Medical Plastics Data Service January - February 2018

CToabnletoef nts Vol. 26 No. 1 Jan. - Feb. 2018 20 Cover Story • Medical Device Rule 2017 It is advised to all manufacturers of medical devices for compliance with the condition with the requirement of Medical Devices Rules, 2017 before the due date… • Frequently Asked Questions On Medical Device Rule, 2017 For creating public awareness about MEDICAL DEVICES REGULATIONS, the Central Drugs Standard Control Organization, CDSCO has published Replies to the FAQs on Medical Device Rule, 2017 on the CDSCO website… 24 Rewards & Recognitions • Dr. S Eswara Reddy Appointed As New DCGI • Award For “Outstanding Contribution For Image Building Of Plastics” To D L Pandya, Editor & CEO, Medical Plastics Data Service at Plasticon Awards 2018 25 Technology • Medical Components Cleaning by Vapour Degreasing • Covestro’s Developes New Tougher Medical Grade PC • Teleflex Medical Launches New Suture Technology to Reduce Tissue Strangulation • Needle-Free Injection Device Developed by MIT spinout 33 Global Trends • 13485 Revision: What it Means for Medical Device OEMs and their Supply Chains “The new version drives you to consider risk in all areas of your quality system – purchasing controls, management review and the basic documentation system for managing change control. Different levels of risk management now are incorporated into your system,” explained Conrad… 35 Industry News • QCI, AMTZ and AiMeD form Indian Bio-Medical Skill Consortium to certify capacity of Indian biomedi- cal engineers • MTaI pitches for tax breaks to medical device R&D centres to boost investment in innovation based in-house capabilities centres • Domestic medical device makers seek hike in basic custom duty • PolyOne to Begin Thermoplastic Elastomer Production in India • Inauguration of Clariant's new healthcare packaging plant in Cuddalore, Tamil Nadu. 37 Product Gallery • Revolutionary PenBlade® Safety Scalpels • Line of Stopcocks 18 Did You Know? • Improper Design or Use Of Blood Collection Devices Adversely Affect Accuracy Of Lab Test Results. 37 Event Calender • Medical Fair India : March 16-18, 2018. Mumbai • Medical Manufacturing Asia 2018 : August 29 – 31, 2018 Singapore • 15th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposables / Implants Industry 2018 October 2018, Ahmedabad. • K 2019 : October 16 - 23, 2019, Germany Jan.-Feb. 2018 17

Flashback ?YoDKuindow ? Select Article Index Improper Design or Use Of Blood Collection Devices Adversely Affect Accuracy Of Lab Test Results. July. 2005 to Nov. 2007 Improper design or use of blood collection devices can adversely affect the accuracy of • Engineering Adhesives For The Assembly laboratory test results. Vascular access devices, such as catheters and needles, exert shear Of Medical Devices (July-Aug 2005) forces during blood flow, which creates a predisposition to cell lysis. Components from blood Mr. Pradhyumna Ingle, Marketing Manager, collection tubes, such as stoppers, lubricants, surfactants, and separator gels, can leach into Henkel Loctite India specimens and/or adsorb analytes from a specimen; special tube additives may also alter analyte stability. Because of these interactions with blood specimens, blood collection • Medical Device Manufacturing : Definition devices are a potential source of pre-analytical error in laboratory testing. Accurate labora- of Medical Device (Sept-Oct 2006) tory testing requires an understanding of the complex interactions between collection Dr. G.L. Jain - M. Sc (Chem.) Ph.D. (Bio-Med devices and blood specimens. Manufacturers, vendors, and clinical laboratorians must Engg.) consider the pre-analytical challenges in laboratory testing. • Technology Event: Indo – Australian Con- In May 2017, the FDA advised Americans that Magellan's LeadCare test systems performed ference - Biomaterials, Implants, Tissue En- on blood drawn from the vein (venous) may provide inaccurate results and recommended gineering & Regenerative Medicine that laboratories and health care professionals follow the FDA's recommendations concern- (Sept- Oct 2006) ing retesting using blood drawn from a finger or heel stick. Prior to this warning, Magellan informed its customers that the inaccurate results may potentially be related to the composi- • Polymeric Biomaterials : With Improved tion of the rubber stopper of certain brand of blood collection tubes — specifically, tubes with Biocompatibility And A Greater Range Of lavender- or tan-colored tops — and advised customers to no longer use these types of Applications (Sept- Oct 2006) tubes with Magellan’s blood lead tests.. • Medical Device Manufacturing : Under- During the investigation of the manufacturing facility, it was revealed that the company failed standing Important Issues to comply with the good manufacturing practice requirements of FDA’s Quality System (July-August 2006) regulation including violations of device design validation requirements and failure to Dr. G. L. Jain - M. Sc. (Chem) Ph.D. (Bio-med adequately review, evaluate, and investigate complaints. Engg.) BCTs consist of tube walls, rubber stoppers, lubricants, anticoagulants, separator gels, clot • Outsourcing of Medical Products to Asia activators, and SFs, all of which can affect the quality of the specimens, accuracy and (July–Aug 2006) precision of laboratory tests • Why TPES (Thermoplastic Elastomers) can Because BCTs function properly under most circumstances, many laboratorians are replace Thermoset rubbers in medical unaware of their complexity and limitations. A widespread surfactant (SF) problem revealed applications? (May-June 2006) how these devices can adversely affect laboratory test results (7,8) and emphasized the (Mr. Manan Shah, Rubber Technologist) importance of understanding device limitations. • Medical Device Innovations (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3936985/ ) (May-June 2006) In a • Guidelines for Selection of Thermoplastic Nutshell.... Elastomers for Medical Products (March- April 2006) “My worldview says that Mr. Manan Shah, Rubber Technologist competition is the • Guidelines for Import and Manufacture of consumer's best friend.” Medical Devices (March-April 2006) -Moshe Kahlon, Israeli Politician • General Medical Requirements for Thermo- plastic Elastomers (Jan-Feb 2006) Jan.-Feb. 2018 Mr. Manan Shah, Rubber Technologist • Medical Device Complaint Handling Prac- tices (Jan- Feb 2006) Nancy Singer, Compliance-Alliance, USA • The Internet as a Marketing Tool for the Medical Device Industry (Jan- Feb 2006) • Opportunities for Medical Devices in East- ern Europe (Jan-Feb 2006) • Indo-Australian Conference on Biomaterials Implants, Tissue Engineering & Regenerative Medicine (Nov- Jan 2007) • Seldinger Technique for Introducing Cath- eters Percutaneously into Vascular Chan- nels (Nov-Dec, 2007) 18

EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. Medical Device Regulation EDITORIAL ADVISORY BOARD Heeding to the Industry demands, the Government has now notified “Medical Device Rules 2017” as separate from Drugs. The CDSCO has also classified Dr. TARANG PATEL Medical Devices on the basis of risks. Association of Indian Medical Device M.B.B.S., M.Ch. (ONCO) Industry ( AiMeD ) under the leadership of Mr Rajiv Nath, Forum Coordinator had Cancer & Reconstructive Surgeon sought clarification and transition period implementation of Rules to permit smooth transition as detailed in his write up covered in this this issue. Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. The CDSCO has also published FAQs on their website for creating public aware- Chairman - Mobilexion Technologies Pvt. Ltd. ness about the rules which have become applicable from Jan. 1, 2018. Few select FAQs and their replies are also included in this issue. Trivandrum Year 2017 was remarkable with some of the very significant developments for the Dr. DILIP H. RAIKER industry as summarized. Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai One of them was price cap on Medical Devices . Reacting to the sudden shifting of the NPPA Chairman, “AiMeD” reacted that, “ Change is inevitable but should not be ING LOUIS C. SUHUURMAN disruptive and when Good Officers leave suddenly, it’s disconcerting and not Formerly Sales Director motivating for other officers. Let’s hope, the excellent initiatives taken by Shri COLPITT B.V., Holland Bhupendra Singh are carried forward by next incumbent & he tooearns the trust of consumers & Ethical Manufacturers and is transparent in decision making Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group ISO 13485:2016 - Implications for the Supply Chain Dr. Vinny Sastri The ISO 13485 revision includes significant changes in number of important areas. President, Winovia LLC, U.S.A. It provides greater emphasis on a risk-based thinking approach to compliance and an increased focus on supplier management. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd As elaborated in the “Global Trends” coloumn in this issue “Regulators understand that the majority of medical devices are not made by OEMs who have deep and Dr. BHARAT GADHAVI wide supply chains”. “As such, quite a bit of information in the revision relates to CEO, HCG Medisurge Hospitals purchasing controls and flow-down of requirements into the OEM’s supply base”. Mr. A.S. ATHALYE “Suppliers certified to ISO 13485, should exercise due diligence and upgrade to the Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai 2016 revision, particularly if they are categorized as critical suppliers.” Dr. SUJOY K. GUHA Under the column “Technology” this issue highlights important process develop- B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. ment related to “Medical Component Cleaning” as well as New Polymeric Materials as well as Devices. The regular column like Industry News, Events as well as “Did IIT, Kharagpur You Know” are also included. Dr. G. S. BHUVANESHWAR Consultant, Medical Devices – Design, development, testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: [email protected] Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-54 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. Jan.-Feb. 2018 19

Cover Story MEDICAL DEVICE RULE, 2017 Rajiv Nath, The Medical Device Rules became applicable on 23 Medical Devices Notified as Drugs on 01.01.2018. The Industry had sought clarification and transition period for implementation of Rules to permit Forum Coordinator of smooth transition from D&C Rules to MDR 2017 and had Meetings with Additional Secretary, Association of Indian Medical MOH&FW, Dr. R K Vats and Joint Drug Controller, Dr. V Somany who have been helpful. Device Industry (AIMED) and To ensure Ease of Doing Business the following steps have been taken which will specially help Joint MD of Hindustan anyone who has Drug Manufacturing License prior to 27th October 2017 or renewed prior to 27th Syringes and Medical October 2017. Devices Ltd (HMD) As per notification, GSR 1337(E), dated 27.10.2017 the licence issued under Form 25 or 28, unless sooner suspended or cancelled, shall remain valid perpetually. It is advised to all manufacturers of medical devices for compliance with the condition with the re- quirement of Medical Devices Rules, 2017 before the due date of the payment of applicable license retention fee e.g. their Factory Audited by a Certification Body who is Accredited by NABCB. For those of you have got ISO 13485 or ICMED 13485 by an NABCB Accredited Certification Body you may seek simultaneous Audit or a Bridge Audit. The application for grant of licence which are applied before 01.01.2018 but are still in process and not granted the licence, the applicant will need to pay balance fees and also reapply on the online portal as per the Current Medical Device Rules 2017. For inclusion of additional products on existing manufacturing licence as per practices followed, addi- tional fees and documents will have to be submitted as per current Medical Device Rules 2017 to the State Licensing Authority. The above addresses concerns of existing manufacturing licence holders. Any new manufacturing site will need to be approved as per MDR 2017 and applied online”. FREQUENTLY ASKED QUESTIONS ON MEDICAL DEVICE RULE, 2017 For creating public awareness about MEDICAL DEVICES 01.01.2018 but are still in process and not granted the licence, REGULATIONS, the Central Drugs Standard Control the applicant will need to pay balance fees and also reapply on Organization, CDSCO has published Replies to the FAQs on the online portal as per the Current Medical Device Rules 2017. Medical Device Rule, 2017 on the CDSCO website. While few select FAQs are reproduced below for the benefit of our 3.What will be the status of application for additional readers, more detailed list of FAQs can be referred to on products on old existing licence in similar category, made CDSCO before and after 01.01.2018 which are not yet issued? 1. If a license is granted in Form 25 or Form 28 before or • For inclusion of additional products on existing licence as per after publication of GSR 1337(E) dated 27.10.2017, what practices followed, additional fees and documents will have to will be validity period of such licence? be submitted as per current Medical Device Rules 2017. • As per notification, GSR 1337(E), dated 27.10.2017 the licence 4. For importing of raw materials or / components intended issued under Form 25 or 28, unless sooner suspended or to be used for further manufacture of Finished Medical cancelled, shall remain valid perpetually. Devices under a valid manufacturing licence issued under the provisions of Drugs and Cosmetic Act and Rules 2. a) What will be status of application for renewal of licence thereunder, whether the importer needs to obtain the issued in Form 25 or Form 28 which are pending for import license for such raw materials / components ? approval by licensing authority or central licensing approving authority on or after 27.10.2017? b) What will • As per existing practices and circulars, in such cases, no be the status of the application for grant of licence which import licence is required. are applied before 01.01.2018 but are still in process and Note: The first four questions and answers applies to IVD’s not granted the licence? also • a) As per notification, GSR 1337(E), dated 27.10.2017, the 5. By when will the revised Notified Medical Device listing Drugs and Cosmetic Rules, As per provisions in Rule 75 and be made available? Rule 76 the word “renewal” is omitted however, the licensee shall deposit licence retention fee and documents as per the • As per Medical Device Rules 2017, provisions of Current Medical Device Rules 2017. (i) substances used for in vitro diagnosis and surgical dress- It is advised to all manufacturers of medical devices for compli- ings, surgical bandages, surgical staples, surgical sutures, ance with the condition with the requirement of Medical ligatures, blood and blood component collection bag with or Devices Rules, 2017 before the due date of the payment of without anticoagulant covered under sub-clause (i); applicable license retention fee. (ii) substances including mechanical contraceptives (condoms, b) The application for grant of licence which are applied before intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and (iii) 15 classes of Medical devices notified from time to time 20 Jan.-Feb. 2018

