Medical Plastics Data Service Magazine November - December 2019 by Medical Plastics Data Service

Table of

Contents Vol. 27

No. 6

Nov.-Dec. 2019

COVER STORY Medical Polymers : Emerging Trends & Opportunities Most future trends are generated within Research Groups , Industry R & D Activities, and during the applications. Also by integration between the Engineers, Medical Professionals and Patients. PVC-Free Plastic Solutions for the Medical and Pharmaceutical Industry - Dr. Ralf Ziembinski, Head of the Tubing Business Unit, RAUMEDIC PVC, has been the choice of many medical applications. But today, there is a growing focus on other materials; the market is demanding alternatives. There are alternatives like TPE for drip chambers, soft PP for medical tubing, …………. Medical Polymers, Components & Processing - Innovations and Developments More and more developments by Medical Polymer Companies made available to the Indian Industry has created not only growth opportunities but opportunity to move up the value chain by offering high end critical care products.

GLOBAL TRENDS Nurses On Front Lines Of Medical Plastics Recycling Initiatives When it comes to recycling medical plastics, hospital nurses are on the front lines: Their engagement is critical to a successful “green transition” in the healthcare sector.

AiMeD & REGULATORY UPDATES • NITI Aayog Proposes Single Regime For Medical Devices, Penalty For Faulty Products: Report • CDSCO Notifies Four Medical Devices Testing Labs In The Country To Ensure Quality • DoP Approves Financial Assistance Of Rs.100 Crore For Common Facility Centres In Four Medical Device Parks • Healthcare Experts Hail Niti Aayog’s Draft Medical Devices Bill For Development Of Indigenous Medical Devices Industry

INDUSTRY NEWS • Horiba is working on the biggest medical factory in India: Dr Jai Hakhu, Chairman and CEO, Horiba • Indian Market Full Of Unauthentic Certificates For QMS In Medical Devices: Experts

Medical & Healthcare Plastics Pavilion @ PLASTIVISION INDIA 2020 - Includes knowledge Pavilion, Exhibitors & Seminars

16 38 37 Nov.-Dec. 2019

DID YOU KNOW? • About the best tubing for medical device applications?

ARTICLE INDEX • Medical Plastic Data Service - 2019 Article Index

EVENT CALENDER • PLASTIVISION INDIA 2020 • Medical Fair India 2020 • Medicall

Flashback Select Article Index

Jan 2013 to Jul. 2013 • Cover Story : Global Medical Device Business And India's Chaing Role : Trends and Challenges (January - February 2013) • Global Trends : Medical Device Industry Primed for Expansion in 2013 (January - February 2013) • Global Trends : ‘The Global Medical Device Contract Manufacturing Market Will be Worth $119.5bn by 2023’ (January - February 2013) • Global Trends : Sabic Touts Antimicrobial Materials (January - February 2013) • Did You Know : About India’s Success In Developing Its Own Health Related Technologies (January - February 2013) • Cover Story : Emerging Trends In Medical Plastics (March - April 2013) • Learning Zone : The Bandage - Reinvented for the 21st Century (March - April 2013) • Did You Know : How Easily Bacteria Clog the Medical Devices (March - April 2013) • Cover Story : Perfect Medical Device Packaging (May - June 2013) • Global Trends : Medical Device Packaging To Be Significantly Improved By 2020 (May - June 2013) • Learning Zone : Additional Methods For Dye Penetration Test For Porous Medical Packaging (May - June 2013) • Did You Know : About Packaging Failures: The Largest Source of Sterility Recalls (May - June 2013) • Cover Story : Healthcare Plastics Waste Recycling (July - August 2013) • Cover Story : Bio-Medical Waste Management Emphasizing Plastic Waste In Healthcare Organization (July - August 2013) - Dr. Pradeep Bhardwaj-CEO, Six Sigma Star Healthcare, Delhi • Cover Story : PVC Recovery In Hospitals: Global Benchmark (July - August 2013)

Did You Know ? About The Best Tubing For Medical Device Applications?

Device designers have to investigate application parameters while also dealing with the products’s regulatory and compliance requirements to choose the right tubing. Here is the process for selecting the right tubing product and supplier for a given application. When selecting a tubing material for your medical device application, the most important considerations are the key physical parameters of temperature range, pressure capabilities and chemical resistance to fluids that the application will see. However, other important physical attributes of the tubing may be durometer, or softness of the material, as well as bend radius, which will dictate the kink resistance of the product in application use. Lastly, cost is always a consideration when specifying a tubing product for use in an application. In addition to the physical performance characteristics of a given material, another important factor is choosing a tubing supplier that has current data and validation information to back up claims made around their product, meets the quality and compliance standards set by the governing bodies involved with the application and has the breadth of product offerings to meet all the tubing needs for the application. There is a wide range of materials that can be used for fluid transfer in medical device applications. https://www.medicaldesignandoutsourcing.com/what-is-the-best-tubing-formedical-device-applications/

• Global Trends : Plastics in Medical Technology on Course for Further Success - K 2013 to Showcase: Single-use Syringes, Cannula & Beyond (July - August 2013)

The Greatest Difficulty In The World Is Not For People To Accept New Ideas, But To Forget About Old Ones

• Did You Know : About Establishing A Healthcare Plastics Recycling Program (July - August 2013)

- John Maynard Keynes, Economist

Nov.-Dec. 2019

EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.

EDITORIAL ADVISORY BOARD Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai Mr. 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, HCG Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. 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. Dr. AJAY D. PADSALGIKAR, Ph.D. Senior Principal Scientist DSM Biomedical in Exton Pennsylvania, USA Dr. K.Sivakumar, M.Pharm, Ph.D Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 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 : Image Virtual Creation, Ahmedabad-54 •Ph:098795 55948 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.

Nov.-Dec. 2019

Editor’s Desk

From the

As we all know, Medical Care is recolonized by Polymeric / Plastics materials. Medical Plastics has transformed several aspects of the healthcare industry , which shows the importance of Materials. Like any other sector, the Plastic industry or the Medical Device Industry is also looking for emerging trends. The origin for some of the trends are from campaign based ideology - the examples for which in the medical applications are requirements for bisphenol-A free materials, Polyvinylchloride free devices etc. However, it is said that most future trends in the medical device sector are generated within research groups, industry R & D activities and during the applications. All very good looking ideas may be an actual trends. Some of the ideas which are tested after thorough investigation, have shown potential for implementation and are driven by higher integration level of technologies between technocrats, medical professionals and patients. A few of such material based innovations and developments are highlighted in the cover story in this issue. More and more developments by Medical Polymer Companies made available to the Indian Industry has created not only growth opportunities but opportunity to move up the value chain by offering high end critical care products , as highlighted in the Cover Story in this issue. “MEDICAL HEALTHCARE PLASTICS” PAVILION @ PLASTIVISION INNDIA 2020 “Medical Plastics Data Service”, will be providing concepts and co-ordination for creation of a “MEDICAL & HEALTHCARE PLASTICS “Pavilion” in the “PLASTIVISION INDIA 2020” event as part of our efforts to create Inter Sectorial coordination between Indian Polymer / Plastics Sector and Indian Medical Device Industry Sector for the broader objective to support make-in-India mission. PLASTIVISION INDIA, an event organized by All India Plastics Manufacturers Association (AIPMA) is the largest Plastics Industry Event held once in three years in Mumbai and the coming event with about 100,000 sq.m. area will have 1500 exhibitors from 25 countries and 2,50,000 visitors. The “MEDICAL & HEALTHCARE PLASTICS” will include a knowledge Pavilion highlighting information and opportunities in the Medical Plastics Sector by way of Posters, Audio-Visuals, Models, Product Samples etc. It will also include exhibits by companies providing Materials, Machinery, Technology & Services. Over the five day event, Techno-Commercial Seminars will be organized to the visitors / participants by the Industry Experts in the Seminar Room within the Pavillion. This will not only be a unique opportunity to the existing Companies looking for developments / diversifications, but also for the non-medical plastics based units to branch out to medical plastics products. Apart from the cover story, this issue also includes Industry & Regulatory Updates, Global Trends, Product Gallery etc.

