andhealth, the
costs of poor quality control can be enormous.In today’s fast-
moving global markets, thestakes are higher than ever. As com-
petition and timepressures have grown, the industry and its
regulatorshave come to recognize that traditional testing
methodscan be slow and potentially risky. Package integritytesting
has been acknowledged to be an importanttool for ensuring the
safety of package systems and the products they protect. UL test-
ing and validation services are based on ISO 11607-1:2006 and
ASTM standards are designed to assure compliance with FDA,
ISO, EN and CE Mark requirements. UL can support the non
active medical device manufacturers with Biocompatibility test-
ing as per ISO 10993, Materials Characterization, Microbiologi-
cal testing, Virological testing, Physico-Chemical analysis, Shelf
Life of devices and packages, Transport safety and Testing of
Ophthalmic devices.
References
1. ISO 11607-1:2006, Packaging for Terminally Sterilized Medi-
cal Devices; Part 1: Requirements for Materials, Sterile
Barrier Systems and Packaging Systems
2. ASTM D999 – 08, Standard Test Methods for Vibration
Testing of Shipping Containers
it from discoloring the seal for 5 seconds. The study can be con-
ducted through different methods like injection, edge dip and eye
dropper.
Mar.-Apr. 2017 29

30. Global Trends
Mar.-Apr. 2017
30
Global Medical Disposables Market to Reach US$193.9 Bn by 2018
As per a recent study by Transparency Market Research,
the global medical disposables market was worth US$144.6
Bn and is anticipated to be worth US$193.9 Bn by the end
of 2018, growing significantly at a 4.30% CAGR between
2012 and 2018.
Rising demand for healthcare due to the rising global aging
population, rising prevalence of chronic conditions that need
long-time therapies, and expanding volume of inpatient days
and hospital admissions are some of the major factors boosting
the demand for medical disposables in the coming years. On
the other hand, rigid FDA and GMP approval norms and reduction
in the prevalence of healthcare-associated infections are the
factors that are expected to curb the growth of this market in the
forecast period.
The market has been classified on the basis of end use into
home healthcare facilities, outpatient facilities, emergency care,
hospitals, and physician offices. Among these, the hospitals
segment is at the forefront of the U.S. medical disposables
market. The demand for medical disposables is anticipated to
rise in hospitals, thanks to the rising number of patient
admissions, surgical procedures, and emergency visits.
It has been further segmented on the basis of geography into
North America, Asia Pacific, Europe, and Rest of the World.
Among all these regions, NorthAmerica exhibited strong demand
for all product segments of the market in the recent years. The
U.S. medical disposables market held around 70% of the North
America medical disposables market. In 2011, and was
accounted for the largest share of 35% in the global medical
disposables market. On the other hand, Asia Pacific is
expected to witness rapid growth owing to rising awareness
for healthcare. Some of the other factors that are expected
to boost the demand for medical disposables in the Asia
Pacific market are the huge aging population, increasing
disposable income, and rising expenditure by governments
on healthcare. The substantial rise of developing nations
such as China and India is anticipated to propel the Asia
Pacific medical disposables market.
(Ref.: http://www.transparencymarketresearch.com/
pressrelease/medical-disposables-market.htm)
Medical Polymers Market size is slated to cross USD 24
billion by 2024; as per a new research report by Global Market
Insights, Inc. rapidly enhancing pharmaceutical devices demand
owing to the prevalence of heart diseases, infections, or general
illness and technological advancements in the treatment process
will steer the global medical polymers market growth in upcoming
years. Increasing health awareness among developed nations
will also support the industry throughout the forecast spell.
Pharmaceutical device industry generated over USD 300 billion
in 2015, of which U.S. had a major share of around 45%. U.S.
recorded over 6,500 pharmaceutical device manufacturers by
2015 and the growing demand in the country as well as export
demand in the emerging economies will escalate the market
growth in coming years. Growing application of polymers
including polysulfone, polyphenylsulfone, polyether-ether-
ketone or PEEK, and polyetherimide in pharmaceutical
devices will propel the overall medical polymers industry
growth.
Increasing global geriatric population will also be a significant
medical polymers market driver. Population over the age of 65
years increased from 7.6% of global population in 2010 to around
8.3% in 2015 and will increase owing to pharmaceutical
developments and increasing geriatric care units. The American
Geriatrics Society has predicted the U.S. geriatric population to
reach 20% of total population by 2030. Ubiquity of chronic
disorders such as cardiac diseases, calcium deficiencies,
arthritis, etc. will likely have a positive influence on global.
