CToabnletoef nts 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 17
Flashback ?YoDKuindow ? May. - Jun. 2004 About Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices From Editor’s Desk Dear Readers, FDA’s Center for Devices and Radiological Health (CDRH) is responsible for assuring the safety, effectiveness, performance and quality of medical devices This issue of “MEDICAL PLASTICS DATA SERVICE” and radiation emitting products used to treat, prevent, and diagnose disease takes a closer look at Intravenous Infusion Therapy throughout the product life cycle thereby reducing the time to market, improving Products. Majority of surgical patients and almost a third safety, and making the process least burdensome. of non-surgical inpatients need intravenous therapy. While CDRH has published FY 2017 regulatory science priorities to help focus the Center’s the bulk of demand is for traditional gravity flow design for attention on the most important regulatory science gaps or needs as under : the I.V.Sets, there many specific application requirements • Leverage “Big Data” for regulatory decision-making which are discussed in this issue. • Modernize biocompatibility and biological risk evaluation of device materials • Leverage real-world evidence and employ evidence synthesis across multiple This is also a medical technology industry segment which accounts for a very large number of SMEs. domains in regulatory decision-making • Advance tests and methods for predicting and monitoring medical device clinical With the changing market scenario, increasing quality awareness, globalisation, tightening Drug Control performance Regulations, there are many challenging issues the • Develop methods and tools to improve and streamline clinical trial design industry is facing to-day. • Develop computational modeling technologies to support regulatory MPDS took the opportunity to interact with the leader of decisionmaking the industry in India, Mr K J Park, Managing Director of • Enhance the performance of Digital Health and strengthen medical device Hyderabad based “Sangam Healthcare ProductsLtd”. We are grateful to Mr. Park for being generous in cybersecurity sharing his rich techno-commercial experience with • Reduce healthcare associated infections by better understanding the our readers. effectiveness of antimicrobials, sterilization and reprocessing of medical devices One more important issue highlighted is regarding • Collect and use patient input in regulatory decision-making selecting the European Authorized Representative. • Leverage precision medicine and biomarkers for predicting medical device This is an important requirement for non-European medical device manufacturers and exporters to EU performance, disease diagnosis and progression countries. Mr. Sanjay Shah who is an eminent Quality Document providing an overview of the process that CDRH used to generate these Certification Consultant, provides guidelines for selection Priorities is available at : http://www.fda.gov/downloads/MedicalDevices/ of The European Authorized Representative for CE ScienceandResearch/UCM521503.pdf Certified Medical Devices Manufacturers. In a This issue of “MEDICAL PLASTICS DATA SERVICE” also Nutshell.... covers regular features like Important Events viz. HOSPIMedica ASIA 2004, Medica and ComPaMED 2004, The pursuit of knowledge is MediNET Forum, Industry News, Global Trends etc. never-ending. The day you stop seeking knowledge is the day you CONTENTS stop growing. • Cover Story : - Intravenous Therapy Products • Face To Face with Mr. K J Park - Brandon Travis Ciaccio • Quality : The European Authorized Representative for Sept.-Oct. 2016 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 18
EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. The government of India has an ambitious plan to increase EDITORIAL ADVISORY BOARD competitiveness of the Indian Medical Device industry globally by Dr. TARANG PATEL helping it to bring down the manufacturing cost significantly. As per Mr Ananth Kumar, Minister for Chemicals & Fertilizers and M.B.B.S., M.Ch. (ONCO) Parliamentary Affairs, “Setting up of Medical Device parks can bring down the Cancer & Reconstructive Surgeon manufacturing cost by another 30 per cent and make Indian medical technology sector globally competitive, due to pooling of common facilities,” Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. With the initiative from the Hon. Chief Minister of Andhra Pradesh Mr N. Chandrababu Chairman - Mobilexion Technologies Pvt. Ltd. Naidu, Andhra Pradesh us emerging as manufacturing hub for medical devices with establishment of country’s first Medical Technology Manufacturing Zone, Andhra MedTech Trivandrum 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 Dr. DILIP H. RAIKER enterprises, build and support them so that they become exporters, essentially meaning Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) strengthening of the micro , small & medium enterprise (MSME) sector”. Former Chief Manager(P), CIPET - Chennai Mr Ananth Kumar has also put forward a proposal that the Central government will soon ING LOUIS C. SUHUURMAN establish three mega industry parks in Gujarat which will include Medical Devices, Formerly Sales Director Pharmaceutical Formulations and Bulk Drugs Parks. The Gujarat Chief Minister Mr COLPITT B.V., Holland Vijaybhai Rupani has already accepted the centre’s proposal and would like to see that these parks come up at the earliest. Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group 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 Dr. C.S.B. NAIR into contact with human tissue must all be evaluated for biocompatibility. Through a very Director (R&D), Peninsula Polymers Ltd 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 Dr. BHARAT GADHAVI Components”. Dr Sastr, apart from his long and rich experience in the Quality CEO, Medisurge Hospitals Management Systems (QMS), is also the author of the book,” Plastics In Medical Devices : Properties, Requirements and Applications”. Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai 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 Dr. SUJOY K. GUHA issue also highlights the global regulatory science priorities for assuring safety, B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. effectiveness and quality of medical devices. IIT, Kharagpur It also includes our regular columns highlighting Global Trends, Industry News , Technology as well as important events for the benefit of our readers. 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: [email protected] Website:www.medicalplasticsindia.com DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-58 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. Sept.-Oct. 2016 19
