Table of
Contents 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? • About Implants As The Fastest Growing Application For Medical Plastics
36 Events • • • • • • • July - August 2016
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
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Flashback Mar. - Apr. 2004 From Editor’s Desk Dear Readers, Healthcare Industry in Asia is witnessing accelerating growth for various obvious reasons discussed at length in this issue. In several parts of Asia, there is no problem in finding the skills required to run a plant of equivalent complexity to those in the U.S. or Europe. The skill sets are all available here. Many US and European companies now have a strong direct manufacturing presence in Asia. According to an Industry Leader, “The driving factors behind moving production to Asia are improved market access and service to our customers, and, on reaching economies of scale for certain products, reduced cost at consistent worldwide quality levels. Similarly, for many OEMs, manufacturing is an entry point to access the Asian markets. Asia can give them cost advantages they can get nowhere else in the world, besides having a strong growth potential. With a population of 3.5 billion, Asia’s healthcare markets offer significant scope for growth compared with the established markets of the U.S. and Europe. HOSPIMedica ASIA 2004, will therefore be a good opportunity to market medical technology products. The recent visit by Mr Horst Giesen, Project Manager of Messe Dusseldorf GmbH, Germany is indicative of the increasing importance, particularly of the Indian Medical technology Industry. Mr. Giesen met and interacted with the Indian Industry at New Delhi, Ahmedabad, Mumbai and Banglore between March 22 to March 25. He mentioned that the volume of Medical Products’ market in India is about US $ 340 million and it will grow to 6 to 7 times of today’s numbers. Mr. Giesen also mentioned that the continuously rising numbers of exhibitors and visitors to MEDICA, ComPaMED and REHACare have shown over the last 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
Did You Know ?
?
About Implants As The Fastest Growing Application For Medical Plastics The global medical device market is comprised of about 8,500 types of medical devices, ranging from simple bandages and spectacles, through life-maintaining implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimally-invasive surgery equipment. As per the recent study carried out by n-tech research, the global market for medical polymers will grow to £2bn ($2.9bn) by 2021. The report reviews the markets for medical polymers used for medical applications, including developing implants, diagnostic systems and hospital labware. One of the findings of the report says, “Implants currently consume about half the medical polymers produced and are expected to account for around £1.19bn ($1.7bn) in polymer sales by 2021.” One more study carried out by “Markets & Markets” has summarized their finding as follows. • Global Medical Plastics growing due to intensive investment in R&D. • Asia - Pacific has the highest growth potential in medical plastics market. • Disposables have the largest market while implants have the highest growth rate. • Poly Vinyl chloride has the largest market share globally followed by Polypropylene, Engineering Plastics, and others. • Increasing demand for customized polymer that can effectively replace metals is the important opportunity for various market players.
In a Nutshell.... True ignorance is not the absence of knowledge, but the refusal to acquire it. - Karl Popper
• Events Calendar
20
July - August 2016
EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.
EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, 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 Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, 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: 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-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
Editor’s Desk
From the
With the implementation of “Make-in-India” policy, the Indian medical device industry needs not only just increase the share of indigenous manufacturing, but it is essential that the Industry should move up the technology and value chain. And for this to happen, the collaboration and co-operation with Medical Polymer Companies will help in a big way since advances in polymer and material sciences has significant impact on medical technology. Globally, Medical Plastics processing companies focus on R & D to provide innovative polymers. There are numerous breakthroughs happening in the world in the Medical Device Industry supported by emerging polymeric materials and technologies for processing of the materials. Brief highlights of some of such developments are covered in this issue. As per the recent research studies, “Implants currently consume about half the medical polymers produced “. As an humble effort to create linkages with the Indian Plastics industry , “Medical Plastics Data Service” will be supporting and coordinating a “ Medical & Healthcare 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 Manufacturers Association ( AIPMA ) “ – the largest plastic industry event held once every three years with about 1500 exhibitors and more than 125000 visitors from more than 25 countries. This dedicated Medical Plastics knowledge Pavilion will highlight new developments, innovations, technologies as well as business opportunities. It will also be participated by companies showcasing their technologies and products in the field of Medical Plastics. A special focused visitor promotion is being done to create awareness to the Medical Plastics, Medical Devices and Pharmaceuticals Industry. While out sourcing of materials, components and services is an important contribution 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 be met . An article on the “Supply Chain Management – Boon or Bane For The 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 Mr Anil Chaudhari for sharing his knowledge and experience through this article. We once again appeal medical device industry executives to come forward and contribute for the benefit of Indian Industry. This issue also covers important global developments like effect of “Brexit” on the Industry as well as the setting up of medical device industry “R & D” facilities by “NIPER”, Ahmedabad in the public sector as well as Boston Scientific, in the private sector. Our heartfelt Congratulations to “Hindustan Syringes & Medical Devices”, HMD, for setting a benchmark in the industry by being the first “ICENED” certified Company in India.
