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Home Explore Medical Plastics Data Service July - August 2016

Medical Plastics Data Service July - August 2016

Published by Medical Plastics Data Service, 2021-04-26 05:06:11

Description: The Only Indian Portal Site On The Medical Plastics/Devices Technology And Trade www.medicalplasticsindia.com

Keywords: medical plastics news, medical device news, medical plastics magazine, medical device magazine, magazine, medical plastics data service, medical tubing, medical grade plastics, medical packaging, sterilization services, I.V. component, medical equipments, clean room supplies, catheters, medical design, implants, medical devices, biomedical technology, regulatory affairs, medical technology, injection molding, medical component, surgical products, plastics, medical plastic applications, machines for medical devices, pharmaceuticals, india, gujarat, ahmedabad

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CToabnletoef nts Vol. 24 No. 4 July - August. 2016 22 Cover Story • Medical Plastics – New Materials & Technologies Help Medical Device Industry To deliver value to the patients, the global medical technology industry Invests heavily in Research & Development. Significant impact on medical technology is from the advances in polymer and material science . Some of the breakthrough innovations include …… 24 Manufacturing • Supply Chain Management–Boon Or Bane For The Medical Device Industry - Anil Chaudhari, CEO, Operon Strategist, An Medical Device Consulting Company, Pune Manufacture of medical devices is governed by regulatory requirements at every stage of manufacturing. Specific requirements have to be met at the time of purchase of products. Elaborate & descriptive contract agreements between manufacturers and vendors will ensure… 35 Product Gallery • Qosina Introduces New Barbed Check Valves • New Micro Pinch Clamps From Qosina 26 Global Trends • Medical Device Companies Fear Parallel Regulation After Brexit Vote • Plastics Remain Material Of Choice In Parenteral Packaging Market 31 Industry News • HMD Becomes First ICMED Certified Medical Device Company In India • Boston Scientific Launches Integrated Facility In India To Develop Minimally Invasive Technologies • States And Central Health Agencies For Indian Products While Procuring Medical Devices • New Niper Campus In Gandhinager ( Gujarat ) To Emerge As A Vibrant R & D Centre Dedicated To Medical Device Industry • Gujarat FDCA To Tie-Up With NIPER Ahmedabad For Skilled Manpower For Medical Device Park 20 Did You Know? 19 • About Implants As The Fastest Growing Application For Medical Plastics 36 Events • Medicall 2016, 16th Edition: Sept. 09 – 11, 2016, Delhi. • ICMD Autumn 2016: 30st August - 1st September 2016. China. • K 2016: Oct. 19 – 26, 2016. • CMEF 2016: 29 October - 1st November 2016. China • MEDICA and COMPAMED 2016: 14-17 November 2016. Germany. • Meditech Healthcare Asia 2017: 10-12 February, 2017, Ahmedabad. • Medical Fair India 2017: April 06 - 08, 2017 July - August 2016

Flashback ?YoDKuindow ? About Implants As The Fastest Growing Application For Mar. - Apr. 2004 Medical Plastics From Editor’s Desk The global medical device market is comprised of about 8,500 types of medical Dear Readers, devices, ranging from simple bandages and spectacles, through life-maintaining implantable devices, equipment to screen and diagnose disease and health Healthcare Industry in Asia is witnessing accelerating conditions, to the most sophisticated diagnostic imaging and minimally-invasive growth for various obvious reasons discussed at length in surgery equipment. this issue. As per the recent study carried out by n-tech research, the global market for medical In several parts of Asia, there is no problem in finding polymers will grow to £2bn ($2.9bn) by 2021. the skills required to run a plant of equivalent The report reviews the markets for medical polymers used for medical applications, complexity to those in the U.S. or Europe. The skill including developing implants, diagnostic systems and hospital labware. sets are all available here. Many US and One of the findings of the report says, “Implants currently consume about half the European companies now have a strong direct medical polymers produced and are expected to account for around £1.19bn manufacturing presence in Asia. According to an Industry ($1.7bn) in polymer sales by 2021.” Leader, “The driving factors behind moving One more study carried out by “Markets & Markets” has summarized their finding production to Asia are improved market access and as follows. service to our customers, and, on reaching • Global Medical Plastics growing due to intensive investment in R&D. economies of scale for certain products, reduced cost • Asia - Pacific has the highest growth potential in medical plastics market. at consistent worldwide quality levels. • Disposables have the largest market while implants have the highest growth Similarly, for many OEMs, manufacturing is an entry point to access the Asian markets. Asia can give them cost rate. advantages they can get nowhere else in the world, • Poly Vinyl chloride has the largest market share globally followed by besides having a strong growth potential. With a population of 3.5 billion, Asia’s healthcare markets offer significant Polypropylene, Engineering Plastics, and others. scope for growth compared with the established markets • Increasing demand for customized polymer that can effectively replace metals of the U.S. and Europe. HOSPIMedica ASIA 2004, will therefore be a good is the important opportunity for various market players. opportunity to market medical technology products. The recent visit by Mr Horst Giesen, Project Manager In a of Messe Dusseldorf GmbH, Germany is indicative of Nutshell.... the increasing importance, particularly of the Indian Medical technology Industry. Mr. Giesen met and True ignorance is not interacted with the Indian Industry at New Delhi, the absence of knowledge, Ahmedabad, Mumbai and Banglore between March 22 to March 25. He mentioned that the volume of Medical but the refusal to Products’ market in India is about US $ 340 million acquire it. and it will grow to 6 to 7 times of today’s numbers. Mr. Giesen also mentioned that the continuously rising - Karl Popper numbers of exhibitors and visitors to MEDICA, ComPaMED and REHACare have shown over the last July - August 2016 years that the health care market is a growth market. This issue also highlights alongwith other important columns, the mediNET Forum highlighting “Networking Business Opportunities”. CONTENTS • Cover Story : - Asia still holds many opportunities for Foreign Medical Companies - Asia: Medical Product Outsourcing • Global Trends : Healthcare Market is Growth Market • Industry News : - Docs See Jackpot in medical tourism - Bharat Scans turns hi-tech - Apollo Hospitals looks for pacts in West Asia, Africa • Did You Know ? About Potential Cross-Contamination Linked to Haemodialysis Treatment • Articale Archieves • Events Calendar 20

EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. With the implementation of “Make-in-India” policy, the Indian medical device industry needs not only just increase the share of indigenous EDITORIAL ADVISORY BOARD manufacturing, but it is essential that the Industry should move up the technology and value chain. And for this to happen, the Dr. TARANG PATEL collaboration and co-operation with Medical Polymer Companies will help in a big M.B.B.S., M.Ch. (ONCO) way since advances in polymer and material sciences has significant impact on medical Cancer & Reconstructive Surgeon technology. Globally, Medical Plastics processing companies focus on R & D to provide innovative polymers. There are numerous breakthroughs happening in the world in Mr. C. BALAGOPAL the Medical Device Industry supported by emerging polymeric materials and Director - Enter Technologies Pvt. Ltd. technologies for processing of the materials. Brief highlights of some of such Chairman - Mobilexion Technologies Pvt. Ltd. developments are covered in this issue. As per the recent research studies, “Implants Trivandrum currently consume about half the medical polymers produced “. Dr. DILIP H. RAIKER As an humble effort to create linkages with the Indian Plastics industry , “Medical Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Plastics Data Service” will be supporting and coordinating a “ Medical & Healthcare Former Chief Manager(P), CIPET - Chennai Plastics Pavilion” during the “Plastivision India 2017 “ exhibition to be held in Mumbai between Jan. 19 – 23, 2017 , to be organized by “All India Plastics ING LOUIS C. SUHUURMAN Manufacturers Association ( AIPMA ) “ – the largest plastic industry event held once Formerly Sales Director every three years with about 1500 exhibitors and more than 125000 visitors from COLPITT B.V., Holland more than 25 countries. Dr. A.V. RAMANI This dedicated Medical Plastics knowledge Pavilion will highlight new developments, Group Sr. Vice President (R&D), The TTK Group innovations, technologies as well as business opportunities. It will also be participated by companies showcasing their technologies and products in the field of Medical Dr. C.S.B. NAIR Plastics. A special focused visitor promotion is being done to create awareness to the Director (R&D), Peninsula Polymers Ltd Medical Plastics, Medical Devices and Pharmaceuticals Industry. Dr. BHARAT GADHAVI While out sourcing of materials, components and services is an important contribution CEO, Medisurge Hospitals in successfully running of the Medical Device Industry, it is very important , both for the manufacturers as well as the vendor to understand the regulatory requirements to Mr. A.S. ATHALYE be met . An article on the “Supply Chain Management – Boon or Bane For The Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Medical Device Industry “ by Mr Anil Chaudhari, CEO, Operon Strategist , very lucidly explains the essential aspects to be considered . We highly appreciate the initiative of Dr. SUJOY K. GUHA Mr Anil Chaudhari for sharing his knowledge and experience through this article. We B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. once again appeal medical device industry executives to come forward and contribute for the benefit of Indian Industry. IIT, Kharagpur This issue also covers important global developments like effect of “Brexit” on the Dr. G.S. BHUVANESHWAR Industry as well as the setting up of medical device industry “R & D” facilities by Director - Innovation & Edn, “NIPER”, Ahmedabad in the public sector as well as Boston Scientific, in the private Trivitron Healthcare Pvt. Ltd., Chennai and sector. Our heartfelt Congratulations to “Hindustan Syringes & Medical Devices”, HMD, Jt. Co-ordinator - Regulation, AIMED, India. for setting a benchmark in the industry by being the first “ICENED” certified Company in India. Dr. J. V. Tyagi Consultant, Medical Device Certification 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: [email protected] 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-58 •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. July - August 2016 21

Cover Story Medical Plastics – New Materials & Technologies Help Medical Device Industry The Medical Device Industry is making important contributions to advances in healthcare supported by emerging poly- meric materials and technologies for processing of the materials. There are numerous opportunities related to develop- ment of products for this industry. To deliver value to the patients, the global medical technology industry invests heavily in Research and Development. The level of R & D spending in the medical device and diagnostics industry (as a percentage of its sales) has increased 20 percnt on a cumulative annual basis since 1990. This has resulted in a significant impact on medical technology through advances in polymer and materials science thereby growth of the medical polymers’ market. Medical Plastics processing companies focus on R & D to provide innovative polymers and high quality services to their customers. They also aggressively collaborate and enter into joint ventures with medical device companies. We take this opportunity to highlight some of these important breakthroughs by various companies covering materials, manufacturing as well as applications. Breakthroughs that can be worn safely for up to 12 hours. The outer edge of the disc is made of a proprietary blend of medical-grade • New Elastomers With 5000 % Elongation At Break polymer, which conforms to the user’s natural shape under exposure to body heat to create a leak-free seal. The soft A US based company Gelest Inc. recently introduced a new center catch collects rather than absorbs the menstrual fluid. class of elastomers that achieves unprecedented elongation The circumference of the edge is made to fit inside the vaginal and shape-recovery properties. The silica nanoparticle- fornix, covering the cervix, and preventing menstrual fluid reinforced material approaches 5000% elongation at break; from entering the vaginal canal, explains the company on its for example, a two-yard piece of the elastomer can stretch website. the length of a football field and return to its original shape. The material can be used as the base polymer in microfluidic • New Breast Pump Using TPE Materials devices, used for in vitro diagnostics, that can be stretched and rolled without failure. Its properties also hold potential German materials firm Kraiburg TPE partnered with BeauGen for wearable medical LLC to design Perfect devices that can be Latch, a new product for stretched to suit various breast-feeding mothers. anatomies and next- generation prosthetics. Perfect Latch acts as a cushion between the • Sponge-like Polymer breast pump and the Graft For Spinal Surgery mother’s skin to make it more comfortable to Scientists have pump and to protect sensitive skin areas. engineered biodegradable polymer grafts designed to repair • Innovative Materials damaged vertebrae in the For Bioengineered spinal column.Typically, Tissue Adhesives, surgeons insert Sealants And expandable titanium rods Fasteners via minimally invasive surgery (MIS) to treat this condition. Incisive Surgical Inc.’s patented Insorb 20 subcuticular skin stapler is a sterile, single-patient-use device that deploys up to Lichun Lu, PhD, of the Mayo Clinic, and her postdoctoral 20 absorbable staples, sufficient to close a 17-centimeter fellow, Xifeng Liu, PhD, sought a more affordable material incision. The Insorb 20 represents a new skin closure modality that would work with the MIS approach. They found a material designed to combine the cosmetic result of an absorbable that could be dehydrated down to a size compatible with suture with the rapid closure times associated with metal skin posterior spinal surgery, and, once implanted, would expand staplers. to replace the missing vertebrae through fluid absorption. • Medical-Grade Polymers Revolutionize Tampon Technology The absorbable staple offers increased patient comfort over metal staples while eliminating the need for metal staple removal The Flex company USA, has developed a tampon that post-operatively. The product also provides lower risk of infection promises “mess-free” sex during menstrual cycles as well and may shorten operative time, compared to other wound- as a more comfortable overall wearing experience. closure methods. The product is a disposable, single-use menstrual product 22 July - August 2016

