Medical Plastics Data Service May - June 2016 Issue

May-June 2016 CToabnletoef nts Vol. 24 No. 3 May. - Jun. 2016 22 Cover Story • Effective Vendor Management For Medical Device Industry Companies serving other markets are shifting their focus to medical technology due to the stability of the marketplace. While many of them have good intentions, they often don’t understand the complexities of medtech manufacturing. Although manufacturers are ultimately responsible for complying with regulations and standards, their vendors should…........ • Supplier Quality Management For Medical Device Manufacturers: A Critical Step Towards Global Regulatory Compliance - Ms. Preeti Vani, Plant Head, Sahajanand Laser Technology, Gandhinagar Global regulatory compliance is important because in today’s world of globalized supply and demand networks, companies need to efficiently optimize the supply base given a broad set of requirements that go well beyond cost. To effectively do this, companies should………. • Medtech Companies Need Collaboration With External Partners For Innovation And Growth 36 Technology • Innovative Computer-Aided Catheter Reprocessing System (CRS) for Cleaning Catheters De veloped By Chandigarh Biomedical Engineer CRS machine intends to replace the conventional method for cleaning of catheters. The machine is …… • India’s New IPR Policy Looking To Spur Innovation In Med-Tech Sector The med-tech industry, both domestic and international, has generally welcomed India’s new intellectual property rights (IPR) policy, in large part due to…... 35 Product Gallery • Qosina Adds 40 Enteral Feeding Connectors that Meet the ISO 80369-3 Standard 25 Global Trends • Medical Adhesives : Fastest growing Segment 31 Industry News • Andhra Med Tech Zone Gets Formal Registration To Set Up Asia’s First Dedicated Medical Devices Park • Gujarat Govt Allocates Land For Setting Up Medical Device Park At Sanand • Industry Wants ICMED Certification Mandatory For All Medical Devices Marketed In India • India And Japan To Seek Regulatory Collaboration For Medical Products • Separate Rules To Spur Medical Devices Sector Soon • Centre To Notify Revised Schedule M III For Medical Devices By June End 20 Did You Know? • About Best Practices to Ensure Good Supplier Management 38 Events • Medicall 2016, 15th Edition: July 22 – 24, 2016, Chennai. / 16th Edition: Sept. 09 – 11, 2016, Delhi. • ICMD Autumn 2016: 30st August - 1st September 2016. China. • Medical Manufacturing Asia: Aug. 31st – Sept. 2nd, 2016. • K 2016: Oct. 19 – 26, 2016. • CMEF 2016: 29 October - 1st November 2016. China • MEDICA and COMPAMED 2016: 14-17 November 2016. Germany. • Medical Fair India 2017: April 06 - 08, 2017 19

Flashback ?YoDKuindow ? Jan. - Feb. 2004 About Best Practices to Ensure Good Supplier Management. From Editor’s Desk Companies that manage their suppliers well, do so through a number of best practices. They carefully select and contract with their suppliers, often with deep Dear Readers, involvement from the internal quality organization, and they identify vendors that deal with the most critical aspects of their product and invest heavily in training First of all, I am pleased to inform our readers that, the and monitoring them. Finally, they are highly disciplined about cutting off even Seminar on “Medical Plastics: Materials, Applications preferred suppliers once it is clear that quality performance has dropped. They And Processing For Medical Devices And also recognize that resources for supplier management often do not reduce with Pharmaceuticals Industries” organized by “MEDICAL improved quality, unlike in manufacturing, for example. PLASTICS DATA SERVICE” was a big success .More Communication with vendors has to be purely professional and than 150 participants attended the Seminar which was confidential. Vendors should be allowed to place their suggestions in front of top first of its kind in India. Presentations were made by leading bosses in a well managed forum. The vendor’s suggestion is the most valuable Companies and professionals from the Medical Plastics / piece of advice, as regards consumer satisfaction. In case a product is not Devices Industries as well as research institutions. achieving good sales, suggestion from vendors can be used to rectify the mistakes. Participants represented Medical Product Manufacturers, A close watch needs to be kept on the performance of vendors. The contract Machinery Manufacturers, Raw Materials Manufacturers, signed should ensure good profit margin to the company as well as the vendors. Consultants, Marketing Companies, Research & The company and vendors can help each other by advertising in television media Academic Institutions, Publications from all most all parts or via brochures, by sharing the costs. On monthly basis, vendors should be of the country including Chennai, Trivandrum, Mumbai, encouraged to have open discussions with vendors selling similar products. This Hyderabad, Gujarat, New Delhi, Kanpur, Gwalior, will promote exchange of ideas, sharing of needs of consumers, different Chandigarh etc. approaches and strategies to maximise sales. In addition, multiple interviewees suggested establishing an industry certification On behalf of “MEDICAL PLASTICS DATA SERVICE” and and shared auditing program for suppliers to drive quality and standardization. the Indian Medical Devices/Plastics industry, we thank Dr Sushil Verma, Director General, Central Institute Of (Ref.: https://doctors.practo.com/best-practices-medical-vendor-management/ Plastics Engineering & Technology, (CIPET), Chennai for http://www.fda.gov/downloads/aboutfda/centersoffices/ not only accepting our invitation to inaugurate the Seminar but also deliver a thought provoking presentation on “ officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm277323.pdf) Plastics - A Front Runner In Medical & Healthcare Applications”. We are happy to reproduce the presentation In a in the issue. Nutshell.... We also acknowledge with most sincere gratitude, the “Beware of contributions by all the following learned speakers and false knowledge; the leaders of the industry for sharing their valuable it is more dangerous experience with the participants of the Seminar. than ignorance.” CONTENTS - George Bernard Shaw • Cover Story May-June 2016 Plastics - A Front Runner in Medical & Healthcare Applications • Seminar Report : Seminar on \"Medical Plastics : Materials, Applications And Processing For Medical Devices And Pharmaceuticals Industries\" • Global Trends Innovative Miniature Plastic Parts : Microtechnology Is Becoming Established In Medicine • Industry News - Medical part cos to benefit from expansion in health sector - Budget Impact on Pharma - Hindustan Latex, Chinese co in JV for contraceptives - Pharmaexcil action plan to be in by April • Did You Know ? About Coatings For Blood-Contacting Devices • Events - HOSPIMedica ASIA 2004 • Events Calendar20