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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 polymeric materials and technologies for processing of the materials. There are numerous opportunities related to development 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 • New Elastomers With 5000 % Elongation At Break A US based company Gelest Inc. recently introduced a new class of elastomers that achieves unprecedented elongation and shape-recovery properties. The silica nanoparticlereinforced material approaches 5000% elongation at break; for example, a two-yard piece of the elastomer can stretch the length of a football field and return to its original shape. The material can be used as the base polymer in microfluidic devices, used for in vitro diagnostics, that can be stretched and rolled without failure. Its properties also hold potential for wearable medical devices that can be stretched to suit various anatomies and nextgeneration prosthetics. • Sponge-like Polymer Graft For Spinal Surgery Scientists have e n g i n e e r e d biodegradable polymer grafts designed to repair damaged vertebrae in the spinal column.Typically, surgeons insert expandable titanium rods via minimally invasive surgery (MIS) to treat this condition. Lichun Lu, PhD, of the Mayo Clinic, and her postdoctoral fellow, Xifeng Liu, PhD, sought a more affordable material that would work with the MIS approach. They found a material that could be dehydrated down to a size compatible with posterior spinal surgery, and, once implanted, would expand to replace the missing vertebrae through fluid absorption. • Medical-Grade Polymers Revolutionize Tampon Technology The Flex company USA, has developed a tampon that promises “mess-free” sex during menstrual cycles as well as a more comfortable overall wearing experience. The product is a disposable, single-use menstrual product
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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 polymer, which conforms to the user’s natural shape under exposure to body heat to create a leak-free seal. The soft center catch collects rather than absorbs the menstrual fluid. The circumference of the edge is made to fit inside the vaginal fornix, covering the cervix, and preventing menstrual fluid from entering the vaginal canal, explains the company on its website. • New Breast Pump Using TPE Materials German materials firm Kraiburg TPE partnered with BeauGen LLC to design Perfect Latch, a new product for breast-feeding mothers. Perfect Latch acts as a cushion between the breast pump and the mother’s skin to make it more comfortable to pump and to protect sensitive skin areas. • Innovative Materials For Bioengineered Tissue Adhesives, Sealants And Fasteners Incisive Surgical Inc.’s patented Insorb 20 subcuticular skin stapler is a sterile, single-patient-use device that deploys up to 20 absorbable staples, sufficient to close a 17-centimeter incision. The Insorb 20 represents a new skin closure modality designed to combine the cosmetic result of an absorbable suture with the rapid closure times associated with metal skin staplers. The absorbable staple offers increased patient comfort over metal staples while eliminating the need for metal staple removal post-operatively. The product also provides lower risk of infection and may shorten operative time, compared to other woundclosure methods. July - August 2016
Cover Story
The disposable acetal.
