Nov. - Dec. 2016 CToabnletoef nts Vol. 24 No. 6 Nov. - Dec. 2016 23 Cover Story • Medical & Healthcare Plastic Pavilion – The Dedicated Zone In The Biggest Plastics Show A. Medical & Healthcare Plastics Knowledge Platform - Including Posters, Audio-Visuals, Models, Product Samples & Publications. B. Exhibitors’ Profile : Offering Materials, Machinery, Products & Technology 25 Manufacturing • Diversifying Into Medical Device Molding Medical Device molding is much different from other markets because of tight-tolerance, highly regulated and critical nature of components ,…. 26 Industry Cluster • Gujarat Medical Device Industry : Moving Up in Value & Technology Chain With the passage of time, as the medical device industry sector became visible, manufacturing of relatively high investment as well as high technology critical care medical device products started getting manufactured in Gujarat with investments ranging from few crores to few hundred crores. 41 Product Gallery • New Multi - Cavity Channel Clips With Guide Wire Slit 28 Global Trends • Healthcare Plastics Recycling • Europe Medical Plastic Market - Trends and Forecast by 2024 • Global Medical Polymers Market Estimated To Register CAGR Of 13% By 2022 34 Industry News • Medical Devices Industry Wants Govt To Create Investor - Friendly Environment • Med. Device Ind. Rules Recommendations Not Incorporated In Draft For New Med. Device Rules • AIDCOC Urges Health Ministry To Empower State Licensing Authorities (SLAs) To Grant License To Critical Medical Devices 18 Did You Know? • About Modernizing Biocompatibility and Biological Risk Evaluation of Medical Device Materials 37 Artical Index • Important Articles Published in the Magazine from January - December 2016 42 Press Notes • PLASTINDIA 2018 – Special Preview • Qosina Receives ISO-13485 Certification • Revolutionary Conveying System with Variable Speed Capability from Conair 43 Events Calendar • Plastivision India 2017 : 19-23 January 2017, Mumbai. • Confederation of Indian Industry (CII), Health Tech India : 3-5 February 2017, New Delhi. • 3rd National Conference On Safety And Risk Management For Healthcare Professionals 2017 : 11 February 2017, Ahmedabad. • Meditech Healthcare Asia 2017 : 10-12 February, 2017, Ahmedabad • 14th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposable / Implants Industry 2017 : March, 2017. Ahmedabad • Medical Fair India 2017 : 06-08 April 2017, New Delhi. 17
Flashback Did You July. - Aug. 2004 From Editor’s Desk ?Know ? Dear Readers, About Modernizing Biocompatibility and Biological Risk The Medical Plastic Industry is passing through a very Evaluation of Medical Device Materials critical phase because of recent unprecedented price hikes for the Plastic Raw Materials. Both , for medical FDA’s Center for Devices and Radiological Health (CDRH) has identified disposables as well as diagnostic products, plastics is the “Modernizing biocompatibility and biological risk evaluation of device materials” major and a very important constituent. Even for as one of the CDRH’s top ten regulatory science priorities for FY2017. The regulatory Pharmaceutical packaging requirements, polymers are science priorities serve as a guide for making strategic intramural research funding major ingredients. For most of the products, more than decisions to ensure that CDRH research is focused on needs that are relevant 75 % of the manufacturing cost is for the Plastic and critical to medical devices and radiation-emitting products. Materials. And hence, these price hikes would significantly affect the Indian Medical Disposables To determine the safety profile of implantable or patient-contacting medical devices, Manufacturing Industry. it is critical to perform biocompatibility evaluation to assess the risk of adverse events. This helps us understand and address the risks posed by the potential As per the industry sources, many of the small scale units presence of harmful chemicals or immune response triggers such as contaminants, have either stopped or reduced their operations since even manufacturing materials, residues and byproducts as well as device degradation with the increased prices, the availability is also a byproducts. problem. Moreover, the increased prices and restricted availability has in turn increased the working capital needs While animal studies have historically been used to predict long-term safety and of the industry. effectiveness, tests for carcinogenicity, reproductive toxicity and systemic toxicity are expensive, time consuming, use large numbers of animals and sometimes do In one of our previous issues, we had quoted the not provide results that are easily translatable into a human risk assessment. New, consultant, writer and former healthcare materials manager less burdensome approaches that are more patient-centric and predictive of real- Lynn James Everad as “patient care is at risk unless world device performance are needed to modernize and transform biocompatibility healthcare systems find new ways to reduce their evaluation of medical devices and their materials. The biocompatibility review of costs. Improving supply chain efficiency would be a device materials could be further enhanced by developing acceptance criteria, giant step in that direction .” which could include multidisciplinary evidence obtained from integrating chemical characterization, computational modeling, device surveillance and emerging risk The fundamental problem?“Each link in the chain assessment tools. Modernizing biocompatibility and biological risk evaluation will operates solely its best interest with littleor no reduce healthcare costs and patients would have access to safer devices faster. concern for the overall efficiency of the chain”, Everad noted. (Ref: More details at : http://www.fda.gov/downloads/MedicalDevices/ ScienceandResearch/UCM521503.pdf) We hope, the Industry is able to come out of this challenging situation. And also while trying to In a maintain the price lines, the quality should not be Nutshell.... sacrificed. “Spend eighty percent of your “HOSPIMedica ASIA 2004” the Southeast Asia’s leading time focusing on the healthcare industry exhibition is an unique opportunity for the Indian Healthcare Industry to widen their business opportunities of tomorrow outreach and enter into meaningful collaborations with the rather than the problems regional players in the healthcare business. of yesterday.” CONTENTS • Cover Story : - Challenges faced by Indian Medical - Brian Tracy Disposables Mfrs. Nov. - Dec. 2016 • Quality : The European Authorized Representative for CE Certified Medical Devices Manufacturers • Global Trends : Russia : Medical Equipment Market Overview • Industry News : - - NASA to collaborate with Indian bio-medical Industry - Manipal introduces laser technology for ENT surgery - Heart Core ties up with Synchron for medical imaging - India's Healthcare is thriving 'privately' - Polar Pharma to make equipment • Did You Know ? - About Failure of the Tracheostomy Tube • Events Calendar 18
