Table of
Contents Vol. 24
No. 5
Sep. - Oct. 2016
20 Technology
• INDIA ’S First Medical Technology Zone – AMTZ Goal of this progressive initiative is to make Andhra Pradesh an internationally recognized manufacturing hub for medical devices help in national agenda of import substitution, make Andhra Pradesh a leader in medical technology………
22 Manufacturing • How To Meet Biocompatibility Needs Of Polymeric Medical Components - Mr. Vinny Sastri, President, Winovia LLC, U.S.A When materials come in contact with human skin or tissue , their biocompatibility should be evaluated. The importance of patient safety with respect to biocompatibility continues to be an important area that………
25 Quality • Quality Management System: Changing Scenario & Challenges In Medical Device Regulations - Mr. Sanjay shah, Owner Promoter, Unikal Consultants, Ahmedabad Lot of changes are taking place in QMS. What is the basis for current trend in changes in regulations for Medical Devices ?.....
36 Product Gallery • New Barbed Check Valves • BPSA’s 2016 Inaugural European Summit
28 Global Trends • How Plasma Can Aid Catheter Manufacturing
32 Industry News • NIPER Ahmedabad To Collaborate With 2 US-Based Cos Towards Development Of Medical Device Industry • Centre To Establish 3 Mega Industrial Parks In Gujarat For Medical Devices, Bulk Drugs • Sahajanand Medical Technologies Opens New R&D Facility In Ireland
18 Did You Know? • About Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices
37 Events • MEDICA and COMPAMED 2016 : 14-17 November 2016, Germany. • PLASTIVISION INDIA 2017 : 19-23 January 2017, Mumbai. • 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 2016 : February, 2017. Ahmedabad • Medical Fair India 2017 : 6-8 April 2017, New Delhi. Sept.-Oct. 2016
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Flashback May. - Jun. 2004 From Editor’s Desk Dear Readers, This issue of “MEDICAL PLASTICS DATA SERVICE” takes a closer look at Intravenous Infusion Therapy Products. Majority of surgical patients and almost a third of non-surgical inpatients need intravenous therapy. While the bulk of demand is for traditional gravity flow design for the I.V.Sets, there many specific application requirements which are discussed in this issue. This is also a medical technology industry segment which accounts for a very large number of SMEs. With the changing market scenario, increasing quality awareness, globalisation, tightening Drug Control Regulations, there are many challenging issues the industry is facing to-day. MPDS took the opportunity to interact with the leader of the industry in India, Mr K J Park, Managing Director of Hyderabad based “Sangam Healthcare ProductsLtd”. We are grateful to Mr. Park for being generous in sharing his rich techno-commercial experience with our readers. One more important issue highlighted is regarding selecting the European Authorized Representative. This is an important requirement for non-European medical device manufacturers and exporters to EU countries. Mr. Sanjay Shah who is an eminent Quality Certification Consultant, provides guidelines for selection of The European Authorized Representative for CE Certified Medical Devices Manufacturers. This issue of “MEDICAL PLASTICS DATA SERVICE” also covers regular features like Important Events viz. HOSPIMedica ASIA 2004, Medica and ComPaMED 2004, MediNET Forum, Industry News, Global Trends etc. CONTENTS • Cover Story : - Intravenous Therapy Products • Face To Face with Mr. K J Park • Quality : The European Authorized Representative for CE Certified Medical Devices Manufacturers • Global Trends : European Union: The Largest Market and Trading Zone for the Healthcare Industry • Industry News : - Baxter to make Indian arm global hub - Manufacturing medical devices Indigenously can reduce health care cost: Dr. Reddy - Bar Code Technology For Healthcare Sector • Did You Know ? About Prevention of Catheter-related Infections • Events
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Did You Know ?
?
About Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices FDA’s Center for Devices and Radiological Health (CDRH) is responsible for assuring the safety, effectiveness, performance and quality of medical devices and radiation emitting products used to treat, prevent, and diagnose disease throughout the product life cycle thereby reducing the time to market, improving safety, and making the process least burdensome. CDRH has published FY 2017 regulatory science priorities to help focus the Center’s attention on the most important regulatory science gaps or needs as under : • Leverage “Big Data” for regulatory decision-making • Modernize biocompatibility and biological risk evaluation of device materials • Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making • Advance tests and methods for predicting and monitoring medical device clinical performance • Develop methods and tools to improve and streamline clinical trial design • Develop computational modeling technologies to support regulatory decisionmaking • Enhance the performance of Digital Health and strengthen medical device cybersecurity • Reduce healthcare associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices • Collect and use patient input in regulatory decision-making • Leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis and progression Document providing an overview of the process that CDRH used to generate these Priorities is available at : http://www.fda.gov/downloads/MedicalDevices/ ScienceandResearch/UCM521503.pdf
In a Nutshell.... The pursuit of knowledge is never-ending. The day you stop seeking knowledge is the day you stop growing. - Brandon Travis Ciaccio
Sept.-Oct. 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. 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 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-58 •Ph:098795 55948
Editor’s Desk
From the