Cover Story • The devices which are already notified or to be notified by Government of India shall be regulated as per Medical under sub-clause (iv), of clause (b) of section 3 of the Drugs Device Rules 2017. and Cosmetics Act, 1940 (23 of 1940) Government of India may notify more devices under section 3 (b) (iv) of the Drugs 11. Will a list of products classified into Class A, B, C and D and Cosmetics Act, 1940 in due course of time which will be be released by CDSCO or the companies have to do a displayed on the CDSCO website. self-classification of the products as per their under- standing of the definition of the risk factors? 7. What would be the transition timeline given to manufac- turers and importers w.r.t grandfathering of already • List of devices based on risk classification is published on existing devices? the CDSCO website which is dynamic in nature. • If the device is already in the market and government of India 12. If a manufacturing firm is complying with ISO/IEC notify the same under 3(b)(iv) of Drugs and Cosmetics Act, standards, would it still need to follow BIS standards? 1940 (23 of 1940) then the device will be regulated under the Medical Device Rules 2017. • (i) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under 9. What is the process for classification verification with section 3 of the Bureau of Indian Standards Act, 1985 (63 of CDSCO or notified body prior to submission? 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time. • The Central Licensing Authority shall, classify medical devices referred to in Rule 2, based on their intended use and other (ii) Where no relevant standard of any medical device has parameters specified in the First Schedule. Based on the been laid down under sub-rule (1), such device shall classification referred to in sub-rule (3), class wise list of conform to the standard laid down by the International medical devices shall be published on the website of the Organization for Standardization (ISO) or the International Central Drugs Standard Control Organization (CDSCO): Electro Technical Commission (IEC), or by any other Provided that the Central Licensing Authority may, from time to pharmacopoeial standards. time, make additions or deletions in such list of medical devices or modify the class of any medical device. CDSCO (iii) In case of the standards which have not been specified has already displayed the list of medical devices with under sub-rule (1) and sub-rule (2), the device shall conform classification, which is dynamic in nature. to the validated manufacturer’s standards. 10. In the event CDSCO considers any devices to be website at : http://www.cdsco.nic.in/writereaddata/ regulated beyond the notified devices as additional Updated%20%20FAQ%20MDR.pdf devices or as subset of device, what will be the process of regulating such device? Jan.-Feb. 2018 21

Cover Story 2017 in Review: Milestones in the Medical Device Revolution in India 2017 was another year that took the medical device revolution in make medical devices more affordable. Year 2018, will be a year the country to another level. Here are the most significant to watch out for which would clarify further course of action to ‘medical device’ highlights that ensured that it remained at the make medical devices more affordable. top of the agenda from regulations to retaliations. Maximum Retail Price Medical Device Rules 2017 Later this year amendments to the Legal Metrology (Packaged The year 2017 started with a big news in the industry when Commodities) Rules, 2011 took place which are also applicable Medical Device Rules 2017 got published. The notification came to regulated medical devices effective from 1st January 2018. a day after the Union Finance Minister mentioned during his Budget speech about forming new rules to regulate medical It was reported that consumers at large were facing difficulty as devices. This heeded the industry’s long standing demand to have prices of devices were sold according to the paying capacity of medical device rules separate from drugs. The rules have been the consumer. Even after capping of MRP many companies were framed in conformity with Global Harmonisation Task Force not displaying the same. Also there are important declarations (GHTF) framework and have enhanced clinical trial norms as other than MRP that need to be displayed, are brought into the per International best practices. For the first time, certified purview of declarations to be made under the rules. Further, these agencies would be involved to audit the manufacturing units. rules provide that every package shall bear the name, address, telephone number, e-mail address of the person who can be or Subsequently, the National Regulatory Authority, CDSCO also the office which can be contacted, in case of consumer came up with classification of medical devices. As per the Rules, complaints. these will be classified on the basis of parameters specified in the first schedule, viz a viz low risk as Class A; low to moderate 1st World Conference on Access to medical prod- risk as Class B; moderate to high risk as Class C; and high risk ucts and International Laws for trade and health as Class D. The State licensing authority will regulate Class A and Class B medical device and DCGI under the Union Govern- In the context of 2030 agenda for Sustainable development, ment will regulate Class C and Class D medical device. Ministry of Health & Family Welfare, Indian Society of Interna- tional Law and World Health Organisation hosted the 1st World CDSCO with an aim to facilitate single window clearance for Conference on Access to Medical Products and International Laws medical device and diagnostics industry, launched an online for Trade and Health. The conference was inaugurated by the service for grant of import, manufacture, clinical investigation, Union Health Minister himself. The objective of the conference sale and distribution licences of medical devices and diagnostics was to exchange knowledge and expand understanding on through ‘Sugam portal’. This shall also be in effect in line with contemporary issues in international trade law, research and Medical Devices Rules, 2017. innovation for access to medical products. Global Forum on Medical Devices Kalam Institute of Health Technology In May 2017, WHO headquarters in Geneva hosted the 3rd Global Forum on Medical Devices represented by 85 countries Named after the 11th President of India, an institute dedicated and their 650 dignitaries. The delegation from India was very well for medical technology came up in Vishakhapatnam. The represented by the industry, government and quasi government institute is funded by the Department of Biotechnology, Govern- institutions who in turn presented the work of their respective ment of India with the aim to identify critical gaps in medical domains. The biggest news came during the closing ceremony technology and suggest the government to do focused spending when Indian delegates were invited on stage to announce the on such areas. It shall also help bridge the gap between next Global forum in India. This would certainly help the govern- academic research and industrial market access, by auctioning ment as well as the industry to enhance the growth of the of patents and prototypes available with government funded medical device industry. academic research institutions. KIHT shall broadly function on Innovation & Market Access, Enabling Technology Transfer, and Price Caps Research & Development Support. This year most talked of topic in the industry was price cap on Accomplishments under National Health Mission medical Devices. In February this year National Pharmaceutical (NHM) Pricing Authority (NPPA) slashed coronary stent prices by as much as 85 percent and imposed price ceilings for all drug-eluting stents As per the achievements of Ministry of Health & Family Welfare and bioabsorbable stents. The order on price caps were valid for during the year 2017 published under Press Information Bureau, a year and would be reviewed once again in February 2018. The many technology intensive programs have flourished. In order to matter was of grave concern for the US manufacturers, so much increase access to better healthcare services, some of these so that US trade representative (USTR) had to intervene and programs have been implemented under Public Private Partner- write to Union commerce minister and the Prime Minister’s ship (PPP) mode. principal secretary that the policy has created serious problems for US stent makers in India. The matter was also discussed Under the Pradhan Mantri National Dialysis Program, access to during Prime Minister Narendra Modi’s visit to Washington in June. Dialysis services have been increased to 219 districts with 2039 However the move was very well taken by the Indian manufac- dialysis machines. These dialysis services are free for patient turers, it was also reported in the Economic Times that some of Below Poverty Line (BPL) and at a subsidised rate to other Private equity firms are now approaching the Indian manufactur- patients. Under NHM’s Free Diagnostic services Rs. 759.10 Crore ers for investments. Later this year, continuing its agenda, NPPA have been approved to 29 sates/UTs to provide these services capped prices for orthopaedic knee implants aswell in a move to free for all. In order to ensure a sustainable model, Government of India is also supporting states for Biomedical Equipment Main- 22 Jan.-Feb. 2018