EDITOR D.L.PANDYA, B.E.(Chem), M.I.E. EDITORIAL ADVISORY BOARD From the Editor’s Desk Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) It is a proven fact that collaborations across the disciplines and Cancer & Reconstructive Surgeon sectors contribute significantly towards innovation and competitiveness. And that is how use of plastics has revolutionized Mr. C. BALAGOPAL the field of healthcare making patients safer and procedures simpler. Director - Enter Technologies Pvt. Ltd. One such activity is the “Medical & Healthcare Plastics” Theme Pavilion at the Chairman - Mobilexion Technologies Pvt. Ltd. forthcoming “10th PLASTIVISION INDIA 2017”, globally recognized as one of the largest plastics trade exhibitions in India to be held In Mumbai between Jan 19 to 23, 2017. Trivandrum “The All India Plastics Manufacturers’ Association – AIPMA” through this unique initiative of integrating Plastics & Medical Technology sectors not Dr. DILIP H. RAIKER only contributes immensely towards Hon. Prime Minister’s “Make-In-India” Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) mission but also towards humanity. “MEDICAL PLASTICS DATA SERVICE” is Former Chief Manager(P), CIPET - Chennai proud to be associated with this noble cause. ING LOUIS C. SUHUURMAN For the first time in India , such a Theme Pavilion provides a knowledge platform Formerly Sales Director to highlight opportunities in the Medical Plastics Sector through Posters , Audio- COLPITT B.V., Holland Visuals, Models, Samples & Publications along with an opportunity to see demonstrations & interactions with Industry Experts covering Materials, Dr. A.V. RAMANI Machinery, Products & Technology. Group Sr. Vice President (R&D), The TTK Group This issue focuses on two very important aspects related to Medical Plastics / Materials. Dr. Vinny Sastri President, Winovia LLC, U.S.A. While animal studies have historically been used to predict long-term safety and effectiveness, tests for carcinogenicity, reproductive toxicity and systemic toxicity are Dr. C.S.B. NAIR expensive, time consuming, use large numbers of animals and sometimes do not Director (R&D), Peninsula Polymers Ltd provide results that are easily translatable into a human risk assessment. And hence, very rightly, CDRH has identified “Modernizing biocompatibility and biological Dr. BHARAT GADHAVI risk evaluation of device materials” as one of the CDRH’s top ten regulatory CEO, Medisurge Hospitals science priorities for FY2017. Mr. A.S. ATHALYE The second is related to “Healthcare Plastics Recyling” – about a collaborative Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai multi-hospital recycling project between the Healthcare Plastics Recycling Council (HPRC) and the Plastics Industry Association (PLASTICS) proved to be successful. Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. Understanding the Industry Clusters helps a lot to promote indigenous industry. The article, “Gujarat Medical Device Industry : Moving Up in Value & Technology IIT, Kharagpur Chain” gives a very good overview. As mentioned in the article, with the passage of time, as the medical device industry sector became visible, manufacturing of relatively Dr. G.S. BHUVANESHWAR high investment as well as high technology critical care medical device products Director - Innovation & Edn, started getting manufactured in Gujarat with investments ranging from few crores to few hundred crores. Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India. This issue also covers regular features like Industry News, Global Trends, Product Profile, Events etc. 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-54 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. Nov. - Dec. 2016 19
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Manufacturing Diversifying Into Medical Device Molding Many injection molders currently serving markets that are • Regulatory processes slumping are beginning to recognize the value of diversification, • Experience in designing and developing medical devices in a and the mantra of many has become, “I want to get into medical molding.” It’s easier said than done. regulated environment • Capabilities across all classes of devices The medical industry, while it may look a stable, high-volume • Certifications: ISO 13485, ISO 9001, etc. segment, is a tough market to enter. The barriers are primarily • Registrations: U.S. FDA, CDSCO, etc. regulatory, and Good Manufacturing Practices (GMPs), clean • Flexibility rooms, and the high cost of compliance restrict many molders • Global footprint from gaining entry. • Proven track record A major misconception in the molding community is that big money Medical Component Manufacturing : Some Important is to be made in medical devices, however, the reality is that the Developments pricing pressures are just as heavy in medical as in automotive or consumer products. Micro-Moulding While molded components for nearly all markets require quality, New medical technologies are driving demand for smaller plastic on-time delivery, and best cost, meeting those requirements in components and hence micro-injection moulding has evolved as a medical device molding is much different from other markets technology for the mass production of minute - intricate polymer because of compliance issues. The overall company culture and composite components for medical applications Hot Runner requires a different mindset for employees who need to Moulding. understand the medical device manufacturing business. Medical products require thin wall components that can be moulded Molding medical device or healthcare products tends to require in large volume, to the tightest tolerances and at a very reasonable more resources. cost and hence in some cases economics justify hot runner moulds. The goal of the medical part designer should be to provide a part that combines maximum functionality with minimum complexity. All Electric Injection Moulding Some of the important principles as enlisted below, when overlooked results in increased mold costs, a defective final The process is said to offer lowest energy cost, extreme product, or premature part failure. reproducibility, narrow processing window for thin walled component in engineering polymers, prolonged accuracy and instant What Are OEMs Looking For? repeatability, high uptime, smaller short size utilization, low emission, water saving, noiseless environment need, clean room Because of the tight-tolerance, highly regulated, and critical nature necessity etc. of components manufactured, various factors are being evaluated by OEMs in determining which outsourced manufacturers will be Automation of Medical Device Moulding used, including: There are a variety of elements in the molding process that can be • Product reliability automated. • Proven ability to assist in medical device design Material Handling : Part Removal • History of strong performance and financial health Mold Setting : In-Line Assembly • Product performance in the marketplace Cost Process Data Input : Packing / Boxing • Value-added capabilities, including assembly, packaging, Quality Control : Production Analysis The Degree to which a project can be automated depends upon: and sterilization, among others Part Design, Quality Demands, Run Length, Economics • OEMs are looking for manufacturers largely dedicated to Normally, higher levels of quality will justify higher levels of automation. medical with full production and clean room capabilities and systems in place to adhere to stringent regulatory and quality requirements Challenges For Global Medical Device OEMs Competition Driven Challenges • Keep designing and making innovative products • Keep designing and making new versions of existing products • Do both of the above at reduced cost Contract Manufacturing Partner Eelated Challenges • Global designing and manufacturing capabilities Team MPDS • Global regulatory capabilities • Communication barriers • Cultural differences • Fluctuating currencies Nov. - Dec. 2016 25