Cover Story

Medical Polymers : Emerging Trends & Opportunities Like any other sector, the Plastic industry or the medical device industry is also looking for emerging trends. The origin for some of the trends are from campaign based ideology - the examples for which in the medical applications are requirements for bisphenol-A free materials, Polyvinylchloride free devices etc. History has shown that such public-driven trends generally follow the cycle of becoming public and disappearing regularly without major changes. However, it is said that most future trends in the medical device sector are generated within research groups, industry R & D activities and during the applications. All very good looking ideas may be an actual trends. Some of the ideas which have, are tested after thorough investigation, shown potential for implementation and are driven by higher integration level of technologies between technocrats, medical professionals and patients. A few of such material based trends are highlighted in this article. These trends are mainly driven by general aspects of higher integration level of technologies, but also between engineers, medical professionals, and patients.

Thermoplastic Elastomers Many medical devices need combination of hard and soft materials such as respiratory masks, precision syringes, tubings, catheters, bags for infusion solutions, implants such as artificial heart valves and joints etc requiring a long time use. The reason such materials will be preferred is because of their high degree of purity (low level of extractable compounds), their recyclability and cost effectiveness. Also for their application to replace latex which is understood to cause allergic reactions in some patients. In addition, they are easy to sterilize and are flexible. Technological advancement in the thermoplastic elastomer processing industry has made these elastomers an ideal choice for medical device manufacturing, leading to an increase in demand for thermoplastic medical elastomers in medical devices. As per “Markets & Markets”, Medical Elastomers Market was valued at USD 5.11 Billion in 2016 and is projected to reach USD 7.92 Billion by 2022, at a CAGR of 7.5%.

Biodegradable Polymers Within the world of medical devices, biodegradable polymers usually refer to a plastic that will be dismantled inside the human body by means of metabolism within a period between several days and years. Put simply, an implant manufactured from these materials will completely disappear without further action.

A well-established medical application is absorbent surgical suture materials that were introduced in the early 1960s.Currently there are five major groups of biodegradable plastic materials commercially available. However, by combining these by means of copolymerization or compounding, an enormous variety of materials may be obtained. • Polyglycolic Acid (PGA) • Polylactic Acid (PLA) • Polycaprolactone (PCL) • Polyanhydrides • Polylactic-Co-Glycolic Acid (PLGA) An implant basing on one of these biodegradable polymers subsequently will be replaced by body’s own material, making implant removal after healing superfluous. Widespread applications are screws, plates, and fixing pins for osteosynthesis. This comes along with several advantages. The implant does bear the entire load direct after implantation. The patient regains mobility immediately and the body gets time to start bone healing. According to an estimate, Biogradable Bone Graft Polymers market size was over USD 350 million in 2016 (including Joint Reconstruction, Cramiomaxillio facial, Dental, Spine, Orthobiologics & others) and is expected to grow at a CAGR over 7.5 % till 2024.

Biodegradable Polymers for Targeted Drug Delivery Over the past decades, biodegradable polymers have proven to be a very meaningful approach for targeted drug delivery. These types of polymers will disintegrate and eventually vanish when implanted into the human body, whereas the time and process of disintegration may be actively influenced by engineering. For instance, many medical devices are used as implants, serving as drug delivery system, intended to continuously administering a drug without any need for repeating intake of medicines. This offers diverse benefits. Drug may be delivered continuously right at the desired location within the human body, bypassing the digestive system and the liver. Further, convenience of the patient is increased as he is released from remembering when and how to intake drugs or any additional surgical intervention to remove the implant. Prominent example is small subcutaneous rodshaped implants, a few millimeters in diameter and 5-10 mm in length, applied as a contraceptive. Nov.-Dec. 2019

Cover Story Shape-Memory Polymers

growth of disease-causing pathogens.

Another interesting group of plastics are shape-memory polymers (SMPs). Just like the better-known shape-memory alloys, these will “remember” their original shape when deformed, and flip back to the initial shape when exposed to an external stimulus. These stimuli may be an electric field, light, changes in pH value, or, as most commonly, changes in temperature. Some SMPs even can retain three shapes, their initial (permanent) shape and two deformed morphologies. This effect offers several interesting options.

Owing to their multifarious applications, antimicrobial plastics have witnessed a significant rise in demand in the past few years, especially in industries such as healthcare, packaging, and personal care. The trend is likely to remain strong in the near future as well, with their rising set of applications in the fields of biomedical devices and implants expected lead to a massive rise in growth opportunities for antimicrobial plastics. Typical end use applications are : • Vascular Access Devices : Cath eters, Injection Systems, Needleless Connectors, etc. • Fluid Management Devices : IV Systems & Bags, Valves, Tubing, etc. • Device/Instrument Housings • Airway Management Devices : En dotracheal & Tracheotomy Tubes, etc. • Laparoscopic Instruments • Wound Dressings • Class I, II and III Medical Devices that come in contact with patients or their caregivers • And many other applications

A commonly known application is bracelets that alter the position of teeth over a period of several months, or coronary stents that strut the artery and prevent an elastic recoil. The alteration in shape also may be used for clamping. Feasible are form - and/or forcefitting fastenings. Applications for that are devices such as surgical staplers, remotely controlled switchable implants, or clamps to fix artificial heart valve. More over, while shape-memory alloys already find widespread applications in medical devices, such as dental wires, cardiovascular stents, or orthopaedic implants, the utilization of SMPs still is in its very beginnings. SMPs have potential applications as intravenous cannula, self-adjusting orthodontic wires and selectively pliable tools for small scale surgical procedures where currently metal-based shape memory alloys such as Nitinol are widely used. Another application of SMP in the medical field could be its use in implants, e.g. minimally invasive (trough small incisions or natural orifices) implantation of a device in its small temporary shape which after activating the shape memory by e.g. temperature increase assumes its permanent (and mostly bulkier) shape. The integration of SMPs in fabric provides many fascinating and improved properties such as good aesthetic appeal, comfort, textile soft display, smart controlled drug release, fantasy design, wound monitoring, smart wetting properties and protection against extreme variations in environmental conditions. Different SMPs such as shape memory polyurethane (SMPU), polyester, poly-hydroxyproline, polysilamine, etc., and some responsive hydrogels including poly (N-isopropylacrylamide) (PNIPAAm) hydrogels, polythiophene gel, etc., are used to fabricate such smart textile. Indeed, a detailed assessment of the factors that influence the biocompatibility and toxicity of SMPs is crucial for the safe and sustainable development of those that are emerging.

Antimicrobial Plastics Antimicrobial plastics are polymers that impede the growth of microorganisms owing to the presence of active antimicrobial agents on the polymer. Antimicrobial plastics inhibit the growth of microorganisms in a variety of products that they enclose or contain, thus playing a big role in extending the quality and shelf life of the products. Moreover, antimicrobial plastics help in curtailing infections and preventing illnesses by resisting the Nov.-Dec. 2019

• • • •

Some of the possible antimicrobial compounds (silver-and non-silverbased) include : • Butyl Rubber (IIR) Ethylene Propylene Diene Monomer (EPDM) Polyisoprene (IR) Polyurethane (TPU) Silicones (LSR and HCR)

Transparency Market Research estimates that the U.S. antimicrobial plastics market will exhibit a 9.3% CAGR from 2014 to 2020, rising from a valuation of US$662.3 mn in 2013 to a revenue opportunity of nearly US$1,227 mn by 2020. Emerging Trends In Manufacturing Technologies. While the above discussion is focused on trends and applications for Medical Polymers, the emerging trends in manufacturing of polymer based medical devices are also equally important to look into. It can include not only new trends in the commonly used plastics conversion technologies but also manufacturing environment / hygienic manufacturing as well as procedures like surface treatment / modification, 3D Printing bonding, antibacterial processing / coatings, anticounterfeiting, new sterilization approaches, packaging, printing and many more. I will take another opportunity in future to elaborate more on emerging trends and opportunitie in manufacturing technologies in future . Mr D L Pandya Editor & CEO, MEDICAL PLASTICS DATA SERVICE and www.medisourceasia.com

Cover Story

PVC-Free Plastic Solutions for the Medical and Pharmaceutical Industry Dr. Ralf Ziembinski Head of the Tubing Business Unit RAUMEDIC

“

Medical device manufacturers look closely at materials intended for use before starting the development period. In the plastics segment, polyvinyl chloride, or PCV, has been the choice for many medical applications. But today, there is a growing focus on other materials; the market is demanding alternatives. In our interview, Dr. Ralf Ziembinski discusses the possibilities.

“

Dr. Ralf Ziembinski is Head of the Tubing Business Unit at RAUMEDIC. With a doctorate in chemistry, he specialized in the research of inorganic polymers as far back as his post-doc studies at the University of Toronto, before bringing his know-how to RAUMEDIC beginning in 2004.