Cover Story The staple is composed of a copolymer of polylactic acid and polyglycolic acid, which is absorbed by the body over a period of a few months. The disposable stapler is made of sterilizable acetal. • Polyurethane Foam Pad For Wound Dressing 3M has innovated with a highly absorbent, breathable wound dressing that is constructed from a conformable polyurethane foam pad, and an additional absorbent nonwoven layer from National Wovens, with a border of transparent adhesive film impermeable to liquids, bacteria and viruses. The polyurethane foam pad prevents exudate pooling and migration onto surrounding tissue while the film barrier helps prevent external contamination and exudate strike-through, and evaporates moisture vapor out of the dressing. The 3M foam adhesive dressing is used for treating moderate to highly exuding dermal wounds such as pressure ulcers, neuropathic ulcers, abrasions and first- and second-degree burns. 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 Swivel Mount) • Endotracheal Tube Holder With Bit • Ventilator Circuit • Ventilator Circuit with Single Water Block Oxygen Therapy Products Trap(Adult, Pediatric, Neonatal) • Inflatable Anaesthesia Mask • Nasal Cannula • Ventilator Circuit with Double Wa- • Anaesthesia Mask Silicon ter Trap(Adult, Pediatric, Neonatal) • Breathing Filters(HME & BVF) • Trachostomy Tube With Cuff • Oxygen Mask Breathing Filters • Resuscitator(Ambu Bag) Airovent T-Humidifier • Anaesthesia Circuits (Mapleson D, • Endotracheal Tube Holders • Multi flow Venturi Mask Mapleson F, Bain Circuit with APL Valve) • Yankaures Suctions Systems • Single Dial Venturi Mask • Stylet • Guedel Airway • Airovent T-Humidifier • High Concentration Mask • Nasopharyngeal Airway • Dialflow Regulator • Nebulizer Set • Laryngeal Mask Airway • Airopap Full Face Mask • Nebulizer Chamber • Mallaeble gum Bougie • Close Ventilation Suction System • Incentive Spirometer • 3 Ball Spirometer • Three-way Stopcock • Extension Tubing for Infusion Systems • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Anaesthesia Circuits Incentive Spirometer Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, High Concentration ET Holder with Bite Expandable Catheter Goregoaon (E), Mumbai - 400 063, INDIA. Mask Block Mount 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 : [email protected] [email protected] • Web : www.airwayssurgical.com July - August 2016 23

Manufacturing Supply Chain Management–Boon Or Bane For The Medical Device Industry Anil Chaudhari CEO, Operon Strategist An Medical Device Consulting Company, Pune Manufacture of medical devices is governed by regulatory requirements at every stage – procurement of materials, manufacture process, labeling, packaging, sterilization& distribution in foreign markets. As per regulators & ISO standards, specific requirements have to be met at the time of purchase of products. elaborate contract agreements between manufacturer & vendor should be signed to define the extent of control. Depth of contract agreements may cover but is not limited to costing, delivery timelines, product liability, product specifications, process parameters, notification to manufacturer about any changes in product/process/activity etc. The phrase supply chain criteria thus established should be management (SCM) invokes images proportionate to the risk associated of the three biggest e-commerce with the medical device. It also enterprises presently operating in requires the results of all these India – home grown activities be documented & records Flipkart&Snapdeal& American maintained. The clause also requires giant Amazon. the manufacturer to determine the controls to be applied to external Flipkart,Snapdeal& Amazon are vendor.Subpart E purchasing examples of companies who have controls (820.50) also states similar effectively & efficiently used the requirements at the time of purchase supply chain management to deliver of products & services. However, the diverse products to millions of type & extent of control of the customers across the country. manufacturer over the vendor depends on potential effect of So why can’t it be replicated in the purchased product/service on the medical device industry? Why is the final product quality. For this reason, elaborate contract medical device industry slow in adapting to the changing trends agreements between manufacturer & vendor should be signed in the logistics field? The answer lies in the different working to define the extent of control. The depth of contract models of Flipkart& medical device manufacturer. Flipkart follows agreements may cover but is not limited to costing, delivery a marketplace model of e-commerce which acts as a facilitator timelines, product liability, product specifications, process between buyer & seller by providing an information technology parameters, notification to manufacturer about any changes platform on a digital & electronic network i.e. Flipkart is not involved in product/process/activity etc. in the manufacture of any of the products it sells. On the other hand, medical device manufacturers source raw materials Manufacturers can follow ‘push’ or ‘building-to-stock’model which (components, semi-finished goods, packing materials, finished is producing stock on the basis of anticipated demand. Another goods), manufacture/assemble, label, package, model that manufacturers can follow is the ‘pull’ or ‘building-to- sterilize&distribute their products. Another important factor to be order’model which is producing stock in response to actual demand. considered while applying supply chain management in the In order to overcome the drawbacks of both pull & push model, the medical device industry is the regulatory requirements. push-pull model can be used wherein both the push & pull models Manufacture of medical devices is governed by regulatory are incorporated at different points in the supply chain. In this, requirements at every stage – procurement of materials, upstream units employ ‘building-to-stock’, while the downstream manufacture process, labeling, packaging, sterilization & units employ ‘building-to-order’. For a legal manufacturer, upstream distribution in foreign markets. activity may include but is not limited to procurement of raw materials, components, semi-finished goods, finished goods, According to the expectations of regulators & ISO standards, packing materials, sterilization services, other relevant lab services specific requirements have to be met at the time of purchase etc. The downstream activities may include but is not limited to of products.Clause 8.4 Control of externally provided processes, distribution of final product via the network of distributors, products & services in ISO 9001:2015 and Clause 7.4 Purchasing wholesalers & retailers. in ISO 13485:2016 outlines the need to document the criteria for selection, monitoring, evaluation & re-evaluation of vendors. The July - August 2016 24