EDITORD.L.PANDYA, B.E.(Chem), M.I.E. ASSOCIATE EDITOR FromDtheeEsdkitor’s Ms. Bishuna Singh, B.E. (Biomedical Eng.) A strong supply chain is essential to support Indian Medical Device Industry in order to accelerate the “Make-in-India” process. However, EDITORIAL ADVISORY BOARD it is also essential that the companies select potential suppliers, contractors and service providers with due care. After all, Medical Device Company - Dr. TARANG PATEL not the supplier – is responsible for complying with regulations and standards. Choosing M.B.B.S., M.Ch. (ONCO) the right vendors and managing them effectively can increase a manufacturer’s efficiency Cancer & Reconstructive Surgeon in terms of time, cost and quality. This issue highlights critical issues related to effective Vendor Management for Medical Mr. C. BALAGOPAL Device Industry. We highly appreciate Ms Priti Vani, Plant Head, Sahajanand Laser Director - Enter Technologies Pvt. Ltd. Technology Ltd for contributing an article on “Supplier Quality Management” and sharing Chairman - Mobilexion Technologies Pvt. Ltd. her knowledge and experience with our readers. We appeal all the Executives of Indian Medical Device Industry to come forward and contributes articles related to their areas Trivandrum of specialization. Strengthening the Ecosystem for Innovations, Growth and sustainability is the need of Dr. DILIP H. RAIKER the hour for Indian Medical Device Industry. Creation of Medical Device Parks in the Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) country is an important requirement for strengthening the ecosystem. Governments of Former Chief Manager(P), CIPET - Chennai Andhra Pradesh and Gujarat have taken active steps in the direction. “Andhra Med Tech Zone, ( AMTZ )” will be Asia’s first dedicated Medical Device Park to be established ING LOUIS C. SUHUURMAN in an area of 226 acres at Vishakhapatnam in Andhra Pradesh. AMTZ is the brain child Formerly Sales Director of Dr Jitendar Sharma, Head, Health Technology Dept., National Health Systems COLPITT B.V., Holland Resource Centre and advisor to Chief Minister of Andhra Pradesh for Health and Medical Technology. Government of Gujarat has also allocated land for setting up Medical Device Dr. A.V. RAMANI Park at Sanand. As per Dr H G Koshia, Commissioner, FDCA Gujarat State, “Medical Group Sr. Vice President (R&D), The TTK Group Device Park is very relevant for Gujarat as the state has 135 licensed Medical Device Companies as against 240 in the entire country”. As per Dr Koshia, “setting up of this Dr. C.S.B. NAIR park will bring about quality, compliance and cost effectiveness”. Director (R&D), Peninsula Polymers Ltd On the regulatory front also, there are many developments. After the development of ICMED, the country’s first indigenously developed quality assurance system, a joint Dr. BHARAT GADHAVI initiative of AIMED and Quality Council of India, the Industry now wants ICMED CEO, Medisurge Hospitals Certification mandatory for all Medical Devices marketed in India. The Government of India has also agreed to align Schedule M III with ISO 13485 by delinking it from Schedule Mr. A.S. ATHALYE M for Pharmaceuticals industry. The revised Schedule M III is expected to be notified by Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai end June 2016. The recently announced new IPR Policy is also expected to spur Innovation in Med – Tech Sector. Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. 21 IIT, Kharagpur Dr. G.S. BHUVANESHWAR Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India. Dr. J. V. Tyagi Consultant, Medical Device Certification PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: [email protected] Website:www.medicalplasticsindia.com Reg.No.GUJ-ENG-00446/23/ALL/TC/94 dt.3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-58 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.May-June 2016

Cover Story Effective Vendor Management For Medical Device IndustryMedical device manufacturers rely on suppliers for Medical Device manufacturers should evaluate and selectmany things. Choosing the right vendors and potential suppliers, contractors, and consultants on the basismanaging them effectively can increase a of their ability to meet specified requirements, includingmanufacturer’s efficiency — in terms of time, cost, and quality requirements.quality. Unfortunately, suppliers can also sometimesput their clients in hot water when their quality The major issues that impact a device manufacturer’sstandards are below par. Compliance efforts are:There are a lot of contract manufacturers that are shifting 1 Vague Quality Requirements: Not having qualitytheir focus to medical technology due to the stability of the requirements for suppliers is one of the major problems.marketplace as compared with the automotive oraerospace industry. While many of them have good Working closely and collaboratively with suppliers inintentions, they often don’t understand the complexities ofmedtech manufacturing. creating and documenting the criteria is very essential.However, for Medical This result in making suppliers part of quality processDevice Manufacturers, their which in turn results in better quality for your materials/suppliers are their partners. components. It will alsoAlthough they are ultimately help manufacturing to produce high quality products at reasonable cost.responsible for complying 2 Participation inwith regulations and Validation: It is god tostandards, their vendors prefer suppliers thatshould provide support by implement meaningfulbeing compliant validation program.themselves. This along with strictThe manufacturer of the change control is veryfinished device — not the essential. It is alsosupplier — is responsible necessary to ensurefor compliance. However, the regulations also specify that that suppliers are notifying us of any changes thatdevice manufacturers should select only suppliers with the take place in material and/or processes.capability to provide quality products. It is said that, “Quality For, effective Vendor Management, some of the important considerations are:cannot be inspected or tested into Products and Services.It must be built into device.” • Getting the right references from the suppliers. • Installing good software system to have a robust auditMedical Device Manufacturers should identify suppliersthat have a successful track record in the device industry. program.They should be competent to satisfy quality and regulatory • Use of latest technology to incorporate purchasing controlsneeds.Purchasing Controls: It is necessary to establish and in the Quality Management Systems (QMS)maintain quality requirements for suppliers, vendors, and • Ensuring that the suppliers and their suppliers/sub-contractors. contractors are in harmony and the suppliers have control over their outsourcing process. Medtech Companies Need Collaboration With External Partners For Innovation And GrowthAs per a recent global study by “PwC Health Research Institute”, Medtech executives are beginning toappreciate that innovation must occur outside of traditional research and development units, they co-create — that is, they involve customers or external partners from idea generation to execution — on one-third or less of their products and services. Most Medtech companies identify “open innovation” — exter-nal and internal people generating and commercializing ideas together — as one of the top two ap-proaches that will generate the most growth. Nearly 81% of executives have plans to collaborate withstrategic partners during the next three years, but more than half said a major challenge is finding theright partners. How they collaborate with these partners will be key.22 May-June 2016

Cover StorySupplier Quality Management For Medical Device Manufacturers: A Critical Step Towards Global Regulatory Compliance Preeti Vani associated with it. Also, identify the controls associated with the Plant Head (Medical Division) product for both of manufacturer and supplier. Controls can be auditing the supplier facility, supplier’s quality management system Sahajanand Laser Technology Ltd. certificate and other required regulatory certificate, certificate of analysis with each supplied batch, batch size and lot size requiredThe quality of supplier’s product or service plays a vital role at each order time, Inventory control, traceability, change controlfor the quality of final product manufactured by Medical and quality system records. These are the important controls;Device Manufacturer. Hence, supplier quality management is a require following for the supplier. Assess the supplier based oncritical part of the quality management system. Supplier Quality this controls. These controls can address and control the identifiedManagement is a confidence in supplier’s ability to deliver a good risks associated with product.product or service that will satisfy the customer’s needs. It canbe achieved through interactive relationship between the customer 2. Supplier Evaluation And Qualificationand the supplier; it aims to ensure that product is ‘fit’ to thecustomer’s requirements with little or no adjustment or inspection. Potential suppliers for proposed product or service shall be selected. Their contact details are saved into database. SelectionEvery manufacturer in the healthcare industry is required to document of supplier from the database is done based upon its businessthe qualification of suppliers and the ongoing capability and operational capability. A potential supplier’s businessevaluation of those suppliers. Supplier qualification and conduct, practices, reputation and financial viability may provideevaluation activities should be strategic. There are no specific useful information about the business capabilities of that supplier.rules and regulations on how supplier qualification and evaluation A potential supplier’s business capability could have an importantis done. The only requirement is that company shall have a effect on a manufacturer’s ability to deliver safe and effectiveprocedure, do it and keep records. Now the recently updated devices. The financial viability of the potential supplier is particularlyquality management standard ISO 13485:2016 has enhance important especially when a manufacturer intends to enter into asupplier qualification requirement. The standard suggested to use long-term partnership. Investigation of the supplier’s technologicalrisk based approach for it. capability should include the assessment of the supplier’s ability to meet the manufacturer’s product and/or service specifications.Thus, risk based approach for supplier management includes Things to consider may include the adequacy of manufacturingfollowing phases and activities. processes or equipment, information technology, system infrastructure, engineering resources, etc.1. Planning The scope of the investigation may include the supplier’s past Planning phase includes various activities like Identification performance, experience, expertise, and human resources. Basedof Product or services to be obtained from the supplier, Technical on that, supplier evaluation criteria are fixed and all potentialand process information of the product or service to be purchased, suppliers are evaluated based on that. Communicate with supplierIdentification of potential suppliers, Identification of risk and and evaluate its ability to fulfill the requirements for manufacturers.Identification of controls to reduce the associated risk. Thus, evaluate and qualify the supplier.Identify what type of service or product need to be purchasedfrom the external source. It can be critical raw material, It Should Be Supported By Following Documents.consumables used into the manufacturing process, packagingmaterial. Services to be obtained from supplier include • The manufacturer’s assessment of the supplier’s resourcessterilization, calibration, validation, design, manufacture, transport, (e.g. facilities, personnel, infrastructure), current product/external quality testing of product or consultant etc. Finished service portfoliomedical device may also become supplier’s product for own brandlabelers. • Documentation and records provided by the supplier, such as environmental control records, equipment maintenance After identification, define the technical requirement of to be programs, calibration records, qualification records ofpurchased product. Technical requirement can be product appropriate personnel, process validation records, capacityspecifications, part requirements, some detail about its planning, certificates, etc.manufacturing process or work instructions. This can becomparable to your existing supplier or other potential suppliers. Based on the evaluation and acceptance criteria, supplierLater, prepare a list of potential supplier who can provide you the qualification should be done and shall be supported by necessaryproduct or service you want. Collect and make a list of name and documentation.contact information of all potential supplier. Now identify the risk On selection of supplier for particular product or process, manufacturer and supplier should sign a quality agreement with agreed terms and conditions. It should mention the time period of the contract, other business and quality requirements. It should be thorough enough to be used as a reference for any violation that may occur in future.May-June 2016 23