The government of India has an ambitious plan to increase competitiveness of the Indian Medical Device industry globally by helping it to bring down the manufacturing cost significantly. As per Mr Ananth Kumar, Minister for Chemicals & Fertilizers and Parliamentary Affairs, “Setting up of Medical Device parks can bring down the manufacturing cost by another 30 per cent and make Indian medical technology sector globally competitive, due to pooling of common facilities,” With the initiative from the Hon. Chief Minister of Andhra Pradesh Mr N. Chandrababu Naidu, Andhra Pradesh us emerging as manufacturing hub for medical devices with establishment of country’s first Medical Technology Manufacturing Zone, Andhra MedTech Zone ( AMTZ ) in Vishakhapatnam. As per Dr Jitender Sharma, CEO, AMTZ, the brain behind the project, one among many opportunities is to, “Get to the small and medium enterprises, build and support them so that they become exporters, essentially meaning strengthening of the micro , small & medium enterprise (MSME) sector”. Mr Ananth Kumar has also put forward a proposal that the Central government will soon establish three mega industry parks in Gujarat which will include Medical Devices, Pharmaceutical Formulations and Bulk Drugs Parks. The Gujarat Chief Minister Mr Vijaybhai Rupani has already accepted the centre’s proposal and would like to see that these parks come up at the earliest. As we all agree, the medical device manufacturer is responsible for the safey and effectiveness of the final device. The device, its components and raw materials that come into contact with human tissue must all be evaluated for biocompatibility. Through a very well researched article, Dr Vinny Sastri, President, Winovia LLC, U.S.A., has given very detailed understanding of “ How To Meet Biocompatibility Needs Of Polymeric Medical Components”. Dr Sastr, apart from his long and rich experience in the Quality Management Systems (QMS), is also the author of the book,” Plastics In Medical Devices : Properties, Requirements and Applications”. One more important aspect covered in this issue is about QMS and the changing scenario & challenges in Medical Device Regulations through an article by Mr Sanjay Shah. This issue also highlights the global regulatory science priorities for assuring safety, effectiveness and quality of medical devices. It also includes our regular columns highlighting Global Trends, Industry News , Technology as well as important events for the benefit of our readers.
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.
Sept.-Oct. 2016
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Technology INDIA ’S First Medical Technology Zone Andhra Pradesh is emerging as manufacturing hub for medical devices with establishment of country’s first Medical Technology Manufacturing Zone, Andhra Med Tech Zone (AMTZ) in Vishakhapatnam Medical device manufacturing sector has remained nascent, leading to tremendous import dependency. Lack of domestic manufacturing of medical devices is the main reasons for this import dependency and high cost of medical products and services in the country. To address this situation, Govt. of Andhra Pradesh aims to establish country’s first Medical Technology Manufacturing Park at Vishakhapatnam. The goal of this progressive initiative would be to make Andhra Pradesh an internationally recognized manufacturing hub for medical devices, help in national agenda of import substitution, make Andhra Pradesh a leader in medical technology exports, generate employment, and contribute to volume generated cost reduction of medical devices for patients. In a meeting organized on 6th Nov, 2015, Hon’ble Chief Minister of Andhra Pradesh shared his vision on this important project with Medical Devices Manufacturing Associations, Central Govt. officials and State Health Authorities.
• Component Testing centre • Electro-magnetic interference laboratory • Medical grade low vacuum molding, cabinet molding, injection molding centres • 3 D designing and printing for medical grade products • Sterilization & Toxicity testing centre • Radiation testing centre • Gamma Irradiation facility • Rapid Prototyping Centre • Industrial R & D Centre • Incubation Centre • Convention Centre & Expo Halls • Warehousing • Regulator’s office • Other facilities commonly required in manufacturing of medical devices All investment towards land development, and building of common facilities as above would be done by the Govt. of Andhra Pradesh with support of Central G o v e r n m e n t Departments through Andhra Pradesh Med Tech Zone. Pvt Ltd – an SPV established under the Department of Health, Medical & Family Welfare, Govt. of AP.
The creation of such as park is based on the fact that medical devices manufacturing requires certain high investment facilities which are too capital intensive for individual manufactures to invest upon. A park with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40%-50%. The AMTZ Team is led Currently, due to lack of AMTZ Foundation Stone Laying Ceremony such centrally located under the able sharable facilities, either guidance of Dr. manufacturers do not undertake production of technologies Jitendar Sharma who is the CEO of AMTZ and the brain behind this requiring them or send their products abroad for process up- entire project. Senior Management of AMTZ includes Shri Manish gradation and value addition. While the park would have all Gangal, Vice President (Operations), Shri Judish Raj, Vice President such facilities in-house to reduce manufacturing process costs, (Planning), Shri Vipin Das Ramachandran, Vice President (Finance) it would be located in an area which is well connected with and Shri Nitin Bharadwaj, Vice President (HR & Admin). Each of Railways, Roadways, Waterways and Airways with near them bring along with them valuable industry experience and a presence of Industrial Corridors, Port and Harbour to reduce dedication to serve the nation in this noble mission. logistical costs. The park will provide for certain capital intensive scientific facilities required by most medical device The Foundation Stone was laid on August 19, 2016 by the Chief manufacturers and modern state of art 180-200 independent Minister of Andhra Pradesh, Shri N. Chandrababu Naidu in presence manufacturing units, with varying sizes of 0.25 acre,o.5 acre of Venkaiah Naidu, Ananthkumar, Y S Chowdary, Dr Kameneni and 1 acre. Government of Andhra Pradesh would develop Srinivas (Health Minister, AP), Dr Poonam Malakondaiah (Principal approximately 270 acres of land for this project. The park would Secretary, Health) and Dr Jitendar Sharma. He also interacted with prospective manufacturers and service providers under the AMTZ include following facilities:
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Sept.-Oct. 2016
Technology ISO : 13485 : 2012
JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 &
CERTIFIED COMPANY
Manufacturers & Exporters of Disposable Medical Devices AMTZ Investors’ Summit 2016 Investors’ Summit 2016. The Chief Minister also launched the AMTZ Investors’ Brochure and it is available for download on AMTZ’s official website. EOI for Common Scientific Facilities as well as Online bookings for manufacturing units is opened and the application forms are available on AMTZ’s official website www.AMTZ.in
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.