Medical polymers market will also be driven by the growing
home-based private healthcare demand due to its ease and
affordability along with factors including commotions in public
facilities, chronic or contagious diseases, and elderly patients
will enhance the home-based healthcare industry in the
upcoming years. In 2015, the global home-based private
Medical Polymers Market to exceed $24bn by 2024
healthcare industry generated more than USD 200 billion and it
will grow by CAGR over 8% up to 2024.
Medical fibers & Resins will be a noteworthy product segment
which generated more than USD 8 billion in 2015. Polypropylene
based fibers & resins will likely grow at a significant rate owing
to its chemical inertness, light weight, and favorable mechanical
properties. Overall medical fibers & resins will flourish at more
than 8% CAGR up to 2024.
Developments and preferences of bio-based polymers for
environmental sustainability will characterize the growth of
biodegradable medical plastics and are likely to register a CAGR
over 15% in the overall medical polymers market. Medical
packaging applications will be a fast-growing segment owing to
mandatory sterilization and medical disposable regulations.
Regional medical polymers market growth will be focused
around the emerging economies in Asia Pacific, Latin
America, and Middle East & Africa, owing to rapidly
increasing medical awareness and government initiatives.
Asia Pacific will register more than 10% CAGR in the
forecast time span.
Raw material price volatility will hinder the medical polymers
market growth. As, Petrochemical based raw materials prices
are dependent on the global crude oil prices, which is highly
fluctuating in nature. Strict norms about volatile organic
compound (VOC) content in the polymers may also restrain the
medical polymers market. End products are based on superior
biocompatibility with various product blends, and the expensive
manufacturing technologies will restrain the entry of new market
participants.
(Ref.: https://www.gminsights.com/pressrelease/medical-
polymers-market)

31. Availability of reprocessed medical devices at low prices, coupled
with assurance of qualitative production, has also prompted the
market’s growth to a considerable extent. According to recent
report by ‘Future Market Insights’ on the reprocessed medical
devices market in Asia-Pacific region projects that in 2017
and beyond, Japan, China and Southeast Asia will
collectively account for more than 60% share of overall
market revenues. It estimates that reprocessed medical
devices market in Asia-Pacific is presently valued at US$
236.9 Mn. In a ten-year forecast period, the market is being
projected to expand at 15.7% CAGR and bring in a little
over US$ 1 Bn by the end of 2027.
Rising focus of government authorities towards dumping of
medical waste or biowaste is slated to promote the reprocessing
of medical devices. Manufacturers of medical devices are
continuously striving to control their product costs for recording
greater sales. Reprocessed medical devices, thus, become the
most feasible option for both, manufacturers and end-users.
Availability of reprocessed medical devices at low prices, coupled
with assurance of qualitative production, has also prompted the
market’s growth to a considerable extent.
The report reveals that in 2016, more than US$ 100 Mn worth
of reprocessed medical devices turned out to be used in
the field of cardiology. Demand for reprocessed cardiology
devices is expected to continue surging in the years to come,
registering the highest revenue CAGR of 18.4%. Reprocessing
will also gain traction among laparoscopic tools & devices,
revenues from which are predicted to reach US$ 111 Mn by
Global Trends
Asia-Pacific Reprocessed Medical Devices Market Will Hit at a CAGR
of 15.7% by 2017 to 2027
2027-end. Meanwhile, orthopedic or arthroscopic devices,
gastroenterology devices, ENT devices and other such medical
devices will be showcasing a comparatively steady growth in
terms of revenues.
By the end of 2027, one of every two reprocessed medical
devices sold in Asia-Pacific will be classified under semi-
critical medical devices. This indicates that demand for
reprocessing is higher for semi-critical medical devices, as
opposed to critical or non-critical medical devices. The most
prominent method of reprocessing medical devices,
observed across Asia-Pacific, is likely to be third-party
reprocessing. Third parties assisting drug makers in
reprocessing businesses is serving as a consolidator for
Asia-Pacific’s reprocessed medical devices market.
The hospitals are identified as the largest end-user of
reprocessed medical devices inAsia-Pacific. Similarly, diagnostic
centers and ASC’s will also contribute significantly, by exhibiting
revenues growth at more than 11% CAGR. Furthermore, the
leading reprocessed medical device manufacturers partaking
in the Asia-Pacific region are companies such as Stryker
Sustainability, Medline ReNewal, Hygia Health Services, Inc.,
CLEANPART HEALTHCARE, ReNu Medical, Inc., SureTek
Medical, and NEScientific.