Cover Story Phase-3: Verification of purchased product and purchasing information3. Verification Of Purchased Product And Purchasing Activities: Information a. Purchased product inspection plan b. Verification of purchased product against requirements Supplier performance assessment is a continuous process. It c. change control maintenance for both supplier andis done by verifying the purchased product. Establish inspectionplan for each batch or lot of supplied product to verify it against manufacturerthe product requirements. The extent of these verification activitiesis based on the supplier evaluation results and proportionate to Phase-4: Supplier monitoring and re-evaluationthe risks associated with the purchased product. Activities:When any changes occur to the purchased product, the a. Supplier monitoring and re-evaluation planmanufacturer should determine whether these changes affect the b. Supplier performance assessmentfinal product quality or not. Certificate of analysis must be included c. Supplier facility audit planinto the purchasing information for each supplied batch or lot. Itmentions the product specification, acceptance criteria, performance of supplier for meeting the requirements of theprocedures or equipment used, whenever necessary. This purchased product. These results of the monitoring provide an inputpurchasing information shall be maintained for the purpose of into the supplier re-evaluation process. Non-fulfillment of purchasingtraceability. Any changes occurred in the processing or requirements shall be addressed with the supplier; discuss the riskspecification of product that may affect the final product quality, associated with the purchased product and its failure to complysupplier should notify to manufacturer in this regard by written with applicable regulatory requirements.communication. Change control should be maintained by bothsupplier and manufacturer. Figure 1 summarizes The Supplier Qualification And Evaluation Process In Brief.4. Supplier Monitoring And Re-Evaluation Figure-1: Flow Chart Of Supplier Qualification And After selecting supplier for any particular product or services, Evaluation ProcessSupplier monitoring and re-evaluation is a continuous process. Itis required to be done in a timely manner. Make a qualification • Supplier Facility Audit:plan for monitoring and re-evaluation of suppliers. It should beseparate for each supplier. Assess the supplier performance Supplier audit constitute major part of the supplier qualificationduring this period and give the ranking to it. Performance is programme. It should also be conducted on regular bases aschecked based on supplier’s ability to deliver good products, continuous evaluation of supplier. Make audit strategy and prioritizedelivery time, supplier initiated issues, supplier- initiated change the audit based on risk. One manufacturer may have number ofrequests, supplier facility audit, change control etc. Monitor the suppliers. Each supplier facility cannot be audited. Hence, decide it based upon quantifying supplier risk, accounting for both Phase-1: Planning performance and criticality; we can effectively prioritize issues that Activities: require the most attention. It is advisable to treat these external a. Identification of Product or services to be obtained risks similar to internal insufficiencies or gaps. Employing CAPA or deviation management techniques, as you would in-house, will from the supplier mitigate supplier risk while also avoiding the same issues from b. Technical and process information arising in the future. Supplier audit frequency is also to be decided c. Identification of potential suppliers in audit plan. a. Identification of risk associated and its impact on These all requirement fulfills the supplier quality management quality of final product requirement and allows medical device manufacturer for global b. Identification of control regulatory compliance. Global regulatory compliance is important because in today’s world of globalized supply and demand networks, Phase- 2: Supplier evaluation and qualification companies need to efficiently optimize the supply base given a broad Activities: set of requirements that go well beyond cost. To effectively do this, a. Supplier’s business capability companies should begin to use a risk based approach that looks at b. Supplier’s technical capability both the criticality of a supplier and the likelihood of failure of a c. Planning for evaluation and qualification of supplier supplier. By applying standardized risk and audit tools, the long d. Communication with supplier and supplier facility audit term successes of initiatives around supplier quality are much more e. Supplier acceptability likely to succeed. f. Quality agreement with supplier24 May-June 2016

Global Trends Medical Adhesives : Fastest Growing SegmentAdhesives are critical components in the design and are expected to persist as successful medical adhesives markets.manufacture of the majority of medical devices. As medical The key players in the medical adhesives market are Bostik Ltd.devices become smaller and more complex, greater demands are (France), Henkel AG & Company (Germany), B. Braun Melsungenbeing made on the materials and components used in them. New AG (Germany), 3M Company (U.S.), CryoLife, Inc. (U.S.),advances are widening the performance envelope for medical Chemence Ltd. (U.K.), Cyberbond LLC (U.S.), Itac Ltd. (U.S.),adhesives. Ethicon Inc. (U.S.), Covidien Ltd. (Ireland), GluStitch Inc. (Canada), Adhezion Biomedical (U.S.), Cohera Medical, Inc. (U.S.), BaxterVariations in polymer compositions, coupled with compounding International Inc. (U.S.), Gem S.r.l (Italy), Meyer-Haake Gmbhdifferences, are allowing properties to be tailored to meet specific (Germany), and Biocoral, Inc. (France) , and others.application requirements, including biostability, sterilization effects,and mechanical properties. Perhaps even more exiting are The medical adhesives demand, in terms of value and volume,estimates that only about one-half of the applications that could depicts the current and future projections according to the parallelbe served by adhesives are actually using adhesives in assembly, economic and industrial outlook. This analysis covers importantleaving significant growth opportunity. By all measures, growth developments, investments & expansions, partnerships &potential is very attractive and this market segment generates a agreements, and mergers & acquisitions of the leading globallot of interest among adhesive suppliers. companies.Markets Cost cutting in the healthcare industry is a reality and likely here to stay. Hospitals and other large healthcare providers have formedThe market for adhesives used for medical applications is one of very successful buying groups who are pressuring suppliers forthe exciting segments in the specialty chemicals industry. lower prices and additional services, which, in turn, create cost pressures on all suppliers throughout the value chain. In someAs per a recent report by the Business Communications Company instances, high-end devices that were manufactured for singlethe 2001 US market for specialty adhesives was about $5.7 billion, use are being cleaned via sophisticated on-site processes toand is forecast to grow at 4.3% per year, with medical and dental stretch the healthcare dollar even further. There has also beenapplications being the fastest-growing sector at 5.9% per year. significant consolidation via merger and acquisition of participantsFrost and Sullivan report the size of the European PSA market at all levels of the value chain. In recent years, large distributors(medical and non-medical) to be $620 million in 2000, and $796 have emerged and everyone is aware of the consolidation ofmillion in 2007. hospital and other large healthcare providers. As a result, the industry screams for lower total costs, and adhesives offer theZion Research has published a new report titled “Medical potential for ever-increasing production speeds.Adhesives and Sealants (Synthetic and Natural) Market for Internal,External and Dental Applications: Global Industry Perspective, (Ref: http://www.dolcera.com/wiki/Comprehensive Analysis and Forecast, 2014 – 2020.” According index.php?title=Pressure_sensitive_adhesivesto the report, global demand for medical adhesives and sealants https://globenewswire.com/news-release/2016/04/20/830668/0/market was valued at USD 6.0 billion in 2014, and is expected to en/Global-Medical-Adhesives-and-Sealants-Market-Poised-to-reach USD 10.50 billion in 2020, growing at a CAGR of 8.5% Surge-from-USD-6-0-Billion-in-2014-to-USD-10-50-Billion-by-between 2015 and 2020. 2020-MarketResearchStore-Com.html )North America is the largest market, both in terms of volume andvalue, followed by Europe. China, U.S., Japan, India, and GermanyPressure-Sensitive Adhesive Stick-to-skin PSAs have the following general properties:Some of the applications of Pressure – Sensitive Adhesive are • Nontoxicity;plaster and pads, transdermal drug delivery systems (TDDS), • Adhesion to organic and inorganic surfaces;Tapes, biomedical electrodes, self-adhesive hydrogels and • 100% solid;surgical drapes. Pressure Sensitive Adhesive tapes are most • Optimized for wetting and gap filling;widely used. • Working characteristics suitable for high-volume production • Compatibility with different forms of sterilization;Pressure-sensitive adhesive tapes (PSAs) are easily adapted • Sterilizable;to a range of medical applications from joining components likepanels in medical equipment, to joining and sealing parts in Hydrocolloids and silicone PSAs are increasingly popular forhandheld diagnostic devices, to joining and sealing surgical their low skin trauma characteristics. These medical tapes aredrapes and wound care dressings to skin. often required to provide secure adhesion for a device or dressing long enough for a therapeutic effect to occur. When adhesion isPSA tapes require pressure to adhere to a surface. These tapes too low, the device won’t stay in place long enough; too highcan be formulated to form high strength bonds when used in and the skin and wound may suffer trauma upon removal of themedical equipment or to join different dressing and drape device or dressing.substrates together, or to provide gentle adhesion when used ina stick-to-skin application. PSA tapes can be acrylics, silicones,or styrene block co-polymers.May-June 2016 25