7 Questions for Dr. Ralf Ziembinski Q: PVC was indispensable for years and is still widely used today. But the material is increasingly the subject of public criticism. Is it warranted? This is where we have to make a strict distinction. In the field of medical technology, the criticism is largely aimed at the plasticizers in the material. It has been proven that DEHP or DOP exhibit reprotoxic characteristics and can be comparatively easily dissolved out of the material. We have used DEHP-free plasticizers, such as noDOP, for years to rule out this risk. The probability of migration is 100 times less with these substances. The EU Commission is also taking action: The present exemption that permits the now discredited phthalate for blood bags and transfusion tubes will only be valid for a further three years after Appendix XIV of the REACH regulation comes into effect. Q: Are there still any arguments in favor of PVC? There certainly are for medical-grade plastic disposable products, because the material is cost-effective, it is suitable for secondary processing and it has been proven for decades. While earlier materials such as glass and rubber were used in medicine, PVC has helped make healthcare better and safer. As long as it is DEHP-free medical grade quality, the material is also highly tissue and blood compatible. In the clinical setting, it is also extremely important that PVC parts

and components can be easily sterilized before use. Because no one wants to risk an infection caused by germs. Q: Will PVC disappear from medical and pharmaceutical applications? This is a matter of cost more than anything. If alternative materials with a similar price point and comparable properties break through in the market, that is certainly possible. Otherwise the healthcare system would be heavily impacted. We therefore believe that PVC will continue to have a certain right to exist in the medical and pharmaceutical industry. Its qualities such as biocompatibility and sterilization capability as well as technical factors such as flexibility, transparency and strength along with its low cost can simply not be dismissed. Q: Nevertheless, PVC is not always the material of choice. Why? For applications where PVC will come into direct contact with drugs, possible interactions must be carefully monitored in advance. Because there are actually several ingredients, including Taxol, nitroglycerin, Diazepam and insulin that are incompatible with PVC. There are often two aspects to this problem: First of all, the solubilizers in PVC can result in the plasticizer dissolving out of the material. Secondly, certain drug ingredients can become deposited on the PVC surface. This adsorption is Nov.-Dec. 2019

Cover Story associated with an undesirable loss of active ingredient, i.e. a lower dosage. Q: What is your prognosis for the future? More and more customers are already asking us about PVC alternatives, which is often driven by the requirements of hospitals. This trend is likely to intensify. A complete transition to PVC-free materials in medical devices would be a lengthy process, in my view. And manufacturers would also have to expect higher prices for the alternative materials. Q: Which PVC-free materials do you offer your customers? There are a few possibilities. We used TPE in the development of a new drip chamber, for instance. For medical tubing, we can offer soft PP, especially when optimal drug tolerability is required. This is because polypropylene doesn’t require plasticizers – as is the case with polyurethane, incidentally. In addition, the material characteristics are very similar to those of PVC.

When a more cost-efficient PVC alternative is needed, coextrusion could be a solution. We have developed a medical-grade twolayer tubing made from EVA and styrene-butadiene rubber (SBR) in this field. Because the outer layer can be dyed, the tubing enables optimal administration of light sensitive drugs such as chemotherapeutic substances. Thanks to the transparent inner layer, the active ingredient does not come into contact with the color pigments. In terms of price, our chlorine and plasticizer-free EVA/SBR combination is only approximately 25 percent higher compared to PVC. In addition, the outer layer of tubing made from SBR can be easily glued, which plays a key role during secondary processing. Q: Speaking of secondary processing, which applications can be considered for these alternative materials? There are many. Our Coex tubing made from EVA and SBR and the TPE drip chamber are ideal for gravity infusion kits. For example, when nutritional solutions or drugs need to be parenterally administered. These PVC-free materials could also be used for transfusions. Soft PP is also suitable for replacing PVC tubing in infusion pumps.

The PVC-free drip chamber made from TPE enables visual control for the dosage of medications or saline solutions.

Alpha Medicare and Devices Ltd.

(taking care…Since1984)

Manufacturers & Exporters of Disposable Medical Devices

GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY 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 NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. ISO 13485 : 2003 • Exporting our products to almost more than 23 countries. 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 Nov.-Dec. 2019

0434

Cover Story

Medical Polymers, Components & Processing Innovations and Developmnets Covestro Pushes Development for Medical Wearables At the combined Compamed 2019 and Medica 2019 trade fairs from 18 to 21 November in Düsseldorf, Covestro will be presenting solutions for portable medical devices and an innovative wound care concept in Halls 8b and 13. For several years now, the company has been positioning itself as an important material supplier for this emerging market. At Booth D46 in Hall 13, material solutions for flexible medical electronic patches based on Platilon® and Baymedix® polyurethane materials will be presented, as well as new solutions for on-body drug delivery devices made of Makrolon® polycarbonate and Bayblend® blends.

A growth market: electronic patches Electronic patches are already being used in many areas such as patient monitoring, and with the increasing digitization of healthcare, market demand for such products is growing rapidly. In the field of flexible materials, applications such as electroencephalograms (EEG), maternity belts, blood pressure measuring tapes and individual electrocardiograms (ECG) are at the heart of the markets that Covestro is targeting. Covestro will therefore show prototypes made of its flexible integrated materials: • Soft, breathable and stretchable Platilon® films for outstanding patient comfort • Printable substrates for printed electronics • Skin- and application-friendly adhesive systems based on Baymedix® materials • Weldable foams based on Baymedix® for safe use of electronics

Plastics for on-body equipment In addition to flexible materials, Covestro also offers the ideal materials for wearables with hard covers that are required for mobile drug delivery devices or sensitive diagnostic devices, for example. Makrolon® polycarbonate medical grades meet the requirements for excellent dimensional stability and outstanding mechanical properties and enable the development of safe, patient-friendly devices. Thanks to its high degree of transparency and good surface texture, Makrolon® also provides a wide range of design options such as the integration of LED light guides. Polycarbonate blends such as Bayblend® (PC+ABS blends) and Makroblend® (PC+PBT blends) meet additional customer requirements.

Covestro expert Dr. Ulrike Lützow will give a lecture on "Wearable Housings: Material solutions between medicine and electronics" on November 19, 2019.

Innovative concept for wound prevention Covestro will be presenting innovations in the field of wound management at Booth H30 in Hall 8b. The company has developed a design study for wound prevention that deals with the three most important factors for bedsore (decubitus): Pressure, friction and shear. A highly breathable prototype is being manufactured exclusively from polyurethane materials from Covestro. The main features of this prototype wound prevention dressing made of Baymedix® and Platilon® materials are: • Optimized friction, shear and pressure management • Excellent moisture management to support a healthy microclimate • Application- and skin-friendly polyurethane adhesive • Efficient and sustainable manufacturing technology Components based on these products help increase both cost and manufacturing efficiency by allowing roll-to-roll processing and inline production of all layers. During processing, thermoplastic welding of the edges is possible. Moreover, the process is energy-saving and environmentally compatible because production steps are reduced. In the course of the Compamed Suppliers Forum Covestro expert Dr. Marc-Stephan Weiser will present the design study for focused wound prevention on November 20, 2019, at 3.30 pm in Hall 8b.

About Covestro: With 2018 sales of EUR 14.6 billion, Covestro is among the world’s largest polymer companies. Business activities are focused on the manufacture of high-tech polymer materials and the development of innovative solutions for products used in many areas of daily life. The main segments served are the automotive, construction, wood processing and furniture, and electrical and electronics industries. Other sectors include sports and leisure, cosmetics, health and the chemical industry itself. Covestro has 30 production sites worldwide and employs approximately 16,800 people (calculated as full-time equivalents) at the end of 2018.

Novel S-TPE Solution for IV Tubing INEOS Styurolution has newly developed S-TPE (Styrene Thermoplastic Elastomer), called “Styroflex 4G80”, for IV tubing

application. The key advantages of this material are, less drug absorption due to its plasticizer-free composition, excellent bondNov.-Dec. 2019

Cover Story ing performance with other IV components, good kink-resistance and clarity. Styroflex 4G80 can be processed on standard tubing extrusion equipment at superior processing rates when compared to other materials. Styroflex 4G80 has been developed through collaborations with global OEM’s and would be an attractive alternative material for next generation IV system. Styroflex 4G80 is available with INEOS Styrolution’s medical grade package which includes up to 12 months notification of change (NOC), locked formulations as defined in a

Kuraray offers a diverse portfolio for the medical market with more than 30 different types of TPEs with individual product properties. Kuraray’s TPE products, SEPTON™ and HYBRAR™ combine the elastic properties of rubber with the benefits of thermoplastics. Due to this thermoplastic nature, they can be processed into almost any shape.