For AMTZ Investors’ Brochure and further queries please contact Andhra Pradesh MedTech Zone Ltd. Hill No. 2, IT Park, VSEZ, Madhurwada, Visakhapatnam – 530045. P.No.- 08885092122 | Email: amtz.in@gmail.com / Website: www.AMTZ.in
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
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Manufacturing How To Meet Biocompatibility Needs Of Polymeric Medical Components
Vinny Sastri, Ph.D. President Winovia LLC, U.S.A Medical device manufacturers need to ensure that their products are safe and effective. Safety considerations should include usability, energy, operation, informational, and chemical and biological hazards. Biological hazards can be extensive and complex. When materials come in contact with human skin or tissue, their biocompatibility should be evaluated. The importance of patient safety with respect to biocompatibility continues to be an important area that regulatory bodies continue to focus on.
Regulation. Section 7 of Annex 1 details the requirements for a medical device and material chemical, physical and biological properties.
In September 2016, the Center for Devices and Radiological Health (CDRH) in the USA published the CDRH Regulatory Science Priorities (FY2017). One of the top 10 priorities for 2017 is to “Modernize biocompatibility and biological risk evaluation of device materials”. The report states that “it is The international standard ISO 10993-1Biological evaluation of critical to perform biocompatibility evaluation to assess the risk medical devices —Part 1: Evaluation and testing within a risk of adverse events” “to determine the safety profile of implantable or patientmanagement process, contacting medical updated in 2009, added the devices” The report risk management process FINISHED DEVICE MANUFACTURER emphasizes that “less based on ISO 14971 in the b u r d e n s o m e selection and evaluation of (PRODUCES THE FINISHED DEVICE) approaches that are biocompatible materials. In Evaluate the biocompatibility of the total finished device more patient-centric 2016, the United States FDA and predictive of realpublished its final guidance world device titled Use of International performance are Standard ISO 10993-1, needed to modernize Biological evaluation of PROCESSOR, CONVERTER and transform medical devices - Part 1: (PRODUCES PARTS, COMPONENTS, DEVICE) biocompatibility Evaluation and testing within Ensure biocompatibility of material is maintained evaluation of medical a risk management process. after processing. Control production. devices and their This guidance document materials.” covers the use of the standard including specific The medical device requirements that the manufacturer is agency expects in selection, ultimately responsible RAW MATERIAL MANUFACTURER testing, evaluation and for the safety and documentation. In June (PRODUCES RESIN, COMPOUNDED RESIN) effectiveness of the final 2016, the European Evaluate biocompatibility of the resin. device. The device, its Parliament and the Council components and raw Control formulation and production. of the European Union materials that come into published its draft proposal Raw Material To Finished Device Value Chain contact with human on its new Medical Device
Vinny Sastri, Ph.D., is the President of WINOVIA® LLC a company that provides customized solutions, strategies and training in the implementation of effective quality management systems. Areas of expertise include FDA and ISO quality management systems for medical devices and pharmaceuticals, product development processes, design controls, manufacturing and process validation, risk management, six sigma and design for six sigma, CAPA and plastics. He is a certified Six Sigma black-belt. Dr. Sastri is the author of the book Plastics in Medical Devices: Properties, Requirements and Applications the 2nd Edition of which published by Elsevier, London in 2013. 22
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Manufacturing tissue must all be evaluated for biocompatibility. As a result, suppliers of parts, components and resin that are used to build the device should also do their part in ensuring that the products or processing conditions do not adversely affect the biocompatibility of those products. Figure 1 illustrates the raw material to finished device value chain with respect to plastic materials and components. There may be instances where the resin manufacturer directly supplies the raw material to the medical device manufacturer who does their own processing and converting. The steps involved the selection of materials and their evaluation and testing is as follows: 1. Risk Assessment The intended use and application of the final device is first identified. The initial design concepts can be used to conduct an initial risk assessment of the device design, the material and component characteristics, the manufacturing processes including sterilization, the clinical use of the device, and the nature and duration of contact with human tissue. The nature of contact falls into three categories per the standard. • Surface contacting devices – Those devices contacting skin, mucosal membranes or breached and compromised surfaces (broken skin) • External contacting devices – Those devices that contact blood paths indirectly, tissue/bone/dentin and circulating devices • Implantable devices – Those devices that come into long term contact with tissue and bone, and blood The durations of contact are: • Limited Exposure – Contact up to 24 hours • Prolonged exposure - Contact between 24 hours and <29 days • Permanent contact – Contact e” 30 days This information should be used to identify potential risks with respect to biocompatibility and the types of biocompatibility tests that need to be conducted. The standard and the guidance document allow for the use of historical data and information to make informed decisions before committing to extensive biocompatibility testing. 2. Identification of Potential Risks and Exposure Assessment The physical and chemical characteristic of the materials under evaluation should be listed. Before conducting any biocompatibility tests the potential risks can be evaluated using methods like literature and historical data.Sources of information on potential biocompatibility risks can include previous experience with the same material(s) that have been used in the same or similar devices in the same anatomical location. In addition post market data for similar devices and applications can also provide a rich source of data as an initial risk assessment for biocompatibility. 3. Material selection When selecting materials to be used in a specific device design, manufacture and use, consideration should be given Sept.-Oct. 2016