Airways Surgical Pvt. Ltd.Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia TherapyCritical 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 LineContact : Dr. Inder Jain +91 9820321901 Anaesthesia Circuits Incentive SpirometerHead Office : 106, Vijay Industrial Estate, I. B. Patel Road, High Concentration ET Holder with Bite Expandable CatheterGoregoaon (E), Mumbai - 400 063, INDIA. Mask Block MountTel.-Fax : 91-22-2685 2973 / 2686 9090Works : Airway House, Plot No. 2209 & 2210 Phase IV,GIDC Vatva, Ahmedabad - 382 446. INDIA.Tel. : 91-79-2584 2525 / 2584 0905Email : [email protected]@airwayssurgical.com • Web : www.airwayssurgical.com26 May-June 2016

Manufacturer And Exporter Of a ISO 9001-2000Quality 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.comMay-June 2016 27

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® Alpha Medicare and Devices Ltd. (taking care…Since1984) Manufacturers & Exporters of Disposable Medical DevicesGMP, ISO 13485 : 2003 & CE CERTIFIED COMPANYProduct Range :• Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • UromeasureUrine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 wayStop 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 CultureBottles 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 • NebulizersChemical, Sterility & Micro Biological Tests.• Exporting our products to almost more than 23 countries. ISO 13485 : 2003Contact : 0434Mr. Dinesh Shah (Manager)(M) 963897979897, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIAPhone : +91-79-25390601/25390832 • Fax : +91-79-25353680Website : www.alphamedicare.com • E-mail : [email protected] SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • Regulators / Cord Clamp • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • PP Mucas Container • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : [email protected] May-June 2016

Industry NewsAndhra Med Tech Zone Gets Formal Registration To Set Up Asia’s First Dedi- cated Medical Devices ParkAndhra Med Tech Zone (AMTZ)- company participate in the preparation of DRP for the A park with in-house high investmentestablished under government of Andhra prestigious project, no effort would be scientific facilities would helpPradesh has finally received formal spared in getting technical excellence to manufacturers reduce the cost ofregistration which will kick start establishing design and implement the project- said Dr. manufacturing by more than 40 per cent toAsia’s first dedicated medical device park Jitendar Sharma, the Chief Executive Office 50 per cent.in an area of 226 acres at Visakhapatnam of AMTZ Ltd. Indian medical device industry is worth overin Andhra Pradesh. Rs. 60,000 crore and country’s humongous Andhra Pradesh health department has import bill for this segment amounts to overAMTZ has cleared a major milestone- with formally taken over 226 acres of land to set Rs. 23,000 crore while export amounts tothe release of RFP for selection project up Asia’s first dedicated medical device park only over Rs. 7,000 crore. India’s importconsultancy firm for preparing a Detailed at Visakhapatnam. AMTZ is proposed to dependency on high-end medical devicesProject Report (DPR). have in-house high investment scientific is over 80 per cent and 60 per cent to 70 facilities that would help manufacturers per cent for other devices. And this is whereAndhra Med Tech Zone Ltd. (AMTZ) in its reduce the cost of manufacturing and is first the dedicated medical device park wouldmarathon target to be the first of its kind of its kind in Asia as it aims to flourish as a be of great value - reducing humongousmedical equipment manufacturing hub, has hub of medical device manufacturing, import dependency, increasing export whilecleared another major milestone- with the putting India on the global map of high endrelease of RFP for selection project medical equipment production. generating wealth and employment within.consultancy firm for preparing a DetailedProject Report (DPR). The RFP for DPR The park will provide for modern state of (Ref.: http://www.pharmabiz.com/agency was released on 3rd of June and a art common facilities such as specialized NewsDetails.aspx?aid=94934&sid=1pre-bid meeting with Industrial Partners was laboratories, warehousing, testing centreheld on 17th June at Visakhapatnam. apart from 100 to 150 independent http://ealth.economictimes.indiatimes. manufacturing units, each in a built-in readyWhile champions in industrial designing and to use area of 0.5 to 1 acre each. com/news/medical-devices/amtz-opens-infra-tech development are expected to detailed-project-report-opportunity-for- global-cos-/52815286)Gujarat Govt Allocates Land For Setting Up Medical Device Park At SanandSubsequent to Union minister of chemicals state has the largest number of 135 licensed too capital intensive for individualand fertilisers Ananth Kumar medical device companies as against 240 manufacturers to invest upon.announcement for setting up medical in the entire country which are nurtured bydevices and pharma parks in Gujarat, Gujarat FDCA with an exemplary approach Currently, due to lack of such centrallyGujarat government has finally identified and has received recognition in the country.” located common facilities, manufacturersand allocated the land for the same at do not undertake production ofSanand near Ahmedabad. He explained government’s plan to set up technologies and therefore send their medical device parks will bring about quality, products abroad for process up-gradationDetailed Project Report (DPR) has also compliance and provide cost effectiveness and value addition.been submitted and a favourable response in the industry by providing infrastructurehas been awaited on the same from the to boost medical device manufacturing in This will also help facilitate to create anCentre, informed an official associated with India. ecosystem for manufacturing of high endthe development. medical device manufacturing aimed at The creation of manufacturing park for import substitution and export opportunitiesGujarat Food and Drug Control medical devices is the need of the hour as and would be a major boost to SMEs.Administration (FDCA) commissioner Dr H medical devices manufacturing requiresG Koshia said, “A medical device park is certain high investment facilities which are (Ref.: http://www.pharmabiz.com/also very much relevant for Gujarat as the NewsDetails.aspx?aid=95558&sid=1) Industry Wants ICMED Certification Mandatory For All Medical Devices Marketed In IndiaExperts have urged the Centre to make medical devices with the top government license to high risk device manufacturersIndian Certification of Medical Devices officials with special focus on drafting and importers on basis of defined criteriaScheme (ICMED), country’s first regulatory framework for granting and inspection. This according to sourcesindigenously developed quality assurance manufacturing licenses for medical devices. will be done by CDSCO medical devicessystem for medical devices mandatory for officers with a predefined competency orall medical devices marketed in the country. The meeting stressed upon the need for through 3rd party certification bodies.This was proposed in recently concluded registration of low risk and moderate riskmeeting called to draft (separate) rules for devices on basis of 3rd Party (CAB) Association of Indian Medical Devices certification and grant of manufacturingMay-June 2016 31