Manufacturing Manufacturer looking to adapt supply chain management must manufacturer. For this, packaging validation is completed at the follow the same regulations that they would if they were individually time of design & development to ensure that the packaged product sourcing materials. Prior to including vendors in the supply chain, is not damaged during handling & distribution. Manufacturers manufacturers must conduct vendor qualification to ensure that outsourcing logistics via the supply chain must give clear instruction the vendor will supply quality products/service& will follow the on how to handle the product. If any special environmental delivery schedules.If required, manufacturers can sample & test conditions are required to be met, it must be clearly instructed to the vendor materials prior to finalizing them as approved vendors. the logistic vendor. Again, elaborate contract agreement will help Materials/services will always be sourced from theses approved reduce ambiguities in the scope of the logistic vendor. As with other vendors. These vendors are also evaluated regularly to ensure activities involved in the manufacture of a medical device, the that they continue providing quality services. Elaborate & validation of supply chain must be carried out to demonstrate the descriptive contract agreements between manufacturers & integrity & feasibility of the supply chain in maintaining the quality vendors will ensure no ambiguity in the scope of services of the & safety of the product. vendor. In case of discrepancies in the services of the vendor at the time of actual delivery, a manufacturer can always stop The idea of supply chain management in medical device industry sourcing from the vendor & instead look for alternate vendors sounds appealing. It can help manufacturers focus on design, who will provide quality services. development & manufacture of the product while outsourcing the supply chain management to a reputed firm. It will help in reducing Supply chain management can be applied even on the the overall expenses that are incurred during the sourcing & delivery downstream side, i.e. for the distribution of finished products of materials & dispatch of semi-finished & finished goods. Several from the manufacturers to the consumers either directly or factors need to be considered while studying the feasibility of through a network of distributors, wholesalers & retailers. applying supply chain management at a manufacturing site. The Once again when the manufacturer is looking at applying supply type of product being manufactured, raw material availability, chain management for distribution of finished goods, they have country regulations, customs and taxes are only some of the to follow all applicable regulations. A main concern during deciding factors. While it may not always work in favor of the distribution is maintaining the integrity of the final product while manufacturer, it nevertheless has proven to be an efficient in distribution so that the product reaching the consumer is of the management tool in other industries which we hope can be equally same packaging & labeling as originally intended by the adapted in the medical device industry in the coming future. Professional Consultancy Services Surgical Industry Available For For All Types Of Syringes & Needles Including Auto Disable Syringes. SALE Backgound : In Hyderabad, R. R. District, • Graduate Mechanical Engineer with total 36 years’ experience Telangana. • 26 years in Medical Devices in standard & auto disable An ISO 9001:2008, 13485:2012 syringes manufacturing in top management role at & GMP Certified Company diverse locations including overseas . Contact through: • Very rich techno-commercial knowledge of project planning, advice on building design, machine layouts, [email protected] selection of right production machinery & equipment, selection of HVAC equipment including clean room 25 standards, product design i.e. selection of right patent for auto disable / safety syringe, raw material sourcing, vendor development, inventory control for material & spare parts, complete engineering affairs of syringe manufacturing plants. Additionally production and factory shop floor management. Also can assist in product & plant certification like ISO 9001-2008, ISO13485-2003, CE Mark , WHO-PQS along with local govt. bodies. For more details / discussion, Contact : Mr Mahesh Thawani, Mobile: +91 - 9617894235 Email : [email protected] July - August 2016