Industry Cluster Gujarat Medical Device Industry : Moving Up in Value & Technology Chain As is already highlighted in one of the earlier articles, Gujarat (BDS), creating institutional linkages and finally building the capacity State has the largest number of licenced Medical Device of existing and newly created associations to ensure the sustainability companies in India with wide ranging products from common of the process. hospital disposables to most critical cardio-vascular devices. The major problems faced by the cluster at the beginning of the History: intervention were: The industry in Gujarat originated with the I. V. Fluid i. Need for quality up-gradation manufacturing industry in the 1970s followed by manufacturing ii. Need of manpower training of common medical disposables products like I.V. Sets as well iii. Business linkage through new channels as catheters like suction and urethral catheters. The iv. Strengthening of institutional linkages manufacturing of these products was facilitated by easy availability of basic plastic materials as well as plastic processing Implementation Strategy machineries in Gujarat. The above problems were addressed in a step-by-step approach Gujarat state is already known for strong entrepreneurial by creating awareness among firms, building consensus on group characteristics of the people and also the government and approach, organizing institutional linkages and building capacity of bureaucratic system. And hence with the exposure to the new the associations. business opportunity, number of small companies manufacturing I.V. sets and related products started coming one after the In these interventions , industry association , “Medical Disposables another. This resulted in Gujarat state companies manufacturing Manufacturers’ Association,” ( MDMA ) , played a special role in almost 90% of the low end common medical disposables in India. disseminating a new vision for the cluster, which initially contributed However, these products were not covered under any drug law significantly to ice-breaking and later triggered multiplication of as well as the entrepreneurs also did not have the back ground initiatives; technical institutions provided training inputs; private BDS and understanding of requirements for medical device sector. providers propped up confidence by securing business orders; and financial institutions provided financial support to the various With the covering of I.V. sets, needles and some other products activities. All these initiative where coordinated by the UNIDO under the food and drug control requirements, the medical device methodology that triggered a proactive mentality and a growing industry in Gujarat entered in a transition stage facing many dialogue among the various cluster actors. challenges both for the manufacturing as well as quality requirements. As a result of these initiatives large number of units in Gujarat embarked on quality up-gradation, many of them made an Around this time, UNIDO initiated a cluster development program investments varying from Rs 5 to 50 lakhs. New BDS providers were for the pharmaceutical units in Gujarat which was extended to introduced in the areas of quality, factory level training, contract the medical device industry also. This program was carried business, export market and other support services. The program forward by Foundation of MSME Clusters (FMC). created or strengthened linkages with technical/developmental institutions like PERD, CIPET, SIDBI, GITCO, SIDBI, SISI, etc. At the suggestion of the Ministry of Small Scale Industries, International networking has been undertaken with development Government of India, the United Nations Industrial Development agencies like CBI and NMCP. Organisation (UNIDO) conceptualized and initiated the process of creating the Foundation for MSME Clusters. Subsequently, Strong Supply Chain Industry : the Foundation was legally constituted as a non-government, non-profit registered trust under the auspices of the Parallel to the growth of the medical device industry, number of supply Entrepreneurship Development Institute of India (EDI), chain and ancillary units also started growing. At present there are Ahmedabad, in the year 2005. more than 150 small and big companies manufacturing important inputs starting from basic raw materials to components, sub- Gujarat Medical Device Industry Cluster Support Program assemblies, manufacturing / testing / sterilization and other By UNIDO : A Unique Success Story. machineries. The UNIDO program also supported number of service providers to focus on this sector. The SME Medical Device units of Ahmedabad/Vadodara faced a major challenge in achieving the stricter quality norms Moving To The High End Technology Products: increasingly demanded by the Indian regulatory authority as well as by large-scale units, which can be their potential clients. This With the passage of time, as the medical device industry sector is because, in order to attain quality certifications the small firms became visible, manufacturing of relatively high investment as well often lack the required information, appropriate technical training, as high technology critical care medical device products started in knowledge of desired plant layout/machinery requirements and Gujarat with investments ranging from few crores to few hundred were not able to locate affordable Business Development Service crores. With more and more products getting covered under drug ( BDS ) providers to organize such activities. licensing, the span of the industry also started widening . This is further supported by the presence of large scale engineering units The programme addressed these challenges in a step-by- in the state as well as support by the state and central governments step approach by building awareness among firms, sustaining a group approach to purchase of business development service in establishment of industrial infrastructure as well as research institutes like NIPER. 26 Nov. - Dec. 2016
Industry Cluster The wide range of manufacturing of medical devices include guiding and motivation force all through out the growth of medical products like : device companies in Gujarat. With many innovative initiatives like E-Governance the Gujarat FDCA has won even many awards not • Orthopedic Implants only in India but from international agencies like WHO, Bill and • Ophthalmic Implants / Products Melinda Foundation etc. Many of these initiatives by Gujarat FDCA • Diagnostic Products have been replicated by various leading states in the country. • Cardiology Implants / Products • Surgical Instruments / Accessories (Ref: Chronicle Pharmabiz, Sept. 01, 2016. The Author is Editor • Bandages And wound care products & CEO, Medical Plastics Data Service) • Non-woven and medical textiles • Dental Implants / Products • Electro-Medical Equipments • Medical Electronics Equipments These units are supported and serviced by manufacturers / companies across the value chain • Packaging Materials For Medical Devices And Pharmaceuticals • Plastics Raw Materials / Components (Injection moulded / extruded) Laboratory Supplies • Services including: Testing / Sterilization / Calibration / Validation / Quality Certification / Product Developments / R & D / Man Power Training etc. • Engineering Services including : Surface Treatments / Coating / Electrical Mechanical Maintenance Catalytic Role By Gujarat FDCA From the beginning to the current stage of development, the role of Gujarat FDCA has been exemplary. It has remained more a Contact Address : Operon Strategist, 27 Office : 10, Third Floor, MSR Capital, Pimpri, Pune-411 018. Tel. : 020-65283438 Mobile : +91-98232 83428 +91-90280 43428 E-mail : [email protected] [email protected] Skype : operonstrategist Nov. - Dec. 2016