Drug Master File (DMF), and a variety of regulatory compliance documents and biocompatibility information (e.g. USP Class VI, ISO 10993). Contact details: Partha Mohapatra (Healthcare Lead India) INEOS Styrolution India Limited Phone: +91 1166454511, Mobile: + 91 9811819934, Email: partha.mohapatra@ineos.com

physical properties but lower density. Being halogen and phthalate free, HYBRAR™ meets many of the environmental and safety standards that PVC cannot meet.

Orthopedic Gels:

Medical Tubing: As environmental standards increase, medical tubing is now being replaced with polymers such as HYBRAR™ as an alternative solution for soft-touch applications. HYBRAR™ blends with PP are soft, transparent, offer good kink resistance, have high-temperature performance and are solvent bondable. In comparison to PVC, HYBRAR™ has similar

SEPTON™ 4000-series can be used to create orthopedic gels. The SEPTON™ 4000-series provide orthopedic gels with their necessary stability and super soft characteristics giving the products a natural skin-like feel. Additionally, developed for high-performance products where long lasting stability and compression set are key requirements, SEPTON™ 4000-series can be used in applications such as cushions for artificial limbs, orthopedic bandages, prostheses and burn plasters. Kuraray Booth @ Plastivision2020: Hall 4 C-2 Block Stall No. 2

Tekni-Plex announces new Tekni-Plex Medical business Wayne, Pa. (December 17, 2019) — Tekni-Plex is announcing the formation of the Tekni-Plex Medical business unit, which will facilitate the supply of mission-critical, high-value components, materials, and solutions to medical device manufacturers worldwide. The new operating unit will offer products and services formerly supplied separately by its Colorite, Natvar and Dunn businesses. Medical device companies will now have a dedicated sales and customer service team representing all product lines. “Our goal is to be a trusted advisor, helping our customers make the best decisions on their most important business issues through deep engagement, expertise, innovation and quality,” said Paul Young, president and chief executive officer, Tekni-Plex. “Our globally integrated operations will help us provide better and faster solutions to meet customer needs.” Manufacturing will continue in the same locations, with the ability to run the same material specifications on the same equipment around the world for multinational customers. Going forward the Colorite, Natvar and Dunn names will be used as product brands. Nov.-Dec. 2019

The Colorite brand’s advanced medical-grade compounds are used by the world’s foremost healthcare and medical device manufacturers. They are globally recognized for consistently meeting or surpassing rigorous regulatory and industry standards. The Colorite brand also includes an extensive line of PVC and TPE medical-grade compounds that have been engineered to meet product objectives. The Natvar brand includes multilayer and multi-lumen tubing, as well as a range of value-added options including tapered, striped, thermoformed and special profile products. These extruded tubes are used in applications including intravenous therapy, dialysis, respiratory, and surgical equipment. The Dunn brand features precision extruded tubing for endovascular catheters and minimally invasive devices. Dunn also manufactures custom medical tubing for diagnostic and interventional devices from a wide range of thermoplastics.

About Tekni-Plex Medical Tekni-Plex Medical provides advanced medical grade, polymerbased solutions (compounds,tubing and other products) for medi-

Cover Story cal devices and other applications. Its nine global manufacturing locations enable supply backup and benefit from the latest in lean manufacturing to perfect the balance between high quality and economic requirements.

About Tekni-Plex, Inc. Tekni-Plex is a globally-integrated company focused on develop-

ing and manufacturing products for a wide variety of end markets, including medical, pharmaceutical, food, beverage, personal care, household and industrial. Tekni-Plex is headquartered in Wayne, PA, and operates manufacturing sites across ten countries worldwide to meet the needs of its global customers. For more information visit www.tekni-plex.com.

Using Stock Components To Reduce Time To Market Getting your product to market is rarely an easy task. In fact, it can be quite daunting. You may feel that you spend much more time searching for and developing parts than actually creating products. Qosina hopes to alleviate that stress by providing medical OEM components and innovative solutions to make your device concept a reality. Here’s how Qosina helps to eliminate your go-to-market challenges:

Prototyping is easier—and cheaper

If you’re still in the prototyping phase of research and development, you don’t want to order a bulk quantity of a part that might not work for you. Sampling is key early in the process, and Qosina’s selection of 5,000+ in-stock SKUs is perfect for building out your prototypes without committing to large orders. Qosina offers complimentary samples on most of its products, so you can explore a wide range of materials, colors and configurations. This allows you to evaluate and test in advance of purchase, removing technical risk from the product development process.

tooling to quoting secondary operations for secure supply chains will streamline your vendor list and prevent complicated outsourcing. Consolidating purchases and suppliers with one order can also significantly reduce overhead.

Education on relevant industry topics

Qosina keeps you in the loop regarding complex and pressing subject matter in the medical device industry. Download white papers and case studies for information, guidance and solutions on hot-button issues. Qosina’s number one priority is to offer the best solutions to fit its customers’ needs and adapt as the development process continues. The company is constantly adding new products to its line and providing cost-effective solutions to help you get your project off the ground and into production.

Sourcing and customizing components

Using stock components can significantly lower the cost and time of creating a mold since one may already exist. However, if the item you require is not in Qosina’s inventory, they will work to develop the part to your exact specifications. A slight alteration of an existing mold can be a cost-effective way to create a new part to meet your requirements. Qosina’s knowledgeable product development team can easily adjust stock design size, color and material for your purposes.

Required documentation is in one place

With the ever-increasing demands on engineers, a certified, technically proficient component distributor should offer additional value propositions to reduce any supply chain-related burdens. Qosina provides 3D CAD models and material specifications that allow you to easily implement components into your designs while staying up-to-date with government and safety regulations. Qosina offers CAD files in a variety of formats, which can be helpful for everything from adapting engineering drawings to sharing visuals with non-technical team members. Qosina also provides comprehensive technical specifications, such as material safety and data sheets, technical data sheets, material certification and compatibility information on all of its products. You can easily access these resources on qosina.com.

Streamline your vendors Using one supplier for everything from running materials through

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. Sanjay Y .Shah – Owner Promoter M : +91 98240 17850

Obelis European 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.

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

Nov.-Dec. 2019

Global Trends

Nurses On Front Lines Of Medical Plastics Recycling Initiatives been contaminated with bodily fluids or drugs, an important distinction as potentially contaminated materials must not enter the recycling stream. This possibility has stymied recycling efforts in medical facilities in the past; however, it should be noted that a vast amount of medical plastic waste, notably packaging, does not come in contact with patients.

When it comes to recycling medical plastics, hospital nurses are on the front lines : Their engagement is critical to a successful “green transition” in the healthcare sector. Efficient sorting of plastic waste also was a key discussion point. Attendees learned that In the capital region of Denmark, the plastic is collected at the hospital without further sorting. To simplify sorting and recycling efforts, it’s important to begin at the beginning and design products with recycling in mind,

Nov.-Dec. 2019

Medical device manufacturers, nurses and representatives from hospitals, the Danish Environmental Protection Agency, the Danish Medicines Agency and the PVCMed Alliance attended the workshop on Nov. 25, 2019, in Copenhagen, which focused on PVC, the most widely used plastic in hospitals. Stressing that the commitment of medical professionals is “crucial to the green transition of healthcare,” Mette Skriver Revsbech, a nurse at Copenhagen University Hospital, explained to attendees how much plastic waste is generated after just five surgical procedures. That realization motivated her co-workers to take part in a project to collect and repurpose 2,000 used oxygen masks, said Revsbech. Tobias Johnsen of the PVCMed Alliance reinforced that message by discussing examples of recycling projects initiated in healthcare settings in Australia, New Zealand, South Africa, Guatemala and the United Kingdom, where it was “striking” that nurses were at the forefront. One program in Australia is illustrative of what can be achieved. As reported in PlasticsToday in February 2019, the PVC Recycling in Hospitals program, developed by the Vinyl Council of Australia and sponsored by medical device OEM Baxter Healthcare, began in 2009 with a single healthcare provider and has since grown to more than 140 hospitals across Australia and New Zealand. It provides recycling bins and training material for staff. Nurses separate three PVC products—IV fluid bags, oxygen tubing and oxygen masks, none of which have