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, • Component Testing centre leading to tremendous import dependency. Lack of domestic • Electro-magnetic interference laboratory manufacturing of medical devices is the main reasons for this • Medical grade low vacuum molding, cabinet molding, injection import dependency and high cost of medical products and molding centres services in the country. To address this situation, Govt. of Andhra • 3 D designing and printing for medical grade products Pradesh aims to establish country’s first Medical Technology • Sterilization & Toxicity testing centre Manufacturing Park at Vishakhapatnam. The goal of this • Radiation testing centre progressive initiative would be to make Andhra Pradesh an • Gamma Irradiation facility internationally recognized manufacturing hub for medical • Rapid Prototyping Centre devices, help in national agenda of import substitution, make • Industrial R & D Centre Andhra Pradesh a leader in medical technology exports, • Incubation Centre generate employment, and contribute to volume generated cost • Convention Centre & Expo Halls reduction of medical devices for patients. In a meeting organized • Warehousing on 6th Nov, 2015, Hon’ble Chief Minister of Andhra Pradesh • Regulator’s office shared his vision on this important project with Medical Devices • Other facilities commonly required in manufacturing of medical Manufacturing Associations, Central Govt. officials and State devices Health Authorities. All investment towards The creation of such as land development, and building of park is based on the fact common facilities as above would be done that medical devices by the Govt. of Andhra Pradesh with support manufacturing requires of Central Government certain high investment Departments through Andhra Pradesh Med facilities which are too Tech Zone. Pvt Ltd – an SPV established capital intensive for under the Department of Health, Medical & individual manufactures Family Welfare, Govt. of AP. 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%. Currently, due to lack of AMTZ Foundation Stone Laying Ceremony The AMTZ Team is led 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 include following facilities: prospective manufacturers and service providers under the AMTZ 20 Sept.-Oct. 2016
Technology ISO : 13485 : 2012 JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 & CERTIFIED COMPANY AMTZ Investors’ Summit 2016 Manufacturers & Exporters of Disposable Medical Devices Investors’ Summit 2016. The Chief Minister also launched the AMTZ Investors’ Brochure and it is available for download on Infusion Set, Blood Administration Set, AMTZ’s official website. EOI for Common Scientific Facilities IV Cannula, Urine Bag, Catheters, Gloves, as well as Online bookings for manufacturing units is opened HIV KITs, Ophthalmic KITs, Ophthalmic Knives and the application forms are available on AMTZ’s official (Blades), Cap, Mask, Gown, Drapes, Bandages, website www.AMTZ.in Dressings etc. For AMTZ Investors’ Brochure and further queries please contact Andhra Pradesh MedTech Zone Ltd. Specialized in Handling Large Quantity Hill No. 2, IT Park, VSEZ, Madhurwada, & OEM / Contract Manufacturing Visakhapatnam – 530045. P.No.- 08885092122 | Email: [email protected] / Website: www.AMTZ.in 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 : 21 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] Sept.-Oct. 2016
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 Regulation. Section 7 of Annex 1 details the requirements for a are safe and effective. Safety considerations should include medical device and material chemical, physical and biological usability, energy, operation, informational, and chemical and properties. biological hazards. Biological hazards can be extensive and In September 2016, the Center for Devices and Radiological complex. When materials come in contact with human skin or Health (CDRH) in the USA published the CDRH Regulatory tissue, their biocompatibility should be evaluated. The importance Science Priorities (FY2017). One of the top 10 priorities for of patient safety with respect to biocompatibility continues to be 2017 is to “Modernize biocompatibility and biological risk an important area that regulatory bodies continue to focus on. 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 management process, implantable or patient- updated in 2009, added the contacting medical risk management process FINISHED DEVICE MANUFACTURER devices” The report based on ISO 14971 in the (PRODUCES THE FINISHED DEVICE) emphasizes that “less selection and evaluation of burdensome biocompatible materials. In Evaluate the biocompatibility of the total finished device approaches that are 2016, the United States FDA more patient-centric published its final guidance and predictive of real- titled Use of International world device Standard ISO 10993-1, performance are Biological evaluation of PROCESSOR, CONVERTER needed to modernize medical devices - Part 1: and transform Evaluation and testing within (PRODUCES PARTS, COMPONENTS, DEVICE) biocompatibility a risk management process. Ensure biocompatibility of material is maintained evaluation of medical This guidance document devices and their after processing. Control production. covers the use of the materials.” standard including specific The medical device requirements that the agency expects in selection, manufacturer is testing, evaluation and documentation. In June RAW MATERIAL MANUFACTURER ultimately responsible 2016, the European Parliament and the Council (PRODUCES RESIN, COMPOUNDED RESIN) for the safety and of the European Union Evaluate biocompatibility of the resin. published its draft proposal Control formulation and production. effectiveness of the final on its new Medical Device Raw Material To Finished Device Value Chain device. The device, its components and raw materials that come into contact with human 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 Sept.-Oct. 2016
Manufacturing to the fitness for the device’s intended use with respect to chemical, toxicological, physical, electrical, morphological and tissue must all be evaluated for biocompatibility. As a result, mechanical properties. With respect to the biological suppliers of parts, components and resin that are used to build evaluation of the device, the following should be considered: the device should also do their part in ensuring that the products or processing conditions do not adversely affect the biocompatibility i. The properties of the base resin of those products. Figure 1 illustrates the raw material to finished device value chain with respect to plastic materials and The choice of the base resin can be constrained by the components. There may be instances where the resin application and process needs of the device. For example, manufacturer directly supplies the raw material to the medical hydrolytically unstable resins cannot be used in implants. device manufacturer who does their own processing and Highly porous materials may not be suitable under ethylene converting. oxide sterilization because unremoved residuals from ethylene oxide could impact patient safety. Thermally unstable The steps involved the selection of materials and their evaluation grades cannot be used in applications where high temperature and testing is as follows: autoclave sterilization is required. In addition to physical and mechanical instability, degradation products could affect the 1. Risk Assessment material’s biocompatibility. The intended use and application of the final device is first ii. The material formulation identified. The initial design concepts can be used to conduct an initial risk assessment of the device design, the material Additives, catalysts, colorants, fillers, nanoparticles, and component characteristics, the manufacturing processes plasticizers and other materials either alone