(Ref.: http://www.crossroadstoday.com/story/35077832/
asiapacific-reprocessed-medical-devices-market-will-hit-at-a-
cagr-of-157-by-2017-to-2027)
AVAILABLE
PRE USED SYRINGE
MANUFACTURING
EQUIPMENT
 Moulds : 2, 3, 5, 10ml
 Syringe Printing Machine :
2/3, 5, 10ml
 Syringe 4 Parts Assembly Machine :
2/3, 5, 10ml
Contact : 7895648113
Contact : 7895648113
Contact : 7895648113
Contact : 7895648113
Contact : 7895648113
Mar.-Apr. 2017 31
pawantiwari1978@gmail.com

32. Industry News
Mar.-Apr. 2017
32
Between FY12 to FY16, the import of medi-
cal devices into India has increased by 16.8
per cent, whereas export increased by 25.7
per cent, as per the key findings of a gov-
ernment led study in collaboration with
Andhra Pradesh MedTech Zone (AMTZ)
and World Health Organisation (WHO).
India is one of the top 20 global medical
device markets and the 4th largest
medical device market in Asia.
The import of medical devices has grown
from USD 2.46 billion ( Rs.15,990 crore) in
FY12 to USD 2.87 billion ( Rs.18,655 crore)
in FY16. The export of medical devices has
grown from USD 0.78 billion ( Rs.5,070
crore) in FY12 to USD 0.98 billion
(Rs.6,370 crore) in FY16.
Diagnostic imaging (e.g. CT scan, X-Ray,
MRI, USG, X ray-tubes etc.), IV Diagnostic
(lab equipment and reagents, etc.) and
Other Medical Device (ECG, opthal equip-
ment, heart lung machine, etc.) form 70%
of total import in India in FY16.
However it is estimated that import trade
will fall with increasing number of interna-
tional and Indian manufacturers setting up
medical device manufacturing in India.
Diagnostic imaging, consumables and
Med Devices Import up 16.8%, Export By 25.7% During 2012-16
other medical devices form 86 per cent of
total export trade in India in FY1613.
Amongst the exporters’ portfolio, USA was
the chief destination for export and contrib-
utes close to 15 per cent of the export trade.
Singapore, Germany and China were the
other leading export destinations with
shares of 7.0 per cent, 6.7 per cent and 6.4
per cent respectively.
The European Union (including Germany)
cumulatively constitutes of 21.7 per cent of
the total export trade13. USA, Germany,
China, Japan, and Singapore constitute the
five largest exporters of high technology
medical equipment to India.
In FY 2015 imports alone from these five
countries accounted for approximately 65
per cent of total import of high technology
medical equipment while USA, remained
the largest exporter accounting for 28.1 per
cent.
Diagnostic imaging medical device import
trade has grown by 19% from USD 636
million ( Rs.4,134 crore) in FY12 to USD
757 million ( Rs.4,921 crore) in FY 16. IV
Diagnostic medical device import trade has
grown by 43.2% from USD 225 million (
Rs.1,463 crore) in FY12 to USD 322 mil-
lion ( Rs.2,093 crore) in FY 16. Other Medi-
cal Device (e.g. ECG, opthal equipment,
heart lung machine, etc.) has grown by
9.6% from USD 878 million ( Rs.5,707
crore) in FY12 to USD 964 million
(Rs.6,266 crore) in FY 16.
Diagnostic imaging medical device export
trade has grown by 27.2 per cent from USD
210 million ( Rs.1,365 crore) in FY12 to
USD 267 million ( Rs.1,736 crore) in FY16.
Medical Consumables export trade has
grown by 26.1 per cent from USD 228 mil-
lion ( Rs.1,482 crore) in FY12 to USD 288
million ( Rs.1,872 crore) in FY16. IV Diag-
nostic devices export trade has grown by
58.7 per cent from USD 24 million ( Rs.156
crore) in FY12 to USD 39 million ( Rs.254
crore) in FY16.
While technological advancement and ex-
pertise that the global market leaders of-
fered has proved to be an advantage,
India’s medical device sector is dominated
by multi-national companies, which is evi-
dent from the fact that about 78% of the
sales are generated by imported medical
devices.
http://www.pharmabiz.com/
ArticleDetails.aspx?aid=100896&sid=1
The Drugs Controller General of India
(DCGI) has started the process of registra-
tion of notified bodies to carry out audit of
manufacturing sites of Class A & Class B
medical devices as laid down in the Medi-
cal Device Rules 2017 which will come into
effect in the country from January 1, 2018.
The Medical Device Rules 2017 have al-
ready been published vide G.S.R. 78 (E)
dated 31.01.2017 under Drugs and Cos-
metic Act, 1940 to regulate the clinical in-
vestigation, manufacture, import, sale and
distribution of the medical devices. The
Chapter III (Rule 13) of Medical Device Rule
2017 provides for the registration of noti-
fied bodies with the DCGI office (CDSCO).