to the fitness for the device’s intended use with respect to chemical, toxicological, physical, electrical, morphological and mechanical properties. With respect to the biological evaluation of the device, the following should be considered: i. The properties of the base resin The choice of the base resin can be constrained by the application and process needs of the device. For example, hydrolytically unstable resins cannot be used in implants. Highly porous materials may not be suitable under ethylene oxide sterilization because unremoved residuals from ethylene oxide could impact patient safety. Thermally unstable grades cannot be used in applications where high temperature autoclave sterilization is required. In addition to physical and mechanical instability, degradation products could affect the material’s biocompatibility. ii. The material formulation Additives, catalysts, colorants, fillers, nanoparticles, plasticizers and other materials either alone or by interactions with each other can significantly affect biocompatibility. If each individual component of the formulation is claimed to be biocompatible, it does not automatically mean that the complete, formulated material is biocompatible. Compounders should evaluate the breadth of additives and a range of levels in their formulations to gain maximum flexibility of biocompatible materials in their portfolio. iii. Manufacturing Processes – Degradation and Residues Excessive heat and shear during the manufacturing of plastic parts can change the levels of extractables and leachables in the final part and thus significantly affect biocompatibility. Joining and cleaning of parts and residues from materials used in facilitating production (e.g. mold release) can also change a product’s biological properties. Processors should define the process ranges that will not affect biocompatibility. iv. Master Files In the case where formulations are proprietary, Device Master Files (MAF) of the product can be used. Material suppliers can submit a Device Master File that is privy only to the FDA for review and evaluation of final device submissions. Device Master Files typically contain the name of the product, its formulation (ingredients and levels), manufacturing conditions, sterilization compatibility, physical and mechanical properties, known impurities and chemical characterization. Included are also biocompatibility screening studies. 4. Biological Evaluation In order to reduce unnecessary testing, including animal testing, manufacturers should first consider all available relevant information from literature and test data. For example, in some circumstances, a chemical analysis can demonstrate that the extractables and leachables using a specific solvent have not changed compared to a baseline material, eliminating the need for additional biocompatibility testing using that type of solvent. In addition, chemical analyses can be used to assess the toxicological risk of the chemicals that elute from devices. For example, chemical analysis using exhaustive extraction techniques can also be helpful to
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Manufacturing evaluate long-term toxicity endpoints such as potential carcinogens. It is critical that test articles are prepared using the proper methods and solvents and also using representative configurations of the end product. Both polar and non-polar solvents should be used. Extraction conditions based on the device application and use should also be employed. Justification of the selected extraction conditions should be provided. Developing “finger prints” of the extractables and leachables can help in decisions for additional biocompatibility testing if there are changes to materials and manufacturing conditions. If the “finger prints” match the rationale not to conduct additional biological tests can be made. When biocompatibility tests are required, the decision on the applicable tests can be identified using the Table A.1 in Annex A of the standard. The evaluation tests described should be considered and carried out where necessary tocomplete the data sets needed for the biological evaluation of the particular medical device or its materials and components.
understand the critical characteristics and application of the final device their products go into, the lines of communication between medical device manufacturer and their suppliers should be seamless and effective. Processors of the components and parts should control their production processes so as not to affect or change the biocompatibility of the material provided by the resin supplier. Resin suppliers (virgin or compounded) should provide the basic biocompatibility characteristic to both the processor and the finished medical device manufacturer. Any changes to material or process should be communicated to the medical device manufacturer, as the medical device manufacturer is ultimately responsible to ensure safety, effectiveness and biocompatibility of their finished device.
wishing our Readers a Very
Happy Diwali & Prosperous New Year
Considerations should be made for testing like cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive and developmental toxicity and degradationassessments. 5. Biocompatibility Documentation Due to the diversity of medical devices, not all biocompatibility tests identified in a category will be necessary or practical. Documentation of biocompatibility evaluation and testing should include: • The strategy, plan and content for the biological evaluation of the medical device, part or material; • The criteria for determining the acceptability of the material for the intended purpose using risk-based methodology • The adequacy of the material characterization; • The rationale for selection of methods used • The interpretation of existing data and results of testing; • The need for any additional data to complete the biological evaluation; • The overall biological safety conclusions for the material component and the medical device. 6. Changes to Product or Process When there are changes to an existing, approved and tested material, component or device, biocompatibility should be reevaluated if there is: • Any change in the source or in the specification of the materials used in the manufacture of the product; • Any change in the formulation, processing, primary packaging or sterilization of the material or product; • Any change in the manufacturer’s instructions or expectations concerning storage, e.g. changes in shelf life and/or transport; • Any change in the intended use of the product; • Any evidence that the material or product may produce adverse effects when used in humans. 7. Conclusions
Team MPDS
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In order for plastics processors and resin manufacturers to
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Sept.-Oct 2016