Global Trends Medical Device Companies Fear Parallel Regulation After Brexit Vote Medical Device companies fear that Britain’s exit from the Currently, medical devices can be marketed throughout the E.U. European Union could result in a “parallel” regulatory system which with only CE Mark approval by any of the approximately 70 notified would require them to file separate applications to access the U.K. bodies which are overseen by national regulators. and E.U markets, according to a new report from ScienceBusiness. “It’s a question of what they will be able to rescue from the Only 2 weeks ago, the Environment, Public Health and Food Safety wreckage. If a deal cannot be done, device manufacturers would Committee of the European Parliament and Council’s Committee need to go through approval twice, once for the U.K. market and of Permanent Representatives voted to endorse new medical once for the EU market, and I don’t see any value in that for device and in vitro diagnostic regulations. anyone,” U.K. Health Research Authority research ethics advisor Hugh Davies told ScienceBusiness. The approval paves the way for the adoption of 2 new draft regulations by the end of 2016, though the new rules would not Davies said he expects the country will try to keep things “as take effect for 3 years in relation to medical devices and 5 years harmonised as possible,” which would allow for the mutual for IVD. The regulations cover the design, manufacturing and recognition of U.K. and EU notified bodies, with the U.K. following clinical testing of medical devices and in vitro diagnostics, and will the previously agreed upon rules and regulations. affect all device manufacturing and sales in the E.U. “The U.K. MHRA has been incredibly influential in leading on so Whether those regulations will now apply to products in the U.K. many aspects of how healthcare products are regulated. Now we is still uncertain, according to the report from ScienceBusiness. are marginalized. We may be invited to the table but won’t have a voice,” Davies told ScienceBusiness. “From a business perspective it is hard to see an upside to the UK’s decision to leave the EU. Britain’s influence in the (Ref: http://www.massdevice.com/medical-device-companies- development of the European MedTech regulatory environment fear-parallel-regulation-brexit-vote/) has been extremely positive and we now face an uncertain situation with possible regulatory divergence over time,” Cook Medical EMEA exec veep Bill Doherty told ScienceBusiness. Plastics Remain Material Of Choice In Parenteral Packaging Market Polymer-based packaging forecast to grow by double digits Norbert Sparrow Medical Materials, Packaging July 22, 2016 Parenteral packaging, which protects drugs and other fluids that Parenteral Packaging Market, Ready-to-mixsystems are administered to patients via injection or similar means, is experiencing significant growth, according to a market report Value share, by product type, 2016 & 2026 Prefilled Syringes published by Future Market Insights (Valley Cottage, NY), and & Cartridges that is good news for plastics suppliers and processors. Vials The plastic and polymer segment of the market is projected to grow 10.5% in 2016 compared with 8.7% for glass. The global Ampoules parenteral packaging market is expected to reach a value of $8.6 billion in 2016 and will grow at a compound annual growth rate of 10.2% through 2026, according to the consultancy. The “shifting trend of primary packaging material from glass to Bags plastic and polymer is an exclusive factor, which is anticipated to drive the parenteral packaging market in the near future,” writes FMI, which adds that regulatory agencies are pushing this transition. Also contributing to growth in parenteral packaging demand, 2016 Source FMI. 2016 2026 according to FMI, is the rising incidence of chronic diseases, government-sponsored preventive programs and an aging Meanwhile, Asia Pacific (not including Japan) is expected to population. expand at 10.2% CAGR thanks to economic manufacturing conditions and favorable trade agreements, according to FMI. In the report, the parenteral packaging market is segmented into Among all the regions, the Eastern Europe market is expected to bags, ampoules, vials, prefilled syringes and ready-to-mix systems. expand at a moderate CAGR of 8.2% over the forecast period. Prefilled syringes are expected to grow at the highest CAGR. (Ref: http://www.plasticstoday.com/medical/plastics-remain- North America has the largest market share, followed by Western material-choice-parenteral-packaging-market/ Europe. The North American parenteral packaging market is 63579139524945) expected to expand at a CAGR of 11.2% over the forecast period, and will continue to dominate the market in terms of value. 26 July - August 2016

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Manufacturer And Exporter Of a ISO 9001-2000 Quality Medical Devices wide range Of Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, REGISTERED Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, FIRM Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Wide Range Of Products : Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical The company Cord Clamp etc... manufactures a wide range The company markets products its own brand name ANGELTOUCH. of Medical devices, which Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. fall under the main domains of : Expertise & Experience : Infusion Therapy, – OEM/Contract Manufacturing. Transfusion Therapy, – Supply of Components for Medical Devices. Dialysis, Gastroenterology, Urology, Anesthesia, ANGIPLAST and Surgery. Private Limited 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: [email protected]/[email protected] Website : www.angiplast.com 28 July - August 2016

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® 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. • Exporting our products to almost more than 23 countries. ISO 13485 : 2003 Contact : 0434 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 : [email protected] SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • Regulators / Cord Clamp • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • PP Mucas Container • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : [email protected] 30 July - August 2016

Industry News HMD Becomes First ICMED Certified Medical Device Company In India Setting a benchmark in the industry, the Council of India (QCI) and the National requirements)’ for medium and higher risk Hindustan Syringes & Medical Devices Accreditation Board for Certification Bodies devices. A third level, which would (HMD) became the first Indian Certification (NABCB). This Scheme is intended to additionally prescribe medical device of Medical Devices Scheme (ICMED) significantly eliminate trading of sub- specifications developed by NHSRC of certified medical device company in India. standard products or devices of doubtful health ministry is still under development With this accreditation the company has origins, a widespread and injurious and would be launched later this year. achieved a significant milestone as it brings phenomenon in the Indian market. quality, accountability and competitiveness “The manufacturers would need to into the system. For manufacturers, it aims to bring down approach any one of the certification bodies the substantial time and cost-run to obtain approved by QCI under the scheme for ICMED is the country’s first indigenous globally accepted quality certification for obtaining certification. The certification quality assurance system for medical Indian companies and eliminate the bodies shall be under the oversight of devices that was launched recently to fill in malpractices of sub-standard or fraudulent NABCB, which as the national accreditation a big regulatory vacuum in quality certification or quality audits, thereby body, would accredit these certifying bodies certification space for medical devices in ensuring substantial savings, enhanced as per applicable international standards. India. This scheme ushers new standards credibility and increased competitiveness, The certification scheme is open to both for device; patient safety for consumers and informed Rajiv Nath, joint managing indigenous and foreign manufacturers the convenience of obtaining international director, HMD. He further added that in due though Indian manufacturers would be class quality certification within the country course this scheme will also bring respect expected to queue up initially. Since it’s a for manufacturers, thereby ensuring to brand India for those carrying this voluntary certification scheme its initial significant savings and enhancing certificate. success would ride on procurement competitiveness. agencies demanding for this as a qualifying The certification scheme has presently two criteria,” said Nath who is also the forum Keen to enhance the competitiveness and options for certification, one being ‘ICMED coordinator of AIMED. profitability of Indian medical device 9000 Certification (an ISO 9001 plus industry, this initiative was jointly additional requirements)’ for low risk (Ref: http://www.pharmabiz.com/ undertaken by Association of Indian medical devices and other being ‘ICMED NewsDetails.aspx?aid=96174&sid=1) Medical Device Industry (AIMED), Quality 13485 (An ISO 13485 Plus additional Boston Scientific Launches Integrated Facility In India To Develop Minimally Invasive Technologies Boston Scientific has officially opened a local healthcare industry and need for “India is an important market and it holds 100,000 sq. ft. research and development, medical devices. great potential for the global medical training and commercial center that will devices industry,” said Prabal Chakraborty, enable it to develop and sell minimally By establishing a consolidated presence in vice president and managing director for invasive technologies fit for India and the the region, Boston Scientific will extend its Boston Scientific in India. “The Indian greater Asian market, and train physicians reach in India, offering solutions to ecosystem has all the right ingredients for in using them effectively. physicians and patients combatting innovation, namely a best-in-class conditions in areas such as cardiovascular technical talent pool in the areas of STEM The state-of-the-art Institute for Advancing disease, cardiac arrhythmias, (Science, Technology, Engineering and Science (IAS), a physician training facility gastrointestinal and urologic disorders, and Math), world-renowned physicians who equipped with world-class simulators for chronic pain. bring an understanding of clinical unmet hands-on training on innovative needs, and top-notch academic technologies, is the newest addition to the The launch was attended by Faggan Singh institutions. growing global network of Boston Scientific Kulaste, minister of state for health and IAS facilities. family welfare, Capt. Abhimanyu, finance Boston Scientific has been operating in minister, government of Haryana, and John India since 2003, transforming lives The new facility marks a strategic M. McCaslin, minister counselor for through innovative medical solutions that investment by Boston Scientific. The commercial affairs, United States Embassy, improve the health of patients around the Research and Development (R&D) Center New Delhi. world. As a global medical technology will focus on creating market-appropriate leader for more than 35 years, we advance products based on unmet clinical needs in Health minister Kulaste said, “The need for science for life by providing a broad range emerging markets, and will also serve as a innovation in medical technology is a high of high performance solutions that address global product engineering center. priority in many countries worldwide, and unmet patient needs and reduce the cost the government will support all efforts in of healthcare. As a key country in the company’s research and innovation so that affordable emerging market strategy, India’s improving and quality care is accessible to more and (Ref: http://www.pharmabiz.com/ economic conditions and healthcare more patients in India.” NewsDetails.aspx?aid=96268&sid=2) access show potential for the growth of the July - August 2016 31