Subsequently, with effect from July 1, 2017,
the notified bodies have to file their appli-
cation to the Central Licensing Authority
(DCGI) for registration in Form MD-1
DCGI begins registration of notified bodies to carry out audit of mfg sites of
Class A & Class B medical devices
through online portal to carry out the audit
of manufacturing sites of Class A & Class
B medical devices to verify conformity with
the Quality Management System and other
applicable standards. In this regard,
CDSCO has put in place an online portal
for the registration of notified bodies.
http://www.pharmabiz.com/
ArticleDetails.aspx?aid=101382&sid=1
The prices of all medical devices except
for stents, condoms and intrauterine de-
vices can only be raised by up to 10% in a
year, the National Pharmaceutical Pricing
Authority (NPPA) said in a new office order
on Friday.
The drug price regulator also clarified that
all medical devices notified as drugs under
the Drugs and Cosmetics Act, including
stents, orthopaedic implants, catheters and
intra-ocular lenses, will have to mandato-
rily carry their maximum retail price (MRP)
on their packs.
10% price hike cap on most medical devices
While the government has notified 22 medi-
cal devices as drugs under the Act, the
prices of stents, condoms and intrauterine
devices are capped by the NPPA directly,
and companies manufacturing or selling
these products have to take permission
from the regulator before implementing any
hike. However, for other 'non-scheduled'
products, the regulator has allowed an an-
nual increase of 10% in prices. For any hike
beyond the limit, companies will have to
seek permission from the regulator.
Cautioning companies against overcharg-
ing consumers, the regulator said it was
closely monitoring prices of not only sched-
uled but also non-scheduled products, and
any violation wo*uld attract severe action
and penalty under the Essential Commodi-
ties Act.
Several leading hospitals have already
come under the NPPA's scanner for
allegedly overcharging

33. The Central Drugs Standard Control Organisation (CDSCO) is
set to become paperless within six months with completely
shifting its services to online portal Sugam. The agency
digitized 60-70 per cent of its services through Sugam portal so
far.
In another six months we are planning to go completely elec-
tronic for all our services by doing away with requirement of any
physical documents, said a senior CDSCO official.
With the launch of Sugam on November 14, 2015, firms can
apply online for grant of registration certificates for import of drugs
or import license of drugs in Form 10, under D&C Rules. They
can also file online applications with respect to import registra-
tion and license of medical devices. Online submission has also
been started for grant of approval to conduct bioequivalence
studies for export purposes.
The main aim of this e-governance drive is to bring in transpar-
ency, accountability and competency in CDSCO which allows
creating a real time platform and improve the safety and
security programmes taken up by it.
http://www.pharmabiz.com/
PrintArticle.aspx?aid=100721&sid=1
Industry News
CDSCO to go online for all services
in six months
Mar.-Apr. 2017 33

34. Product Gallery
Mar.-Apr. 2017
34
Ronkonkoma, NY, March 15, 2017—
Qosinacarries a large selection of
dilatorsavailable with and without tear-away
introducer sheaths in various lengths, sizes,
materials and colors.
Tear-away introducer sheaths with dilatorshave
a zero clearance dilator-to-sheath transition and
are equipped with a unique locking mechanismon the hub. The
sheaths areconstructed of Teflon® for a smoother tear-away, or
pre-scored polyethylene, which ensures consistent peel-away
performance.
Tear-away introducer sheaths and dilators with griplock hubsalso
have a zero clearance, a locking mechanism on the hub and an
ergonomically designed handle for easy removal.
Valved tear-away introducer sheaths with dilatorsincludetabs for
more comfortable handling after device insertion, and the valve
maintains a tight seal to help prevent air or fluid leakage.The
Teflon® sheath allows for a smoother peel.
Qosina also carries introducer needlesin a wide range of gauge
sizes, hub configurations, needle lengths and tips to complete
your project needs.
Dilators and Introducer Sheaths
For Immediate Release
Contact : Qosina, Rachelle Morrow, 2002-Q Orville Drive
North, Ronkonkoma, NY 11779
Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230
Email: rmorrow@qosina.com
Qosina offers low minimums and short lead
times. Log on to qosina.com to see pricing, obtain
our latest catalog, request complimentary
samples and place orders. Be sure to sign up
for our monthly e-newsletter to stay current with
our newest product additions. Our product
development team can work to customize a part
to your specifications. Call our customer service
specialists to discuss your project in detail via phone +1(631)
242-3000 or email info@qosina.com.
Founded in 1980, Qosina is a worldwide supplier of thousands
of stock OEM components including bioprocessing accessories,
compression fittings, ENFit™ connectors, luers, clamps, clips,
check valves, stopcocks, hemostasis valves, tuohy borst
adapters, swabs, spikes, syringes and tubing to the medical and
pharmaceutical industries. Qosina is based in Ronkonkoma, NY
in a 95,000 square-foot facility with an ISO Class 8 Clean Room
and is ISO 9001, ISO 13485 and ISO 14001registered.