Global Trends Healthcare Plastics Recycling A collaborative multi-hospital recycling project between the demonstrate value through energy conversion and chemical Healthcare Plastics Recycling Council (HPRC) and the recycling, showing that value can still be realised through Plastics Industry Association (PLASTICS) in Chicago proved other recovery processes. to be successful . Chris Rogers, HPRC project manager said: “This project provided Plastic materials in hospitals are currently difficult to recycle in an valuable insights into the realities of implementing plastics economically viable way due to the material failing to represent recycling programs in clinical healthcare settings. What we learned enough value to attract the attention of recyclers. The project is that collection of plastics must be made simple for clinical brought together multiple hospitals in an attempt to overcome this staff in order to be effective. Detailed sorting at the point of issue. generation is too complex and a distant priority from clinician’s primary focus of ensuring positive patient Plastics primarily from main operating rooms and ambulatory outcomes. It’s also important to remember that behavioural surgery centres were collected and then transported by waste change around recycling can be a slow process, one that haulers to material recovery facilities (MRFs) for processing, or takes constant reinforcement over time.” transferred to specialised plastics recyclers. A project aimed to address the issues surrounding the use and Kim Holmes senior director of recycling and diversion at recycling of plastics used in the healthcare industry was carried PLASTICS said: “In addition to testing the recovery and out in Chicago . HPRC and Plastics aimed to introduce a viable mechanical recycling of healthcare plastics, we were also recycling model for healthcare plastics, the focus being on non- able to explore alternative pathways of chemical recycling infectious plastic packaging and products collected from clinical and conversion to fuel products with our technology partners. areas of the hospitals. Proving the value of these hospital plastics in the conversion process was an exciting dimension of this project and The project was a success in many areas, such as defining the underscores the importance of adding non-mechanical relative quantities of material types and understanding the recovery technologies to our resource management tool kit.” complexity of sorting the materials once collectively amassed. The highest volume of material collected was sterilisation wrap Participating hospitals included Advocate Illinois Masonic Medical and as such, the material was evaluated as a viable substitute Centre, and NorthShore University HealthSystem’s Evanston, or supplement for virgin resins in product manufacturing. Skokie and Glenbrook Hospitals. Other packaging materials such as film plastics, as well as rigid plastic packaging were also collected. Ref: (http://www.medicalplasticsnews.com/news/healthcare- plastics-recycling-project-is-a-success/ - December 20, 2016) The team were also successful in testing the potential to Europe Medical Plastic Market - Trends and Forecast by 2024 The Europe medical plastic market is expected to reach USD 4.84 competitiveness and product quality are anticipated to be the key billion by 2024, according to a new report by Grand View Research, factors influencing buyer power decision. High production volumes Inc. Growing demand for medical plastics in applications such as and ease of availability of the product is expected to propel demand disposables, surgical instruments, diagnostic components, over the projected period. implants, and orthopedics is expected to drive demand. Rising demand for healthcare services and facilities coupled with Polyethylene was the largest product segment for Europe medical increasing government support to the medical industry in the plastic industry in terms of volume in 2015 and is expected to Europe is expected to have a positive impact on the industry grow at a CAGR of over 5% from 2016 to 2024. Rising demand growth. for the product for manufacturing artificial tendons, surgical cables, tubing and orthopedic sutures is expected to drive growth. Rising R&D expenditure related to the manufacture of bio- compatible medical plastics with superior quality, low cost, and Disposable was the key application segment for the industry, minimal health hazards is anticipated to propel demand. However, accounting for 25% of the total market in 2015 and this trend is stringent regulatory scenario associated with the medical device expected to continue over the forecast period. Growing demand manufacturing and waste disposal are anticipated to be key for devices such as disposable enemas, cleaning gloves, contact challenges for the industry in the region. lenses, hypodermic needles and Dialysis disposables is anticipated to drive demand for various plastic materials such as Europe medical plastic industry is highly competitive and PVC, silicones, and PE. fragmented owing to the presence of numerous players. Manufacturers are coming up with various innovative technologies In the UK, demand for silicon for surgical instrument manufacturing in order to reduce cost and improve product quality and durability. was valued over 3 million in 2015 and is expected to grow at a Price volatility of the feedstock and stringent government CAGR of over 5% over the projected period. Silicone furnishes regulations associated with the medical device manufacturing are medical device manufacturers with numerous choices for expected to be the key factors affecting the industry growth. improvement of new items. Rising demand for silicone in surgical Competition in the medical plastic market is likely to help instrument manufacturing owing to its biocompatibility, bio- consumers in terms of cost, quality and product innovation. Cost inactivity, and superior physical properties is expected to have a positive impact on the industry growth. 28 Nov. - Dec. 2016
Global Trends Engineering plastics demand for implants in France was valued Key players in the industry include Rochling Group, Nolato AB, over USD 6 million in 2015 and is expected to grow at a CAGR of GW Plastics, Saint-Gobain Performance Plastics Corporation, over 7%, from 2016 to 2024. Polyetheretherketone (PEEK), an Orthoplastics Ltd., Eastman Chemical Company, Celanese engineered plastic material finds wide application scope in the Corporation, The Dow Chemical company and Tekni-Plex. implants. Biocompatibility, strength, and inertness offered by the product is expected to open new avenues for the market growth For more details : Orbis Research (orbisresearch.com ) - Hector over the forecast period. Costello , Senior Manager – Client Engagements , 4144N Central Expressway, Suite 600, Dallas, Texas–75204, U.S.A. P.N. Germany is a key market for the medical plastic industry in the :+1(214)884-6817;+9164101019,[email protected] Europe and is expected to grow at a CAGR of over 5% from 2016 to 2024. The country is one of the leading business locations for Ref: (http://www.medgadget.com/2016/11/europe-medical- medical technology in the world. The manufacturers in country plastic-market-analysis-share-trends-and-forecast-by-2024- invest over 9% of their total income in the R&D and product innovation, which is likely to open new avenues for the industry market-research-report-2016.html) growth over the projected period. Global Medical Polymers Market Estimated To Register CAGR Of 13% By 2022 Medical Polymers Market is expected to reach US$19,014 mln contributes majorly towards the revenue of the segment. by 2022, growing at an estimated CAGR of 13% from 2016 to • Disposables is the fastest growing application segment and 2022, according to a report by Allied Market Research. Resins is the leading segment in 2015 and is expected to maintain its lead is expected to grow at an estimated CAGR of 14.2% during throughout the forecast period. Further, in the application segment, the