or by interactions including sterilization, the clinical use of the device, and the with each other can significantly affect biocompatibility. If each nature and duration of contact with human tissue. individual component of the formulation is claimed to be biocompatible, it does not automatically mean that the The nature of contact falls into three categories per the complete, formulated material is biocompatible. standard. Compounders should evaluate the breadth of additives and a range of levels in their formulations to gain maximum flexibility • Surface contacting devices – Those devices contacting skin, of biocompatible materials in their portfolio. mucosal membranes or breached and compromised surfaces (broken skin) iii. Manufacturing Processes – Degradation and Residues • External contacting devices – Those devices that contact Excessive heat and shear during the manufacturing of plastic blood paths indirectly, tissue/bone/dentin and circulating parts can change the levels of extractables and leachables in devices the final part and thus significantly affect biocompatibility. Joining and cleaning of parts and residues from materials • Implantable devices – Those devices that come into long used in facilitating production (e.g. mold release) can also term contact with tissue and bone, and blood change a product’s biological properties. Processors should define the process ranges that will not affect biocompatibility. The durations of contact are: iv. Master Files • Limited Exposure – Contact up to 24 hours • Prolonged exposure - Contact between 24 hours and <29 In the case where formulations are proprietary, Device Master Files (MAF) of the product can be used. Material suppliers can days submit a Device Master File that is privy only to the FDA for • Permanent contact – Contact e” 30 days review and evaluation of final device submissions. Device Master Files typically contain the name of the product, its This information should be used to identify potential risks formulation (ingredients and levels), manufacturing conditions, with respect to biocompatibility and the types of sterilization compatibility, physical and mechanical properties, biocompatibility tests that need to be conducted. The standard known impurities and chemical characterization. Included are and the guidance document allow for the use of historical also biocompatibility screening studies. data and information to make informed decisions before committing to extensive biocompatibility testing. 4. Biological Evaluation 2. Identification of Potential Risks and Exposure Assessment In order to reduce unnecessary testing, including animal testing, manufacturers should first consider all available The physical and chemical characteristic of the materials relevant information from literature and test data. For example, under evaluation should be listed. Before conducting any in some circumstances, a chemical analysis can demonstrate biocompatibility tests the potential risks can be evaluated that the extractables and leachables using a specific solvent using methods like literature and historical data.Sources of have not changed compared to a baseline material, information on potential biocompatibility risks can include eliminating the need for additional biocompatibility testing previous experience with the same material(s) that have been using that type of solvent. In addition, chemical analyses can used in the same or similar devices in the same anatomical be used to assess the toxicological risk of the chemicals that location. In addition post market data for similar devices and elute from devices. For example, chemical analysis using applications can also provide a rich source of data as an exhaustive extraction techniques can also be helpful to 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 23
Manufacturing understand the critical characteristics and application of the final device their products go into, the lines of communication evaluate long-term toxicity endpoints such as potential between medical device manufacturer and their suppliers carcinogens. should be seamless and effective. Processors of the components and parts should control their production It is critical that test articles are prepared using the proper processes so as not to affect or change the biocompatibility of methods and solvents and also using representative the material provided by the resin supplier. Resin suppliers configurations of the end product. Both polar and non-polar (virgin or compounded) should provide the basic solvents should be used. Extraction conditions based on the biocompatibility characteristic to both the processor and the device application and use should also be employed. finished medical device manufacturer. Any changes to material Justification of the selected extraction conditions should be or process should be communicated to the medical device provided. manufacturer, as the medical device manufacturer is ultimately responsible to ensure safety, effectiveness and biocompatibility Developing “finger prints” of the extractables and leachables of their finished device. can help in decisions for additional biocompatibility testing if there are changes to materials and manufacturing conditions. wishing our Readers a Very If the “finger prints” match the rationale not to conduct additional biological tests can be made. Happy Diwali & Prosperous New Year When biocompatibility tests are required, the decision on the applicable tests can be identified using the Table A.1 in Annex Team MPDS A of the standard. The evaluation tests described should be considered and carried out where necessary tocomplete the Required data sets needed for the biological evaluation of the particular medical device or its materials and components. Medical Device Manufacturing Facility On Loan License Basis Considerations should be made for testing like cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, We are looking for loan license for genotoxicity, carcinogenicity, reproductive and developmental Epidural, CVC and Dialysis catheters, toxicity and degradationassessments. fistula needles, biopsy needles, spinal needles, pressure monitoring lines, 5. Biocompatibility Documentation Guidewires, ETC. Due to the diversity of medical devices, not all biocompatibility Party having manufacturing license or tests identified in a category will be necessary or practical. willing to take license or interested to Documentation of biocompatibility evaluation and testing work together should write immediately. should include: For Enquiries and Detail mail us on :- [email protected] • The strategy, plan and content for the biological evaluation of the medical device, part or material; Sept.-Oct 2016 • 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 In order for plastics processors and resin manufacturers to 24