Industry NewsIndustry (AIMED) strongly advocated that requirements) for low risk medical devices and injurious phenomenon in the IndianICMED certification should be made and ICMED 13485 (An ISO 13485 plus market. Most importantly, it will bring downmandatory as the scheme will be able to fill additional requirements) for medium and the substantial time and cost-run to obtainbig regulatory vacuum in quality certification higher risk devices. A third level, to globally accepted quality certification forspace for medical devices in the country and additionally prescribe medical device Indian companies, thereby ensuringwill enhance the competitiveness and specifications developed by health substantial savings, enhanced credibility,”profitability of Indian medical device ministries NHSRC is still under stressed Rajiv Nath, forum coordinator,industry. Currently, there is no India-specific development and would be launched later AIMED and chairman, technicalofficial quality assurance system, due to this year. committee, QCI-AIMED.which Indian medical device manufacturersencountered loss of competitiveness to “Why not make ICMED certification ICMED is the first home developed inter-foreign companies while consumers ended mandatory, as it is aimed at enhancing national class certification scheme for theup paying extra premium with no patient safety, provide enhanced consumer medical devices in the country. It is a jointconcomitant benefits, ICMED also fills a big protection along with much needed product initiative of AIMED, Quality Council of In-regulatory void. credentials to manufacturers for instilling dia (QCI) and the National Accreditation confidence among buyers and users. This Board for Certification Bodies (NABCB).Launched in March, ICMED has two Scheme is intended to significantlycertification options, ICMED 9000 eliminate trading of sub-standard products (Ref.: http://www.pharmabiz.com/certification (an ISO 9001 plus additional or devices of doubtful origins, a widespread NewsDetails.aspx?aid=95101&sid=1)India And Japan To Seek Regulatory Collaboration For Medical ProductsThe Japan has extended support to harmonisation of regulatory frameworks will Japanese side has extended support toGovernment of India for Indian regulators’ benefit trade exchange & technology Government of India for Indian regulators’skill enhancement through its Asia Training exchange for larger good. Japan is the third skill enhancement through itsCentre largest medical devices manufacturer and Asia Training Centre. consumer in the world. It is a pioneer forIndia and Japan are looking to accelerate development of several pharmaceutical and This is a great start. We have achievedcollaboration for medical products through medical devices. much needed momentum for ourincreased collaboration between the regulators to meet and collaborate. Fromregulators of the two countries. Against this Japan and India are strong cultural and this point onwards, we collectively commitbackground, the first ever joint symposium trade partners, with Japan being the fourth ourselves to greater partnership and bi-between India and Japan to facilitate largest FDI contributor to India. Under the lateral relationship”, said Probir Das,regulatory collaboration for medical agreement held in 2015 between PM chairman, FICCI Medical Devices Forum.products was organised by FICCI from May Narendra Modi and Japanese PM Shinzo18-19, 2016 in New Delhi. Abe, FDIs from Japan are likely to be (Ref.: http://www.business- doubled by 2019. standard.com/content/b2b-pharma/india-As India is scaling up its healthcare systems and-japan-to-seek-regulatory-and in parallel streamlining the During the two day symposium, participants collaboration-for-medical-products-pharmaceutical and medical devices from both countries agreed to collaborate 116052100319_1.html)regulatory guidelines, it is envisaged that more comprehensively in future. TheSeparate Rules To Spur Medical Devices Sector SoonIn lines with the prime ministers ‘Make in exempted from other caveats such as the countervailing duty add to the cost whichIndia Campaign’, the department of ‘non-compete clause’, which is applicable has posed a major burden on theindustrial policy and promotion (DIPP) has for FDI in existing pharmaceutical manufacturers. There are 10 majoridentified medical devices as one among manufacturing units. Easing of norms for international players and around eightthe top five sectors having good investment medical devices industry by creating a local players in the highly unorganised andpotential in the domestic as well as export special carve-out in the existing FDI policy unregulated market.market. The government has approached in the pharma sector will encourage FDIthe industry, to gauge the market dynamics inflows. Quality has also taken a beating asand understand their demands and manufacturers from outside India mightchallenges. This comes at a time when manufacturers dump sub-standard products as there is in the country are facing challenges like no regulation in place. Products are oftenIn a bid to encourage investments in import and export related issues, inverted being labeled with a high price due to lackdomestic manufacturing, the government duty status, Free Trade Agreement (FTA) of any regulation in terms of pricing ashas also recently allowed 100 per cent etc.More than Rs 20,000 crore medical most of the medical devices have not beenforeign direct investment (FDI) under device market in India is highly unregulated notified by the government under aautomatic route in the medical devices and unorganised. Besides this, 10 per cent separate set of rules.sector. Such investments would also be standard duty and 12 per cent excise or32 May-June 2016

Industry NewsAdmits an official from the Union Health Further, Para 25 of DPCO, 2013 provides regulation of medical devices, to ensureMinistry, “There is an urgent need for sepa- that every manufacturer /importer shall that Indian patients have timely access torate rules for medical devices which is issue a price list and supplementary price the safest medical technology.”therefore being proposed in the new list in Form V to the dealer, State Drugsamended draft bill on Drugs and Cosmet- Controller and the Government from time The current regulatory practices forics Act to be tabled in the budget session to time. medical devices in India are ad-hoc andof the parliament to give the much required were issued in a knee-jerk manner inboost to the sector. Industry perspective response to the Honourable Supreme Court judgement in 2005. While severalAlarmed by unusual spikes in prices of The MedTech industry has welcomed the efforts have been made to streamline themedical devices like cardiac stents and proposed Drugs and Cosmetics registration process, the genesis of the listdrug-eluting stents, the pricing regulator (Amendment) Bill especially as it recognizes of fourteen notified medical devicesNational Pharmaceutical Pricing Authority medical devices as distinct from drugs/ remains questionable. A risk-based(NPPA) has also sought pricing data from pharmaceuticals. Further, it is important that classification for medical devices, along themanufacturers, importers and distributors the Bill and the subsequent Rules to be lines of harmonized international bestof these devices. For monitoring of price framed incorporate regulations that are practices is the need of the hour.movement of notified medical devices as harmonised with international best practicesdrugs under DPCO, 2013, NPPA has asked such as the International Organization for “There is a need for incremental innova-the manufacturers and importers of medical Standardization (ISO) and International tion in the medical device segment to dif-devices in the country to urgently produce Medical Device Regulators Forum (IMDRF). ferentiate them in terms of pricing and toa slew of documents to examine the extend This effort would help medical device meet varied demands of the Indianof price variations of medical devices in manufacturers achieve the highest healthcare system. Medical device inno-the domestic market. It has also been standards of safety and efficacy, and also vation need not only restrict to the inven-reminded the companies that since such allow indigenous industry to prosper and tion of new devices but also to adjustmentsmedical devices are under non-scheduled become globally competitive. to, or incremental improvements of, exist-drug category, their prices can be increased ing devices and clinical practices. It canonly up to 10 per cent of MRP annually. Some category of products need more focus also denote efforts to adapt devices de-Those who have charged beyond this have in terms of regulations and quality signed for use in one setting, such as ato reduce it to the level of 10 per cent of assurance. A case in point being that Drug modern high-tech hospital, to be used inMRP for the next 12 months. Eluting Stent (DES) meant for cardiac another setting, such as a patient’s home disorder is notified but Cerebral Shunt or at a mobile clinic or primary health cen-“In this regard it has been decided to seek meant for neurological disorders is not tre,” Banerjee added.the following information/documents in notified.order to examine price variation, if any, in Typically, medical devices are developedrespect of notified medical device Says Sanjay Banerjee, Regional Managing through continuous innovation and iterativemanufactured/imported/marketed by the Director, South Asia, Zimmer, “Risk improvements and have short product lifecompany”, the NPPA said. management is a process for identifying, cycles. In the Indian setting, MedTech evaluating and mitigating risk. For medical Industry and Academia need to participateThe NPPA has issued letters to all devices, this means product safety, in active collaborative research andconcerned manufacturers/importers including risks associated with harm to development, which encouragesincluding Abbott Healthcare, Boston people and damage to property or the businesses and researchers to workScientific India, Zimmer India, Edwards Life environment. Risk management is an together on innovative projects in selectSciences, Johnson & Johnson, India integral part of medical device design and areas of therapy–from which successfulMedtronic Corporate, B Braun Medical development, production processes and incremental innovative products andIndia, 3M India, Harsoria Healthcare and evaluation of field experience. services can emerge, contributing toRoche Products India. societal welfare and also economic gain. The Indian regulatory system needs to adopt a risk-based approach to theCentre To Notify Revised Schedule M III For Medical Devices By June EndFollowing strong representation from the governs the Indian medical device sector, in understanding and addressing themedical devices industry, the Centre has which has very different R&D, technologies, issues of the industry, which is evident byagreed to align Schedule MIII with IS/ISO investment, production and taxation the ground breaking decisions taken by the13485 by delinking it from Schedule M for requirements from that of pharma sector. Centre in the last few days. Apart from thisPharma. The revised Schedule MIII will be This, the industry pointed out had a industry friendly decision, the governmentnotified by end of this month and is detrimental impact on medical device also recently conceded to set up separateexpected to attract huge investments into sector Making India import dependent, Medical Devices regulatory framework andR&D which will enable India to emerge as leading to unfavorable business law for the industry with separate rules. Ita world class manufacturing hub for environment especially for the domestic also agreed on the utilization of NABCBmedical devices. manufacturers. accredited third party conformity assessment bodies for QMS quality audit.Drugs & Cosmetics Act, 1940, currently The government has been very favorableMay-June 2016 33