stapler
is
made
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. of sterilizable
• 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 • 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
July - August 2016
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
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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 management (SCM) invokes images of the three biggest e-commerce enterprises presently operating in India – home grown Flipkart&Snapdeal& American giant Amazon. Flipkart,Snapdeal& Amazon are examples of companies who have effectively & efficiently used the supply chain management to deliver diverse products to millions of customers across the country. So why can’t it be replicated in the medical device industry? Why is the medical device industry slow in adapting to the changing trends in the logistics field? The answer lies in the different working models of Flipkart& medical device manufacturer. Flipkart follows a marketplace model of e-commerce which acts as a facilitator between buyer & seller by providing an information technology platform on a digital & electronic network i.e. Flipkart is not involved in the manufacture of any of the products it sells. On the other hand, medical device manufacturers source raw materials (components, semi-finished goods, packing materials, finished goods), manufacture/assemble, label, package, sterilize&distribute their products. Another important factor to be considered while applying supply chain management in the medical device industry is the regulatory requirements. Manufacture of medical devices is governed by regulatory requirements at every stage – procurement of materials, manufacture process, labeling, packaging, sterilization & distribution in foreign markets. According to the expectations of regulators & ISO standards, specific requirements have to be met at the time of purchase of products.Clause 8.4 Control of externally provided processes, products & services in ISO 9001:2015 and Clause 7.4 Purchasing in ISO 13485:2016 outlines the need to document the criteria for selection, monitoring, evaluation & re-evaluation of vendors. The
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criteria thus established should be proportionate to the risk associated with the medical device. It also requires the results of all these activities be documented & records maintained. The clause also requires the manufacturer to determine the controls to be applied to external vendor.Subpart E purchasing controls (820.50) also states similar requirements at the time of purchase of products & services. However, the type & extent of control of the manufacturer over the vendor depends on potential effect of purchased product/service on the final product quality. For this reason, elaborate contract agreements between manufacturer & vendor should be signed to define the extent of control. The 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. Manufacturers can follow ‘push’ or ‘building-to-stock’model which is producing stock on the basis of anticipated demand. Another model that manufacturers can follow is the ‘pull’ or ‘building-toorder’model which is producing stock in response to actual demand. In order to overcome the drawbacks of both pull & push model, the push-pull model can be used wherein both the push & pull models are incorporated at different points in the supply chain. In this, upstream units employ ‘building-to-stock’, while the downstream units employ ‘building-to-order’. For a legal manufacturer, upstream activity may include but is not limited to procurement of raw materials, components, semi-finished goods, finished goods, packing materials, sterilization services, other relevant lab services etc. The downstream activities may include but is not limited to distribution of final product via the network of distributors, wholesalers & retailers. July - August 2016
Manufacturing Manufacturer looking to adapt supply chain management must follow the same regulations that they would if they were individually sourcing materials. Prior to including vendors in the supply chain, manufacturers must conduct vendor qualification to ensure that the vendor will supply quality products/service& will follow the delivery schedules.If required, manufacturers can sample & test the vendor materials prior to finalizing them as approved vendors. Materials/services will always be sourced from theses approved vendors. These vendors are also evaluated regularly to ensure that they continue providing quality services. Elaborate & descriptive contract agreements between manufacturers & vendors will ensure no ambiguity in the scope of services of the vendor. In case of discrepancies in the services of the vendor at the time of actual delivery, a manufacturer can always stop sourcing from the vendor & instead look for alternate vendors who will provide quality services.
manufacturer. For this, packaging validation is completed at the time of design & development to ensure that the packaged product is not damaged during handling & distribution. Manufacturers outsourcing logistics via the supply chain must give clear instruction on how to handle the product. If any special environmental conditions are required to be met, it must be clearly instructed to the logistic vendor. Again, elaborate contract agreement will help reduce ambiguities in the scope of the logistic vendor. As with other activities involved in the manufacture of a medical device, the validation of supply chain must be carried out to demonstrate the integrity & feasibility of the supply chain in maintaining the quality & safety of the product.
Supply chain management can be applied even on the downstream side, i.e. for the distribution of finished products from the manufacturers to the consumers either directly or through a network of distributors, wholesalers & retailers. Once again when the manufacturer is looking at applying supply chain management for distribution of finished goods, they have to follow all applicable regulations. A main concern during distribution is maintaining the integrity of the final product while in distribution so that the product reaching the consumer is of the same packaging & labeling as originally intended by the
The idea of supply chain management in medical device industry sounds appealing. It can help manufacturers focus on design, development & manufacture of the product while outsourcing the supply chain management to a reputed firm. It will help in reducing the overall expenses that are incurred during the sourcing & delivery of materials & dispatch of semi-finished & finished goods. Several factors need to be considered while studying the feasibility of applying supply chain management at a manufacturing site. The type of product being manufactured, raw material availability, country regulations, customs and taxes are only some of the deciding factors. While it may not always work in favor of the manufacturer, it nevertheless has proven to be an efficient management tool in other industries which we hope can be equally adapted in the medical device industry in the coming future.