Making worthwhile products from the recyclate is also a key tool for engaging medical personnel, who already have intense professional lives, in recycling initiatives. At the workshop, attendees were shown one example - school shoes donated to South African children living in deep poverty that were made from recycled medical plastics. It takes only 20 IV bags to make a pair of those shoes, according to workshop participants. Efficient sorting of plastic waste also was a key discussion point. Attendees learned that In the capital region of Denmark, the plastic is collected at the hospital without further sorting, which is done outside the facility because of space considerations. The PVCMed Alliance proposed a more low-cost solution, whereby sorting takes place in the respective hospital departments. Every hospital could use its own granulator that simply crushes the plastic. Sufficiently large quantities of recyclate can then be sold to a recycler. Such a practice poses no particular risk of infection, said the organization, which represents the PVC medical industry chain. Hospital waste is handled exclusively by professional nurses who know which patients could pose a risk. The experiences from Copenhagen University Hospital and around the world show that mis-sorting is extremely rare, according to PVCMed Alliance. To simplify sorting and recycling efforts, it’s important to begin at the beginning and design products with recycling in mind, noted Annette Bitz from Danish medical device OEM Ambu. She presented a new design manual at the workshop, which makes the case that, as much as possible, a single type of polymer should be specified for the fabrication of a medical device. Plastics expert Peter Sommer-Larsen from the Danish Technological Institute cited the example of oxygen masks, which consist of soft and hard parts. They can be made either in PVC of varying softnesses, or two different types of polymers. Choosing the latter option makes recycling impossible, partly because of the plastics’ different melting points, stressed SommerLarsen. Considering the product's entire lifecycle at the design stage can lead to a more sustainable outcome when the device has fulfilled its primary purpose. https://www.plasticstoday.com/medical/nurses-onfront-lines-medical-plastics-recycling-initiatives/ 158515334361958

NITI Aayog Proposes Single Regime For Medical Devices, Penalty For Faulty Products: Report The changes have been put forth in the draft Medical Devices Bill, which is expected to be notified within the next six months. The NITI Aayog, on December 18, has suggested a single regulatory regime to oversee medical devices and a separate four-division Medical Devices Administration (MDA) to improve ease of doing business in the sector, the Business Standard reported. Moneycontrol could not independently verify the report. The MDA would function parallel to the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services (DGHS), the proposal states. It would likely employ 700 in permanent posts for four separate divisions — health and safety, conformity assessment, enforcement, and laboratories and medical devices testing, it added. Besides this, the requirement for manufacturing licences to register devices or acquire conformance certificates would be waived. The changes have been put forth in the draft Medical Devices Bill, which is expected to be notified within the next six months, the paper noted. A window of 12-36 months would be given for

existing medical devices to adhere to the new Act, once it comes into force. The bill also proposes a penalty of up to Rs 1 crore in cases where importers or manufacturers sell faulty medical devices, where a patient’s identity is revealed or if a product is launched without obtaining a certificate of conformance, the Economic Times reported. The penalty, plus three years imprisonment, was suggested for fraudulently acquired conformance certificates, the ET report added. Moneycontrol could not independently verify the ET report. Other proposals in the draft include a National Register of Medical Devices, presently governed by the Drugs and Cosmetics Act, 1940; mandatory registration of all devices and compliance certificates by the regulator, mandatory for manufacturers and importers to get unique identification (UID) number for their devices. https://www.moneycontrol.com/news/trends/health-trends/nitiaayog-proposes-single-regime-for-medical-devices-penalty-forfaulty-products-report-4745041.html

CDSCO Notifies Four Medical Devices Testing Labs In The Country To Ensure Quality With the objective to effectively regulate all medical devices under Drugs and Cosmetics (D&C) Act in a phase wise manner, the Central Drugs Standard Control Organisation (CDSCO) has notified four medical devices testing laboratories (MDTL) for carrying out evaluation of medical devices under the new Medical Devices (MD) Rules 2017 on behalf of manufacturers in the country. The new MD rules were notified on January 31, 2017 under D&C Act to regulate manufacture, import, sale and distribution of medical devices which were effective from January 1, 2018. As per Rule 81 of MD Rules, 2017, Sipra Labs Ltd based in Telangana, Hyderabad will carry out test or evaluation of medical devices like Copper -T, Condoms, Sterile Hypodermic Needles, Tubal Rings, Hypodermic Syringes and Blood Bags. Star Imaging and Path Lab Pvt Ltd based in West Delhi will evaluate Bilirubin (Total and Direct) test, Reagents / Kits, Creatinine Test Reagent/ Kit, Aspartate Amino Transferase (AST/SGOT) test, Alanine Amino Transferase (ALT/SGPT) test, Uric Acid Test reagents/ kits, total Protein test reagents/kits, activated partial thromboplastin time (APTT) test and Prothrombin Time (PT) Test Reagents/ kits. Alcatec Research Laboratories India Pvt Ltd, Haryana will evaluate Sterilized Surgical Ligatures, Sterilized Disposable Device and Sterilized Surgical Sutures. Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvanthapuram will evaluate Cardio Vascular Devices (Biological Evaluation as per ISO 10993), Neuroprosthesis

(Biological Evaluation as per ISO 10993) and Orthopedic Implants (Biological Evaluation as per ISO 10993), all medical devices and materials (biological evaluation as per ISO 10993) and dental implants (Biological Evaluation as per ISO 10993). In the meantime, the Union health ministry is planning to upgrade manpower at CDSCO towards effective licensing and enforcement activities to ensure safety, quality and performance of medical devices. Considering that bringing all medical devices into regulatory control will lead to increase in work load considerably, a total of 754 CDSCO regulatory officers and laboratories staff will be inducted into the existing manpower of 119 regulatory and lab staff at CDSCO before implementation of the second phase. As per the road map outlined till 2020, the ministry has set out to upgrade CDSCO manpower by creating additional 1,195 new posts, including 64 experts, and additional 4,300 personnel for new laboratories, mobile drug testing labs, e-governance and training. The regulatory infrastructure including manpower need to be strengthened proportionately for licensing as well as enforcement activities, as per the Drugs Technical Advisory Board (DTAB) report. DTAB also recommended that 5 laboratories should be set up within a span of five years for testing of various medical devices and in-vitro diagnostics (IVDs) medical device. http://gubbagroup.com/cdsco-notifies-four-medical-devicestesting-labs-in-the-country-to-ensure-quality/ Nov.-Dec. 2019

DoP Approves Financial Assistance Of Rs.100 Crore For Common Facility Centres In Four Medical Device Parks In order to boost indigenous medical device industry in the country, the Department of Pharmaceuticals (DoP) has approved a financial assistance of Rs.25 crore each for setting up common facility centres in the existing four medical device parks in the country. DoP had received four proposals under this sub-scheme from Andhra Pradesh Medtech Zone (AMTZ) Ltd (AMTZ), Andhra Pradesh, Telangana Medical Device Park, Telangana, Kerala State Industrial Development Corporation (KSIDC), Kerala and HLL, Medipark Ltd (HML), Tamil Nadu. Based on the proposals, DoP has given in-principle approval to all the parks for their holistic development. DoP under the Union ministry of chemicals and fertilizers had devised a sub-scheme - Assistance to Medical Device Industry for Common Facility Center under the umbrella scheme for development of pharmaceuticals industry.

These facilities include Centre for Electro-Magnetic Interference or Electro Magnetic Compatibility (EMI/EMC) and Electrical Safety Testing (EST), Centre for Biomaterials Testing, Centre for X-ray and CT Scan Tube Manufacturing, Centre for 3D Designing, canning, Printing, Rapid Prototyping and Tooling, Centre for Gamma Irradiation and AMTZ Central Warehouse. Complementing the above-mentioned ecosystem, AMTZ has firmed up strategic tie-ups with industry associations including Association of Indian Medical Device Industry, Andhra Chamber of Commerce, GMDN Agency, India Angel Network, PHD Chamber of Commerce and Industry, Quality Council of India (QCI), UNITED ASIA and World Association for Small and Medium Enterprises (WASME) among others. Medical device parks with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40 per cent to 50 per cent.

Under this sub-scheme, financial assistance to the tune of Rs.25 crore or 70% of the project cost, whichever is less may be provided for creation of common facilities under any medical device park promoted by state governments or state corporations.

Currently, due to lack of such centrally located shareable facilities, either manufacturers do not undertake production of technologies requiring them or send their products abroad for process up-gradation and value addition.

AMTZ - India’s first medical devices manufacturing park have also inked formal agreements with various scientific facilities for medical equipment manufacturing, project development, construction, setting up agencies for technology transfer and financial support at Vishakhapatnam based manufacturing park spread over 270 acre.