Manufacturers and Suppliers of Medical Disposable & Surgical ProductsProduct Range:• TRANSFUSION / DIALYSIS RANGE• UROLOGY RANGE• GASTRO - ENTROLOGY RANGE• ANAESTHESIA RANGE• SURGERY RANGE• MISCELLANEOUS RANGESpecialized in Handling Large Quantity & Contract ManufacturingManufacturing Address : Corresponding Address:HINDUSTAN SURGICAL HINDUSTAN SURGICALHasmukhbhai B. Patel Hasmukhbhai B. Patel749/2, 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 - 380008Tele/Fax : (O) ++91-25440223 Email : [email protected] :9824060964 MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS • I.V. Infusion Sets • Blood Administration Sets • Scalp Vein Set • Urine Collection Bags • Ryles / Feeding Tubes • Catheters and Tubes • Surgical Gloves. Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 079- 25733318 (R) 079-25430211 (M) +91-9825018952 Email : [email protected], [email protected] Website : www.mescosurgical.com34 May-June 2016

Product GalleryQosina Adds 40 Enteral Feeding Connectors That Meet The ISO 80369-3 StandardRonkonkoma, NY – May 25, 2016 – Administration sets and syringes have a female connector endQosina is pleased to announce the that fit into a male patient-access feeding tube port.addition of 40 enteral feeding The Global Enteral Device Suppliers Association (GEDSA.org)connectors that meet the ISO 80369-3 was formed to facilitate the transition to the new type of connectorsstandard and will not mate with the ISO and has created the brand ENFit to represent the new ISO 80369-594-1 and ISO 594-2 luers. Qosina is 3 standard.Qosina is actively researching the upcoming changes offering ENFit™ male and female connectors, caps, stepped adapters, Y and is a member of GEDSA. Qosina will be adding compliantconnectors, stopcocks and syringes, as well as the ENFit to components to its extensive line as the standards become approved. To learn more about the ISO 80369 standard, pleaseENLock adapters, ENPlus cross spikes and universal bottle visit www.qosina.com/iso-80369.adapters for the ENPlus cross spike. All of these parts havebeen added in various sizes and materials. Qosina will continue Qosina is a worldwide supplier of thousands of stock OEMto add more ENFit connectors to meet the needs of your enteral disposable components to the medical and pharmaceuticalproject. Please visit our ENFit section at www.qosina/ industries including bag ports, connectors, luers, clamps, adapters,ENFit.Qosina can modify any existing component to meet your etc. Qosina operates an ISO 9001 and ISO 14001 registeredneeds or build new tooling to meet your exact requirements. facility.Enteral is the first clinical application to make the transition tonew, safer connectors. The New Enteral Feeding Connectors Qosina offers low minimums and short lead times. Call ourhave been designed to improve patient safety and reduce the Customer Service Specialists to request a sample, obtain our latestrisk of enteral feeding misconnections. The new standard has catalog or place an order via phone +1(631) 242-3000, emailchanged the configuration of the male and female connectors. [email protected]. Visit us at www.qosina.com to see our latestThese enteral connectors are larger and will not allow connectivity products.with the male luer or female luer connectors that meet the ISO594 standards or any other connectors for any other clinical use. Contact: Maria Stazzone, Qosina 2002-Q Orville Drive North, Ronkonkoma, NY 11779, P. No. +1(631)242-3000. F:+1(631)242-3230 [email protected] : Attention : 35 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] 2016

TechnologyInnovative Computer-Aided Catheter Reprocessing System (CRS) For Cleaning Catheters Developed By Chandigarh Biomedical Engineer Having developed an innovative cheaper. His other achievements include developing a helium compressor and coldhead monitoring device for MRI systems, computer-aided Catheter advanced in-house repair of medical devices and a digital safety Reprocessing System (CRS) for cane for visually impaired people. cleaning catheters, 27-year-old city- Goel now intends to start a company for production of the CRS machine, in line with the Make In India campaign. “At the investor based biomedical engineer Vikram meet in US, I will now be convincing potential investors to fund my project so that I can start production for this machine. The Goel has won the DST-Lockheed idea is to facilitate healthcare and make it more affordable.” Martin India Innovation Growth With an intention to make healthcare more accessible, Goel, who currently works as a senior biomedical engineer at Fortis Hospital, Programme (IIGP) 2016, which was Mohali, developed the CRS machine which is likely to reduce the treatment cost for cardiovascular diseases by up to 55 recently conducted in collaboration per cent. Saving Rs 526 per catheter and reducing the catheter replacement process by 80 per cent, the CRS was awarded withwith the Department of Science and Technology, Government of the Innovation Award at IIGP 2016, along with 30 other innovatorsIndia, in New Delhi. from across India.Talking about the CRS machine developed by him, which intends Having won the project, which is also along the lines ofto replace the conventional method for cleaning of catheters, Goel PM Narendra Modi’s Make In India campaign and Swach Bharattold Chandigarh Newsline, “The machine is fully automatic, Abhiyaan, Goel will now be participating in a leadershipand also adopts a stringent cleaning process for removal of programme for innovative business development methodsmicrobes and antigen for each catheter. The CRS also takes sponsored by Stanford University in the Silicon Valley in the USA.care of everything. Using this machine, catheters can be This year, the Indian delegation will be led by PM Modi.attached with the press of a single button, thus eliminatingthe need for any human intervention.” (Ref: http://indianexpress.com/article/cities/chandigarh/for- developing-machine-to-clean-catheters-chandigarh-biomedical-The CRS machine developed by Goel had also won the awardfor the Best Medical Innovative Product for 2016 at the 22nd engineer-wins-award-iigp-2836731/)International Medical Fair held in Mumbai earlier this year. Notonly this, Goel was also awarded the Young Innovator Award 2016by PGIMER for his project. Having developed the fully automaticcatheter reprocessor, Goel has now also applied to patent thesystem under his name. Prior to this, he has also worked onseveral projects for making healthcare more accessible andIndia’s New IPR Policy Looking To Spur Innovation In Med-Tech SectorThe med-tech industry, both domestic and international, has IP gap as the implementation and other details have yet to begenerally welcomed India’s new intellectual property rights (IPR) seen. However, I think that things are headed in the right direction.”policy, in large part due to the fact that it has something for At the same time, the new rules will give more incentive to domesticeverybody, from industry to public health policy makers. However, medical device manufacturers in terms of research andIPR policy experts have expressed reservations over what they development.see as an over-emphasis on IPR creation. New Policy ObjectivesThe policy, released last month, makes it clear that India will strictlycomply with the Agreement on Trade-Related Aspects of The new policy has seven objectives, including stimulating theIntellectual Property Rights (TRIPS) but will not adopt anything generation of IPRs, developing strong and effective IPR laws thatbeyond that. balance the interests of rights owners and the larger public interest and broader commercialization of IP. Another key objective is toRajiv Nath, founder and forum coordinator of Association of Indian modernize and strengthen service-oriented IPR administrationMedical Device Industry (AIMED) welcomed the new policy, which by setting up a special “Cell for IPR Promotion and Management’he signals that India is evolving to be in accordance to the U.S. (CIPAM) to facilitate more effective and synergistic work betweenand EU’s standard in terms of protecting intellectual property. various IP offices, as well as help promote, create and“This will bring more investors to India, especially to medical devicesector,” he said. commercialize IP assets.Lacking IP protection was the one of the biggest blocks that The policy also aims to strengthen the enforcement andkeep foreign capital flowing into India’s med-tech sector, adjudicatory mechanisms to combat IPR infringements.according to the founder of the association. Other objectives include improving IPR outreach and promotion“Multinational companies lack confidence in protecting their by creating public awareness about the economic, social andintellectual property if they move manufacturing facilities to India. cultural benefits of IPRs among all sections of society and toThe new policy addresses the criticism from companies,” Nath strengthen and expand human resources, institutions andtold Medical Device Daily. “I am not sure how much this fills the capacities to teach, train, research and build skills related to IPR. Some See Flaws In New Policy36 May-June 2016