Professional Consultancy Services Available
Surgical Industry
For All Types Of Syringes & Needles Including Auto Disable Syringes. Backgound : • Graduate Mechanical Engineer with total 36 years’ experience • 26 years in Medical Devices in standard & auto disable syringes manufacturing in top management role at diverse locations including overseas . • Very rich techno-commercial knowledge of project planning, advice on building design, machine layouts, selection of right production machinery & equipment, selection of HVAC equipment including clean room 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 : maheshnt56@yahoo.co.in July - August 2016
For
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An ISO 9001:2008, 13485:2012 & GMP Certified Company Contact through:
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Global Trends Medical Device Companies Fear Parallel Regulation After Brexit Vote Medical Device companies fear that Britain’s exit from the European Union could result in a “parallel” regulatory system which would require them to file separate applications to access the U.K. and E.U markets, according to a new report from ScienceBusiness. Only 2 weeks ago, the Environment, Public Health and Food Safety Committee of the European Parliament and Council’s Committee of Permanent Representatives voted to endorse new medical device and in vitro diagnostic regulations. The approval paves the way for the adoption of 2 new draft regulations by the end of 2016, though the new rules would not take effect for 3 years in relation to medical devices and 5 years for IVD. The regulations cover the design, manufacturing and clinical testing of medical devices and in vitro diagnostics, and will affect all device manufacturing and sales in the E.U. Whether those regulations will now apply to products in the U.K. is still uncertain, according to the report from 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 development of the European MedTech regulatory environment 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.
Currently, medical devices can be marketed throughout the E.U. with only CE Mark approval by any of the approximately 70 notified bodies which are overseen by national regulators. “It’s a question of what they will be able to rescue from the wreckage. If a deal cannot be done, device manufacturers would need to go through approval twice, once for the U.K. market and once for the EU market, and I don’t see any value in that for anyone,” U.K. Health Research Authority research ethics advisor Hugh Davies told ScienceBusiness. Davies said he expects the country will try to keep things “as harmonised as possible,” which would allow for the mutual recognition of U.K. and EU notified bodies, with the U.K. following the previously agreed upon rules and regulations. “The U.K. MHRA has been incredibly influential in leading on so many aspects of how healthcare products are regulated. Now we are marginalized. We may be invited to the table but won’t have a voice,” Davies told ScienceBusiness. (Ref: http://www.massdevice.com/medical-device-companiesfear-parallel-regulation-brexit-vote/)
Plastics Remain Material Of Choice In Parenteral Packaging Market Polymer-based packaging forecast to grow by double digits
The plastic and polymer segment of the market is projected to grow 10.5% in 2016 compared with 8.7% for glass. The global 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 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, according to FMI, is the rising incidence of chronic diseases, government-sponsored preventive programs and an aging population. In the report, the parenteral packaging market is segmented into bags, ampoules, vials, prefilled syringes and ready-to-mix systems. Prefilled syringes are expected to grow at the highest CAGR. North America has the largest market share, followed by Western Europe. The North American parenteral packaging market is expected to expand at a CAGR of 11.2% over the forecast period, and will continue to dominate the market in terms of value.
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Value share, by product type, 2016 & 2026
Parenteral packaging, which protects drugs and other fluids that are administered to patients via injection or similar means, is experiencing significant growth, according to a market report published by Future Market Insights (Valley Cottage, NY), and that is good news for plastics suppliers and processors.