SANIDHYA ENTERPRISE
Manufacturers of :
Medical Plastic Injection Molded Articles & Job Works
Our Product Range Includes
Medical Components like :
• Urine Container
• Adaptors (PP)
• Regulators / Cord Clamp
• All types of Urine Bag parts like H.D. - ABS
& PVC Connectors / Covers, PVC Closures
• PP Mucas Container
• And many other Surgical Medical Components
Contact :
Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646
SANIDHYA ENTERPRISE
Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road,
Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789
E-mail : sanidhya.ent@gmail.com

35. Events
MEDICAL FAIR INDIA 2017 closes with a huge boom in
visitors
New programme highlights were well received
With a huge boom in visitors, the MEDICAL FAIR INDIA has
definitely marked out its position as the leading medical trade
fair for the Indian market and built on the growth of the previous
years. 13,480 decision makers from all sectors of the healthcare
industry came to MEDICAL FAIR INDIA 2017 at the Pragati
Exhibition Center in New Delhi from 6 to 8 April. They visited
519 exhibitors to learn about the latest trends and innovations
for medical healthcare.
“Visitor numbers increased by 15% in comparison with the 2016
event in Mumbai. The floor space booked by the exhibitors also
expanded by 16%. As expected with great results like these, the
atmosphere in the trade halls was buzzing”, summed up Thomas
Schlitt, Managing Director of Messe Düsseldorf India. The
MEDICAL FAIR INDIA takes place in New Delhi and Mumbai,
alternating between these locations each year.
“The MEDICAL FAIR INDIA is the top event for the healthcare
industry. We saw that it was even better than our expectations”
said Raghvendra Bansal, Managing Director of RR Instruments,
recapping the successful trade fair on behalf of many very
satisfied exhibitors. The synopsis of Prashant Narula, Marketing
Director of Narula Udyog was also positive: “Not only the
numbers but also the quality of the visitors was well above our
expectations. We are very happy with the outcome.”
New highlights also contributed to the success of MEDICAL FAIR
INDIA. They enriched the supporting programme for the event
and aroused much interest from visitors on all three of the trade
fair days.Anovel digital health platform was created in the FTR4H
Lab & Lounge (Future for Healthcare powered by MEDICA).
The Lab & Lounge centred around information, start-ups
presenting their product ideas, expert dialogues and networking
on all the fascinating topics concerning the digital transformation
of the healthcare industry (i.e. mobile health, the internet of things
and targeted and secure data handling).
The Indian market for health IT offers particularly good
opportunities, with an estimated volume of 2.5 billion USD
(Deloitte). High-tech infrastructures for state-of-the-art clinics in
big cities as well as remote medical applications that ensure
medical care in remote countryside regions are included in this,
among others.
The CLIN LAB INDIA also celebrated its premier as an integral
part of the programme of MEDICAL FAIR INDIA this year. The
conference and its accompanying exhibition were designed by
Scherago International and organized in cooperation with the
Messe Düsseldorf Group. The focal point of the talks was on
trend topics that are particularly relevant to the practice of
laboratory medicine, such as point-of-care testing, molecular
diagnostics and clinical chemistry. The CLIN LAB INDIA
exhibition area (in Hall 9) had booked out 330 square metres,
with companies such as Mindray, Randox and SMC
Pneumatics along with others, taking up this space.
In terms of content, the MEDICAL FAIR INDIA 2017 included
the following areas and many more: Medical products and
medical technology, laboratory technology and diagnostics,
equipment and furniture for clinics and health centres, products
for physiotherapy and rehabilitation as well as health IT and
mobile health solutions.
All the details on MEDICAL FAIR INDIA are available online at:
http://www.medicalfair-india.com.
The next MEDICAL FAIR INDIA will take place from 16 - 18
March in Mumbai.
Opportunity For Exporters And Manufacturers Of Medical
Plastics Processing Machinery, Pharmaceuticals /Medical
Products Packaging Machinery, Medical Polymers,
Components / Tubings / Adhessives, Packaging Films /
Pouches etc.
EXHIBIT IN THE ”Medical & Healthcare Plastics
Pavilion” @ T – PLAS BITEC, Bangkok, Thailand.