Industry News States And Central Health Agencies For Indian Products While Procuring Medical Devices The Union The July 18 advisory directs the health analysers, opthalmological equipment and Health Ministry agencies to consider the Central Drug lenses; several types of evacuation tubes has asked the Standards Control Organisation (CDSCO) and in-vitro diagnostic equipment and states and cen- permitted medical devices rather than reagents. tral health insisting on the US Food and Drug “The insistence of USFDA certification by agencies to Administration (USFDA) approval. central and state government health open their institutions had seriously undermined the doors for Indian products while procur- A large number of tenders by the central credibility of our own regulators. No other ing medical devices like coronary stents. and the state health agencies insisted on country in the world insists on only one USFDA certifications to qualify for the same, Last month, the ministry had sent an which is a disadvantage for the domestic certification source and that too USFDA advisory to all the agencies asking them to sector. The tenders often do not even exclusively. All major countries have their change their tender conditions so that consider alternative options such as ISO own domestic or alternate international Indian medical device manufacturers too 13485 certification. “This results in denial certification,” said Rajiv Nath, forum can take part in the bids, sources told DH. of a fair chance to the domestic coordinator in the Association of Indian If the states relent and modify the manufacturers to compete in such Medical Device Industry. procurement documents, then it may lower procurements, which not only impedes the cost of several medical procedures, competition but also affects the Make in (Ref: http://www.deccanherald.com/ including coronary angioplasty, as Indian India effort,” says the advisory. content/563184/buy-indian-medical- devices-states.html) devices are available at a fraction of the Besides the coronary stents, other common cost of the imported instruments. devices procured in bulk are chemistry New Niper Campus In Gandhinager ( Gujarat ) To Emerge As A Vibrant R & D Centre Dedicated To Medical Device Industry In a strategic development, the National commenced its operations from the towards achieving research activities that Institute of Pharmaceutical Education and academic year 2007-08 in Gujarat, was are internationally recognised to cater to Research (NIPER), Gandhi Nagar in housed in the reputed institute B V Patel the needs of the industry and the Gujarat, has recently started the operations Pharmaceutical Education and Research academia world-wide.” of its independent campus at Palej village. Development (PERD) Centre. It is important This comes as a much needed reprieve for to note that NIPER till now had only one Built in 60 acres of land provided by the the pharma and medical device sector, as fully functional campus, at Mohali in Punjab. State government with an estimated this campus has the capacity to support the The Gandhi Nagar campus in Gujarat being investment of over Rs. 500 crore, the new ongoing research and development the second one to have an independent campus has the potential to emerge as a requirements to meet the growing demands campus. vibrant research and development centre in the sector for innovation and skilled dedicated in the field of medical devices. manpower. Dr. H G Koshia, commissioner of Gujarat NIPER Gandhi Nagar is expected to FDCA, informed that it has already started further pro-actively encourage students to Interestingly, NIPER campus, which is post graduate and PhD courses on various take up research activities so that they can still under construction, is also the subjects relating to pharma technology, establish themselves as innovators. It is country’s first national Centre of quality assessment, etc. understood that the students will go Excellence (CoE) for medical devices. through the specialised courses designed Apart from imparting studies and He added, “The new campus is far more to achieve the goals which is required in conducting research and development spacious and built keeping in mind the the pharmaceutical sciences and in the field of pharmaceutical, this current R&D and educational demands of management. institute will also work on developing the country. Most importantly, NIPER new medical devices for the Gandhi Nagar will be able to take in more (Ref: http://www.pharmabiz.com/ pharmaceutical industry. students and engage them in a healthy ArticleDetails.aspx?aid=96941&sid=1) environment that will encourage them to Till recently, NIPER Ahemdabad, which had play an important role in contributing Gujarat FDCA To Tie-Up With NIPER Ahmedabad For Skilled Manpower For Medical Device Park Gujarat Food and Drug Control for its upcoming medical device park at than 70 per cent of devices are imported Administration (FDCA) is planning to tie- Sanand near Ahmedabad. as of today which is impacting the up with National Institute of Pharmaceutical development of the domestic industry. Education and Research (NIPER), High quality and skilled manpower in the Ahmedabad to help get trained manpower country is one of the critical requirements in the medical devices sector today as more 32 July - August 2016