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 technology, regulatory requirements is also a dynamic process. It awareness & requirement as also advancement in medical science keeps on changing with time. is substantial but not significant as far as medical device industry is concerned especially in Indian context. In India scenerio, there is still no special Act for medical devices. It is covered under Drugs & Cosmetics Act & Rules and defined Reasons are many but mainly due to lack of appropriate regulations as drug. Also the medical devices included in the Act are very few and consumer enlightement. and included by specific name and NOT by genral Harmonized defination of Medical Device. As for manufacturers world over including India, basic of the requirement, drawing a simile to c-GMP, requirement is QMS So almost un-regulated it is in the hands of either non qualified & (Quality Management System) as per ISO:13485. unregulated manufacturers or foreign manufacturers from whom they are imported. Lot of change is happening the curent QMS. Neither there is found need or encouragement to manufacture in It is important to know what is meant by Quality, various definations: India, medical device industry is in the nascent stage. Except in a few cases of low cost devices like IV Sets, Syringes etc. or • In manufacturing, a measure of excellence or a state of being manufactured by struggling but enterprising Indian companies free from defects, deficiencies and significant variations. It is producing Intra Ocular Lensees or coronary stents, rest of them brought about by strict and consistent commitment to certain ranging from catheters to MRI Scanning machines are imported. standards that achieve uniformity of a product in order to satisfy specific customer or user requirements. What are changes in medical device QMS based on ISO 13485? • Quality of something can be determined by comparing a set of inherent characteristic with a set of requirements. If those Following are excerpts from various sources: inherent characteristics meet all requirements, high or excellent quality is achieved. If those characteristics do not The International Organization for Standardization (ISO) late last meet all requirements, a low or poor level of quality is achieved. month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), • According to this definition, quality is a relative concept. By which replaces the previous version from 2003. linking quality to requirements,ISO 9000 argues that the quality of something cannot be established in a vacuum.Quality is The new revision places a greater emphasis on QMS throughout always relative to a set of requirements. the supply chain and product lifecycle, as well as device usability and post-market surveillance requirements. Quality is therefore a question of degree, as a result, ISO 8402- 1986 standard defines quality as ”the totality of features and Over the next three years, ISO 13485:2003 and ISO 13485:2016 characteristics of a product or service that bears its ability to will coexist, allowing manufacturers, accreditation/certification satisfy stated or implied needs”. bodies and regulators time to transition to the new standard. So what is QMS: According to a draft transition planning guidance, organizations will still be able to be accredited for either ISO 13485:2003 or ISO QMS is collection of business processes focused on consistently 13485:2016 for the first two years of the transition period; however, meeting customer requirements and enhancing their satisfaction. after the second year, new accreditation will only be given for ISO 13485:2016. What is the basis for current trend in changes in regulations of Medical Devices? After the third year, the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.” EU Directive says, Background Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance Many organizations involved with medical device development, levels attributed to them by the manufacturer; whereas, therefore, including manufacturers and service providers use ISO 13485 to the maintenance or improvement of the level of protection attained “demonstrate [their] ability to provide medical devices and related in the Member States is one of the essential objectives of this services that consistently meet customer and applicable regulatory Directive. requirements.” This means world is moving towards Risk based regulations. Regulators worldwide have integrated ISO 13485 into their What is the risk involved in using the Medical Device, how to regulatory systems, including those in the US, EU, Canada, mitigate or reduce the risk to the user. Since this is continuous Australia and Japan. The standard is sometimes adapted to meet process, changing with enhancement of knowledge and local requirements, for example, EN ISO 13485:2012 in the EU Sept.-Oct. 2016 25
Quality adds a forward and several annexes to the standard specific to for regulatory documentation; the region. • Application to organizations throughout the lifecycle and supply ISO 13485 is also used for the Medical Device Single Audit chain for medical devices; Program (MDSAP), an international effort to reduce redundant • Harmonization of the requirements for software validation for audits of medical device manufacturers. different software applications (QMS software, process “Many jurisdictions have got quality management system control software, software for monitoring and measurement) requirements for medical device manufacture and supply, so it’s in different clauses of the standard; really important that there’s a common understanding between • Emphasis on appropriate infrastructure, particularly for the regulator and the industry as to what’s required for that quality production of sterile medical devices, and addition of management system,” said Eamonn Hoxey, former chair of ISO’s requirements for validation of sterile barrier properties; technical committee for quality management and corresponding • Additional requirements in design and development on general aspects for medical devices in a video interview on ISO’s consideration of usability, use of standards, verification and website. validation planning, design transfer and design records; What are ISO 13485:2016 Major Revisions ? • Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and The new edition of the ISO 13485 standard was published on consideration of post-market surveillance; and March 1 2016, concluding almost five years of intense discussion • Planning and documenting corrective action and preventive and development by experts around the world to improve and action, and implementing corrective action without undue update the standard with new international regulatory changes, delay. implemented since its previous revision in 2003. “it’s important to bear in mind that ISO 13485 does deal with the ISO representative Maria Lazarte, relayed a list of major changes whole lifecycle from design and development, through from the technical committee for ISO 13485. manufacture, transport … and on to the end of life.” Some of the biggest changes between the 2003 and 2016 version Quote from Mr. Hoxey. include: The new ISO 13485:2016 focuses on how companies should • Incorporation of risk-based approaches beyond product manage risk-based decisions related to purchasing, design, realization. Risk is considered in the context of the safety and development, manufacturing, production control activities and performance of the medical device and in meeting regulatory other aspects of the quality management system. requirements; • Increased linkage with regulatory requirements, particularly 26 Sept.-Oct 2016
Sept.-Oct. 2016 27