September 20 – 23, 2017
Organized By : Messe Dusseldorf Asia
A dedicated “Medical & Healthcare Plastic Pavilion” is
conceptualized by “T-PLAS 2017 “ in association with “MEDICAL
PLASTICS DATA SERVICE” which will be participated by
Exporters and Manufacturers of: Clean Room Products, Medical
Plastics-Components, Sub-assemblies, Medical Plastic Tubing’s
and Extruded Products, Medical Resins, Chemical & Additives,
Medical Plastics Processing Machinery, Medical Plastics
Devices, Medical Packaging Films and Pouches, Medical &
Pharmaceutical Packaging Supplies & Machinery.
T – PLAS 2017 (www.tplas.com), organized by “Messe
Dusseldorf Asia, provides a global platform with an ASEAN
perspective on the buoyant opportunities in the region by
bringing together local and international industry leaders from
these dynamic growth sectors.
The top 6 country visitors for this show are from Indonesia,
Malaysia, Singapore, Thailand and Vietnam on and above
India.
A SPECIAL VISITOR COMPAIGN FOR MEDICAL PLASTICS,
MEDICAL DEVICE AND PHARMACEUTICALS INDUSTRIES
IS BEING CARRIED OUT
Capitalize on the leading trade show and connect with the world
today!
Driven by the nation’s various burgeoning sectors such as
Medical, Pharmaceuticals, Packaging as well as Lifestyle,
Thailand is well positioned to become Southeast Asia’s very own
hub for its plastics and rubber industries. These areas of interests
have seen significant growth in recent years, and are projected
to expand to new heights in years to come.
For more details, please write to: Medical Plastics Data
Service, mpds00@vsnl.com
International Tradefair
for the Plastic and
Rubber Industries
Mar.-Apr. 2017 35

36. Mar.-Apr. 2017
36
: Attention :
MEDICAL PRODUCTS MANUFACTURERS
FOR
Surgical Peelable & Tearable Pouches,
Lids & Reels For Sterilized
Medical Disposables & Devices
Contact :
Surgi Pack India Pvt. Ltd.
PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar,
Thane - 401 506 India. • Tel. No. : 93245 51325
OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West),
Mumbai - 400 067 India.
Contact Person :
BIRJU TANNA (CEO)
Cell : +91 98199 70333
E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com
®
Alpha Medicare and Devices Ltd.
Manufacturers & Exporters of Disposable Medical Devices
0434
Contact :
Mr. Dinesh Shah (Manager)
(M) 9638979798
97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA
Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680
Website : www.alphamedicare.com • E-mail : contact@alphamedicare.com
(taking care…Since1984)
Product Range :
• Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure
Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way
Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit
• Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture
Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm)
• Class 10000 Assembly
• In house Imported Injection Molding Machines
• Latest ET.O. Sterilization Facilities
• Own certified laboratory to perform Physico
Chemical, Sterility & Micro Biological Tests.
• Exporting our products to almost more than 23 countries.
• Easy Morning Walker • Adult Diapers
• Blood Pressure Monitors • Dial Flow Controllers with I.V. Set
• Personal Weigh Scales • Nebulizers
NEW PRODUCTS
GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY
ISO 13485 : 2003

37. ISO 9001-2015
ISO 13485-2012
CE
WHO GMP
• ECG Paper & ECG
Accessories
• ECG Paper Roll & Z
Folding
• Nasal Canula
• Oxygen Mask
• Nebulizer Mask &
Nebulizer Compressor
• Multiflow Mask
• Ventury Mask
• High Concentration Mask
• Breathing Filter
Life-O-Line Technologist
Mfg. & Importer of : Medical Surgical Devices &
Healthcare Products
Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026.
M. : 9898162576 • E-mail : lifeoline2011@yahoo.com
Customer Care No. +91 9898162576 & 7600020901
• Mount Catheter
• “T” Recovery Kit
• Breathing Circuit
• Ambu Bag
• Bain Circuit
• 3 Ball Spirometer
• Patient ID Belt
• Yankur Suction Set
• Nebulizer Chamber
• Guidal Airways
• B. P. Meter
Range of Products
Mar.-Apr. 2017 37

38. Mar.-Apr. 2017
38
JIMIT MEDICO
SURGICALS PVT. LTD.
AN ISO 13485 : 2012 & CERTIFIED COMPANY
Tele : +91-79-25835567, +91-79-25834850
E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com
Factory : 16, Ranchodnagar, Near Vinzol Railway,
Crossing, Vatva, Ahmedabad-382445, INDIA
Specialized in Handling Large Quantity
& OEM / Contract Manufacturing
Infusion Set, Blood Administration Set,
IV Cannula, Urine Bag, Catheters, Gloves,
HIV KITs, Ophthalmic KITs, Ophthalmic Knives
(Blades), Cap, Mask, Gown, Drapes, Bandages,
Dressings etc.