Parenteral Packaging Market,
Norbert Sparrow Medical Materials, Packaging July 22, 2016
Ready-to-mixsystems Prefilled Syringes & Cartridges Vials Ampoules Bags
2016
Source FMI. 2016
2026
Meanwhile, Asia Pacific (not including Japan) is expected to expand at 10.2% CAGR thanks to economic manufacturing conditions and favorable trade agreements, according to FMI. Among all the regions, the Eastern Europe market is expected to expand at a moderate CAGR of 8.2% over the forecast period. (Ref: http://www.plasticstoday.com/medical/plastics-remainmaterial-choice-parenteral-packaging-market/ 63579139524945)
July - August 2016
July - August 2016
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Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking
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
ISO 9001-2000
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
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July - August 2016
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. 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
0434
SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • • • • • •
Urine Container Adaptors (PP) Regulators / Cord Clamp All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures PP Mucas Container And many other Surgical Medical Components
Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : sanidhya.ent@gmail.com 30
July - August 2016
Industry News HMD Becomes First ICMED Certified Medical Device Company In India Setting a benchmark in the industry, the Hindustan Syringes & Medical Devices (HMD) became the first Indian Certification of Medical Devices Scheme (ICMED) certified medical device company in India. With this accreditation the company has achieved a significant milestone as it brings quality, accountability and competitiveness into the system. ICMED is the country’s first indigenous quality assurance system for medical devices that was launched recently to fill in a big regulatory vacuum in quality certification space for medical devices in India. This scheme ushers new standards for device; patient safety for consumers and the convenience of obtaining international class quality certification within the country for manufacturers, thereby ensuring significant savings and enhancing competitiveness. Keen to enhance the competitiveness and profitability of Indian medical device industry, this initiative was jointly undertaken by Association of Indian Medical Device Industry (AIMED), Quality
Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB). This Scheme is intended to significantly eliminate trading of substandard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market. For manufacturers, it aims to bring down the substantial time and cost-run to obtain globally accepted quality certification for Indian companies and eliminate the malpractices of sub-standard or fraudulent certification or quality audits, thereby ensuring substantial savings, enhanced credibility and increased competitiveness, informed Rajiv Nath, joint managing director, HMD. He further added that in due course this scheme will also bring respect to brand India for those carrying this certificate. The certification scheme has presently two options for certification, one being ‘ICMED 9000 Certification (an ISO 9001 plus additional requirements)’ for low risk medical devices and other being ‘ICMED 13485 (An ISO 13485 Plus additional
requirements)’ for medium and higher risk devices. A third level, which would additionally prescribe medical device specifications developed by NHSRC of health ministry is still under development and would be launched later this year. “The manufacturers would need to approach any one of the certification bodies approved by QCI under the scheme for obtaining certification. The certification bodies shall be under the oversight of NABCB, which as the national accreditation body, would accredit these certifying bodies as per applicable international standards. The certification scheme is open to both indigenous and foreign manufacturers though Indian manufacturers would be expected to queue up initially. Since it’s a voluntary certification scheme its initial success would ride on procurement agencies demanding for this as a qualifying criteria,” said Nath who is also the forum coordinator of AIMED. (Ref: http://www.pharmabiz.com/ NewsDetails.aspx?aid=96174&sid=1)
Boston Scientific Launches Integrated Facility In India To Develop Minimally Invasive Technologies Boston Scientific has officially opened a 100,000 sq. ft. research and development, training and commercial center that will enable it to develop and sell minimally invasive technologies fit for India and the greater Asian market, and train physicians in using them effectively. The state-of-the-art Institute for Advancing Science (IAS), a physician training facility equipped with world-class simulators for hands-on training on innovative technologies, is the newest addition to the growing global network of Boston Scientific IAS facilities. The new facility marks a strategic investment by Boston Scientific. The Research and Development (R&D) Center will focus on creating market-appropriate products based on unmet clinical needs in emerging markets, and will also serve as a global product engineering center. As a key country in the company’s emerging market strategy, India’s improving economic conditions and healthcare access show potential for the growth of the July - August 2016
local healthcare industry and need for medical devices. By establishing a consolidated presence in the region, Boston Scientific will extend its reach in India, offering solutions to physicians and patients combatting conditions in areas such as cardiovascular disease, cardiac arrhythmias, gastrointestinal and urologic disorders, and chronic pain. The launch was attended by Faggan Singh Kulaste, minister of state for health and family welfare, Capt. Abhimanyu, finance minister, government of Haryana, and John M. McCaslin, minister counselor for commercial affairs, United States Embassy, New Delhi. Health minister Kulaste said, “The need for innovation in medical technology is a high priority in many countries worldwide, and the government will support all efforts in research and innovation so that affordable and quality care is accessible to more and more patients in India.”