Quality Quality Management System : Changing Scenario & Challenges In Medical Device Regulations Mr. Sanjay Shah Owner Promoter Unikal Consultants, Ahmedabad. The impact of changing world scenerio vis-à-vis consumer awareness & requirement as also advancement in medical science is substantial but not significant as far as medical device industry is concerned especially in Indian context. Reasons are many but mainly due to lack of appropriate regulations and consumer enlightement. As for manufacturers world over including India, basic of the requirement, drawing a simile to c-GMP, requirement is QMS (Quality Management System) as per ISO:13485. Lot of change is happening the curent QMS. It is important to know what is meant by Quality, various definations: • In manufacturing, a measure of excellence or a state of being free from defects, deficiencies and significant variations. It is brought about by strict and consistent commitment to certain standards that achieve uniformity of a product in order to satisfy specific customer or user requirements. • Quality of something can be determined by comparing a set of inherent characteristic with a set of requirements. If those inherent characteristics meet all requirements, high or excellent quality is achieved. If those characteristics do not meet all requirements, a low or poor level of quality is achieved. • According to this definition, quality is a relative concept. By linking quality to requirements,ISO 9000 argues that the quality of something cannot be established in a vacuum.Quality is always relative to a set of requirements. Quality is therefore a question of degree, as a result, ISO 84021986 standard defines quality as ”the totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs”. So what is QMS: QMS is collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. What is the basis for current trend in changes in regulations of Medical Devices? EU Directive says, Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive. This means world is moving towards Risk based regulations. What is the risk involved in using the Medical Device, how to mitigate or reduce the risk to the user. Since this is continuous process, changing with enhancement of knowledge and Sept.-Oct. 2016
technology, regulatory requirements is also a dynamic process. It keeps on changing with time. In India scenerio, there is still no special Act for medical devices. It is covered under Drugs & Cosmetics Act & Rules and defined as drug. Also the medical devices included in the Act are very few and included by specific name and NOT by genral Harmonized defination of Medical Device. So almost un-regulated it is in the hands of either non qualified & unregulated manufacturers or foreign manufacturers from whom they are imported. Neither there is found need or encouragement to manufacture in India, medical device industry is in the nascent stage. Except in a few cases of low cost devices like IV Sets, Syringes etc. or manufactured by struggling but enterprising Indian companies producing Intra Ocular Lensees or coronary stents, rest of them ranging from catheters to MRI Scanning machines are imported. What are changes in medical device QMS based on ISO 13485? Following are excerpts from various sources: The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003. The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and post-market surveillance requirements. Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing manufacturers, accreditation/certification bodies and regulators time to transition to the new standard. According to a draft transition planning guidance, organizations will still be able to be accredited for either ISO 13485:2003 or ISO 13485:2016 for the first two years of the transition period; however, after the second year, new accreditation will only be given for ISO 13485:2016. After the third year, the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.” Background Many organizations involved with medical device development, including manufacturers and service providers use ISO 13485 to “demonstrate [their] ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.” Regulators worldwide have integrated ISO 13485 into their regulatory systems, including those in the US, EU, Canada, Australia and Japan. The standard is sometimes adapted to meet local requirements, for example, EN ISO 13485:2012 in the EU
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Quality adds a forward and several annexes to the standard specific to the region. ISO 13485 is also used for the Medical Device Single Audit Program (MDSAP), an international effort to reduce redundant audits of medical device manufacturers. “Many jurisdictions have got quality management system requirements for medical device manufacture and supply, so it’s really important that there’s a common understanding between the regulator and the industry as to what’s required for that quality management system,” said Eamonn Hoxey, former chair of ISO’s technical committee for quality management and corresponding general aspects for medical devices in a video interview on ISO’s website. What are ISO 13485:2016 Major Revisions ? The new edition of the ISO 13485 standard was published on March 1 2016, concluding almost five years of intense discussion and development by experts around the world to improve and update the standard with new international regulatory changes, implemented since its previous revision in 2003. ISO representative Maria Lazarte, relayed a list of major changes from the technical committee for ISO 13485. Some of the biggest changes between the 2003 and 2016 version include: • Incorporation of risk-based approaches beyond product realization. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements; • Increased linkage with regulatory requirements, particularly
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for regulatory documentation; • Application to organizations throughout the lifecycle and supply chain for medical devices; • Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard; • Emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties; • Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records; • Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and consideration of post-market surveillance; and • Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay. “it’s important to bear in mind that ISO 13485 does deal with the whole lifecycle from design and development, through manufacture, transport … and on to the end of life.” Quote from Mr. Hoxey. The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.
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Global Trends How Plasma Can Aid Catheter Manufacturing Leading Supplier Of Instruments Systems And Technology, Henniker, Explains How Plasma Can Aid Catheter Manufacture. a lower energy state). All of these components can interact with the surface during plasma treatment. By choosing the gas mixture, power, pressure etc we can quite precisely tune, or specify, the effects of the plasma treatment. Many polymers used in catheter manufacture are chemically inert and cannot bond easily to other materials, displaying poor adhesion with inks, paint and glues. The reason for this is the absence of polar and reactive functional groups in their structure. Plasma surface activation renders many polymers receptive to other coatings. Oxygen is usually used as the process gas, however, many plasma activations can also be carried out with just ambient air. Typical results for PU catheter materials that were modified by plasma treatment and then heparin coated revealed little or no protein binding after 30 days indwelling for example. In another example, hydrogel adhesion and friction reduction improvement figures up to 70% have been achieved by plasma treatment. Catheter function and patient health rely on strict material biocompatibility in order to prevent pathogen introduction and propagation and to reduce instances of associated urological and vascular problems.