forecast period of 2016-2022. devices dominate occupying a share of nearly half of the global • U.S. was the largest market in terms of demand for medical medical polymers market. polymer in 2015. Medical polymers are widely used across various applications, (Ref: http://www.plastemart.com/plastic-facts- as they are easy to manufacture and facilitate customizations. information.asp?news_id=38734&news=Global-Medical- Moreover, they provide ease of fabrication, flexibility, and Polymers-market-estimated-to-register-CAGR-of-13-by-2022) biocompatibility, and remarkable mechanical, electrical, chemical, and thermal properties of materials that are used as composites for medical implants. Increasing number of medical procedures, such as joint reconstruction & heart surgeries and rise in cosmetic and plastic surgeries in the developing countries are the few other key drivers of the market. “Increase in adoption of medical polymers owing to low prices and versatility, coupled with increase in the sales of medical implants and devices globally will garner the growth of the global medical polymer market”, said Eswara Prasad. Resins dominate the medical ceramics market due to a significant replacement trend of conventional medical devices materials with advanced polymers such as polyphenylene ether and few others, which provide high- quality medical devices. Further the application segment is led by devices holding nearly half of the global polymers market. This is mainly due to advancement in the technology provided by the polymers manufacturers such as polymer laminate technology and so on. Devices captured a major share in the global medical polymers market followed by disposables such as gloves, syringes and others. Key Findings of the Medical Polymers Market • The bioresorbable plastics (PGA) of polymer market is expected to grow at a highest CAGR of 17.1% during the forecast period. • Resins hold the highest share of four-fifths of the total medical polymers market in 2015. • In the application segment, devices hold nearly half of the market share in 2015, where Diagnostics equipment Nov. - Dec. 2016 29
Required ISO : 13485 : 2012 Medical Device Manufacturing JIMIT MEDICO Facility On Loan License Basis SURGICALS PVT. LTD. We are looking for loan license for AN ISO 13485 : 2012 & CERTIFIED COMPANY Epidural, CVC and Dialysis catheters, fistula needles, biopsy needles, spinal Manufacturers & Exporters of needles, pressure monitoring lines, Disposable Medical Devices Guidewires, ETC. Infusion Set, Blood Administration Set, Party having manufacturing license or IV Cannula, Urine Bag, Catheters, Gloves, willing to take license or interested to HIV KITs, Ophthalmic KITs, Ophthalmic Knives work together should write immediately. (Blades), Cap, Mask, Gown, Drapes, Bandages, For Enquiries and Detail mail us on :- [email protected] Dressings etc. Specialized in Handling Large Quantity Contact : Mr. Pradip Barot M. 93214 14111 & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850 E-mail: [email protected] • Web: www.jimitsurgicals.com : Attention : MEDICAL PRODUCTS MANUFACTURERS FOR Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact : Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India. Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : [email protected] • [email protected] 30 Nov. - Dec. 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, REGISTERED Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, FIRM Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, 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 Expertise & Experience : main domains of : – OEM/Contract Manufacturing. Infusion Therapy, – Supply of Components for Medical Devices. Transfusion Therapy, Dialysis, Gastroenterology, Urology, Anesthesia, and Surgery. ANGIPLAST 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 32 Nov. - Dec. 2016
® 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 : 33 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] Nov. - Dec. 2016
Industry News Medical Devices Industry Wants Govt To Create Investor - Friendly Environment Annoyed by the continual lackluster attitude tangible. Centre,” Nath informed. adopted by the central government in ad- dressing the long pending issues of the Instead of taking any pro-active measures He stressed that bureaucrats have to see medical devices industry in the country, in sprucing up the domestic manufacturing the ground realities and work with the in- experts in the sector want immediate inter- arena, the government is further creating a dustry to ensure that the sector gets its vention from the government to bolster the complicated market condition for the indus- due. Reiterating AIMED’s call for action on lagging confidence of the industry. Indus- try. Though the government has started tak- its suggestions, Nath pointed out that since try feels that too many policy decisions ing baby steps towards reviving the sector, medical devices being a critical sector, it awaiting announcement amidst differences their initiatives are not sufficient, and they is only expected of it to have a centralized between the ministers to get consensus need to walk the talk by making sure that regulation for all medium and high risk de- amongst cross lobbyists is hurting the in- the ministers are involved in the reform pro- vices categories, leaving the re-sellers terest of the industry. cess, Nath stressed. whether wholesalers, retailers or healthcare providers to be regulated by Experts stressed that rather than creating “In spite of all these promises, the industry state regulatory bodies. Thus in this con- an investor friendly environment by easing is still reeling under pressure due to the text considering the present limitations of and simplifying the process, the Centre has government creating unfavorable conditions the regulatory bodies in terms of compe- further complicated the matter by creating for the investors. Even after announcing tency, capacity and resource capabilities, fear and confusion among stakeholders. setting up of medical devices park across our suggestions to the regulatory body to Rajiv Nath, forum coordinator of AIMED, the country, there are lot of uncertainties encourage voluntary compliance backed stressed that just marketing and on the regulatory front. We strongly fear that by third party certification to ensure pa- sloganeering about ‘Make in India’ will not it will be huge challenge to attract investors tient safety stands valid, Nath added. do any good for the industry unless it is to these parks with so mach confusion backed by clearly defined policy framework, which will undoubtedly derail the ease of (Ref: http://pharmabiz.com/ strategies and listed reforms that are doing business assurance given by the PrintArticle.aspx?aid=98402&sid=1) Medical Device Industry Rues Recommendations Not Incorporated In The Draft For New Medical Device Rules Government must consider industry Ministry as well as the CDSCO on the Working Group, and Executive Committee recommendations for Medical Device Rules Rules, and if the past is anything to go by, Managing Director, BD India & South Asia to circumvent severe jeopardy to critical their inclusive approach and nuanced said, “All policy decisions need to be based healthcare in India and it falls short of the understanding of the issues will help us on scientific due diligence. The Medical expectations of the medical devices sector, once again reach solutions so that the device draft rules 2016, at this stage, need feels the industry. supply of critical care devices will continue more clarity and alignment with global best uninterrupted to the Indian patient,” practices to fully meet the sector specific In a statement, the