“India is an important market and it holds great potential for the global medical devices industry,” said Prabal Chakraborty, vice president and managing director for Boston Scientific in India. “The Indian ecosystem has all the right ingredients for innovation, namely a best-in-class technical talent pool in the areas of STEM (Science, Technology, Engineering and Math), world-renowned physicians who bring an understanding of clinical unmet needs, and top-notch academic institutions. Boston Scientific has been operating in India since 2003, transforming lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. (Ref: http://www.pharmabiz.com/ NewsDetails.aspx?aid=96268&sid=2)
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Industry News States And Central Health Agencies For Indian Products While Procuring Medical Devices The Union Health Ministry has asked the states and central health agencies to open their doors for Indian products while procuring medical devices like coronary stents. Last month, the ministry had sent an advisory to all the agencies asking them to change their tender conditions so that Indian medical device manufacturers too can take part in the bids, sources told DH. If the states relent and modify the procurement documents, then it may lower the cost of several medical procedures, including coronary angioplasty, as Indian devices are available at a fraction of the cost of the imported instruments.
The July 18 advisory directs the health agencies to consider the Central Drug Standards Control Organisation (CDSCO) permitted medical devices rather than insisting on the US Food and Drug Administration (USFDA) approval. A large number of tenders by the central and the state health agencies insisted on USFDA certifications to qualify for the same, which is a disadvantage for the domestic sector. The tenders often do not even consider alternative options such as ISO 13485 certification. “This results in denial of a fair chance to the domestic manufacturers to compete in such procurements, which not only impedes competition but also affects the Make in India effort,” says the advisory.
analysers, opthalmological equipment and lenses; several types of evacuation tubes and in-vitro diagnostic equipment and reagents. “The insistence of USFDA certification by central and state government health institutions had seriously undermined the credibility of our own regulators. No other country in the world insists on only one certification source and that too USFDA exclusively. All major countries have their own domestic or alternate international certification,” said Rajiv Nath, forum coordinator in the Association of Indian Medical Device Industry. (Ref: http://www.deccanherald.com/ content/563184/buy-indian-medicaldevices-states.html)
Besides the coronary stents, other common 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 Institute of Pharmaceutical Education and Research (NIPER), Gandhi Nagar in Gujarat, has recently started the operations of its independent campus at Palej village. This comes as a much needed reprieve for the pharma and medical device sector, as this campus has the capacity to support the ongoing research and development requirements to meet the growing demands in the sector for innovation and skilled manpower. Interestingly, NIPER campus, which is still under construction, is also the country’s first national Centre of Excellence (CoE) for medical devices. Apart from imparting studies and conducting research and development in the field of pharmaceutical, this institute will also work on developing new medical devices for the pharmaceutical industry. Till recently, NIPER Ahemdabad, which had
commenced its operations from the academic year 2007-08 in Gujarat, was housed in the reputed institute B V Patel Pharmaceutical Education and Research Development (PERD) Centre. It is important to note that NIPER till now had only one fully functional campus, at Mohali in Punjab. The Gandhi Nagar campus in Gujarat being the second one to have an independent campus. Dr. H G Koshia, commissioner of Gujarat FDCA, informed that it has already started post graduate and PhD courses on various subjects relating to pharma technology, quality assessment, etc. He added, “The new campus is far more spacious and built keeping in mind the current R&D and educational demands of the country. Most importantly, NIPER Gandhi Nagar will be able to take in more students and engage them in a healthy environment that will encourage them to play an important role in contributing
towards achieving research activities that are internationally recognised to cater to the needs of the industry and the academia world-wide.” Built in 60 acres of land provided by the State government with an estimated investment of over Rs. 500 crore, the new campus has the potential to emerge as a vibrant research and development centre dedicated in the field of medical devices. NIPER Gandhi Nagar is expected to further pro-actively encourage students to take up research activities so that they can establish themselves as innovators. It is understood that the students will go through the specialised courses designed to achieve the goals which is required in the pharmaceutical sciences and management. (Ref: http://www.pharmabiz.com/ ArticleDetails.aspx?aid=96941&sid=1)
Gujarat FDCA To Tie-Up With NIPER Ahmedabad For Skilled Manpower For Medical Device Park Gujarat Food and Drug Control Administration (FDCA) is planning to tieup with National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad to help get trained manpower
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for its upcoming medical device park at Sanand near Ahmedabad. High quality and skilled manpower in the country is one of the critical requirements in the medical devices sector today as more
than 70 per cent of devices are imported as of today which is impacting the development of the domestic industry.