TechnologyIndia’s leading patent policy expert Shamnad Basheer, a former India has also refused to dilute Section 3(d) of the Indian Patentprofessor at the National University for Juridical Sciences in Act that essentially prevents ‘evergreening,’ where pharmaceuticalKolkata, said “a fundamental flaw” with the new policy is “the companies patent frivolous changes to their drugs in order toassumption that IP is an end in itself and we must notch up more extend IP protection, thereby preventing generic companies fromIP registrations for the mere sake of it. Given this fundamental manufacturing cheaper drugs the poor can better afford,” she said.flaw, the policy makes a number of empiricallyunsound assertions,such as a near compulsion for publicly funded scientists to register “The new IPR policy, which aims to protect inventors andall their new discoveries as IP,” he said. innovators in their quest to create new knowledge but deters frivolous patenting that hinders equitable knowledge creation,” isBasheer said that the policy’s positive features include expedited at the heart of the Indian Prime Minister Narendra Modi-ledexamination, an open IP exchange, and the infusion of corporate government’s mission to generate more innovation in India, shesocial responsibility (CSR) funds into open innovation. added.There is still uncertainty on IPR issues including compulsory What’s more, the new policy also “demonstrates the seriousnesslicensing, section 3(d). Global innovation hubs have a strong IPR of the Indian government in putting in place a well-defined IPRpolicy and mechanisms for patent litigation in cases of IP policy and creating the infrastructure for streamlining the filinginfringement. Given the current negligible contribution of Indian and disposal of IP applications. The policy seeks to not only fast-med-tech companies to global IPR in terms of product patents, it track patent application and processing procedures but also reduceis unclear how the new IPR policy will bridge the demands of the patent approval timelines,” Mazumdar-Shaw said.global IPR community including multinational companies andinvestors vis -a -vis the public health realties in India. Job Opportunity“India’s new national IPR policy strikes a balance between A LEADING MULTINATIONAL COMPANY IS LOOKINGprotecting the rights of patients and promoting innovation FOR SALES / MARKETING EXECUTIVE FORwithin the pharmaceutical industry,” said Kiran Mazumdar- MEDICAL GRADE PLASTIC COMPOUNDS ANDShaw, executive director of Bangalore-based Biocon Ltd. “It TUBINGS IN INDIA. Interested persons may pleaseunambiguously states that India will strictly comply with patent send personal details to [email protected] within the TRIPS framework, but will not go beyond thoseobligations as required in a TRIPS-Plus regime.”May-June 2016 37

EventsFrom Challenges To Opportunities: Favourable Climate For The Plastics IndustryThe plastics industry in ASEAN remains unperturbed Korea, India, Australia and New Zealand, aims to consolidate theby global developments that impacts the growth existing ASEAN FTAs and tie-ups with the other six partnerpath of key industries. With K 2016, the world’s economies. It will impose a 65 % tariff cut, with the percentagelargest trade fair for plastics and rubber, coming up likely to increase to 80 % within a decade.in Düsseldorf, Germany, from 19-26 October. With these optimistic developments taking place, the ASEAN The new norm of economic growths and trends such plastics industry will witness an expansion. In the ASEAN Businessas oil prices, variable supply and demand, and weakening of Outlook Survey 2014, by the American Chamber of Commercemost Asian currencies against the US dollar, have allowed the Singapore & US Chamber of Commerce, Indonesia ranked asregion’s countries to rediscover their strengths to sustain growth the most attractive country for new business expansion, followedeither individually or as a part of the collective grouping of the by Vietnam, Thailand & Myanmar. Availability of low-cost labour10-member ASEAN, which comprises Indonesia, Malaysia, in countries such as Cambodia, Indonesia, Laos, Myanmar, andPhilippines, Singapore, Thailand, Brunei, Vietnam, Laos, Vietnam, renders a competitive advantage. Overall, ASEAN’sMyanmar and Cambodia. growing consumer bases, broadening of plastic import & export markets, and expanding foreign tradingOne of ASEAN’s top export sectors by value is plastics & plastic powers offers foreign investors significant opportunities.products earning US$ 39.3 billion in export revenues in 2013.The sector’s production rates have witnessed a steady average Contact: Tel.+49-211-4560240/F:+49-211-4560 8548growth over the recent years, especially in the ASEAN-6: [email protected] / AngelovaD@messe-Indonesia, Malaysia, the Philippines, Singapore, Thailand, andVietnam, which account for more than 95 % of regional GDP, duesseldorf.de/ [email protected] to McKinsey & Company. Events CalenderVietnam’s relatively nascent plastics industry had an averageannual growth of 16-18 % between 2010 and 2015. It relies on • Medicall 2016 16th Editionimported raw materials, like polypropylene & polyethylene resins, Date: 09-11 Sep, 2016importing an average of 4 million tonnes of raw materials while 15th Edition Venue: Delhi.domestic production totals 1 million tonnes. Date: 22-24 July, 2016 Venue: Chennai.One of ASEAN’s top exporters of plastic products, Malaysia has • ICMD Autumn 2016over 1,500 plastic production companies that export to Europe,China, Singapore, Japan, and Thailand. The 23rd International Component Manufacturing & Design ShowThailand’s plastic consumption is led by packaging (48 %), Date : 30st August - 1st September 2016.electronics (15 %), construction (14 %), and automotive (8 %). Venue : Shenzhen Convention & Exhibition Center, China.Its automotive sector attracts manufacturing opportunities,although itsoverall cost index is 20 to 25 % higher than Indonesia, • Medical Manufacturing AsiaVietnam and the Philippines, largely because of a high qualityand mature automotive manufacturing ecosystem, including 3rd Manufacturing Processes for Medical Technologytiered suppliers of automotive components. Exhibition and Conference Date : 31st August - 2nd September 2016.Around 95 companies are represented on Singapore’s Jurong Venue : Marina Bay Sands, SingaporeIsland, attracting investments in excess of S$ 35 billion, accordingto the Economic Development Board. Presently, companies like • K - 2016BASF, ExxonMobil Chemical, Lanxess, Mitsui Chemicals, Shell& Sumitomo Chemicals have plants. However, BMI Research The World’s No.1 Trade Fair for Plastics and Rubberexpects Singapore to face an uphill climb in 2016, in the face of Date : 19-26 October 2016.a Chinese downturn & regional oversupply. Venue : Dusseldorf, Germany.Pushing further the region’s plastics industry, initiatives are being • CMEF 2016laid out by plastics trade associations, including the ASEANFederation of Plastics Industries, the Malaysian Plastics The 76th China International Medical Equipment FairManufacturers Association, the Thai Plastic industries (CMEF Autumn 2016)Association, and the Philippines Plastics Industry Association. Date : 29 October - 1st November 2016 .The associations are working in tandem with international-scale Venue : Shenzhen Convention and Exhi. Center, China.trade agreement blocs, including the ASEAN EconomicCommunity (AEC), the US-led Trans Pacific Partnership • MEDICA and COMPAMED 2016Agreement (TPPA), and the China-backed RegionalComprehensive Economic Partnership (RCEP). The World’s No.1 Trade Fair for Plastics and Rubber Date : 14-17 November 2016.The RCEP, made up of ASEAN members, China, Japan, South Venue : Dusseldorf, Germany. • Medical Fair India 2017 23rd International Exhibition and Conference Date: 06-08 April, 2017 Venue: Pragati Maidan, New Delhi.38 May-June 2016