Manufacturers & Exporters of
Disposable Medical Devices
ISO : 13485 : 2012
We are a leading Consulting organization
providing an integrated services with
focus on project technology :
Quality Management System as per
ISO 9001, ISO 13485, Medical Devices
CE marking as per MDD/93/42, FDA
510k, Audit, Documentation, training
and c-GMP.
F/6, Goyal Plaza, Vastrapur,Ahmedabad-380 015. INDIA.
Tel. : +91 79 66090225 E-mail : unikal@unikalindia.com, unikal@hotmail.com
Website : www.unikalindia.com
Authorized Representative Center (O.E.A.R.C) based in
Brussels, Belgium since 1988 is one of the largest
Regulatory Centers in Europe, assisting non-European
manufacturers’ successful endeavors into Europe.
Obelis European
Sanjay Y .Shah – Owner Promoter
M : +91 98240 17850

39. Mar.-Apr. 2017 39

40. Mar.-Apr. 2017
40
Manufacturer And Exporter Of a
wide range Of Medical Devices
Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India.
Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009
E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com
ANGIPLAST Private Limited
Wide Range Of Products :
The company
manufactures a wide range
of Medical devices, which
fall under the
main domains of :
Infusion Therapy,
Transfusion Therapy,
Dialysis,
Gastroenterology,
Urology, Anesthesia,
and Surgery.
ISO 9001-2000
REGISTERED
FIRM
Quality
Medical
Devices
ISO
9001
:
2000
&
ISO
13485
:
2003
Products
available
with
CE
marking
Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas
Sterilization Pla nt along with all other amenities and equipments required for
manufacturing and testing of Medical Devices. The Company also have certified
Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests.
Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines,
Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines,
Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag,
Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask,
Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound
Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical
Cord Clamp etc...
The company markets products its own brand name ANGELTOUCH.
Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP.
Expertise & Experience :
– OEM/Contract Manufacturing.
– Supply of Components for Medical Devices.
• Infusion Set
• Blood Administration Set
• Urine Collection Bag
• Urine Specimen Container
• Umblical Cord Clamp
Address
S. Nath & Co.
B. N. Estate, Near Uttam Dairy, Sukhramnagar,
Ahmedabad-380021, Gujarat, India.
Contact No. : +91-79-22743246, 9825360531
Website : www.snathco.com • snathco@hotmail.com
S. Nath & Co.
Excellence in Quality
Manufacturer & Exporter of
Surgical Disposable Products since 1980
IDEAL
®
GMP
ISO - 9001-2008
Certified Company
PACK-EQUIP
(Mfg. Packaging Machinery)
Office / Communication :
91, Avnish Society, Opp. Pavitrakunj Society,
CTM Cross Road, Amraiwadi, Ahmedabad-380 026.
Phone : 25855027 (M) 9825380739
Works :
16, Arbuda Estate, Near Nidhi Bank,
CTM Cross Road, Amraiwadi, Ahmedabad-380 026.

41. • T-Oxygenator
• Catheter Mount(Standard Double
Swivel Mount & Expandable Double
Swivel Mount)
• Ventilator Circuit
• Ventilator Circuit with Single Water
Trap(Adult, Pediatric, Neonatal)
• Ventilator Circuit with Double Wa-
ter Trap(Adult, Pediatric, Neonatal)
• Breathing Filters(HME & BVF)
• Resuscitator(Ambu Bag)
• Anaesthesia Circuits (Mapleson D,
Mapleson F, Bain Circuit with APL
Valve)
• Stylet
• Guedel Airway
• Nasopharyngeal Airway
• Laryngeal Mask Airway
• Mallaeble gum Bougie
Head Office : 106, Vijay Industrial Estate, I. B. Patel Road,
Goregoaon (E), Mumbai - 400 063, INDIA.
Tel.-Fax : 91-22-2685 2973 / 2686 9090
Works : Airway House, Plot No. 2209 & 2210 Phase IV,
GIDC Vatva,Ahmedabad - 382 446. INDIA.
Tel. : 91-79-2584 2525 / 2584 0905
Email : airwaycorporation@rediffmail.com
info@airwayssurgical.com • Web : www.airwayssurgical.com
Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy
Airways Surgical Pvt. Ltd.