July - August 2016
Industry News Prime Minister Narendra Modi’s Make In India campaign has gained further impetus as government is planning to expand NIPERs across the country to nurture manpower and hence boost domestic manufacturing of medical devices in the country. The plan to train manpower is subsequent to Union minister of chemicals and fertilisers Ananth Kumar’s announcement for setting up medical device park in Gujarat. Gujarat government has also identified land at Sanand for the same and Detailed Project Report (DPR) has also been submitted for a favourable response from the Centre, informed an official associated with the development. The Centre has been mulling for quite some time now for setting up the medical devices park in Gujarat in a bid to make India selfreliant in the sector. Says Gujarat Food and Drug Control Administration (FDCA) commissioner Dr H G Koshia, “Since the state of Gujarat has the highest number of 135 licensed medical device companies as against 240 in the entire country, a medical device park would be a relevant breakthrough for
Gujarat.” This would also complement the first upcoming medical device testing lab of the country at Vadodara in Gujarat by the end of this year. Department of pharmaceut-icals (DoP) under the Union ministry of chemicals and fertilisers for the last one year has actively engaged both the NIPERs and the pharma industry to build partnership in areas of education, research and development.
capital intensive for individual manufacturers to invest upon. A park 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. Currently, due to lack of such centrally located common facilities, manufacturers do not undertake production of technologies and therefore send their products abroad for process up-gradation and value addition. This will also help facilitate to create an ecosystem for manufacturing of high end medical device manufacturing aimed at import substitution and export opportunities and would be a major boost to SMEs.
NIPER Ahmedabad is also being developed as a National Centre for Medical Devices (NCMD) which will provide a conducive environment to nurture innovators and industry to further the vision of quality medical device manufacturing in the country (Ref: http://www.pharmabiz.com/ through synergies with the government and ArticleDetails.aspx?aid=97152&sid=1) other stake holders. The creation of www. medicalplasticsindia.com manufacturing park for medical devices is the need of the hour as medical devices manufacturing requires THE ONLY INDIAN PORTAL SITE ON MEDICAL certain high investment PLASTIC / DEVICES TECHNOLOGY AND TRADE facilities which are too
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 Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : lifeoline2011@yahoo.com Customer Care No. +91 9898162576 & 7600020901
July - August 2016
PACK-EQUIP (Mfg. Packaging Machinery) Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Phone : 25855027 (M) 9825380739 Works : 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. 33
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 : HINDUSTAN SURGICAL Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, Village - Pithai - 387630. Ta.: Kathlal, Dist. Kheda, Gujarat. Email : hindustansurgical@yahoo.com Website : www.hindustansurgical.com Tele/Fax : (O) ++91-25440223 Cell :9824060964
Corresponding Address: HINDUSTAN SURGICAL Hasmukhbhai B. Patel 23, Manav Mandir Bungalows, Taxshilla Colony, Old Aradhana School Circle, B/h Ramannagar, Sukhipura, Maninagar, Ahmedabad - 380008 Email : info@hindustansurgical.com
MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
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I.V. Infusion Sets
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Blood Administration Sets
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Scalp Vein Set
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Urine Collection Bags
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Ryles / Feeding Tubes
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Catheters and Tubes
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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) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com 34
July - August 2016
Product Gallery Qosina Introduces New Barbed Check Valves Ronkonkoma, NY –June 6, 2016 – Qosina is pleased to announce the addition of eight new barbed check valves to complement their extensive line of stock components. Available inthree d i f f e r e n t configurations, these barbed valves have a low, 0.087 psi cracking 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