Cover Story Calibration Laboratories (NABL) under Quality Council of India has also announced a national level awareness program on tenance Program (BMMP) and for provisions for radiation safety. accreditation of Medical Device Calibration to be held on 11th BMMP, which is one of the biggest medical equipment and 12th of January 2018 at AERB campus, Mumbai. NABL would maintenance program globally. also launch ‘specific criteria for Medical devices calibration discipline’ at this event. Asian Harmonisation Working Party Medical Device Parks This year India embraced the opportunity to host the 22nd conference on Asian Harmonisation Working Party (AHWP) at After Andhra Pradesh, this year Telangana too inaugurates a New Delhi. The five day conference conducted by Central Drug medical device park with a claim to be country’s biggest. On the Standard Control Organisation (CDSCO) under Ministry of Health day of inauguration itself, the Telangana government had handed & Family Welfare and Federation of Indian Chambers of over land to about 14 medical devices manufacturing compa- Commerce and Industry (FICCI) focussed on Capacity Training, nies. The Telangana Park would work closely with Indian Insti- technical Workshops, technical committee meeting and the 22nd tute of Information Technology Hyderabad (IIIT-Hyderabad) for AHWP Annual Meeting. This year’s edition of the programme medical technology. To weed out the financial constraints for the focussed on ways to harmonize the medical device regulations development in the park, an accelerator seed fund has also been in the Asian and other regions. It also focussed on major regula- proposed. tory and policy updates in the medical device sector and the initiatives taken by the Government of India in the Medical With Medical Parks also planned in Gujarat and Maharashtra; Device Sector. emphasis on excellence in Research and Development (R & D), the medical devices industry in India is poised to grow. Standards and Quality The author is the Senior Consultant, Healthcare Technologies With Medical Device Rules (MDR), 2017 notified, accreditation (Medical devices) at National Health Systems Resource Centre, bodies under Quality Council of India have also become very Ministry of Health & Family Welfare, Government of India which active in the domain of medical device. NABCB has been identi- is a WHO collaborating center for priority medical devices & health fied as an accreditation body for the certification bodies which technology policy. will be designated as the Notified bodies (NB) by the Central Licensing bodies. These NBs will undertake assessment of Quality https://health.economictimes.indiatimes.com/news/medical- Management System for manufacturers of Class A and B devices/2017-in-review-milestones-in-the-medical-device- category devices. In this regard NABCB has formulated a task revolution-in-india/62250639 force to finalise the audit requirements based on MDR, 2017. Meanwhile, National Accreditation Board for Testing and Jan.-Feb. 2018 23

Rewards & Recognitions Dr S Eswara Reddy appointed as new DCGI Joint Drugs Controller Dr S Eswara Reddy has been appointed as the new Drugs Controller General of India (DCGI) for the next three months till regularly appointed person takes charge. Dr. Reddy has obtained his Masters Degree in Pharmacy from College of Pharmaceuticals Sciences Manipal in 1994 and a PhD from JNTU, Hyderabad in 2009. He has experience in pharmaceutical manufacturing, academics and regulations. He started his career as a Drugs Inspector in CDSCO, West Zone, Mumbai in 1998 and has good experience in GMP, GCP and GLP audits. He was promoted as Assistant Drugs Controller of India in 2009. He has participated in many national and international seminars, workshops and meetings on various areas of drugs regulations and undergone training from USFDA, KFDA, South Korea and WHO, Geneva. He was invited to make presentations at various seminars and workshops. He got Best Drugs Inspector award in 2005 and Distinguished Alumni Award from Manipal Academy of Higher Education, Manipal. Dr. Reddy has been awarded with appreciation letters from his superiors for effective implementation of drug regulations. He also published articles in various journals. During his tenure at the headquarters of the Central Drugs Standard Control Organisation (CDSCO), Dr Reddy actively participated in formulating Drugs and Cosmetics Amendment Bill 2013, involved in strength- ening Indian drug regulatory system during 12th Five Year Plan, streamlined medical devices division and handled international matters such as MoU, SOI and quality issues. Award For “Outstanding Contribution For Image Building Of Plastics” To D L Pandya, Editor & CEO, Medical Plastics Data Service at Plasticon Awards 2018 ABOUT PLASTICON preneurship. The winners and runner-ups of each category are selected by an independent panel of jury, who again, are Innovations and Performance Excel- achievers and pioneers in their respective fields. lence of individuals and organisations, contribute to the betterment and Offered across a spectrum of 23 categories (16 for innovations economic wellbeing of the society. and 7 for recognising outstanding performers), these awards cover the widest spectrum of the plastics industry. Recognising these aspects, Plastindia Foundation instituted the program An acclaimed and independent jury, who are brands in their own Plasticon Awards in the year 1997, for right, make sure that the 'best' is truly the best. recognising outstanding innovations and excellence in performance (Individual and Organisations). Plasticon Awards have proved to be the most prestigious and sought after awards for the entire plastics fraternity, including end users, practicing professionals and students. The Awards are sponsored by industry stalwarts, business houses and associations. Recognition categories cover a wide range of activities including industry, academia, research, and entre- 24 Jan.-Feb. 2018