• Endotracheal Tube(Plain & Cuff)
• Endotracheal Tube Reinforced
• Endotracheal Tube Holder With Bit
Block
• Inflatable Anaesthesia Mask
• Anaesthesia Mask Silicon
• Trachostomy Tube With Cuff
• Endotracheal Tube Holders
• Yankaures Suctions Systems
• Airovent T-Humidifier
• Dialflow Regulator
• Airopap Full Face Mask
• Close Ventilation Suction System
• Incentive Spirometer
• 3 Ball Spirometer
• Three-way Stopcock
• Extension Tubing for Infusion
Systems
• Pressure Monitoring Line
Oxygen Therapy Products
• Nasal Cannula
• Oxygen Mask
• Multi flow Venturi Mask
• Single Dial Venturi Mask
• High Concentration Mask
• Nebulizer Set
• Nebulizer Chamber
Critical Care & Anaesthesia Therapy Products
Breathing Filters
High Concentration
Mask
Expandable Catheter
Mount
Airovent T-Humidifier
ET Holder with Bite
Block
Incentive Spirometer
Anaesthesia Circuits
Contact : Dr. Inder Jain +91 9820321901
• I.V. Infusion Sets
• Blood Administration Sets
• Scalp Vein Set
• Urine Collection Bags
• Ryles / Feeding Tubes
• Catheters and Tubes
• Surgical Gloves.
Contact :
Mr. Bhavin Shah
4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi
Mill, Narol - Isanpur Highway, Narol,
Ahmedbad-382405. (India) Phone : (O) 079-
25733318 (R) 079-25430211 (M) +91-9825018952
Email : info@mescosurgical.com,
mesco@rediffmail.com
Website : www.mescosurgical.com
MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
Mar.-Apr. 2017 41

42. Mar.-Apr. 2017
42
National
Healthcare
An ISO 9001 : 2008 Company
Manufacturing & Exports of
Medical Disposables :
I.V. Set, B.T. Set, Urine Bag,
Measured volume set, Cord Clamp, Surgical
Gloves etc.
Injection Moulded Medical Components
and Extended Tubes :
I.V. Set components, Urine bag Components,
Connectors for Catheters, I.V. Set / B. T. Set /
Urine Bag Tubes etc.
Contact :
Naresh Patel
5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M.,
Ahmedabad (India) Ph. : 079-25857530,
Fax : 079-25862206
E-mail : nationalhealthcarectm@yahoo.com
Website: nationalhealthcare.in
Events Calender
Events
GMP. & ISO 9001 – 2000 Certified Company
AMIGO SURGI CARE PVT. LTD.
8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple,
C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi,
Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711
E-mail : bhagwatimedicaredevices@gmail.com
Website : www.medicaredevices.com
AN ISO 13485-2012
CE certified Company
Range of Products :
• Infusion Set
• Blood Administration Set
• Measure Volume Set
• Urine Collecting Bag
• Urine Collecting Bag - Uro Meatry
• Respiratory Exerciser
• Twin Bore Nasal Oxygen Set
• Oxygen Face Mask
• Nebulizer Kit
• Vaccum Suck Suction Set
• Latex Surgical Gloves
• Umblical Cord Clamp
Manufacturer & Exporter of Medical
Disposable Devices & Surgical
Products
MEDICARE DEVICES
Contact Yogesh Patel
M. : +91 98241 21383
I.V.CANNULAS / B.T.SETS / I.V.SETS /
SURGICAL LATEX GLOVES / CORD
CLAMPS / URINE BAGS / MEASURE
VOLUME SETS ETC.
Manufacturers / Exporters / Hospital Suppliers
Dealer are requested to
Contact :
Mr.Chandrakant Sayal , B.E. (Mech. & Elec.)
(DIRECTOR) Mobile:0091-9825057180
Tel.:0091-2764-268249
E-mail : • cannulaexpert2001@yahoo.co.in
• amigo.surgicare@gmail.com
Website:www.amigo-india.com
Plant Address
Plot No.780, Opp.: Kemron Lab
Sola Santej Road,
Rakanpur (Santej) – 382721
Gujarat, India
Manufacturer of
Disposable Surgical Products:
• Medicall 2017 : India’s Largest Hospital Equipment
Expo, 17th
Edition
Date: July 28 - 30, 2017.
Venue: Chennai.
• T-Plas 2017 : A Synergistic Platform With Focused
Medical & Healthcare Plastics Pavilion
Date: Sept. 20 – 23, 2017.
Venue: Bangkok, Thailand.
• Medicall 2017 : India’s Largest Hospital Equipment
Expo, 18th
Edition
Date: Oct. 6 – 8, 2017.
Venue: Mumbai.
• 4th
PLASTIVISION Arabia 2017 : International
Plastics, Printing & Packaging Exhibition
Date: Dec. 11-14, 2017.
Venue: Sharjah, UAE.
• PLASTINDIA 2018 : 10th
International Plastics
Exhibition, Conference & Convention
Date: Feb. 7-12, 2018.
Venue: Gandhinagar – Ahmedabad, Gujarat, India.
• Medical Fair India : 24th
International Exhibition
And Conference
Date: March 16-18, 2018.
Venue: Goregaon (East), Mumbai.