Industry News Prime Minister Narendra Modi’s Make In Gujarat.” capital intensive for individual India campaign has gained further impetus as government is planning to expand This would also complement the first manufacturers to invest upon. A park with NIPERs across the country to nurture manpower and hence boost domestic upcoming medical device testing lab of the in-house high investment scientific facilities manufacturing of medical devices in the country. country at Vadodara in Gujarat by the end would help manufacturers reduce the cost The plan to train manpower is subsequent of this year. Department of pharmaceut-icals of manufacturing by more than 40 per cent to Union minister of chemicals and fertilisers Ananth Kumar’s announcement (DoP) under the Union ministry of chemicals to 50 per cent. for setting up medical device park in Gujarat. Gujarat government has also and fertilisers for the last one year has Currently, due to lack of such centrally identified land at Sanand for the same and actively engaged both the NIPERs and the located common facilities, manufacturers Detailed Project Report (DPR) has also pharma industry to build partnership in do not undertake production of been submitted for a favourable response areas of education, research and technologies and therefore send their from the Centre, informed an official development. products abroad for process up-gradation associated with the development. NIPER Ahmedabad is also being developed and value addition. The Centre has been mulling for quite some as a National Centre for Medical Devices This will also help facilitate to create an time now for setting up the medical devices (NCMD) which will provide a conducive ecosystem for manufacturing of high end park in Gujarat in a bid to make India self- environment to nurture innovators and medical device manufacturing aimed at reliant in the sector. industry to further the vision of quality import substitution and export opportunities medical device manufacturing in the country and would be a major boost to SMEs. Says Gujarat Food and Drug Control through synergies with the government and Administration (FDCA) commissioner Dr H other stake holders. (Ref: http://www.pharmabiz.com/ G Koshia, “Since the state of Gujarat has ArticleDetails.aspx?aid=97152&sid=1) the highest number of 135 licensed medical device companies as against 240 in the The creation of www. medicalplasticsindia.com entire country, a medical device park would manufacturing park for be a relevant breakthrough for medical devices is the need of the hour as medical devices manufacturing requires certain high investment THE ONLY INDIAN PORTAL SITE ON MEDICAL facilities which are too PLASTIC / DEVICES TECHNOLOGY AND TRADE ISO 9001-2015 ISO 13485-2012 CE WHO GMP Range of Products • ECG Paper & ECG • Mount Catheter PACK-EQUIP Accessories • “T” Recovery Kit • Breathing Circuit (Mfg. Packaging Machinery) • ECG Paper Roll & Z • Ambu Bag Folding • Bain Circuit Office / Communication : • 3 Ball Spirometer 91, Avnish Society, Opp. Pavitrakunj Society, • Nasal Canula • Patient ID Belt CTM Cross Road, Amraiwadi, Ahmedabad-380 026. • Oxygen Mask • Yankur Suction Set • Nebulizer Mask & • Nebulizer Chamber Phone : 25855027 (M) 9825380739 • Guidal Airways Works : Nebulizer Compressor • B. P. Meter • Multiflow Mask 16, Arbuda Estate, Near Nidhi Bank, • Ventury Mask CTM Cross Road, Amraiwadi, Ahmedabad-380 026. • High Concentration Mask • Breathing Filter 33 Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : [email protected] Customer Care No. +91 9898162576 & 7600020901 July - August 2016

Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : Corresponding Address: HINDUSTAN SURGICAL HINDUSTAN SURGICAL Hasmukhbhai B. Patel Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, 23, Manav Mandir Bungalows, Village - Pithai - 387630. Taxshilla Colony, Ta.: Kathlal, Dist. Kheda, Gujarat. Old Aradhana School Circle, Email : [email protected] B/h Ramannagar, Sukhipura, Website : www.hindustansurgical.com Maninagar, Ahmedabad - 380008 Tele/Fax : (O) ++91-25440223 Email : [email protected] Cell :9824060964 MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS • 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 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 079- 25733318 (R) 079-25430211 (M) +91-9825018952 Email : [email protected], [email protected] Website : www.mescosurgical.com 34 July - August 2016

Product Gallery Qosina Introduces New Barbed Check Valves Ronkonkoma, NY are also Reach and RoHS compliant as well as Class VI and ISO 10993 approved. Visit qosina.com today to request samples or –June 6, 2016 – place orders of these new valves, which are in stock and available for immediate delivery.Qosina also offers a large selection of Valves, Qosina is pleased Tubing and Clamps to fit your design needs. to announce the Qosina offers low minimums and short lead times. Log on to Qosina.com to see pricing, obtain our latest catalog, request addition of eight complimentary samples and place orders. Be sure to sign up for our monthly e-newsletter to stay current with our newest product new barbed check additions. Custom sourcing services are available through our extensive network. Call our Customer Service Specialists to discuss valves to your project in detail via phone +1(631) 242-3000 or email [email protected]. complement their Qosina is a worldwide supplier of thousands of stock OEM extensive line of components including bioprocessing components, compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, stock components. stopcocks, hemostasis valves, tuohyborst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Available inthree Founded in 1980, Qosina is now based in Ronkonkoma, NY in a 95,000 square foot facility with an ISO Class 8 Clean Room and is different ISO 9001 and ISO 14001 registered. configurations, Contact: Deanna Whelan, Qosina 2002-Q Orville Drive North, these barbed Ronkonkoma, NY 1779. Phone +1 (631) 242-3000 valves have a low, Fax +1 (631) 242-3230. 0.087 psi cracking Email: [email protected] pressure. The barb to barb straight and reducing configurations (#80500 - #80503) accommodate 1/8 inch (0.125 inch, 3.2 mm) and 3/32 inch (0.093 inch, 2.4 mm) ID tubes and are made of MABS and silicone. The female luer lock to barb and the barb to male luer lock configurations (#80504 - #80507) are made of SAN, MABS and silicone. Products #80504 and #80505 feature a female luer lock inlet while products #80506 and #80507 have a male luer lock outlet. Both choices offer the option to use 1/8 inch (0.125 inch, 3.2 mm) or 3/32 inch (0.093 inch, 2.4 mm) ID tubing. Ideal for infusion, drainage and irrigation applications, theyprovide controlled directional flow, and eliminate the need for bonding. All versions are ETO and gamma sterilization compatible. They New Micro Pinch Clamps From Qosina Ronkonkoma, Qosina offers low minimums and short lead times. Log on to Qosina.com to see pricing, obtain our latest catalog, request NY – May 17, complimentary samples and place orders. Be sure to sign up for our monthly e-newsletter to stay current with our newest product 2016 – Qosina is additions. Custom sourcing services are available through our extensive network. Call our Customer Service Specialists to discuss pleased to your project in detail via phone +1(631) 242-3000 or email [email protected]. announce the Qosina is a worldwide supplier of thousands of stock OEM addition of five components including bioprocessing components, compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, DEHP-Free pinch stopcocks, hemostasis valves, tuohyborst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. clamps (#13616 - Founded in 1980, Qosina is now based in Ronkonkoma, NY in a 95,000 square foot facility with an ISO Class 8 Clean Room and is #13620), in stock ISO 9001 and ISO 14001 registered. and ready for Contact: Deanna Whelan Qosina immediate 2002-Q Orville Drive North, delivery. Offered Ronkonkoma, NY 11779 in a variety of Phone +1 (631) 242-3000, Fax +1 (631) 242-3230 colors, these Email: [email protected] polypropylene clamps allow for easy identification and prevent the flow of fluid when included in your tubing assembly. Ideal for use in micro bore applications, they are the smallestpinch clamps offered by Qosina; accommodating 0.059 – 0.102 inch (1.5 mm – 2.6 mm) OD tubing. Recommended for ETO and Gamma sterilization, these clamps are also REACH & RoHS compliant. Qosina offers a variety of clamps, connectors and tubing, along with thousands of stock components to help complete your design. July - August 2016 35