Technology Covestro’s Developes New Tougher Medical -Grade PC Medical Components Cleaning by Vapour Degreasing Oncology drugs aggressively attack cancer but they can also affect the medical devices through which they travel. Medical Device manufacturing needs cleaning of Components It is very important materials , particularly , those used to make before use, whether plastic injection-moulded parts, or sub-as- connectors , withstand the aggressive solvents found in these semblies made from stainless-steel or other materials. This is drugs. essential to avoid serious quality implications including the The medical-grade polycarbonate developed by “ Covestro”, bioburden risk. As medical devices are evolving into more typically used to moldluer and IV connectors , combines durabil- compact and complex components, cleaning becomes more and ity, chemical resistance and transparency.The material also more difficult. Perfecting and validating a cleaning method that features structural integrity to allow for thin-walled designs and works effectively on the intricate parts of medical components is dimensional stability during the shipping and storage process. vital to ensure patient safety. Vapour degreasing offers a simple, proven and reliable answer to cleaning processes within the https://www.plasticstoday.com/medical/covestro-s-new- medical manufacturing industry. medical-grade-pc-tougher-rest/130505310658221 Bioburden : Huge Issue In The Cleaning Process Teleflex Medical Launches New Suture Technol- Bioburden can be a huge issue within the cleaning process, ogy to Reduce Tissue Strangulation especially if the cleaning method uses aqueous technologies. Using aqueous-based cleaning systems not only instigates a Teleflex Medical has created a new suture technology that may bioburden risk, but it also generates a waste water stream that reduce tissue strangulation and a cutting effect in situations where requires expensive treatment. Higher temperatures also are tissue pull-through is a risk. required for effective cleaning, which means more energy is used which can have a significant effect only on the environment and The technology, called Force Fiber Fusion, is a two-in-one also on the pocketbook. construct that goes from a round suture to a flat braid center segment and back to round suture. It is made from ultra-high There are many conditions that can cause bioburden, but water molecular weight polyethylene (UHMWPE) and is strong, durable is a primary growth medium for bacteria. Even trace amounts of and lubricious. moisture in hard-to-reach locations can encourage the growth of Force Fiber Fusion sutures are braided using a continuous bacteria, compromising the ability to properly sterilise the device. process that makes seamless transitions between each of the Therefore, it is important to remove water from the cleaning segments. It has a lower knot profile with an average knot height process to minimise this threat. If it is not properly addressed it that is 1/4 the size of similar sutures on the market. The centers can result in increased complications during the validation of the of the flat portions of the suture are also 38% thinner than similar product. sutures. The sutures are cleared for approximation and ligation of soft A solvent-based cleaning process is a non pyrogenic environ- tissues, including in allograft tissue for orthopedic procedures, in ment. This feature alone significantly reduces the risk of the U.S. bioburden. Solvents dry very quickly and completely leaving no Force Fiber Fusion sutures also come in sizes 1 to 5 and have a residues on parts after they exit the vapour degreaser. Solvents variety of colors and patterns to choose from. The widths, lights also do not require additional mechanical action (high pressure and patterns can be customized. sprays or air knives) or increased temperatures to be effective. The process offers an easy way for engineers to validate https://www.medicaldesignandoutsourcing.com/teleflex- bioburden issues out of the manufacturing process. Lastly, medical-suture-technology-reduce-tissue-strangulation/ solvent cleaning has very high throughput because the cleaning is fast and the finished devices are ready for processing immedi- 25 ately after cleaning. The low viscosity and surface tension ratings of solvents, combined with their volatility, allow them to clean very effectively, even in small gaps and areas that water in aqueous systems cannot easily penetrate. Medical device manufacturers can be sure that all surfaces of the finished product will be effectively cleaned and safe for the patient. One of the most effective critical cleaning methods is vapour degreasing. This process makes it easy to clean small compo- nents with complex geometries. The process also successfully satisfies the performance requirements needed within the medi- cal device industry and the regulatory regimes in different coun- tries. Recent advances in solvent technology have generated environmentally progressive, low-temperature cleaning options that greatly minimise the bioburden and economic issues. More Details available at : https://www.med-technews.com/ news/it%E2%80%99s-a-gas/ Jan.-Feb. 2018

Technology Needle-Free Injection Device Developed by MIT After using the device, patients can input how they’re feeling into spinout the app. A digital image of the body is available so patients can input which joints still hurt after using Prime. Doctors can then check A new needle-free injection device could help reduce the pain patients’ adherence levels and satisfaction to potentially and worry for patients needing multiple injections. adjust treatment. Patients suffering from chronic diseases often require numerous Prime can inject drug doses at a specific skin depth, something injections of drugs but due to associated pain and anxiety, some which other jet-injection devices don’t currently do. For instance, patients stop adhering to treatments. The FDA and Centers for the device could have a high-pressure injection for drugs needing Disease Control currently estimate adherence rates for injected to breach the skin or a low-pressure injection to deliver drugs biologics somewhere between 40% and 70%. to the surrounding tissue. Now, a spinout from MIT has developed a device to take away the worries of needle injections, shorten administration time and Portal Instruments has now landed a commercialisation deal for improve adherence. Prime with the Japanese pharmaceutical company, Takeda. Portal Instruments has developed a jet-injection device that Portal Instruments will work with Takeda’s Entyvio drug as a delivers medicine through the skin with little to no pain. The potential candidate for administration through Prime. The drug is device, Prime, is the size of an electric razor and includes a an antibody for people with ulcerative colitis or Crohn’s disease. connected app that tracks medicine doses and enables patients The company is set to receive an initial payment and could and doctors to see their progress. Prime works by having drugs possibly earn milestone payments of up to $100 million. being loaded into a single-use, disposable vessel, which is then fired at high pressure through the device’s nozzle. Speaking about Prime, CEO Patrick Anquetil, who co-founded Portal with Hunter in 2012, said: “It’s an exciting opportunity to improve the lives of patients with Crohn’s and ulcerative colitis. The col- laboration allows Portal to work alongside Takeda’s research and development team on the product while growing the startup’s business.” “Our main driver is to think of patient comfort at the system-level … and fundamentally change how physicians and patients inter- act. That’s comes from our MIT training.” Anquetil continued. https://www.medicalplasticsnews.com/news/medical-devices/ needle-free-injection-device-by-mit-spinout/ I. V. SETS AND MEDICAL DISPOSABLES MANUFACTURING UNIT FOR SALE Unit in Good Running Condition • Holding Gujarat State FDA Mfg. Licence • Located in Industrial Area in Ahmedabad • Built up Area More Than 390 Square Meter • Machinery / Equipments in Good Working Condition • Includes : Assembly Furniture, Clean Room Systems, E.T.O. Sterilizer, Laboratory Equipments, Urine Bag Mfg. Machines, Packaging Equipments, Utilities Etc. • Promoters Interested to sell because of other business commitments. • No Short Term / Long Term Liability Contact : E-mail [email protected], [email protected] 26 Jan.-Feb. 2018

® 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] : Attention : 27 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] Jan.-Feb. 2018