industry experts say that commented Pavan Choudary, director requirements in order to ensure the Medical Device Rules were initially general, Medical Technology Association of predictability in the Indian market, which prepared with industry consultation, India (MTaI) in a statement. is a critical factor when it comes to however the comments of the industry as investment decisions. The current rules well as certain elements where agreement Also, the Advanced Medical Technology address some but not all of the issues that was obtained between industry and Health Association (AdvaMed) – a trade were deliberated upon during several Ministry officials were not incorporated in association expressed that the rules in its industry consultations while working on the draft that was published on October current form lack harmonization with this draft. AdvaMed and its members 17th, 2016 for stakeholder’s comments international norms of medical device appreciate the efforts made by the Indian (within 30 days). regulation, which is necessary to provide government to improve the overall the necessary fillip to the sector that landscape for medical devices. We “In their current form the Medical Device provides extraordinary growth opportunity request the Government to continue Rules could severely jeopardize the for the country through creation of high consultations with the innovative industry continued supply of critical care medical paying jobs, economic value and better and build on their experience to come up devices to India. They will also endanger patient outcomes. In addition to the device with a methodology that will address the huge investments made in rules, the Association also, strongly, reasonable concerns around access and Manufacturing in the country by global recommends inclusion of the globally affordability while promoting research and companies & will dent the FDI which has harmonized definition of medical devices med-tech innovation.” been growing multifold since it was into the current Act, which is not part of the sagaciously brought on the automatic route drug definition, it says in a statement. He also said, “The government needs to by the current government. Having said be mindful of the fact that without sufficient that, we are engaged with the Health Varun Khanna, chairman, AdvaMed India 34 Nov. - Dec. 2016
Industry News capacity it will be challenging for them to cause unnecessary delay in the availability complete implementation including direct implement these rules. Therefore, a critical and access of innovative medical devices part labeling will be over only by 2022. step for the successful implementation of to the HCPs and the patient population. Hence, it is premature to incorporate this the medical device rules would be to take Moreover, the provisions with respect to in the current rules, as manufacturers are measures for building capacity of the labeling of medical devices should be not ready for implementation of UDI. relevant ministries and ensure greater aligned with the Draft rules published in July understanding of the sector dynamics and 2016, and the clause with respect to the The association said that encouraging criticalities among the regulators.” shelf life of medical devices should be measures for medical device regulation amended to be in line with global would enhance penetration of essential The association members have urged the requirements. medical devices, and it is hopeful that its regulators to make necessary revision in perspective would be reflected in the final provisions that hinder operational ease of The members said that while the version. doing business for the device companies. implementation of UDI is a positive step, it For instance, the additional requirement for is imperative for the government to have (Ref: http://pharmabiz.com/NewsDetails clinical investigation of medical devices realistic timelines. For example, as per the .aspx?aid=98982&sid=2&fromNewsdog=1) already approved in GHTF countries shall US and EU implementation timeline, the AIDCOC Urges Health Ministry To Empower State Licensing Authorities (SLAs) To Grant License To Critical Medical Devices The All India Drugs Control Officers be the competent authority for enforcement Class B medical devices may be licensed Confederation (AIDCOC) has urged the of rules in matters relating to manufacture by the SLA only and the Class C and Class Union health ministry that the State of class A or class B medical devices, sale, D medical devices be licensed by SLA and Licensing Authorities (SLAs) should be stock, exhibit or offer for sale of medical approved by Central Licensing Approving made competent authority for grant of devices and other related functions, Authority (CLAA). license to manufacture medical devices of provided that where any person who intends all classes for the purpose of clinical to manufacture any medical device which (Ref: http://www.pharmabiz.com/ investigations or test or evaluation or does not have its predicate medical device NewsDetails.aspx?aid=98933&sid=1) demonstration or training. shall obtain prior approval from the Central Licensing Authority ISO 9001-2015 As per the proposed draft of Medical Device before applying to ISO 13485-2012 Rules, 2016, the licensing of medical the State Licensing CE devices is divided into two categories which Authority for grant of WHO GMP are critical and not so critical. The SLAs manufacturing were entrusted to license the not so critical licence. medical devices and the Central Drugs Standard Control Organization (CDSCO) It further says, the will handle the critical ones. Central Licensing Range of Products With this proposed rules, AIDCOC is of the view that the draft is focusing towards the Authority shall be the centralization of powers rather than ease of delivering goods. competent authority • ECG Paper & ECG • Mount Catheter Accessories • “T” Recovery Kit “It is to bring to the kind attention of the for enforcement of • Breathing Circuit government that the state authorities have • ECG Paper Roll & Z • Ambu Bag been handling all the more critical drugs like these rules in matters Folding • Bain Circuit vaccines, sera, rDNA and high end critical • 3 Ball Spirometer medical devices like cardiac stents all these relating to import, • Nasal Canula • Patient ID Belt years successfully and it is pertinent to • Oxygen Mask • Yankur Suction Set mention that there is no specialized manufacture of Class • Nebulizer Mask & • Nebulizer Chamber knowledge or wherewithal existing with • Guidal Airways CDSCO to be specifically entrusted with the C and Class D Nebulizer Compressor • B. P. Meter handling of critical medical devices. It • Multiflow Mask clearly shows that the proposed draft rules medical devices, • Ventury Mask are focusing towards the centralization of • High Concentration Mask powers rather than ease of delivering goods clinical investigation • Breathing Filter and making the system more complex,” opined Ravi Uday Bhaskar, secretary of and clinical AIDCOC. performance The proposed rule says that the SLA shall evaluation, of medical devices and other related functions. Whereas, the Life-O-Line Technologist AIDCOC has Mfg. & Importer of : Medical Surgical Devices & Healthcare Products proposed that the Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : [email protected] Class A medical Customer Care No. +91 9898162576 & 7600020901 devices need not be licensed at all, the Nov. - Dec. 2016 35