Events ISO : 13485 : 2012 Events Calender JIMIT MEDICO SURGICALS PVT. LTD. • Medicall 2016 : 16th Edition Date: 09-11 Sep, 2016. Venue: New Delhi. AN ISO 13485 : 2012 & CERTIFIED COMPANY • ICMD Autumn 2016 : The 23rd International Component Manufacturers & Exporters of Manufacturing & Design Show Disposable Medical Devices Date : 30st August - 1st September 2016. Venue : Shenzhen Convention & Exhibition Center, China. Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, • K - 2016 : The World’s No.1 Trade Fair for Plastics and HIV KITs, Ophthalmic KITs, Ophthalmic Knives Rubber (Blades), Cap, Mask, Gown, Drapes, Bandages, Date : 19-26 October 2016. Venue : Dusseldorf, Germany. Dressings etc. • CMEF 2016 : The 76th China International Medical Equipment Fair (CMEF Autumn 2016) Specialized in Handling Large Quantity Date : 29 October - 1st November 2016 . Venue : Shenzhen Convention and Exhi. Center, China. & OEM / Contract Manufacturing • MEDICA and COMPAMED 2016 : The World’s No.1 Trade Factory : 16, Ranchodnagar, Near Vinzol Railway, Fair for Plastics and Rubber Crossing, Vatva, Ahmedabad-382445, INDIA Date:14-17 November 2016.Venue: Dusseldorf, Germany. Tele : +91-79-25835567, +91-79-25834850 • Meditech Healthcare Asia 2017 : International Exhibition E-mail: [email protected] • Web: www.jimitsurgicals.com and Conference On Healthcare & Medical Technology Date: 10-12 February, 2017 Venue: The Gujarat University Convention Exhibition Centre, Ahmedabad. • Medical Fair India 2017 : 23rd International Exhibition and Conference Date: 06-08 April, 2017 Venue: Pragati Maidan, New Delhi. 36 July - August 2016

: 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 : [email protected][email protected] GMP We are a leading Consulting organization ISO - 9001-2008 providing an integrated services with Certified Company focus on project technology : S. Nath & Co. Quality Management System as per ISO 9001, ISO 13485, Medical Devices Excellence in Quality CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training Manufacturer & Exporter of and c-GMP. Surgical Disposable Products since 1980 Sanjay Y .Shah – Owner Promoter IDEAL® M : +91 98240 17850 • Infusion Set • Blood Administration Set Obelis European • Urine Collection Bag • Urine Specimen Container Authorized Representative Center (O.E.A.R.C) based in • Umblical Cord Clamp Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European Address manufacturers’ successful endeavors into Europe. S. Nath & Co. F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : [email protected], [email protected] B. N. Estate, Near Uttam Dairy, Sukhramnagar, Website : www.unikalindia.com Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 37 Website : www.snathco.com • [email protected] July - August 2016

AN ISO 13485-2012 GMP. & ISO 9001 – 2000 Certified Company CE certified Company Manufacturer & Exporter of Medical AMIGO SURGI CARE PVT. LTD. Disposable Devices & Surgical Products Manufacturer of Disposable Surgical Products: Range of Products : • Infusion Set I.V.CANNULAS / B.T.SETS / I.V.SETS / • Blood Administration Set SURGICAL LATEX GLOVES / CORD • Measure Volume Set CLAMPS / URINE BAGS / MEASURE • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry VOLUME SETS ETC. • Respiratory Exerciser Manufacturers / Exporters / Hospital Suppliers • Twin Bore Nasal Oxygen Set • Oxygen Face Mask Dealer are requested to • Nebulizer Kit • Vaccum Suck Suction Set Contact : • Latex Surgical Gloves Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) • Umblical Cord Clamp (DIRECTOR) Mobile:0091-9825057180 Contact Yogesh Patel Tel.:0091-2764-268249 M. : +91 98241 21383 E-mail : • [email protected] MEDICARE DEVICES • [email protected] 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, Website:www.amigo-india.com C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Plant Address Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 Plot No.780, Opp.: Kemron Lab E-mail : [email protected] Sola Santej Road, Website : www.medicaredevices.com Rakanpur (Santej) – 382721 Gujarat, India Products • Flexible Packaging Material National • Paper Pouch Healthcare • Aluminium Foil • Foil Seal An ISO 9001 : 2008 Company • Ribbon Pack Pouch Manufacturing & Exports of E. O. Indicator Pouches Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Contact : Measured volume set, Cord Clamp, Surgical Jignesh Patel : +91 94265 25388 Gloves etc. +91 90163 36699 Injection Moulded Medical Components Kavya Packaging and Extended Tubes : Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, I.V. Set components, Urine bag Components, Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat Connectors for Catheters, I.V. Set / B. T. Set / E-mail : [email protected] Urine Bag Tubes etc. 38 Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : [email protected] Website: nationalhealthcare.in July - August 2016
























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