Medical device parks are equipped with all such facilities in-house to reduce manufacturing process costs and should be ideally located in an area which is well connected with railways, roadways, waterways and airways along with presence of industrial corridors, port and harbour to also reduce logistical costs. http://pharmabiz.com/NewsDetails.aspx?aid=119953&sid=1

Healthcare Experts Hail Niti Aayog’s Draft Medical Devices Bill For Development Of Indigenous Medical Devices Industry Public health and industry experts have hailed the government’s efforts to draft a Medical Devices Bill with focus on global harmonisation for development of indigenous medical device industry.

players. This regulatory environment improves the ease of doing business and will help create jobs, add economic value and improve patient outcomes,” stated Malay Mitra, regulatory advisor and retired deputy drugs controller from CDSCO.

They have also emphasised how this move will bring revolution in the medical devices industry and protect patients’ interests.

However, the country’s healthcare policies are at an inflection point and there is rising need to focus on quality and innovation by building medical infrastructure on par with global standards of safety rather than rationing it in the name of wider accessibility at the cost of quality and safety.

Niti Aayog had recently concluded a stakeholders meet in New Delhi to discuss key features of draft Medical Devices Bill. The new regime aims to bring in a robust regulatory mechanism, facilitate ease of doing business and organise India’s semiregulated medical device industry with focus on global harmonization. “A robust regulatory mechanism has been a fairly long wait for India’s semi-regulated medical devices industry. At a time when healthcare experts are expecting a separate regulatory framework for medical devices, the true testament of quality can only be attributed to adoption and implementation of international harmonised. Complying with global standards will open the door for global markets, as well as help the local device sector to follow high standards and carry clinical evaluation in line with global Nov.-Dec. 2019

Calling it a positive move, Dr. Gajendra Singh, Public Health Expert asserted, “The government’s move to hold meetings with relevant stakeholders by adopting global regulatory practices for medical devices is highly laudable. It is important that the government stay on a track of progressive reform in the regulatory structure for medical devices and boost innovative technology. The process going forward should continue to be transparent and inclusive and consider efforts of national regulatory authorities at the global level to develop and share best practices to achieve its goals for the ease of doing business and attracting foreign direct investment in the medical devices sector.”

However, some medical experts also argue that the move will do little to improve the condition of the already “unregulated” medical device sector in India. Others question if a separate regulatory mechanism can act as a yardstick for the safety and efficacy of medical devices. It would be interesting to observe if India is equipped to fill in the gaps in the field R&D, manufacturing and testing facilities with the new medical device authority in place.

the Government of India to consult with relevant stakeholders on the best way to regulate medical devices and diagnostics. Our industry is eager to work with the government of India to develop a robust regulatory regime for medical devices and diagnostics that ensures patient safety, fosters innovation and helps strengthen the ecosystem for the medical devices industry in India.”

While India has policy mechanisms and regulatory practices to compare the country’s domestic produce, the true testament of quality can only be attributed adoption and implementation of international harmonised standards rather than coming up with a new mechanism altogether.

“As Indian government deliberates to develop a comprehensive regulatory framework for medical devices and diagnostics, AdvaMed and its member companies urge the Government to promote the adoption of a globally harmonized system including global consensus standards that will not only help ensure the quality and efficacy of products but also enable an ecosystem for manufacturing, research and innovation for benefits of patients in India,” the association further said.

Elaborating on the Indian Governments’ efforts to improve the overall landscape and benefit patients to get quality medical device in line with global regulations, Washington-based device makers trade association, Advanced Medical Technology Association (AdvaMed) stated, “AdvaMed appreciates initial steps by

http://pharmabiz.com/NewsDetails.aspx?aid=120105&sid=1

www.medicalplasticsindia.com

THE ONLY INDIAN PORTAL SITE ON MEDICAL PLASTICS/DEVICES TECHNOLOGY AND TRADE

Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy • • • • • • • • • • • • •

Critical Care & Anaesthesia Therapy Products T-Oxygenator • Endotracheal Tube(Plain & Cuff) Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block Ventilator Circuit • Inflatable Anaesthesia Mask Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems Breathing Filters(HME & BVF) • Airovent T-Humidifier Resuscitator(Ambu Bag) • Dialflow Regulator Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer Stylet • 3 Ball Spirometer Guedel Airway • Three-way Stopcock Nasopharyngeal Airway • Extension Tubing for Infusion Laryngeal Mask Airway Systems Mallaeble gum Bougie • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 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

High Concentration Mask

Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount Nov.-Dec. 2019

Nov.-Dec. 2019

Align Energize...

Announces 2 Days Workshop on “Medical Device Rules 2017” - Feb. 11 & 12, 2020, @ Ahmedabad Who will benifit ? Programme is beneficial to Owners of Medical Device Manufacturing units, Professionals working inmedical device manufacturing units, QA/QC Professionals, Compliance/legal Officers, Government Officials and Trainers/Consultants. Contents of the Programme Duration - 2 Days • Introduction • Opportunities emerging in Medical Device Industry • The Global Scenario • Introduction to MDR 2017 • Migration to EU MDR 2017 • Discussion on requirement of the Fourth Schedule and Fifth Schedule of India MDR 2017 • Discussion on Requirement of the EU MDR 2017 • Brief discussion on applicable BIS Standards and ISO standards • Introduction to Riak Assessment as per ISO 14971 : 2019 • Exercise and Case Study Tutor : A Senior Faculty From CDSCO Registered Notified Body.

Supported By :

Date : Feb. 11 & 12, 2020 Venue : A decent 3 star hotel Time : 9:30 AM to 5:30 PM (both days) Certificate : To be issued to all Location : Ahmedabad Fees/Investment for 2 Days Per Participant - Rs. 14,750 (includes GST)* Bank Details : Cheque or DD to made in favour of “SEC Global Consulting And Initiatives LLP” Address : ICICI Bank, SG Road Branch, Sarthak 2, Nr. Kiran Motors, Opp. Rajpath Club, SG Highway, Ahmedabad. Account No. 029505003022 • IFSC Code - ICIC0000295 * Includes Cost of Training Material, Breakfast, Lunch and Tea

2 Days Workshop on “Medical Device Rules 2017” Nomination Form for Training - Feb. 11 & 12, 2020 We Nominate the following members from our organization 1. 2. 3. 4. 5. For any queries, Contact : Bhupesh Sood - M. +91 9974803399 Payment Details : Cheque No. Dated Drawn in favour of “SEC GLOBAL CONSULTING AND INITIATIVES LLP” has been issued by our organization, The cheque may be sent to following address - F6, Parth Apartment, Ramdevnagar, Satelliete, Ahmedabad. Nov.-Dec. 2019

Industry News Horiba Is Working On The Biggest Medical Factory In India: Dr Jai Hakhu, Chairman And CEO, Horiba In near future healthcare will have monitors, electronic sensors at home and the doctors will know proactively that what is going on. Some kind of predictive health messages will be sent ahead of time. The devices which we make, in the future, will have wifi connectivity or Bluetooth, so you don't have to visit a doctor to find out what happened, it can simply be done by phone.

For example, we introduced the Helo product for healthcare. It is a track system that was introduced around two-three months back in India and it was accepted by Zeimens as a standard product. They will be using our product globally, so it's not only what we do, but also what we can do with others. Therefore analyzing is the key part.

Shahid Akhter, editor, ETHealthworld, spoke to Dr Jai Hakhu, Chairman and CEO, Horiba, Instruments Incorporated(U.S), President of Horiba, to know more about Horiba's contribution in the field of blood analyzers and their plans to scale up manufacturing in India.

I started Horiba India Healthcare around eight-nine years back. We were two people and our position through distributors was number fifth. Our goal to be number three and team of Horiba India achieved it. Now, we are almost number one in the field of blood analyzers.

Global healthcare technology: Trends

Global healthcare delivery system: Your views

The key thing now is remote connectivity because the next step in healthcare will be that you will have monitors, electronic sensors at your home and the doctors will know proactively that what is going on. For example, in diabetic people where you must have seen that they can have continuous monitoring and that is monitored by a doctor's office. There is no point that people will get a big shock or stroke as some kind of predictive messages will be sent ahead of time. Big data is going to be very important in the medical field. The devices which we make, in the future, will have wifi connectivity or Bluetooth, so you don't have to visit a doctor to find out what happened, it can simply be done by phone. Hence. these trends are emerging.

