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Product Gallery
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A
showcase of select medical technology products
and services |
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January-February 2024
32nd Year of Publication
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A Techno-Economic News Magazine For Medical Plastics,
Medical Devices, Diagnostics And
Pharma Industry
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Cover Story
Medical Device Manufacturing: Importance of Supply
Chain
Starting right from sourcing reliable raw materials
and components, supply chain plays a vital role more
important in emergencies.
A well-managed supply chain is the key to quality,
efficiency, innovation, availability and more
affordability. With a smooth and efficient supply
chain, we can get those life-saving medical devices
to patients who need them without any delays.....
Read Full Article
Manufacturing
Medical Device Manufacturing For Mature Markets
Mr. Manoj Bhardwaj, Managing Director, SMC Ltd.,
Bangalore
Few medical device and pharma manufacturers have
partnered with medical, diagnostic and drug delivery
device contract manufacturers that have the systems,
resources, execution capability and proven track
record of meeting both quality and regulatory
requirements of mature markets. The key
requirements.....
Read Full Article
Vaporized Hydrogen Peroxide For Medical Device
Sterilization
Vaporized hydrogen peroxide (VHP) is the latest
medical device sterilization alternative to ethylene
oxide (EtO) as the industry seeks to limit potential
harm from EtO and increase total sterilization
capacity.
But unlike EtO, VHP is not flammable or explosive
and is not considered by the EPA to be a cancer risk
when inhaled.....
Read Full Article
Materials
PVC vs. Other Polymers In Medical Devices : Facts
And Figures
PVC is the single most used polymer in medical
devices. PVC has a market share of 27% in Europe and
26% globally. It is estimated that PVC will retain
its market position in the years to come.
The largest share goes into medical bags, including
blood bags, IV bags, dialysis bags and urine
bags.....
Read Full Article
Henkel Introduces Instant Adhesives For Medical
Device Applications
Henkel has introduced two next-generation medical
grade, cyanoacrylates-based instant adhesives that
are designed to offer improved safety and
performance.....
Read Full Article
US FDA QSR Amendments : Relevance to Medical Device
Component Manufacturers
Mr. Bhupesh Sood, CEO, SEC Global, Ahmedabad
Excerpts of Medical Devices; Quality System
Regulation Amendments with special reference to
component manufacturers.
The qualitative benefits of the rule include quicker
access to newly developed medical devices for
patients leading to improved quality of life of the
consumers and also contributes to cost savings.....
Read Full Article
Global Trends
EU Report Confirms Safe Production and Essential
Role of PVC in Healthcare
The report confirms that the production of PVC in
Europe adheres to the highest safety standards,
effectively managing risks associated with its
production, particularly concerning worker safety
and environmental impact.
PVCMed Alliance continues to support the responsible
production, use, and end-of-life of PVC in the
medical sector.....
Read Full Article
Global
Market : Medical Devices
Peru Medical Devices Market
Mr. Amit Dave - M. Pharm, MBA, Former CEO – Brazil
Operations/ Vice President Export - Zydus Cadila
Claris Lifesciences
Comparatively a larger market size. Also longer life
expectancy resulting in the larger elderly
population and increasing private market offering a
good opportunity.
A very large population of Indians residing in the
country (mainly in Lima) can be a good support
system. In the healthcare profession, there are many
Indian operators.....
Read Full Article
AiMeD &
REGULATORY UPDATES
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Medical Devices Sector Applauds Budget Announcements
On Healthcare Sector
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DoP Invites Applications Under AMD-CF Scheme
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New Portal For Medical Devices Registration In India
(NSWS)
Read Full Article
Industry News
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Kerala Makes Cut In Medical Device Manufacturing
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Revolutionising Pharma-MedTech: India Allocates Rs
5,000 Crore To Propel Research And Innovation
Read Full Article
Product Gallery
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Qosina Introduces Stopcock Manifolds
Read Full Article
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Did You Know?