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, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, High Concentration ET Holder with Bite Expandable Catheter GIDC Vatva, Ahmedabad - 382 446. INDIA. Mask Block Mount Tel. : 91-79-2584 2525 / 2584 0905 Email : [email protected] [email protected] • Web : www.airwayssurgical.com 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 Address : MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS APEX MEDICAL DEVICES Plot No. 10/B, Shyam Ujjawal Industrial Park, 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Opp. SBI Bank, Phase-1, G.I.D.C. Vatva, Mill, Narol - Isanpur Highway, Narol, Ahmedabad-382 445 (India) E-mail : [email protected] Ahmedbad-382405. (India) Phone : (O) 079- Website : www.apexmedicaldevices.com 25733318 (R) 079-25430211 (M) +91-9825018952 Email : [email protected], [email protected] Website : www.mescosurgical.com 36 Nov. - Dec. 2016
January to December2016 Column Content Column Content November-December 2016 • Plastics Remain Material Of Choice In Parenteral Packaging Market Cover Story • Medical & Healthcare Plastic Pavilion – The Dedicated Industry News Zone In The Biggest Plastics Show Did You Know • HMD Becomes First ICMED Certified Medical Device Company In India Manufacturing • Diversifying Into Medical Device Molding Industry Cluster • Gujarat Medical Device Industry : Moving Up in Value • Boston Scientific Launches Integrated Facility In India To Develop Minimally Invasive Technologies & Technology Chain Product Gallery • New Multi - Cavity Channel Clips With Guide Wire • States And Central Health Agencies For Indian Products While Procuring Medical Devices Slit From Qosina Global Trends • Healthcare Plastics Recycling • New Niper Campus In Gandhinager ( Gujarat ) To Emerge As A Vibrant R & D Centre Dedicated To • Europe Medical Plastic Market - Trends and Forecast Medical Device Industry by 2024 • Gujarat FDCA To Tie-Up With NIPER Ahmedabad For • Global Medical Polymers Market Estimated ToRegister Skilled Manpower For Medical Device Park CAGR Of 13% By 2022 • About Implants As The Fastest Growing Application Industry News • Medical Devices Industry Wants Govt To Create For Medical Plastics Investor - Friendly Environment May – June 2016 • Medical Device Industry Rues Recommendations Not Incorporated In The Draft For New Medical Device Cover Story • Effective Vendor Management For Medical Device Rules Industry • AIDCOC Urges Health Ministry To Empower Slas To • Supplier Quality Management For Medical Device Grant License To Critical Medical Devices Manufacturers : A Critical Step Towards Global Regulatory Compliance Did You Know • About Modernizing Biocompatibility and Biological Risk Evaluation of Medical Device Materials • Medtech Companies Need Collaboration With External Partners For Innovation And Growth Press Notes • PLASTINDIA 2018 – Special Preview • Qosina Receives ISO-13485 Certification Technology • Innovative Computer-Aided Catheter Reprocessing • Revolutionary Conveying System with Variable Speed System (CRS) for Cleaning Catheters Developed By Capability from Conair Chandigarh Biomedical Engineer September – October 2016 • India’s New IPR Policy Looking To Spur Innovation In Med-Tech Sector Technology • INDIA ’S First Medical Technology Zone – AMTZ Product Gallery • Enteral Feeding Connectors that Meet the ISO 80369- Manufacturing • How To Meet Biocompatibility Needs Of Polymeric 3 Standard Medical Components Global Trends • Medical Adhesives: Fastest growing Segment Industry News • Andhra Med Tech Zone Gets Formal Registration To Quality • Quality Management System: Changing Scenario & Set Up Asia’s First Dedicated Medical Devices Park Challenges In Medical Device Regulations • Gujarat Govt Allocates Land For Setting Up Medical Product Gallery • New Barbed Check Valves Device Park At Sanand • Industry Wants ICMED Certification Mandatory For Global Trends • How Plasma Can Aid Catheter Manufacturing All Medical Devices Marketed In India Industry News • NIPER Ahmedabad To Collaborate With 2 US-Based • India And Japan To Seek Regulatory Collaboration Cos Towards Development Of Medical Device Industry For Medical Products • Separate Rules To Spur Medical Devices Sector Soon • Centre To Establish 3 Mega Industrial Parks In Gujarat • Centre To Notify Revised Schedule M III For Medical For Medical Devices, Bulk Drugs Devices By June End Did You Know • About Best Practices to Ensure Good Supplier • Sahajanand Medical Technologies Opens New R&D Management Facility In Ireland Did You Know • About Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices July-August 2016 March – April 2016 Cover Story • Medical Plastics – New Materials & Technologies Help Cover Story • Indian Medical Device Industry: Integrating Market, Medical Device Industry Technology, Innovation And Ecosystem Manufacturing • Supply Chain Management–Boon Or Bane For The • Important Announcements Medical Device Industry - “IC-MED” – QCI-AIMED Voluntary Initiative On Medical Devices. Product Gallery • New Barbed Check Valves - Delinking Medical Devices From Pharmaceuticals • New Micro Pinch Clamps And Revision Of Schedule MIII Global Trends • Medical Device Companies Fear Parallel Regulation After Brexit Vote Nov. - Dec. 2016 37
Column Content Column January to December2016 - BIS Certification For Medical Devices Industry News Content Article Index Markets • Southeast Asia: Region On The Rise For The MedTech Medical Devices & Plastics Disposables / Implants Industry 2016” supported by major leading industry Industry associations as well as Government, Regulatory, Export Promotion and Research Organizations. Materials • Thermoplastic Polyurethanes: Enabling Innovative • Conference Theme : “Indian Medical Device Industry : Integrating Market, Technology, Innovations and Competitive Technologies Through Advanced Ecosystem”. • Speakers’ Introduction Materials • Presentation Abstracts • Exhibitors’ Profile Product Gallery • Needleless Injection Site With A Non-Disconnect Male • List & Profile of Advertisers • Student Programme : Career Opportunity Luer Lock Presentations, Poster Presentations & Paper Presentation Competitiions Global Trends • Medical Plastics Packaging Trends Keep Expanding • Technology Display Show 2016 • Import duty on medical devices raised Industry News • IMDI 2016 Welcomes Govt Industry Friendly • AP showcases exclusive medical device park at Arab Health Expo Measures Towards Growth Of Medical Device Sector • DBT collaborates with AIIMS and IITs for medical device technology • CDSCO To Grant Online Registration Certificate, • Important Articles published in the magazine from Nov.-Dec. 2014 To Nov. - Dec. 2015 Renewal Of Licence For Import Of Medical Device Soon • Medical Plastics Market By Type, By Application And Region-Forecast 2020 Did You Know • About effect of Medical Device Quality Performance On Business Performance January – February 2016 Cover Story • 13th National Conference & Exhibition on “Indian 38 Nov. - Dec. 2016