National An ISO & CE certified Company Healthcare AMIGO SURGI CARE PVT. LTD. An ISO 9001 : 2008 Company Manufacturer of Manufacturing & Exports of Disposable Surgical Products Medical Disposables : I.V.CANNULAS / B.T.SETS / I.V.SETS / I.V. Set, B.T. Set, Urine Bag, SURGICAL LATEX GLOVES / CORD Measured volume set, Cord Clamp, Surgical CLAMPS / MEASURE Gloves etc. VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN Injection Moulded Medical Components and Extended Tubes : SET / CANNULA FIXATOR ETC. Only Manufacturer of IV CANNULA in GUJARAT I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Urine Bag Tubes etc. Mobile : 0091-9825057180 Contact : Tel.: 0091-2764-268249 Naresh Patel E-mail : [email protected] 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Website : www.ivcannulaindia.com Plant Address Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India. E-mail : [email protected] Website: nationalhealthcare.in AVAILABLE AN ISO 13485-2012 PRE USED SYRINGE CE certified Company MANUFACTURING Manufacturer & Exporter of Medical EQUIPMENT Disposable Devices & Surgical Products Moulds : 2, 3, 5, 10ml Syringe Printing Machine : Range of Products : 2/3, 5, 10ml • Infusion Set Syringe 4 Parts Assembly Machine : • Blood Administration Set 2/3, 5, 10ml • Measure Volume Set • Urine Collecting Bag Contact : 7895648113 • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser [email protected] • Twin Bore Nasal Oxygen Set • Oxygen Face Mask Jan.-Feb. 2018 • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp Contact Yogesh Patel M. : +91 98241 21383 MEDICARE DEVICES 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : [email protected] Website : www.medicaredevices.com 28









Global Trends 13485 revision: What it means for medical device OEMs and their supply chains The medical technology industry has gone through some changes in the last 14 years, as has its regulatory environment, and it was on the component they are producing or material or service they time that ISO 13485 reflected that evolution. The global standard are delivering. It will be a little different for everybody.” Contract for medical device quality management systems recently under- sterilizers would be considered critical suppliers, for example, went its first revision since 2003, and it contains a number of and that classification could apply to a plastics processor to whom changes that must be taken into account by medical device production is being outsourced, added Conrad. manufacturers and their critical suppliers. And, yes, there is a deadline: Companies must show compliance to ISO 13485:2016 For companies marketing medical devices in Europe this can be by March 1, 2019. That might seem a ways off, but Notified a do-or-die situation. After March 1, 2019, OEMs may not use Bodies have a lot on their plate right now, and audits are taking components manufactured by suppliers that are not in compli- longer than ever before. PlasticsToday checked in with Garth ance with ISO 13485:2016 until the non-compliance issue has Conrad, Vice President, Quality, at C. R. Bard, now part of BD, to been resolved. It is imperative for any medical device manufac- learn more about how the revision affects the medical turer doing business in countries that recognize CE marking to manufacturing space. monitor the progress of their suppliers in obtaining ISO 13485:2016 certification. “There are three things I would focus on in the revision,” said Procrastination is not a viable strategy, even if the compliance Conrad: The approach to risk management, greater convergence deadline seems fairly distant. Auditors and Notified Bodies are with FDA CFR Part 820 and supply-chain management. stretched very thin right now, according to Conrad. Not only are they dealing with the ISO 13485:2016 revision, they are also Previously, ISO 13485 essentially compartmentalized risk wrapped up with MDSAP compliance, which is set to start next management activities around product development and January, and the European Union’s Medical Device Regulation. post-market complaints. “The revision comprehensively takes risk “That’s further out—2020 to 2022—but the amount of work asso- management and applies it throughout the controls of a quality ciated with that is immense,” said Conrad. “In our experience, management system,” said Conrad. “The new version drives you the response time for audits and the certification update process to consider risk in all areas of your quality system—purchasing has been 25 to 50% longer than in the past.” controls, management review and the basic documentation system for managing change control. Different levels of risk As a final note, Conrad offered three key considerations for management now are incorporated into your system,” explained companies implementing the ISO 13485 revision. Conrad. ISO 13485:2016 also integrates “more of the flavor of what you First, it’s important to “perform a thorough gap assessment see in FDA CFR Part 820 in terms of requirements,” said Conrad. comparing the revised standard to your internal controls. That “Regulators around the world are beginning to converge to a more will set you on the right path for the things you need to do.” common set of requirements and expectations.” The European Union’s new Medical Device Regulation (MDR), which starts to Second, compliance is the beginning, not the end, of the go into effect in 2020, was influenced by the breast implant process. “If you’re using the standard as a minimum compliance scandal, in which a French manufacturer of implants was found item and that’s all you do within your company, you’re missing to be using non-medical grade silicone. As a result, the MDR the bar in terms of what the standard is trying to do, which is to includes a number of safeguards that were absent in the Medical drive a culture of improvement within your business. Use it as a Device Directive, which it replaces. “ISO 13485:2016 was drafted guideline, but don’t stop there. Continue to improve the systems a little before then, but it did capture some of [the same] expecta- and processes you have.” tions,” said Conrad. And the third thing is to do it now, stressed Conrad. “If you have The third foot of this three-legged stool is supply chain manage- gaps, you will have time to fix them before the compliance ment. “Regulators understand that the majority of medical deadline.” devices are not made by OEMs, who have deep and wide supply chains,” said Conrad. “As such, quite a bit of information in the https://www.plasticstoday.com/medical/iso-13485-revision- revision relates to purchasing controls and flow-down of what-it-means-medical-device-oems-and-their-supply-chains/ requirements into the OEM’s supply base.” 52691156758042/page/0/1 While medtech OEMs are not required to work with suppliers that have ISO certification, they must ensure that suppliers have adequate quality control systems in place. “Maintaining ISO certification guarantees a certain level of compliance. If OEMs require ISO certification from their suppliers, they are in the game at a certain level of performance,” said Conrad. Other avenues are available, he added, including FDA’s Medical Device Single Audit Program (MDSAP). Suppliers certified to ISO 13485, however, should exercise due diligence and upgrade to the 2016 revision, particularly if they are categorized as critical suppliers. “As an OEM, part of our certification when we gain CE marking or clearance requires that critical suppliers be identified and maintained as part of the cer- tificate,” explained Conrad. “Critical supplier classification is based Jan.-Feb. 2018 33