Global Trends How Plasma Can Aid Catheter Manufacturing Leading Supplier Of Instruments Systems And Technology, Henniker, Explains How Plasma Can Aid Catheter Manufacture. Catheter function and patient health rely on strict material a lower energy state). All of these components can interact with biocompatibility in order to prevent pathogen introduction and the surface during plasma treatment. By choosing the gas mixture, propagation and to reduce instances of associated urological and power, pressure etc we can quite precisely tune, or specify, the vascular problems. effects of the plasma treatment. Plasma surface modification is proving to be a reliable and effective Many polymers used in catheter manufacture are chemically inert method for treating various component materials, and also finished and cannot bond easily to other materials, displaying poor devices, in order to minimise the potentially harmful side effects adhesion with inks, paint and glues. The reason for this is the of catheter use. absence of polar and reactive functional groups in their structure. Plasma surface activation renders many polymers receptive to Plasmas can be tailored to deliver surface properties including other coatings. Oxygen is usually used as the process gas, anti-fouling, anti-microbial and increased lubricity amongst others. however, many plasma activations can also be carried out with They can achieve a range of desirable properties either directly – just ambient air. by polymeric deposition – or indirectly, by introducing intermediate functional layers prior to application of a final surface finish or Typical results for PU catheter materials that were modified by coating. plasma treatment and then heparin coated revealed little or no protein binding after 30 days indwelling for example. In another Plasmas are not a lab curiosity. Plasma technology has been an example, hydrogel adhesion and friction reduction improvement important production tool for more than 30 years in the fabrication figures up to 70% have been achieved by plasma treatment. of microelectronic devices for example. Over this period, plasma technology has also permeated a much broader range of (Ref: http://www.medicalplasticsnews.com/news/matter-in- industries. hand-how-plasm-can-aid-catheter-manufacturing/) 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 28 Sept.-Oct 2016
Manufacturer And Exporter Of a ISO 9001-2000 Quality Medical Devices wide range Of Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, REGISTERED Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, FIRM Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Wide Range Of Products : Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical The company Cord Clamp etc... manufactures a wide range The company markets products its own brand name ANGELTOUCH. of Medical devices, which Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. fall under the main domains of : Expertise & Experience : Infusion Therapy, – OEM/Contract Manufacturing. Transfusion Therapy, – Supply of Components for Medical Devices. Dialysis, Gastroenterology, Urology, Anesthesia, ANGIPLAST and Surgery. Private Limited Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: [email protected]/[email protected] Website : www.angiplast.com Sept.-Oct. 2016 29
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® Alpha Medicare and Devices Ltd. (taking care…Since1984) Manufacturers & Exporters of Disposable Medical Devices GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. • Exporting our products to almost more than 23 countries. ISO 13485 : 2003 Contact : 0434 Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : [email protected] SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • Regulators / Cord Clamp • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • PP Mucas Container • And many other Surgical Medical Components Contact : 31 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] Sept.-Oct. 2016
Industry News NIPER Ahmedabad To Collaborate With 2 US-Based Cos Towards Development Of Medical Device Industry Following its tie-up with Johnson & Johnson of being set-up at Vishakhapatnam which of the critical factors in building innovation and Sahajanand Laser Technologies for will help in reducing import dependency and ecosystem for medical devices development of industry-oriented skilled increasing export. industry. manpower in the medical device sector, the DoP has identified that academia-industry National Institute of Pharmaceutical Development of domestic industry has linkage as a basic requirement for Education and Research (NIPER), gained further impetus as government of translating research into development Ahmedabad is planning to collaborate with India is planning to expand NIPERs across (commercialisation) and innovation; and two US-based companies to equip the the country to nurture manpower and hence also to fix accountability among the students to aggressively take up job roles boost domestic manufacturing of medical educational institutions. Further in India, the for the holistic development of domestic devices in the country. More than 70 per research and development in industry. cent of medical devices are imported as of pharmaceuticals sector is spread across a today which has impacted the development number of ministries and departments viz., This would also help orient the curriculum of the domestic industry. department of biotechnology, department of the post graduate studies in medical of science and technology, department of devices run exclusively at the NIPER NIPER Ahmedabad had earlier this year scientific and industrial research, health Ahmedabad campus towards equipping signed two MoUs with Johnson & Johnson systems research (ICMR) and department with the latest updates on technology and Sahajanand Laser Technologies to of pharmaceuticals. advancements in the country. develop an ecosystem for development of medical devices sector in the country. The DoP for the last one year has actively This is a significant milestone as India’s engaged both the NIPERs and the pharma import dependency on high-end medical As per official sources, a total of 17 MoUs industry to build partnership in areas of devices is over 80 per cent and 60 per cent were signed between seven NIPERs and education, research and development. to 70 per cent for other devices. A pharma industry for academia industry dedicated medical devices park by the linkages recently. Academia-industry (Ref: http://pharmabiz.com/ government is also currently in the process linkage is a significant development as one 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 Without wasting any time, the Gujarat chief world and even with China. three mega industry parks in Gujarat which minister Vijaybhai Rupani accepted the will include a Medical Devices Park, a Centre’s proposal and said his government The proposed medical devices park will be Pharmaceutical Formulations Park and a would start the work for identifying and the second one in the country similar to Bulk Drugs Park. acquiring the land for these parks at the the Andhra Medical Technology Park, being earliest. “The stategovernment is very set up in Visakhapatnam. Speaking at the inaugural ceremony of the positive about these parks and we will do 7th edition of the Pharmac India 2016 held our best to see that these parks come up The Centre has planned to develop six at the Gujarat University