(Ref: http://www.medicalplasticsnews.com/news/matter-inhand-how-plasm-can-aid-catheter-manufacturing/)
Plasma surface modification is proving to be a reliable and effective method for treating various component materials, and also finished devices, in order to minimise the potentially harmful side effects of catheter use. Plasmas can be tailored to deliver surface properties including anti-fouling, anti-microbial and increased lubricity amongst others. They can achieve a range of desirable properties either directly – by polymeric deposition – or indirectly, by introducing intermediate functional layers prior to application of a final surface finish or coating. Plasmas are not a lab curiosity. Plasma technology has been an important production tool for more than 30 years in the fabrication of microelectronic devices for example. Over this period, plasma technology has also permeated a much broader range of industries. It’s useful to define what a plasma is. Solid, liquid and gas are the three states of matter we are all familiar with. We can move between the states by adding or removing energy (eg heating/ cooling). If we continue to add enough energy, gas molecules will become ionised (lose one or more electrons) and so carry a net positive charge. If enough molecules are ionised to effect the overall electrical characteristics of the gas the result is called a plasma. Plasmas are therefore quite rightly, often referred to as the fourth state of matter. A plasma contains positive ions, electrons, neutral gas atoms or molecules, UV light and also excited gas atoms and molecules, which can carry a large amount of internal energy (plasmas glow because light is emitted as these excited neutral particles relax to
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Sept.-Oct 2016
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
Sept.-Oct. 2016
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Sept.-Oct 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. 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
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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 Sept.-Oct. 2016
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Industry News NIPER Ahmedabad To Collaborate With 2 US-Based Cos Towards Development Of Medical Device Industry Following its tie-up with Johnson & Johnson and Sahajanand Laser Technologies for development of industry-oriented skilled manpower in the medical device sector, the National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad is planning to collaborate with two US-based companies to equip the students to aggressively take up job roles for the holistic development of domestic industry. This would also help orient the curriculum of the post graduate studies in medical devices run exclusively at the NIPER Ahmedabad campus towards equipping with the latest updates on technology advancements in the country. This is a significant milestone as India’s import dependency on high-end medical devices is over 80 per cent and 60 per cent to 70 per cent for other devices. A dedicated medical devices park by the government is also currently in the process
of being set-up at Vishakhapatnam which will help in reducing import dependency and increasing export. Development of domestic industry has gained further impetus as government of India is planning to expand NIPERs across the country to nurture manpower and hence boost domestic manufacturing of medical devices in the country. More than 70 per cent of medical devices are imported as of today which has impacted the development of the domestic industry. NIPER Ahmedabad had earlier this year signed two MoUs with Johnson & Johnson and Sahajanand Laser Technologies to develop an ecosystem for development of medical devices sector in the country. As per official sources, a total of 17 MoUs were signed between seven NIPERs and pharma industry for academia industry linkages recently. Academia-industry linkage is a significant development as one
of the critical factors in building innovation ecosystem for medical devices industry. DoP has identified that academia-industry linkage as a basic requirement for translating research into development (commercialisation) and innovation; and also to fix accountability among the educational institutions. Further in India, the research and development in pharmaceuticals sector is spread across a number of ministries and departments viz., department of biotechnology, department of science and technology, department of scientific and industrial research, health systems research (ICMR) and department of pharmaceuticals. The DoP 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. (Ref: http://pharmabiz.com/ NewsDetails.aspx?aid=97584&sid=1)
Centre To Establish 3 Mega Industrial Parks In Gujarat For Medical Devices, Bulk Drugs The Central government will soon establish three mega industry parks in Gujarat which will include a Medical Devices Park, a Pharmaceutical Formulations Park and a Bulk Drugs Park. Speaking at the inaugural ceremony of the 7th edition of the Pharmac India 2016 held at the Gujarat University Exhibition Hall in Ahmedabad recently, Union minister of chemicals & fertilizers Ananth Kumar put forward a proposal in this regard. The minister offered to develop three pharma sector parks or clusters in Gujarat and promised funds to develop these parks in the state. ”The Centre is ready to give all kind of support to Gujarat if they are ready to start these parks in the state. Each park would require at least 200 acres of land. Central government is ready provide several facilities for these parks, such as effluent treatment plant and roads,” the Union minister said.
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Without wasting any time, the Gujarat chief minister Vijaybhai Rupani accepted the Centre’s proposal and said his government would start the work for identifying and acquiring the land for these parks at the earliest. “The stategovernment is very positive about these parks and we will do our best to see that these parks come up at the earliest. These parks are having a huge potential to provide employment opportunity to local youths and make Gujarat a global pharma hub,” Rupani said.
world and even with China. The proposed medical devices park will be the second one in the country similar to the Andhra Medical Technology Park, being set up in Visakhapatnam. The Centre has planned to develop six pharma clusters in India, where the central government will make the investments and create necessary infrastructure which will include testing facilities, effluent treatment facility, etc.