Available For Sale Auto Disable Syringes Manufacturing Unit (Or Only Machineries) With European Technology / MachineriesA syringe factory in Nigeria with state-of-art facility (factory) to manufacture Auto Disable Syringes is for sale on As-it-Is condition basis located inside an Export Processing Zone in one of the most safest city to live in Nigeria with manylocation benefits .Built on 3 acre land with 99 years lease, the Unit was installed by a European Company in 2005using all European machines & equipment which are still in good condition. Auto Disable Syringes Manufacturing UnitThe Promoters, a well reputed group, is interested to dispose off his syringe plant with immediate effect with followingtwo options.1 Full plant with 3 acre land, complete machinery & laboratory and 40,000 sq. ft building on As-it-Is condition basis(includes 1.5 Acre land is still empty for any new project set up). OR2 Only all machinery with laboratory equipment without (new investor can relocate all the machines/equipment to hisdesired country) Manufacturing Plant Overview• Total production capacity is 90 million pieces per annum • Requires 125 total staff for full utilization in 3 shifts.• Sizes : Auto Disable Syringes of K1 design from UK : • New investor can continue to produce&market K1 design2ml and 5ml AD syringes either at Nigeria location or any other country• Total sales turn over @ 100% plant utilization is USD6.0 across the globe by relocating all production+QCmillion per annum lab+utility equipment. • Plant can be inspected for production for 1 or 2 days.Full details of the Plant and Equipment with specifications can be provided to seriously interested companies on request. Write to : MEDICAL PLASTICS DATA SERVICE / C/O Classic Computer Services B-4, Mandir Apartment, Opp. Jodhpur Char Rasta BRTS Bus Stop, Satellite Road, Ahmedabad - 380015, Gujarat, India.Phone : 0091-79-26740611, Telefax: 0091-79-26754867 Mobile: 0091-9825457563, EMAIL : [email protected] 2016 39

Surgical Industry GMP ISO - 9001-2008 For Certified Company SALE S. Nath & Co. In Excellence in Quality Hyderabad, R. R. District, Manufacturer & Exporter of Telangana. Surgical Disposable Products since 1980An ISO 9001:2008, 13485:2012 IDEAL® & GMP Certified Company • Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Contact through: [email protected] S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] manufacturers PVC COMPOUNDS ac- We are a leading Consulting organizationcording to the customer requirements of providing an integrated services withstrength, flexibility, x-ray traceability, transpar- focus on project technology :ency, colour and extraction resistance. Quality Management System as perBASIL POLYMERS are patronized by ISO 9001, ISO 13485, Medical DevicesHealth Care Industries For CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training• Flexible Extrusion Grade PVC Compounds and c-GMP.• Flexible Injection Moulding Grade Pvc Compounds• Flexible PVC Tube For I.V.Set, S.V.Set.X-Ray Sanjay Y .Shah – Owner Promoter Opaque Tubes M : +91 98240 17850• Flexible PVC Layflate Film For Medical PVC Bags• RF Welded Medical Bags for I.V. Fluid, Enema etc. Obelis European• DEHP free Medical Grade PVC Compound• Injection Moulded Parts like PVC Chambers, Roller Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Clamp, Adapter etc. for I.V.Set and other Medical Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe. Disposable Products. F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. BASIL POLYMERS Tel. : +91 79 66090225 E-mail : [email protected], [email protected] Website : www.unikalindia.com3-B, Verdan Exclusive, Near Stadium Petrol Pump,P. O. Navjivan, Navrangpura, Ahmedabad – 380014. May-June 2016 Phone : 079-26565981 - 82 - 83 Mobile : 9909036411 / 9824045178 E-mail : [email protected] www.basilpolymers.com40

AN ISO 13485-2012 GMP. & ISO 9001 – 2000 Certified Company CE certified Company AMIGO SURGI CARE PVT. LTD. Manufacturer & Exporter of Medical Disposable Devices & Surgical Manufacturer of Products Disposable Surgical Products: Range of Products : I.V.CANNULAS / B.T.SETS / I.V.SETS / • Infusion Set SURGICAL LATEX GLOVES / CORD • Blood Administration Set CLAMPS / URINE BAGS / MEASURE • Measure Volume Set • Urine Collecting Bag VOLUME SETS ETC. • Urine Collecting Bag - Uro Meatry Manufacturers / Exporters / Hospital Suppliers • Respiratory Exerciser • Twin Bore Nasal Oxygen Set Dealer are requested to • Oxygen Face Mask • Nebulizer Kit Contact : • Vaccum Suck Suction Set Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) • Latex Surgical Gloves • Umblical Cord Clamp (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249Contact Yogesh PatelM. : +91 98241 21383 E-mail : • [email protected] • [email protected] MEDICARE DEVICES Website:www.amigo-india.com Plant Address8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, Plot No.780, Opp.: Kemron LabC.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Sola Santej Road,Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 Rakanpur (Santej) – 382721E-mail : [email protected] Gujarat, IndiaWebsite : www.medicaredevices.com ISO 9001-2015 ISO 13485-2012 CE WHO GMP Range of Products Products • ECG Paper & ECG • Mount Catheter • Flexible Packaging Material Accessories • “T” Recovery Kit • Paper Pouch • Breathing Circuit • Aluminium Foil • ECG Paper Roll & Z • Ambu Bag • Foil Seal Folding • Bain Circuit • Ribbon Pack Pouch • 3 Ball Spirometer • Nasal Canula • Patient ID Belt Contact : • Oxygen Mask • Yankur Suction Set Jignesh Patel : +91 94265 25388 • Nebulizer Mask & • Nebulizer Chamber • Guidal Airways +91 90163 36699 Nebulizer Compressor • B. P. Meter • Multiflow Mask Kavya Packaging • Ventury Mask • High Concentration Mask Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, • Breathing Filter Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : [email protected] Life-O-Line TechnologistMay-June 2016 Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : [email protected] Customer Care No. +91 9898162576 & 7600020901 41

PACK-EQUIP National Healthcare (Mfg. Packaging Machinery) An ISO 9001 : 2008 Company Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, Manufacturing & Exports ofCTM Cross Road, Amraiwadi, Ahmedabad-380 026. Medical Disposables : Phone : 25855027 (M) 9825380739 I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Works : 16, Arbuda Estate, Near Nidhi Bank, Gloves etc.CTM Cross Road, Amraiwadi, Ahmedabad-380 026. 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 : [email protected] Website: nationalhealthcare.in ISO : 13485 : 2012 JIMIT MEDICO SURGICALS PVT. LTD.AN ISO 13485 : 2012 & CERTIFIED COMPANY Manufacturers & Exporters of Disposable Medical Devices Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves,HIV KITs, Ophthalmic KITs, Ophthalmic Knives(Blades), Cap, Mask, Gown, Drapes, Bandages, Dressings etc. Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850E-mail: [email protected] • Web: www.jimitsurgicals.com42 May-June 2016