About US FDA Alert Regarding China
Made Plastic Syringes Quality Failures
As per recent safety communication issued by the U.S. Food and Drug
Administration (FDA) for consumers, health care providers, and
health care facilities, FDA is evaluating the potential for device
failures (such as leaks, breakage, and other problems) with plastic
syringes manufactured in China.
Generally, a syringe is used to inject fluid into, or withdraw fluid
from, the body and can be used in a variety of clinical and home
health settings. Some syringes may also be used with infusion pumps
to deliver fluids into the body in a controlled manner.
This alert was for Syringes used for injecting fluids into, or
withdrawing fluids from, the body and not glass syringes, pre-filled
syringes, or syringes used for oral or topical purposes.
FDA is aware of quality issues from recent syringe recalls, Medical
Device Reports (MDRs), and additional complaints about syringes made
at various manufacturing sites in China.
Quality issues reported have included leaks, breakage, and other
problems after manufacturers made changes to the syringe dimensions.
These quality issues may affect the performance and safety of the
syringes.
The differing dimensions reportedly affected their use with syringe
pumps, potentially resulting in pump performance issues like
overdose, underdose, delay in therapy, and delays in occlusion
alarms.
In one of the recalls by a leading US Company, it was found that the
Single Use Sterile Syringes had the potential to leak blood or
heparin back or from the syringe. There were also reports of an
unknown black material inside the syringe. Use of the syringes,
according to FDA, could cause serious adverse health consequences
including sepsis and blood loss due to leakage, or risks like
incorrect heparin dosage.
The FDA is working with federal partners to further test syringes
manufactured in China and may prevent syringes made in China from
entering the United States.
(Ref :
https://www.fda.gov/medical-devices/safetycommunications/evaluating-plastic-syringes-made-china-potential-devicefailures-fda-safety-communication)
(
Ref :
https://www.fda.gov/medical-devices/implants-andprosthetics/breast-implants
)
Read
More Factoids |
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Advertisers'
Index
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Accuprec Research Labs Pvt. Ltd., India |
Ambica Medicare Engineering, India |
Bry-Air Asia Pvt. Ltd., India |
Nu-Vu Conair Pvt. Ltd., India |
Celanese Corporation, India |
CLS Pvt.
Ltd., India |
Carclo Technical Plastics Pvt. Ltd.,
India |
ET Elastomer Technik, Germany |
Eewa Engineering Co. Pvt. Ltd., India |
Elkem South Asia Pvt Ltd,
India |
I-Kare Polyalloys Pvt. Ltd., India |
KLJ
Group, India |
Lubrizol Advanced Materials India Pvt.
Ltd. |
Map
Industries, India |
Milliken & Company, India |
Milacron India Pvt. Ltd., India |
GLR Laboratories
Pvt. Ltd., India |
HighRichja Precision Extrusion Machinery Co. Ltd., China |
PVC Colouring Compounding & Processing,
India |
Qosina,
USA |
R.R. Patel Gases (P) Ltd., India |
Raumedic AG |
SMC Medical Manufacturing Pvt. Ltd.,
India |
Tekni-Plex India Pvt. Ltd., India |
Trustin Analytical Solutions Private
Limited, India |
Yizumi India |
Airways Surgical Pvt. Ltd., India |
Alpha Medicare and Devices Ltd., India |
Alpha Therapeutics Pvt. Ltd., India |
Angiplast Pvt. Ltd., India |
Beacon Plastics, India |
Delux Surgical, Inida |
International Certification Services
Pvt. Ltd., India |
Jain Rubbers Pvt. Ltd., India |
Life-O-Line Technologist, India |
Leelavathy
Medical Device Company, India |
SEC Global Consulting & Initiative LLP,
India |
Surgi Pack India Pvt. Ltd. |
Amigo Surgi Care
Pvt. Ltd., India |
Apex Medical Devices, India |
Jimit Medico Surgicals Pvt. Ltd. |
Morrisons
Lifecare Pvt. Ltd., India |
National Healthcare, India |
Pharmadocx, Inida |
S. Nath & Co., India |
Unikal Consultants, India |
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