(Ref: http://www.pharmabiz.com/ Once in place, these mega parks will reduce NewsDetails.aspx?aid=98129&sid=1) the manufacturing cost by 30 www. medicalplasticsindia.com to 40 per cent, thus allowing t h e industry to compete THE ONLY INDIAN PORTAL SITE ON MEDICAL with the
PLASTIC / DEVICES TECHNOLOGY AND TRADE
Sept.-Oct 2016
Industry News Sahajanand Medical Technologies Opens New R&D Facility In Ireland Sahajanand Medical Technologies Pvt. Ltd.(SMT), India’s largest manufacturer of cardiovascular medical stents, has announced the opening of its new research & Development Centre in Galway City, Ireland. SMT aims to attract global talent through this new facility in Ireland to diversify its product portfolio. The company has significant investment plans to develop this R&D Centre. The core functions of SMT Ireland Centre would be R&D and logistics. The key on-going research projects at the facility are developing next generation of Stent and Advanced Balloon Catheter technology. The centre will have detailed and advanced research on developing next generation stent. It will be working on advanced balloon catheter and stent bifurcation application which will be a great help in complex cases. The centre will also be flexible from logistics point of view as it will be able to track and deliver the stents and other products in various parts of the world. The Ireland centre also plans to develop
new range of peripheral products along with guidewires and other coronary accessories.The R&D leadership team is in place now and more researchers are expected to join the team in the coming weeks. Commenting on the launch, Ganesh Sabat,CEO of SMT,said,“We were pioneers amongst Indian medical device companies and have seen tremendous value in investing in research & deve-lopment (R&D). Our early investments in R&D, beginning one and half decades ago, enabled us to make technology our key differentiator and develop a robust coronary stent for the world. Our core strength lies in our ability to excel in developing technologically complex products through focused teams.” The launch of the centre was attended by Sean Kyne, Minister of State, and Noel Larkin, Mayor of Galway City. This is a major investment by SMT to remain ahead of the curve in adopting latest
technologies through advanced research and compete with global competitors. Our aim is to continue to provide the most advanced technology to our consumers at competitive prices hence aligning with our vision of ‘pledge to save millions’. With this centre, we hope to tap into the global talent pool and explore the possible adaptation into the Indian market and strengthen India as a medical device manufacturing hub. This will provide a big fillip to support our Prime Minister’s dream of Make in India in the medical device industry, said Sabat. Established in the year 1998, SMT became the first indigenous player in India to successfully launch coronary stent. SMT is also the first company to get CE approval for DES with Biodegradable Polymers in the world. It is India’s largest stent manufacturing company and sells its product in more than 60 countries across the world. (Ref: http://www.pharmabiz.com/ NewsDetails.aspx?aid=97809&sid=2)
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
Sept.-Oct. 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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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
Professional Consultancy Services Available 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 34
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.
Surgical Industry For
SALE In Hyderabad, R. R. District, Telangana.
An ISO 9001:2008, 13485:2012 & GMP Certified Company Contact through:
surgicalindustrysale@gmail.com Sept.-Oct 2016
Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE
Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : 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
•
I.V. Infusion Sets
•
Blood Administration Sets
•
Scalp Vein Set
•
Urine Collection Bags
•
Ryles / Feeding Tubes
•
Catheters and Tubes
•
Surgical Gloves.
Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com Sept.-Oct. 2016
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Product Gallery Qosina Introduces New Barbed Check Valves 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. 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 different 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.
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
Qosina To Attend BPSA’s 2016 Inaugural European Summit Ronkonkoma, NY – August 31, 2016–Qosina is pleased toattendthe Bio-Process Systems Alliance’s(BPSA) 2016 European Single-Use Technologies (SUT) Summit at The Crowne Plaza Barcelona – Fira Center in Barcelona, Spain, September 26-28. The European Summit’s goal is to educate, engage and network with European SUT manufacturer colleagues and strengthen BPSA’s bond with existing European-based suppliers and endusers. The European Summit also will address the SUT industry’s business challenges, technical issues and implementation strategies specific to its European audience, and will allow ample networking time for colleagues and customers. For more information on this event and Qosina’s affiliation with BPSA, please call Qosina at +1(631) 242-3000 or email info@qosina.com. Founded in 1980, 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, tuohy borst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Qosina is now based in Ronkonkoma,
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NY in a 95,000 square foot facility with an ISO Class 8 Clean Room and is ISO 9001 and ISO 14001 registered. 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 at +1(631) 242-3000 or email info@qosina.com. Contact: Qosina Deanna Whelan 2002-Q Orville Drive North, Ronkonkoma, NY 11779. Phone +1 (631) 242-3000 Fax +1 (631) 242-3230 Email: deanna@qosina.com
Sept.-Oct 2016
Events MEDICAL MANUFACTURING ASIA 2016: Positive Showing With Top Quality Prospects • Targeted and quality visitor and delegate profile • Southeast Asia continues to be main region of focus for exhibitors 06 October 2016 – MEDICAL MANUFACTURING ASIA 2016 closed on 2 September to a positive note of 5,200 quality trade visitors from 38 countries, with more than 30% coming from overseas. The importance of MEDICAL MANUFACTURING ASIA 2016 as an arena for the display of the latest technologies and solutions from the medical technology and medical manufacturing processes sector was further highlighted by the strong participation of 200 exhibitors from 18 countries. Aside from significant presence of returning national and country groups from Austria, China, Germany, Japan and Singapore, MMA 2016 saw the additions of Italy, USA and Europe – a group presence led by IVAM Microtechnology Network. These figures are on trend and indicative of MEDICAL MANUFACTURING ASIA’s alignment with Southeast Asia’s vibrant MedTech sector which has seen robust growth of downstream medical manufacturers and enhanced manufacturing capabilities in the recent