Different countries have different health systems. For example, in the US healthcare system is not that good. It depends on how much money you make. Similarly, if you go to Canada everybody gets healthcare or even in England, but we have to do a lot of work. In China, I visited hospitals and was very disturbed to see that healthcare does not reach the poorest section. We have a tremendous disparity, even in India. We need to work on that as to how we can normalise it and reduce the cost per test so that we can serve the masses. Therefore it's not in the great state globally.

Global healthcare technology: Market

We are building twelve acres complex in Nagpur and it will have a capacity for us to serve for the next ten to fifteen years. We have also invested in Haridwar and Pune. It's going to be the biggest medical factory in India. My personal goal is to reach the masses at an affordable cost, but we have to make money to keep on investing.

People get sick in both poor or rich countries, so our job is to reduce the cost per test. As far as India is concerned, I want to reach every corner of the country. We have about 12 acres of land in Nagpur and the building is being built right now. The idea is to reach every place at affordable cost and also our goal is to help the society.

Global/Indian healthcare technology: Horiba Medicals Horiba is not the biggest in healthcare, there are many other big companies, but Horiba has the analyzers right from the Founder. If you look at the broad cross-section of Horiba, there is a common thing called analyzers. In healthcare, you are analyzing the blood and we are focusing on the analysis part of the healthcare.

Horiba Medicals: Future plans for India

Make in India: Ease of doing business We need to have manufacturing in India, not only that but also the supply chain as manufacturing alone is simply not the answer. As what happens in the labour for manufacturing is only ten percent, you don't gain much as you have to develop the infrastructure https://health.economictimes.indiatimes.com/news/industry/weare-working-on-the-biggest-medical-factory-in-india-dr-jaihakhu-chairman-and-ceo-horiba/72973637

Indian Market Full Of Unauthentic Certificates For QMS In Medical Devices: Experts Even as concerns have been raised globally about counterfeit or unsafe medical devices, accreditation experts in India say that a large number of certificates of certification for quality management system (QMS) as per international standard, ISO 13485, in medical devices are unauthentic or fake.

It is internationally recognised and represents the interests of the Indian industry at international forums through membership and active participation with the objective of becoming a signatory to international multilateral / mutual recognition arrangements (MLA/ MRA).

In India, certification bodies should be accredited by National Accreditation Board for Certification Bodies (NABCB) for undertaking certification as per ISO 13485 which is an international standard for QMS in medical devices and accepted by many regulators around the world.

It is also a member of International Accreditation Forum (IAF), International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Accreditation Cooperation (APAC) as well as signatory to its MRAs for QMS and product certification.

NABCB provides accreditation to certification and inspection bodies based on assessment of competence as per the applicable international standards and guidelines.

Experts reason out that there is no ban on foreign accreditation bodies which might be members of IAF operating in India. IAF is the only international system of equivalence of certifications but is voluntary in nature and not obligatory. Therefore, there is no regulatory oversight on unauthentic or fake certificates. Nov.-Dec. 2019

Industry News There are many certifying bodies in the Indian market which are either not accredited or are accredited by accreditation bodies which are not members of IAF and are issuing unauthentic certificates. They are also issuing certificates for CE mark, which is the European regulatory mark, without any accreditation or authorisation while only notified bodies of European Commission can issue such certificates. “There is no law which requires certification bodies to go for accreditation or be under the IAF system. That is why there are certification bodies which claim accreditation from some accreditation body which is not part of IAF. NABCB is member of IAF and has signed MRAs for different schemes,” informs Anil Jauhri, former CEO, NABCB. NABCB is a MRA signatory for ISO 17021 which covers QMS for medical devices under a broader framework, Jauhri further explains. List of NABCB-accredited certification bodies for ISO 13485 for Medical Devices Quality Management Systems (MDQMS) are International Certifications Services Private Ltd, TUV SUD South Asia Pvt Ltd, Intertek India Pvt Ltd , TUV Rheinland (India) Pvt Ltd, DNV GL Business Assurance India Pvt Ltd, BSI Group India Pvt Ltd, TUV India Pvt Ltd, BSCIC Certifications Pvt Ltd, TUV InterCert Saar India Pvt Ltd, Zenith Quality Assessors Pvt Ltd and SGS India Pvt. Ltd. CDSCO notifies certification bodies under Medical Device Rules (MDR) -2017 based on NABCB accreditation only and only 6 of the above have been notified till now. The world market is full of private certification bodies issuing certificates to industry and it is important to distinguish an authentic certificate from many unauthentic, fake or fraudulent certificates going around.

ISO : 13485 : 2012

An authentic certificate should contain the following like name and address of the organisation certified, scope of certification describing its activities under certification, standard (or sometimes scheme or regulation) against which certification is granted e.g. ISO 9001 or ISO 22000 (standard) or AS 9100 or FSSC 22000 (scheme). In general guidance standards are not amenable to certification. These have to be formal requirement standards or specifications. The authentic certificate should also include date of issue and expiry of certificate, unique identification number of the certificate, name and address of the certification body (CB), logo of the certification body, accreditation symbol indicating the name of the accreditation body (AB) which has accredited the certification body (in most countries, in the absence of any law requiring certification bodies to register, accreditation is the only way of recognizing a competent, authentic certification body). It should also include IAF Mark – indicating that the certificate is covered under the Multilateral Mutual Recognition Arrangement (MLA) of the International Accreditation Forum (IAF) and hence is internationally equivalent and acceptable in the market. In order to judge authenticity, the names of member ABs of IAF can be seen on its website www.iaf.nu. It also gives information on which accreditation bodies are signatories to IAF MLAs for specific schemes – QMS or EMS or FSMS. Once manufacturer locates the AB in a country, he can go to its website from the link given on IAF website and then on AB’s website to verify if the CB is accredited. “Then from the CB, you can verify the certificate because under international norms, CBs are obliged to help verify certificates issued by them. In case the certificate is issued under a scheme like IATF 16949 or AS 9100, it is possible to verify the certificate through the scheme owners also,” Experts conclude. http://pharmabiz.com/NewsDetails.aspx?aid=120130&sid=1

Events Calender

JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 &

CERTIFIED COMPANY

Manufacturers & Exporters of Disposable Medical Devices 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.

Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA

PLASTIVISION INDIA 2020 16 - 20, January 2020 Venue : Mumbai

Medical Fair India 2020 26th International Exhibition and Conference 5 - 7 March, 2020 Venue : Bombay Convention & Exhibition Centre, Mumbai

Medicall India's Largest & No. 1 Medical Equipment Exhibition 3-5 April, 2020 Venue : Hyderabad, Telangana

Medicall India's Largest & No. 1 Medical Equipment Exhibition 24-26 July, 2020 Venue : Chennai Trade Centre, Chennai Tamilnadu

Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com Nov.-Dec. 2019

January 2019 to December 2019 Column

Content

Column

November-December 2019 Cover Story

• Medical Polymers : Emerging Trends & Opportunities • PVC-Free Plastic Solutions for the Medical and Pharmaceutical Industry • Covestro Pushes Development for Medical Wearables • Novel S-TPE Solution for IV Tubing • Medical Tubing and Orthopedic Gels • Tekni-Plex announces new Tekni-Plex Medical business • Using Stock Components To Reduce Time To Market Global Trends • Nurses On Front Lines Of Medical Plastics Recycling Initiatives AiMeD & Regu • NITI Aayog Proposes Single Regime For Medical latory Updates Devices, Penalty For Faulty Products: Report • CDSCO Notifies Four Medical Devices Testing Labs In The Country To Ensure Quality • DoP Approves Financial Assistance Of Rs.100 Crore For Common Facility Centres In Four Medical Device Parks • Healthcare Experts Hail Niti Aayog’s Draft Medical Devices Bill For Development Of Indigenous Medical Devices Industry Industry News • Horiba Is Working On The Biggest Medical Factory In India: Dr Jai Hakhu, Chairman And CEO, Horiba • Indian Market Full Of Unauthentic Certificates For QMS In Medical Devices: Experts Did You Know? • About The Best Tubing For Medical Device Applications?