are also Reach and RoHS compliant as well as Class VI and ISO 10993 approved. Visit qosina.com today to request samples or place orders of these new valves, which are in stock and available for immediate delivery.Qosina also offers a large selection of Valves, Tubing and Clamps to fit your design needs. Qosina offers low minimums and short lead times. Log on to Qosina.com to see pricing, obtain our latest catalog, request complimentary samples and place orders. Be sure to sign up for our monthly e-newsletter to stay current with our newest product additions. Custom sourcing services are available through our extensive network. Call our Customer Service Specialists to discuss your project in detail via phone +1(631) 242-3000 or email info@qosina.com. Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing components, compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohyborst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. 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 ISO 9001 and ISO 14001 registered. Contact: Deanna Whelan, Qosina 2002-Q Orville Drive North, Ronkonkoma, NY 1779. Phone +1 (631) 242-3000 Fax +1 (631) 242-3230. Email: deanna@qosina.com
New Micro Pinch Clamps From Qosina Ronkonkoma, NY – May 17, 2016 – Qosina is pleased to announce the addition of five DEHP-Free pinch clamps (#13616 #13620), in stock and ready for i m m e d i a t e delivery. Offered in a variety of colors, these 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
Qosina offers low minimums and short lead times. Log on to Qosina.com to see pricing, obtain our latest catalog, request complimentary samples and place orders. Be sure to sign up for our monthly e-newsletter to stay current with our newest product additions. Custom sourcing services are available through our extensive network. Call our Customer Service Specialists to discuss your project in detail via phone +1(631) 242-3000 or email info@qosina.com. Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing components, compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohyborst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. 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 ISO 9001 and ISO 14001 registered. Contact: Deanna Whelan Qosina 2002-Q Orville Drive North, Ronkonkoma, NY 11779 Phone +1 (631) 242-3000, Fax +1 (631) 242-3230 Email: deanna@qosina.com
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Events Events Calender • Medicall 2016 : 16th Edition Date: 09-11 Sep, 2016. Venue: New Delhi. • ICMD Autumn 2016 : The 23rd International Component Manufacturing & Design Show Date : 30st August - 1st September 2016. Venue : Shenzhen Convention & Exhibition Center, China. • K - 2016 : The World’s No.1 Trade Fair for Plastics and Rubber Date : 19-26 October 2016. Venue : Dusseldorf, Germany. • CMEF 2016 : The 76th China International Medical Equipment Fair (CMEF Autumn 2016) Date : 29 October - 1st November 2016 . Venue : Shenzhen Convention and Exhi. Center, China. • MEDICA and COMPAMED 2016 : The World’s No.1 Trade Fair for Plastics and Rubber Date:14-17 November 2016.Venue: Dusseldorf, Germany. • Meditech Healthcare Asia 2017 : International Exhibition 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.
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ISO : 13485 : 2012
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 Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com
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 : birju.t@surgipackindia.com • Sales@surgipackindia.com GMP ISO - 9001-2008 Certified Company
S. Nath & Co. Excellence in Quality Manufacturer & Exporter of Surgical Disposable Products since 1980
IDEAL® • Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp
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.
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 July - August 2016
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
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AN ISO 13485-2012 CE certified Company Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp
Contact Yogesh Patel M. : +91 98241 21383 MEDIC ARE DEVICES
8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : bhagwatimedicaredevices@gmail.com Website : www.medicaredevices.com
GMP. & ISO 9001 – 2000 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 / URINE BAGS / MEASURE VOLUME SETS ETC.
Manufacturers / Exporters / Hospital Suppliers Dealer are requested to Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • cannulaexpert2001@yahoo.co.in • amigo.surgicare@gmail.com Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India
National Healthcare An ISO 9001 : 2008 Company
Products • Flexible Packaging Material • Paper Pouch • Aluminium Foil • Foil Seal • Ribbon Pack Pouch E. O. Indicator Pouches Contact : Jignesh Patel : +91 94265 25388 +91 90163 36699
Kavya Packaging Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : kavyapack@yahoo.com
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Manufacturing & Exports of Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.
Injection Moulded Medical Components and Extended Tubes : I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.
Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in July - August 2016