Product Gallery New Multi - Cavity Channel Clips With Guide Wire Slit From Qosina ETO or Gamma sterilization, these new channel clips are Latex- Free as well as REACH and RoHS compliant. Qosina offers a variety of guidewire accessories and dispensing tubes, along with thousands of stock components to help complete your design. Visit Qosina.com today to request samples! 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 [email protected]. Ronkonkoma, NY – November 2, 2016– Qosina is pleased to Qosina is a worldwide supplier of thousands of stock OEM announce the addition of four newmulti-cavity channel clips components including bioprocessing components, compression (#12536 - #12539) to their line, in stock and ready for immediate fittings, ENFit™ connectors, luers, clamps, clips, check valves, delivery. Equipped with a unique slit which isdesigned to stopcocks, hemostasis valves, tuohyborst adapters, swabs, spikes, retainguidewires, these channel clips help to hold a wire in place syringes and tubing to the medical and pharmaceutical industries. when not in use. Three of these clips have two, 0.144 inch Founded in 1980, Qosina is now based in Ronkonkoma, NY in a channels (#12537 - #12539), while the other (#12536) has two, 95,000 square foot facility with an ISO Class 8 Clean Room and is 0.142 inch channels; all with different size slits to accommodate ISO 9001 and ISO 14001 registered. a variety of guidewires.Made from a soft, TPV (Thermoplastic Vulcanizate) material, these channel clips are flexible, allowing Contact : Deanna Whelan for easy attachment to a dispensing tube. Recommended for Qosina 2002-Q Orville Drive North, Ronkonkoma, NY 11779. Phone +1 (631) 242-3000. Fax +1 (631) 242-3230. Email: [email protected] GMP Surgical Industry ISO - 9001-2008 Certified Company For S. Nath & Co. SALE Excellence in Quality In Hyderabad, R. R. District, Manufacturer & Exporter of Surgical Disposable Products since 1980 Telangana. IDEAL® An ISO 9001:2008, 13485:2012 & GMP Certified Company • Infusion Set • Blood Administration Set Contact through: • Urine Collection Bag • Urine Specimen Container [email protected] • Umblical Cord Clamp 41 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 • [email protected] Nov. - Dec. 2016
Events Plastics Industry In Gujarat Set Qosina Receives ISO-13485 To Grow At 20 % To Over Certification Rs. 90,000 Crores Qosina is pleased to announce that we have received ISO Plastindia Foundation to announce the Special Preview of 13485 Certification, a globally recognized standard that specifies PLASTINDIA 2018 the requirements for a quality management system that can be Swachh Bharat initiative and Make in India campaign used by organizations providing medical devices, components contributing to robust growth Exports of finished plastics goods and delivery of related services. This certification allows Qosina set to double in 5 years. to comply with the ever-changing needs of our customers while Plastic Industry is making significant contribution to the economy, meeting and maintaining regulatory requirements. Qosina is development and growth of various key sectors in the country also ISO 9001 & ISO 14001 certified and is committed to namely Automotive, Agriculture, Electronics, Construction, maintaining and continually improving our quality and Healthcare, Textiles, FMCG etc. It is one of the fastest growing environmental systems. industries in India. Plastic industry would also contribute in a big way in the success of Government initiatives such as Make Founded in 1980, Qosina is a worldwide supplier of thousands in India, Skill India, Digital India, Swach Bharat Abhiyan etc which of stock OEM components and tubing to the medical and are opening up opportunities and accelerating growth even more pharmaceutical industries. Qosina is based in Ronkonkoma, rapidly. NY in a 95,000 square-foot facility with an ISO Class 8 Clean Talking on Gujarat Plastic industry scenario, Gujarat has been Room and is ISO 9001, 14001 and 13485 registered. Contact a major contributor to over all Plastics Industry Globally, India for more details : via p:+1(631) 242-3000 [email protected]. stands third in polymer consumption with China being the second largest consumer, while US tops with 25 million ton polymer Revolutionary Conveying System with consumption per annum. “India per capita consumption is Variable-Speed approx. 10 kg per annum’ and world’s average per capita plastic consumption is more than 25 kg per annum. “Smart cities, rapid Capability from Conair urbanization, increase in sale of packaged products through retail and ecommerce mode, low per capita consumption, shifting Conair displayed dense-phase vacuum-conveying system to consumer lifestyles, large young population, majority of minimize pellet fracturing, “angel hair” and equipment wear population of middle income group, many manufacturing caused by conventional dilute-phase conveying, at K 2016 in segments adopting higher percentage of plastics, etc. are October in Germany . The system can be “tuned” to match contributing towards the growth of Plastics industry. Indian material speed to application requirements and the Plastics industry has geared itself to take up the challenges of quantitative and qualitative growth for serving the nation and its characteristics of the material being conveyed. citizens and also to take the country to a higher growth path”. This was shared by President Plastindia Foundation Mr. K. K. Other products exhibited by Conair included : Seksaria at the formal launch of Plastindia 2018 held in • The new, patent-pending Conair Invisible Line Ahmedabad on Nov. 18, 2016. PLASTINDIA 2018, to be held bet. Feb 7-12, 2018 in Proofing(ILP) system, which is based on an otherwise Gandhinager (Ahmedabad) will showcase the increasing usage standard resin selection station but uses a proprietary non- of Plastics in major Growth sectors, and it shall provide unlimited electrical sensing technology to confirm that the proper opportunities for all who are looking at growth avenues. resin source is connected to the selected destination. Moreover, PLASTINDIA 2018, for the first time, will feature ‘Industry Focused Pavilions’ for the new and emerging sectors • A new dual-spindle automatic cut-and-transfer that are going to redefine the future of Plastics. The sectors in coiler(ATC), designed for high-speed winding of small- focus are Sports, Plastic Composite, 3D Printing, Robotics, etc. diameter extruded tubing and flexible profiles. Even at high speeds, little or no friction or winding tension is generated, preventing deformities in delicate products. Fully automated transfer of winding to a new reel increases line speed and performance during changeover. • The compact and remarkably quiet NCF-814 Granulator, which has a super-tangential cutting chamber to turn containers and other bulky scrap intoclean, uniform regrind for better product quality. The Conair Group (www.conairgroup.com) is a leading global supplier of auxiliary equipment for plastics processors, including resin drying systems, blenders, feeders and material-conveying systems, temperature-control equipment and granulators. Extrusion solutions include line-control systems, film and sheet scrap-reclaim systems and downstream equipment for pipe and profile extrusion. 42 Nov. - Dec. 2016
Events PACK-EQUIP Events Calender (Mfg. Packaging Machinery) • Plastivision India 2017 : International Plastics Exhibition Office / Communication : & Conference 91, Avnish Society, Opp. Pavitrakunj Society, Date : 19-23 January 2017. CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Venue : Bombay Convention & Exhibition Center, Mumbai. Phone : 25855027 (M) 9825380739 • Confederation of Indian Industry (CII), Health Tech India. Date : 3-5 February 2017. Works : Venue : Pragati Maidan, New Delhi, India. 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. • 3rd National Conference On Safety And Risk Management For Healthcare Professionals 2017 : Dedicated Exhibition Pavilion For Safety, Infection Control & Biomedical Wast Management. Date : 11 February 2017. Venue : The Gujarat University Convention Exhibition Centre, Ahmedabad. • 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. • 14th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposable / Implants Industry 2017 : March, 2017. Ahmedabad. • Medical Fair India 2017 : 23rd International Exhibition and Conference Date : 06-08 April, 2017 Venue : Pragati Maidan, New Delhi. Nov. - Dec. 2016 41
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. 44 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 Nov. - Dec. 2016
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