34 Jan.-Feb. 2018

Industry News QCI, AMTZ and AiMeD form Indian Bio-Medical Skill Consortium to certify capacity of Indian biomedical engineers Nandita Vijay, Bengaluru, Tuesday, February 20, 2018, 08:00 Hrs [IST] The Association of Indian Manufacturers of Medical Devices MD & CEO, AMTZ and Dr. Ravi P. Singh, secretary general, QCI. (AIMED) has teamed up with the Andhra Pradesh MedTech Zone (AMTZ) and Quality Council of India (QCI) to form the Indian Bio- According to Nath, healthcare industry is one of the major source medical Skill Consortium (IBSC). of economy to our nation, this industry needs well trained and skilled engineers particularly in medical devices areas. The development of biomedical skill sector in India received a major boost and the objective of the initiative is to understand “The move will help develop skill programs in the areas of medi- and analyse the methodology of existing certification/licencing cal devices and related areas that full fill the required manpower for clinical engineers or biomedical equipment technicians by in- to hospitals, medical equipment companies and manufacturing stitute / association in various countries and prepare a module to industries. This will benefit the manufactures/industries by benefit Indian biomedical engineering professionals. making available skilled manpower very easily who are well trained as per the requirements. It will also create more job opportunities The proposed Skill Cell will be hub for both national and interna- for our engineers across the globe. It will enhance the competi- tional BME students and engineers to learn and gain in-depth tiveness and profitability of Indian medical device industry,” he knowledge on all medical devices, calibration and relevant added. areas. IBSC will give recognition to Indian biomedical engineers based on their years of experience, education and competency Earlier a CT Scan manufacturer in India could not depute his levels. This will benefit to approximately two lakh biomedical engineer to EU or US to install, commission or service his equip- engineers in India and 6,500 or more fresh graduates annually. ment as his Indian employed engineer was not qualified. Now International candidates are also eligible to take this exam. with this competency certification and international agreements we expect to have we will be able to support our exports as the IBSC proposes to develop an equivalence system of value-based above issue is acting as a non-tariff trade barrier, said Dr Sharma. assessment covering educational training, work experience and competency possessed by practitioners of biomedical engineer- Along with representatives from AMTZ, QCI and AIMED, the first ing skills. To facilitate this a large number of assessment centres meeting of IBSC had representation from Kalam Institute of Health are being planned across several states in India where compe- Technology (KIHT), IIT Guwahati (IIT-G), Indian Institute of tency test on key bio-medical engineering skills could be under- Science (IISc), Christian Medical College (CMC), Central taken by practitioners of bio-medical engineering from mechani- Scientific Instruments Organisation (CSIO), Healthcare Sector cal, electronic, electrical, health, IT, clinical and allied engineer- Skill Council (HSSC), Society for Applied Microwave Electronics ing subjects. The outcome - a competency score - shall be framed Engineering & Research (SAMEER), Sree Chitra Tirunal on parity with other such professional bodies in other countries. Institute for Medical Sciences and Technology (SCTIMST), Panjab This equivalence score will help the Indian biomedical skill pool University, BSI Group, Australian Trade and Investment to gain formal recognition and acceptance of their experience Commission (Austrade), TÜV Rheinland India and Phoenix and knowledge in other countries. Medical Systems. The tripartite memorandum of understanding (MoU) was signed http://pharmabiz.com/NewsDetails.aspx?aid=107359&sid=1 by Rajiv Nath, forum coordinator, AiMED, Dr. Jitendar Sharma, MTaI pitches for tax breaks to medical device R&D centres to boost investment in innovation based in-house capabilities centres Our Bureau, New Delhi, Wednesday, January 10, 2018, 08:00 Hrs [IST] The Medical Technology Association of India (MTaI) has asked There are many companies dealing in manufacturing and export the government to provide tax breaks to medical device R&D of generic pharmaceutical drugs under contract manufacturing centres under the transfer pricing act to boost investment in arrangement. There are major litigations on account of margins innovation based in-house capabilities centres. that the contract manufacturer should have earned by transfer pricing cell of income tax department. The Central Board of In its pre-budget recommendations for Union Budget 2018-19, Direct Taxes (CBDT) has notified the Safe Harbour rule covering the association said: \"The government needs to provide tax sectors like IT/ITES, KPO and auto component manufacturers holiday to medical device R&D centres under the transfer pricing prescribing desirable margins to avoid litigations under transfer act to boost investment in high innovation-based in-house pricing regulations. capabilities centres.\" Considering that weighted deductions and tax holidays are being \"We also demand tax incentives for the industry for developing phased out, MTaI recommended that the corporate tax rates global patents from India and tax deduction on income made by should also be reduced for large companies in line with the individuals or a company for rewards earned on patent government's objective to widen the tax base and make these development or licensing of patents,\" it added. companies globally competitive. MTaI also raised concerns over high custom duties on medical devices. There was a significant MTaI further requested that Safe Harbour guidelines be provided increase ranging 50-60 per cent on medical devices. This has for pharmaceutical companies who are manufacturing and adversely impacted costs for these products in India where the exporting the product as contract manufacturer/loan licensee. Jan.-Feb. 2018 35

Industry News government agenda is to provide low cost healthcare available economies like Singapore, Malaysia, Hong Kong and Indone- to masses. sia,” the association said. This is especially important in view of the fact that a significant The association has also urged the government to reduce 67-70 per cent of healthcare spends is through private spending Minimum Alternative Tax (MAT) rate to 15 per cent and amend and there exists a wide gap in local manufacturing of high quality Section 115JAA to provide that in case of an amalgamation, where medical devices. the amalgamating company has carry forward MAT credit, the provisions of said section 115JAA would apply and the “We strongly recommend to restore the import duty rates on amalgamated company would be eligible to set off and carry medical devices to earlier rate of 5 per cent import duty where forward the MAT credit of amalgamating company. the overall import duty costs were within range of 5-10 per cent and commensurate with import duty rates in other competing http://pharmabiz.com/NewsDetails.aspx?aid=106592&sid=1 Domestic medical device makers seek hike in basic custom duty Jan 11, 2018 The government needs to increase the basic customs duty on medical device manufacturing is still floundering. medical devices in the range of 5-15 per cent to promote domes- tic manufacturing, Association of Indian Medical Device Industry On its expectations from the Union Budget (2018-19), AiMeD said (AiMeD) said today. the medical devices sector expects, \"extension of inverted duty tariff rationalisation to medical electronics & diagnostics\". The current slab is 0-7.5 per cent, it said. \"The government has It also urged the government to expedite buy Indian policy drafted rightly revised custom duty on Electronics to up to 20 per cent by Department of Pharmaceuticals which is pending with recently to maintain the investment climate, and same is sought Ministry of Health & Family Welfare. for Medical Electronics where import dependency is 90 per cent,\" AiMeD Forum Coordinator Rajiv Nath told PTI. AiMeD also asked the Department of Pharmaceuticals to accel- erate trade margin capping proposal in the range of 50- 100 per He said nominal import duty on critical items is not protectionism cent, depending on the cost of the devices. but sound 'Make in India' economics. https://economictimes.indiatimes.com/industry/healthcare/ The industry body urged the government to introspect as to why, biotech/healthcare/domestic-medical-device-makers-seek-hike- even after three years of the 'Make in India' campaign, the in-basic-custom-duty/articleshow/62458778.cms PolyOne to Begin Thermoplastic Elastomer Production in India Feb 9, 2018 CLEVELAND, Feb. 7, 2018 /PRNewswire/ — PolyOne Corpora- sire for a domestic supplier able to offer expertise in color, engi- tion (NYSE: POL) today announced it expects to begin produc- neered materials and thermoplastic elastomers,” said Craig tion of thermoplastic elastomers (TPEs) this summer at its exist- Nikrant, president, Specialty Engineered Materials, PolyOne. “We ing facility in Pune, India. PolyOne currently produces color and are the only global company to offer all of these domestically additive concentrates and engineered polymer solutions at the produced materials in India. Customers benefit from shorter lead Pune facility. Adding TPE production enables the company to times due to domestic production, and also from our global support customers in the country even more quickly and with a network of polymer science expertise.” broader portfolio of domestically manufactured materials. https://plastics.com/plastic-news-business-materials-polyone- “This investment at our facility in Pune answers customers’ de- begin-thermoplastic-elastomer-production-india/ Inauguration of Clariant's new healthcare packaging plant in Cuddalore, Tamil Nadu. 22-Jan-18 Clariant in India has established its eminence in the specialty tainly a differentiated product offering. In India, Business Line Medi- chemicals sector, with its presence in the country for more than cal Specialties has grown over the past few years and this 50 years. Clariant in India is living the “Make in India” mantra, facility will give us clear edge against the competition.” and has built a manufacturing hub for both exports and domestic Ketan Premani, India Head of Business Unit - Medical Specialties markets. It comprises 11 production sites spread across said, “Our new greenfield healthcare packaging production plant, Maharashtra, Gujarat, Madhya Pradesh, Tamil Nadu and technology-wise is ‘state-of-the-art’. It is the first and so far the Telangana. Clariant in India aims for accelerated growth in the only ISO-8 clean room facility in the group and particularly in emerg- Indian market through the six business units i.e. Masterbatches, ing markets of the world. The facility will offer Desiccants and link Pigments, Additives, Industrial & Consumer Specialties, our customers to Clariant's global packaging design Catalysts and Functional Minerals. capabilities. Pharmaceutical regulatory compliance and Adnan Ahmad, Region Head, Clariant in India said, “Clariant is consistent quality is the hallmark of our offerings to the ambitious in India and we look to create a material and profitable customers” specialty chemical business through our new greenfield plant for http://www.plastemart.com/news-plastics-information/inaugura- healthcare packaging. While this plant may not fall in the spe- tion-of-clariants-new-healthcare-packaging-plant-in-cuddalore- cialty chemicals category in the traditional sense, but it is cer- tamil-nadu-/48375 36 Jan.-Feb. 2018