years. Once again co-located with MEDICAL FAIR ASIA, the two synergistic exhibitions provided an ideal business-promoting platform for all those involved in medical and healthcare as highlighted in the opening speech by Mr S Iswaran, Minister for Trade and Industry (Industry), and at a new and bigger venue, the Sands Expo and Convention Centre. He also stressed Singapore’s strong position as a gateway for MedTech companies, both local and foreign, to access growing markets in the region, and Singapore’s reputation as a trusted business hub. Reiterating the same standpoint is Mr John Lim, Lead, MedTech Initiative, Precision Engineering Centre of Innovation, SIMTech, and one of the key speakers at the MedTech Business Forum, who shared of Southeast Asia’s tremendous growth potential, primarily due to its sheer size, and growing ageing population. “We are seeing a lot of opportunities in the areas of personalised medicine, especially inter-connectivity, as well as a lot more devices for localisation. I think it is a great platform to basically share not only what we have, by inviting speakers from renowned MedTech players, analysts from Ernst & Young, as well as Frost and Sullivan, our focus is also on driving R&D and innovation, looking at causing some disruption to the industry.” Mr Gernot Ringling, Managing Director, Messe Düsseldorf Asia, commented that MEDICAL MANUFACTURING ASIA continues to address challenges of accessing Asian markets with its differing characteristics, and serves as a central meeting place and launch pad for the medical manufacturing industry to enhance capabilities and to establish networks, as well as to grow their business in the region. “The healthy exhibitor and visitor numbers are testament of the local and international attention and standing of the exhibition, which connects the industry, pairing exhibitors to key decision makers and the right audience profile. Together with the concurrently run forums (IVAM Forum on high-tech medical Sept.-Oct. 2016
devices, and MedTech Business Forum) and workshops which were well-attended by more than 200 delegates, and colocation with MEDICAL FAIR ASIA – this one-stop platform is the only one of its kind in the region that offers a conducive sourcing and knowledge-exchange experience for all involved.” Dr. Thomas R Dietrich, CEO, IVAM Microtechnology Network, pointed out that there are in fact few trade events on the world exhibition calendar that zoom-in on the specifics of medical technology. He said: “It is very important to have this kind of show – what we have only rarely is what we see here at the MEDICAL MANUFACTURING ASIA that is, the technology itself. IVAM represents the micro and nano technology side and I believe that this kind of product and this kind of technology is very important for the medical industry.” Established as Asia’s leading exhibition for the medical technology, medical manufacturing processes and related sectors, MEDICAL MANUFACTURING ASIA 2016 – modelled after COMPAMED in Germany, is jointly organised by SPETA (Singapore Precision Engineering and Technology Association) and Messe Düsseldorf Asia. According to repeat exhibitor and prominent local company SP Manufacturing that specialises in full turnkey manufacturing solutions from prototype services to global technology OEMs, “the quality of responses and enquiries is more genuine, so the opportunities we have been able to gather from the leads that we have received should translate to a higher conversion rate than what I see in other exhibitions where I have attended,” said Mr Mark Teo, Group CEO, SP Industrial Holdings. For Italian preinsulated panel solutions company P3 SRL, Southeast Asia continues to be the region of choice and Singapore the centre for quality solutions. Commenting on the high quality visitor profile, Mr Enrico Chiabrera, Commercial Director, said: “We are very much appreciative of the feedback because many customers and consultants we have seen have been decision makers, and they expressed good impressions regarding our solutions. We also met people from Singapore of course, and from Malaysia, Indonesia and other countries like Thailand and even from Myanmar.” Similar sentiments were also gathered from visitors to MEDICAL MANUFACTURING ASIA 2016. Said first-time visitor, Dr Dominic Er, Executive Chairman of Quantum Health (Singapore): “I was surprised by the size of the exhibition and the turnout. Having been in the medical industry for most of my life, this is one of the best shows that I have visited as I saw many new and interesting exhibits on display. I came here looking for breakthrough products and services that my newly established company can acquire and
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Events I found that the two exhibitions have a good mix of exhibits.” His thoughts were echoed by Mr Mohamed Salih, Chairman of D a m a s Company Pvt Ltd (Republic of Maldives), who mentioned that his visit to MEDICAL MANUFACTURING ASIA 2016 has been a mind-opening one. “I was exposed to the latest medical technologies, cost-effective solutions and innovative products that would benefit end users. I also had the opportunity to interact with the international pool of exhibitors at the exhibition – will certainly be back in 2018”, he said. Optimistic statements at MEDICAL MANUFACTURING ASIA 2016 from both exhibitors and visitors were backed by a host of business matching meetings and strategic alliance building that reflected both the diversity and health of the MedTech industry. The next edition of MEDICAL MANUFACTURING ASIA will take place in September 2018. Press Contact: Fulvia Wong, Exhibitor Contact: Daphne Yo, Tel: + 65 6332 9649 Tel: + 65 6332 9682 fulvia@mda.com.sg daphne@mda.com.sg
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Events Calender • MEDICA and COMPAMED 2016 : The World’s No.1 Trade Fair for Plastics and Rubber Date:14-17 November 2016. Venue: Dusseldorf, Germany. • Plastivision India 2017 : International Plastics Exhibition & Conference Date : 19-23 January. Venue : Bombay Convention & Exhibition Center, Mumbai • 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 2016 : February, 2017. Ahmedabad • Medical Fair India 2017 : 23rd International Exhibition and Conference Date: 06-08 April, 2017 Venue: Pragati Maidan, New Delhi.
Sept.-Oct 2016
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 Sept.-Oct. 2016
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 39
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
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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
Sept.-Oct 2016
A WHOLE RANGE OF MEDICAL TAPES & DRESSINGS
STERIPORE Microporous Tape CLEARPORE Perforated PE Tape
STERIPORE
+ Super Microporous Tape
STERIDERM - IV IV Cannula Fixator
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STERIPORE SAFE Anti Microbial Microporous Tape
STERIPORE SOFT PEEL Silicon Gel Tape
POROUSPLAST
AN ISO 9001:2008, EN ISO 13485:2012 Certified | WHO GMP CERTIFIED COMPANY
Innovating for Tomorrow
Zinc Oxide Plaster