September-October 2019 Cover Story

• Updates on Medical Device Regulations in India & Key Features Of Roadmap Ahead • Excessive MRP’s Stiffling India’s Mfg Growth Waste • Healthcare Plastics Waste Recycling: Improves Management Environment & Job Creation Global Trends • Export Opportunities for Medical Devices in Africa AiMeD & Regu- • Conference on Comprehensive Regulation of Medical latory Updates Devices • AiMeD & BCIL Seek Regulatory Framework On Medical Devices • Govt Issues Draft Notification To Bring All Medical Devices Under Single Regulatory Framework Industry News • Niti Aayog proposes separate regulator for medical devices • India Wooing Japanese Medical Device Firms to Cut Reliance on US • TSIIC Allocates 20 Acres Land To Set Up Cardiac Stent Mfg. Unit At Medical Devices Park In Telangana • Medical Devices Exporter Poly Medicure Eyes 17-18% Revenue Growth • Nu-Vu Conair Pvt. Ltd. Opens A New Factory In Ahmedabad Product Gallery • Tuohy Borst Adapters Did You Know? • About Healthcare Waste Management : Reasons For Failure

Content

July-August 2019 Cover Story

• Global Trends in Medical Plastics Technology and Applications • NMDPC : To Catalyse Growth of Medical Device Sector in India Editorial Board • MPDS Welcomes Two Distinguished Experts To The Editorial Advisory Board Technology • Better Hearing Thanks To Laser Welding - Phonak Hearing Aid • Call For Technology Transfer & Industry Driven Products MEDTECH • DRIPO - A Portable Infusion Monitor To Be Attached To STARTUP IV Sets • Karnataka Govt And IISc To Support Medical Device Start-Ups To Create Affordable Product Solutions Global Trends • Increasing Ageing Population Drive Global Medical Plastic Compounds Market • How Raumedic Are Achieving Enhanced Sliding Properties In Thermoplastic Products AiMeD & Regu- • How GST Failed Medical Devices latory Updates • Health Ministry Constitutes MDTAG To Advise CDSCO On Matters Related To Regulation • CDSCO Notifies 6 Bodies To Audit Medical Device Manufacturing Sites • MVPI Reports 1,213 Medical Devices Adverse Event Reports From Across Country Since 2014 Industry News • Meril Life Sciences Receives CE Marking For Bioresorbable Scaffold Stent Product Gallery • One-Stop Source for the Largest Selection of Open-Bore Syringes Corporate • Qosina Launches European Operations Did You Know? • About Innovation Challenges For New Developments In Medical Device Sterilization

May-June 2019 Cover Story

• Drug Device Combination Products : Market Overview And Opportunities • Low Risk, Patient Friendly Microneedle Arrays: An Emerging Medical Device forEnhanced Local/Systemic, Transdermal Drug Delivery Global Trends • Global Super Absorbent Polymer Market Poised To Cross US$12 bln By 2025 • Asia Regulatory Roundup: China Reports 25% Fall in Initial Medical Device Registrations AiMeD & Regu- • New AiMED Website On A New And Advanced Platform latory Updates : Members Request To Update OnlineRegistration Form • DCGI Asks Medical Device & IVD Manufacturing Associations To Give Feedback On New Online Portal • CDSCO Issues Alert On Pacemakers Industry News • Telangana Govt Allocates 250 Acres Of Land For Medical Device Park At Sultanpur • Phillips-Medisize Showcases Drug Delivery Innovations For Indian Market • CII, AMTZ Join Hands To Help Usher In Business Opportunities For MSMEs Towards Indigenous Nov.-Dec. 2019

January 2019 to December 2019 Column

Content

Manufacturing • Meril’s Myval Transcatheter Heart Valve Receives CE Approval • Tekni-Plex Completes Acquisition Of Amcor Flexible Packaging Units Serving Medical Device OEMs Product Gallery • ISO 80369-7 Compliant Components Did You Know? • About Needs for Medical Devices for Ageing Populations

March-April 2019 Cover Story

• Polymers And Medical Device Manufacturing • Polycarbonate : For Thin-Wall Designs In Healthcare Applications Rewards & • Dr Jitendar Kumar Sharma, AMTZ In Top 40 Under 40 Recognitions EU - India Leaders List Technology • Med-Tech Devices Developed By Start-Ups Stall LifeThreatening Fatalities Like Lung Infection & Neonatal Respiratory Distress Global Trends • Antimicrobial Technology Helps Develop Device For Leg Ulcer And Wound Treatment • How A US Contract Manufacturer Produces Silicon Components For In-Vitro Fertilisation In China AiMeD & Regu- • Categorise All Medical Devices As Drugs : Panel latory Updates • Medical Devices Ind. Urges Govt To Ensure Compliance Of Labeling Requirement As Is Done In Drugs • Government To Introduce Provision For Compensation For Faulty Medical devices / Implants • After J&J Implant row, Govt Plans To Hire 750 Officers To Regulate Medical Devices Industry News • Milacron Investing $30M In Second India Factory • Maharashtra Price Cut Boosts Use Of Drug- Eluting Stents : Study • Cipla Targets Small Airway Respiratory Disease With An Innovative Two-In-One Inhaler • Opto Circuits Expects To Grow At 25% During The

Nov.-Dec. 2019

Column

Content

Current Year • Ascent Meditech Embarks On Rs.70 Crore Expansion Plan To Achieve Four Times Growth Book Review • Emerging Trends In Medical Plastic Engineering And Manufacturing Product Gallery • CPC® ASEPTIQUIK® Series Connectors CPC • Multi-Purpose, Single-use Hand Instruments Did You Know? • About Transvaginal Mesh Complications

January-February 2019 Cover Story • Opportunity For New Entrepreneurs In Medical Textiles Export Marketing • EEPC India Initiatives In The Medical Device Sector Manufacturing • Components Handling Solution For Medical & Pharmaceutical Applications Global Trends • Global Antimicrobial Coatings Market AiMeD & Regu • AHPI & AIMED Collaborate To Promote Indian Medical latory Updates Devices Industry • AiMed Seeks Reduction In Import Duty On Raw Materials, Financial & Technical Support To Spur IVD Industry Growth • Centre Plans To Cut Prices of 400 Medical Implants Industry News • Euro Alliance signs MoU with AMTZ to provide market access to medical technology companies in Switzerland and India • Health Minister confers ‘Award of Appreciation’ to Rajiv Nath of AIMED for his contribution to global healthcare Product Gallery • Qosina Introduces New ISO 80369-7 Compliant Needleless Injection Sites • Qosina’s Barbed, Tube-to-Tube Connectors Help Reduce Time to Market • Surgical Pads : First Time In India With Phase Change Material From Outlast by Natroyal Group Did You Know? • Why Non-Woven Fabrics For Medical Textiles ?

Nov.-Dec. 2019

Management Consultants, Trainers, Customer Compliance • • • • • • • • •

Mr. Bhupesh Sood – COO SEC Global Consulting & Initiatives LLP Contact :

F6, Parth Apartment, Ramdevnagar, Satellite, Ahmedabad – 380015 (India) Mobile : +91 997 480 3399 / +91 95121 00909, Email : info@complianceforgrowth.com, Website : www.complianceforgrowth.com

Nov.-Dec. 2019

Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking

ISO 9001-2000

Manufacturer And Exporter Of a wide range Of Medical Devices 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.

ANGIPLAST Private Limited

REGISTERED FIRM 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.

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

: 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 44

Nov.-Dec. 2019

National Healthcare

GMP ISO - 9001-2008 Certified Company

An ISO 13485 : 2016 Company

S. Nath & Co.

Manufacturing & Exports of Medical Disposables :

Excellence in Quality

I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.

Manufacturer & Exporter of Surgical Disposable Products since 1980

IDEAL®

Injection Moulded Medical Components and Extended Tubes :

• Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp

I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.

Contact : Naresh Patel

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

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

MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

ISO 9001:2008 CERTIFIED COMPANY

•

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 MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

Address :

Apex Medical Devices Plot No. 10/B, Shyam Ujjawal Indurstrial Estate, Opp. SBI Bank, Phase 1, G.I.D.C, Vatva, Ahmedabad-382445. Gujarat, India. Phone No. : +91-79 - 29701333 E-mail : apexmedical@live.in Website : www.apexmedicaldevice.com Nov.-Dec. 2019

4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com 45

ISO 9001-2015 ISO 13485-2012 CE WHO GMP

Range of Products • 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

• • • • • • • • • • •

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

Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Mr. Uday Sinha B-305, Yogeshwar Residency, Nr. Krishnkunj Society, Moti Canal, Vastral, Ahmedabad-382418 Mobile : 09898162576

An ISO & CE certified Company

AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / MEASURE VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN SET / CANNULA FIXATOR ETC.

Only Manufacturer of IV CANNULA in GUJARAT Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Mobile : 0091-9825057180 Tel.: 0091-2764-268249 E-mail : amigo.surgicare@gmail.com Website : www.ivcannulaindia.com Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India.

Nov.-Dec. 2019

Medical Plastics Data Service Magazine November - December 2019

Articles inside

AiMeD & REGULATORY UPDATES