Exhibition Hall in at the earliest. These parks are having a pharma clusters in India, where the central Ahmedabad recently, Union minister of huge potential to provide employment government will make the investments and chemicals & fertilizers Ananth Kumar put opportunity to local youths and make create necessary infrastructure which will forward a proposal in this regard. The Gujarat a global pharma hub,” Rupani said. include testing facilities, effluent treatment minister offered to develop three pharma facility, etc. sector parks or clusters in Gujarat and promised funds to develop these parks in Once in place, these mega parks will reduce (Ref: http://www.pharmabiz.com/ the state. the manu- NewsDetails.aspx?aid=98129&sid=1) ”The Centre is ready to give all kind of facturing www. medicalplasticsindia.com support to Gujarat if they are ready to start cost by 30 these parks in the state. Each park would to 40 per require at least 200 acres of land. Central cent, thus government is ready provide several facilities for these parks, such as effluent allowing THE ONLY INDIAN PORTAL SITE ON MEDICAL treatment plant and roads,” the Union the PLASTIC / DEVICES TECHNOLOGY AND TRADE minister said. industry to compete with the 32 Sept.-Oct 2016
Industry News Sahajanand Medical Technologies Opens New R&D Facility In Ireland Sahajanand Medical Technologies Pvt. new range of peripheral products along with technologies through advanced research Ltd.(SMT), India’s largest manufacturer of guidewires and other coronary and compete with global competitors. Our cardiovascular medical stents, has accessories.The R&D leadership team is aim is to continue to provide the most announced the opening of its new research in place now and more researchers are advanced technology to our consumers at & Development Centre in Galway City, expected to join the team in the coming competitive prices hence aligning with our Ireland. SMT aims to attract global talent weeks. vision of ‘pledge to save millions’. With this through this new facility in Ireland to centre, we hope to tap into the global talent diversify its product portfolio. Commenting on the launch, Ganesh pool and explore the possible adaptation Sabat,CEO of SMT,said,“We were pioneers into the Indian market and strengthen India The company has significant investment amongst Indian medical device companies as a medical device manufacturing hub. plans to develop this R&D Centre. The and have seen tremendous value in This will provide a big fillip to support our core functions of SMT Ireland Centre would investing in research & deve-lopment Prime Minister’s dream of Make in India in be R&D and logistics. The key on-going (R&D). Our early investments in R&D, the medical device industry, said Sabat. research projects at the facility are beginning one and half decades ago, developing next generation of Stent and enabled us to make technology our key Established in the year 1998, SMT became Advanced Balloon Catheter technology. differentiator and develop a robust coronary the first indigenous player in India to The centre will have detailed and advanced stent for the world. Our core strength lies successfully launch coronary stent. SMT research on developing next generation in our ability to excel in developing is also the first company to get CE approval stent. It will be working on advanced balloon technologically complex products through for DES with Biodegradable Polymers in catheter and stent bifurcation application the world. It is India’s largest stent which will be a great help in complex cases. focused teams.” manufacturing company and sells its The centre will also be flexible from logistics product in more than 60 countries across point of view as it will be able to track and The launch of the centre was attended by the world. deliver the stents and other products in Sean Kyne, Minister of State, and Noel various parts of the world. Larkin, Mayor of Galway City. (Ref: http://www.pharmabiz.com/ NewsDetails.aspx?aid=97809&sid=2) The Ireland centre also plans to develop This is a major investment by SMT to remain ahead of the curve in adopting latest Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double Swivel Mount) • Endotracheal Tube Holder With Bit • Ventilator Circuit • Ventilator Circuit with Single Water Block Oxygen Therapy Products Trap(Adult, Pediatric, Neonatal) • Inflatable Anaesthesia Mask • Nasal Cannula • Ventilator Circuit with Double Wa- • Anaesthesia Mask Silicon ter Trap(Adult, Pediatric, Neonatal) • Breathing Filters(HME & BVF) • Trachostomy Tube With Cuff • Oxygen Mask Breathing Filters • Resuscitator(Ambu Bag) Airovent T-Humidifier • Anaesthesia Circuits (Mapleson D, • Endotracheal Tube Holders • Multi flow Venturi Mask Mapleson F, Bain Circuit with APL Valve) • Yankaures Suctions Systems • Single Dial Venturi Mask • Stylet • Guedel Airway • Airovent T-Humidifier • High Concentration Mask • Nasopharyngeal Airway • Dialflow Regulator • Nebulizer Set • Laryngeal Mask Airway • Airopap Full Face Mask • Nebulizer Chamber • Mallaeble gum Bougie • Close Ventilation Suction System • Incentive Spirometer • 3 Ball Spirometer • Three-way Stopcock • Extension Tubing for Infusion Systems • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Anaesthesia Circuits Incentive Spirometer Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, High Concentration ET Holder with Bite Expandable Catheter Goregoaon (E), Mumbai - 400 063, INDIA. Mask Block Mount Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : [email protected] [email protected] • Web : www.airwayssurgical.com Sept.-Oct. 2016 33
ISO 9001-2015 ISO 13485-2012 CE WHO GMP Range of Products • ECG Paper & ECG • Mount Catheter PACK-EQUIP Accessories • “T” Recovery Kit • Breathing Circuit (Mfg. Packaging Machinery) • ECG Paper Roll & Z • Ambu Bag Office / Communication : Folding • Bain Circuit • 3 Ball Spirometer 91, Avnish Society, Opp. Pavitrakunj Society, • Nasal Canula • Patient ID Belt CTM Cross Road, Amraiwadi, Ahmedabad-380 026. • Oxygen Mask • Yankur Suction Set • Nebulizer Mask & • Nebulizer Chamber Phone : 25855027 (M) 9825380739 • Guidal Airways Works : Nebulizer Compressor • B. P. Meter • Multiflow Mask 16, Arbuda Estate, Near Nidhi Bank, • Ventury Mask CTM Cross Road, Amraiwadi, Ahmedabad-380 026. • High Concentration Mask • Breathing Filter Surgical Industry Life-O-Line Technologist For Mfg. & Importer of : Medical Surgical Devices & SALE Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. In M. : 9898162576 • E-mail : [email protected] Hyderabad, R. R. District, Customer Care No. +91 9898162576 & 7600020901 Telangana. Professional Consultancy Services Available An ISO 9001:2008, 13485:2012 & GMP Certified Company For All Types Of Syringes & Needles Including Auto Disable Syringes. Contact through: Backgound : [email protected] • Graduate Mechanical Engineer with total 36 years’ Sept.-Oct 2016 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 : [email protected] 34
Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : Corresponding Address: HINDUSTAN SURGICAL HINDUSTAN SURGICAL Hasmukhbhai B. Patel Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, 23, Manav Mandir Bungalows, Village - Pithai - 387630. Taxshilla Colony, Ta.: Kathlal, Dist. Kheda, Gujarat. Old Aradhana School Circle, Email : [email protected] B/h Ramannagar, Sukhipura, Website : www.hindustansurgical.com Maninagar, Ahmedabad - 380008 Tele/Fax : (O) ++91-25440223 Email : [email protected] Cell :9824060964 Sept.-Oct. 2016 MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS • I.V. Infusion Sets • Blood Administration Sets • Scalp Vein Set • Urine Collection Bags • Ryles / Feeding Tubes • Catheters and Tubes • Surgical Gloves. Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 079- 25733318 (R) 079-25430211 (M) +91-9825018952 Email : [email protected], [email protected] Website : www.mescosurgical.com 35
Product Gallery Qosina Introduces New Barbed Check Valves Ronkonkoma, NY –June 6, 2016 – Qosina is pleased to announce Ideal for infusion, drainage and irrigation applications, theyprovide the addition of eight new barbed check valves to complement their controlled directional flow, and eliminate the need for bonding. All extensive line of stock components.Available inthree different versions are ETO and gamma sterilization compatible. They are configurations, these barbed valves have a low, 0.087 psi cracking also Reach and RoHS compliant as well as Class VI and ISO pressure. The barb to barb straight and reducing configurations 10993 approved. Visit qosina.com today to request samples or (#80500 - #80503) accommodate 1/8 inch (0.125 inch, 3.2 mm) place orders of these new valves, which are in stock and available and 3/32 inch (0.093 inch, 2.4 mm) ID tubes and are made of for immediate delivery.Qosina also offers a large selection of Valves, MABS and silicone. The female luer lock to barb and the barb to Tubing and Clamps to fit your design needs. male luer lock configurations (#80504 - #80507) are made of SAN, MABS and silicone. Products #80504 and #80505 feature a female Qosina offers low minimums and short lead times. Log on to luer lock inlet while products #80506 and #80507 have a male Qosina.com to see pricing, obtain our latest catalog, request luer lock outlet. Both choices offer the option to use 1/8 inch (0.125 complimentary samples and place orders. Be sure to sign up for inch, 3.2 mm) or 3/32 inch (0.093 inch, 2.4 mm) ID tubing. 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]. 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: [email protected] Qosina To Attend BPSA’s 2016 Inaugural European Summit Ronkonkoma, NY – August 31, 2016–Qosina is pleased NY in a 95,000 square foot facility with an ISO Class 8 Clean Room toattendthe Bio-Process Systems Alliance’s(BPSA) 2016 European and is ISO 9001 and ISO 14001 registered. Single-Use Technologies (SUT) Summit at The Crowne Plaza Barcelona – Fira Center in Barcelona, Spain, September 26-28. Qosina offers low minimums and short lead times. Log on to The European Summit’s goal is to educate, engage and network Qosina.com to see pricing, obtain our latest catalog, request with European SUT manufacturer colleagues and strengthen complimentary samples and place orders. Be sure to sign up for BPSA’s bond with existing European-based suppliers and end- our monthly e-newsletter to stay current with our newest product users. The European Summit also will address the SUT industry’s additions. Custom sourcing services are available through our business challenges, technical issues and implementation extensive network. Call our customer service specialists to discuss strategies specific to its European audience, and will allow ample your project in detail via phone at +1(631) 242-3000 or email networking time for colleagues and customers. For more [email protected]. information on this event and Qosina’s affiliation with BPSA, please call Qosina at +1(631) 242-3000 or email [email protected]. Contact: Qosina Deanna Whelan Founded in 1980, Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing components, 2002-Q Orville Drive North, compression fittings, ENFit™ connectors, luers, clamps, clips, Ronkonkoma, NY 11779. check valves, stopcocks, hemostasis valves, tuohy borst adapters, Phone +1 (631) 242-3000 swabs, spikes, syringes and tubing to the medical and Fax +1 (631) 242-3230 pharmaceutical industries. Qosina is now based in Ronkonkoma, Email: [email protected] 36 Sept.-Oct 2016
Events MEDICAL MANUFACTURING ASIA 2016: Positive Showing With Top Quality Prospects • Targeted and quality visitor and delegate devices, and profile MedTech Business • Southeast Asia continues to be main region of focus for exhibitors Forum) and 06 October 2016 – MEDICAL MANUFACTURING ASIA 2016 workshops which closed on 2 September to a positive note of 5,200 quality trade visitors from 38 countries, with more than 30% coming from were well-attended overseas. The importance of MEDICAL MANUFACTURING ASIA 2016 as an arena for the display of the latest technologies and by more than 200 solutions from the medical technology and medical manufacturing processes sector was further highlighted by the strong delegates, and co- participation of 200 exhibitors from 18 countries. Aside from significant presence of returning national and country groups from location with Austria, China, Germany, Japan and Singapore, MMA 2016 saw the additions of Italy, USA and Europe – a group presence led by MEDICAL FAIR ASIA IVAM Microtechnology Network. These figures are on trend and indicative of MEDICAL MANUFACTURING ASIA’s alignment with – this one-stop Southeast Asia’s vibrant MedTech sector which has seen robust growth of downstream medical manufacturers and enhanced platform is the only one of its kind in the region that offers a manufacturing capabilities in the recent years. conducive sourcing and knowledge-exchange experience for all Once again co-located with MEDICAL FAIR ASIA, the two synergistic exhibitions provided an ideal business-promoting involved.” platform for all those involved in medical and healthcare as highlighted in the opening speech by Mr S Iswaran, Minister for Dr. Thomas R Dietrich, CEO, IVAM Microtechnology Network, Trade and Industry (Industry), and at a new and bigger venue, pointed out that there are in fact few trade events on the world the Sands Expo and Convention Centre. He also stressed exhibition calendar that zoom-in on the specifics of medical Singapore’s strong position as a gateway for MedTech technology. He said: “It is very important to have this kind of show companies, both local and foreign, to access growing markets in – what we have only rarely is what we see here at the MEDICAL the region, and Singapore’s reputation as a trusted business hub. MANUFACTURING ASIA that is, the technology itself. IVAM represents the micro and nano technology side and I believe that Reiterating the same standpoint is Mr John Lim, Lead, MedTech this kind of product and this kind of technology is very important Initiative, Precision Engineering Centre of Innovation, SIMTech, for the medical industry.” and one of the key speakers at the MedTech Business Forum, who shared of Southeast Asia’s tremendous growth potential, Established as Asia’s leading exhibition for the medical technology, primarily due to its sheer size, and growing ageing population. medical manufacturing processes and related sectors, MEDICAL “We are seeing a lot of opportunities in the areas of personalised MANUFACTURING ASIA 2016 – modelled after COMPAMED in medicine, especially inter-connectivity, as well as a lot more Germany, is jointly organised by SPETA (Singapore Precision devices for localisation. I think it is a great platform to basically Engineering and Technology Association) and Messe Düsseldorf share not only what we have, by inviting speakers from renowned Asia. MedTech players, analysts from Ernst & Young, as well as Frost and Sullivan, our focus is also on driving R&D and innovation, According to repeat exhibitor and prominent local company SP looking at causing some disruption to the industry.” Manufacturing that specialises in full turnkey manufacturing solutions from prototype services to global technology OEMs, “the Mr Gernot Ringling, Managing Director, Messe Düsseldorf Asia, quality of responses and enquiries is more genuine, so the commented that MEDICAL MANUFACTURING ASIA continues opportunities we have been able to gather from the leads that we to address challenges of accessing Asian markets with its differing have received should translate to a higher conversion rate than characteristics, and serves as a central meeting place and launch what I see in other exhibitions where I have attended,” said Mr pad for the medical manufacturing industry to enhance capabilities Mark Teo, Group CEO, SP Industrial Holdings. For Italian pre- and to establish networks, as well as to grow their business in insulated panel solutions company P3 SRL, Southeast Asia the region. “The healthy exhibitor and visitor numbers are continues to be the region of choice and Singapore the centre for testament of the local and international attention and standing of quality solutions. Commenting on the high quality visitor profile, the exhibition, which connects the industry, pairing exhibitors to Mr Enrico Chiabrera, Commercial Director, said: “We are very key decision makers and the right audience profile. Together with much appreciative of the feedback because many customers and the concurrently run forums (IVAM Forum on high-tech medical consultants we have seen have been decision makers, and they expressed good impressions regarding our solutions. We also Sept.-Oct. 2016 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 37
Events I found that the Events Calender two exhibitions have a good mix • MEDICA and COMPAMED 2016 : The World’s No.1 Trade of exhibits.” His Fair for Plastics and Rubber thoughts were Date:14-17 November 2016. echoed by Mr Venue: Dusseldorf, Germany. Mohamed Salih, Chairman of • Plastivision India 2017 : International Plastics Exhibition Damas & Conference Company Pvt Date : 19-23 January. Ltd (Republic of Venue : Bombay Convention & Exhibition Center, Mumbai Maldives), who mentioned that his visit to MEDICAL MANUFACTURING ASIA 2016 has been a mind-opening one. “I • 3rd National Conference On Safety And Risk Management was exposed to the latest medical technologies, cost-effective For Healthcare Professionals 2017 : Dedicated Exhibition solutions and innovative products that would benefit end users. I Pavilion For Safety, Infection Control & Biomedical Wast also had the opportunity to interact with the international pool of Management exhibitors at the exhibition – will certainly be back in 2018”, he Date : 11 February 2017. said. Venue: The Gujarat University Convention Exhibition Centre, Ahmedabad. Optimistic statements at MEDICAL MANUFACTURING ASIA 2016 from both exhibitors and visitors were backed by a host of business • Meditech Healthcare Asia 2017 : International Exhibition matching meetings and strategic alliance building that reflected and Conference On Healthcare & Medical Technology both the diversity and health of the MedTech industry. The next Date: 10-12 February, 2017 edition of MEDICAL MANUFACTURING ASIA will take place in Venue: The Gujarat University September 2018. Convention Exhibition Centre, Ahmedabad. Press Contact: Fulvia Wong, Exhibitor Contact: Daphne Yo, • 14th National Conference And Technology Exhibition On Indian Tel: + 65 6332 9649 Tel: + 65 6332 9682 Medical Devices & Plastics Disposable / Implants Industry 2016 : [email protected] [email protected] February, 2017. Ahmedabad • Medical Fair India 2017 : 23rd International Exhibition and Conference Date: 06-08 April, 2017 Venue: Pragati Maidan, New Delhi. 38 Sept.-Oct 2016
AN ISO 13485-2012 GMP. & ISO 9001 – 2000 Certified Company CE certified Company Manufacturer & Exporter of Medical AMIGO SURGI CARE PVT. LTD. Disposable Devices & Surgical Products Manufacturer of Disposable Surgical Products: Range of Products : • Infusion Set I.V.CANNULAS / B.T.SETS / I.V.SETS / • Blood Administration Set SURGICAL LATEX GLOVES / CORD • Measure Volume Set CLAMPS / URINE BAGS / MEASURE • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry VOLUME SETS ETC. • Respiratory Exerciser Manufacturers / Exporters / Hospital Suppliers • Twin Bore Nasal Oxygen Set • Oxygen Face Mask Dealer are requested to • Nebulizer Kit • Vaccum Suck Suction Set Contact : • Latex Surgical Gloves Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) • Umblical Cord Clamp (DIRECTOR) Mobile:0091-9825057180 Contact Yogesh Patel Tel.:0091-2764-268249 M. : +91 98241 21383 E-mail : • [email protected] MEDICARE DEVICES • [email protected] 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, Website:www.amigo-india.com C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Plant Address Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 Plot No.780, Opp.: Kemron Lab E-mail : [email protected] Sola Santej Road, Website : www.medicaredevices.com Rakanpur (Santej) – 382721 Gujarat, India Products • Flexible Packaging Material National • Paper Pouch Healthcare • Aluminium Foil • Foil Seal An ISO 9001 : 2008 Company • Ribbon Pack Pouch Manufacturing & Exports of E. O. Indicator Pouches Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Contact : Measured volume set, Cord Clamp, Surgical Jignesh Patel : +91 94265 25388 Gloves etc. +91 90163 36699 Injection Moulded Medical Components Kavya Packaging and Extended Tubes : Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, I.V. Set components, Urine bag Components, Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat Connectors for Catheters, I.V. Set / B. T. Set / E-mail : [email protected] Urine Bag Tubes etc. Sept.-Oct. 2016 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 39
GMP We are a leading Consulting organization ISO - 9001-2008 providing an integrated services with Certified Company focus on project technology : S. Nath & Co. Quality Management System as per ISO 9001, ISO 13485, Medical Devices Excellence in Quality CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training Manufacturer & Exporter of and c-GMP. Surgical Disposable Products since 1980 Sanjay Y .Shah – Owner Promoter IDEAL® M : +91 98240 17850 • Infusion Set • Blood Administration Set Obelis European • Urine Collection Bag • Urine Specimen Container Authorized Representative Center (O.E.A.R.C) based in • Umblical Cord Clamp Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European Address manufacturers’ successful endeavors into Europe. S. Nath & Co. F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : [email protected], [email protected] B. N. Estate, Near Uttam Dairy, Sukhramnagar, Website : www.unikalindia.com Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Sept.-Oct 2016 Website : www.snathco.com • [email protected] 40
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