Product Gallery Qosina Adds Revolutionary PenBlade® Safety Scalpels to Its Line Ronkonkoma, NY, USA, February 1, 2018—Qosina is excited to announce it has added the award-winning, single-use PenBlade® safety scalpels to its product line. Qosina offers the PenBlade® in surgical blade sizes #10, #11P and #15. The rigid body is constructed of medical-grade ABS, and the blade is high-quality British stainless steel for improved sharpness and durability. The ergonomically designed PenBlade® is tapered for blade visibility. The pen-style activation is intuitive, using existing muscle memory (clicking an ink pen). The release button is positioned near the front of the scalpel, where it can be pressed without looking or repositioning the hand. When the blade is retracted, the end of the PenBlade® forms a suture-trimming groove, which encourages the user to finish a procedure in a safe position. This unique patented feature is not available on any other surgical scalpel. Qosina will be showcasing the PenBlade®, in addition to thousands of stock components, at MD&M West, February 6-8, at the Anaheim Convention Center in Anaheim, CA. Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time-to-market by providing thousands of stock com- operates in a 95,000 square-foot facility with an ISO Class 8 Clean ponents. The company’s vast catalog features more than 5,000 Room. To learn about Qosina’s full component offering, products shown in full-scale illustrations on a one-centime- which includes the newest products, ter grid. Qosina offers free samples of most items, visit www.qosina.com or call +1 (631) 242-3000. low minimum order requirements, just-in-time delivery, modifica- Contact : Qosina Corporation, Rachelle Morrow, tion of existing molds, and new product design and development. Qosina is ISO 9001, ISO 13485 and ISO 14001 registered, and +1 (631) 242-3000 [email protected] Qosina Expands Its Line of Stopcocks Ronkonkoma, NY,USA,January 16, 2018—Qosinais excited to announce the addition of 12 new stopcocks to its existing selection of bulk, non-sterile components. These new stopcocks are REACH and RoHS compliant, and feature low profiles, low pressure ratings and unique configurations that include build-in styles. With nearly 100 different options from which to choose, Qosina supplies 1-way, 2-way, 3-way and 4-way stopcocks and stopcock manifolds, with connection options that include male luer locks, female luer locks, male luer slips, barbs and tubing ports. All are offered in a variety of materials and colors for all of your prototyping and production requirements. Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time-to-market by providing thousands of stock components.The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centime- ter grid. Qosina offers free samples of most items, Events Calender low minimum order requirements, just-in-time delivery, modifica- tion of existing molds, and new product design and development. • Medical Fair India : Qosina isISO 9001, ISO 13485 and ISO 14001 registered, and 24th International Exhibition And Conference operates in a 95,000 square-foot facility with an ISO Class 8 Clean Date: March 16-18, 2018. Room. To learn aboutQosina’s full component offering, which Venue: Goregaon (East), Mumbai includes thenewest products, • Medical Manufacturing Asia 2018 visit www.qosina.com or 4th Manufacturing Processes for Medical Technology call +1 (631) 242-3000. Exhibition and Conference Contact : Qosina Corporation, Rachelle Morrow, Date : August 29 – 31, 2018 +1 (631) 242-3000 [email protected] Venue : Marina Bay Sands Singapore www.medicalplasticsindia.com • 15th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposables / The Only Indian Portal Site On Medical Plastics/ Implants Industry 2018 Devices Technology And Trade Date : October 2018 Venue : Ahmedabad Management Association, Ahmedabad, Gujarat • K 2019 The World’s No. 1 Trade Fair for Plastics and Rubber Date : October 16 - 23, 2019 Venue : Dusseldofr, Germany Jan.-Feb. 2018 37

SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 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] 38 Jan.-Feb. 2018

ISO : 13485 : 2012 We are a leading Consulting organization JIMIT MEDICO providing an integrated services with SURGICALS PVT. LTD. focus on project technology : AN ISO 13485 : 2012 & CERTIFIED COMPANY Quality Management System as per ISO 9001, ISO 13485, Medical Devices Manufacturers & Exporters of CE marking as per MDD/93/42, FDA Disposable Medical Devices 510k, Audit, Documentation, training and c-GMP. Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, Sanjay Y .Shah – Owner Promoter HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, M : +91 98240 17850 Dressings etc. Obelis European Specialized in Handling Large Quantity Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest & OEM / Contract Manufacturing Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe. Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : [email protected], [email protected] Tele : +91-79-25835567, +91-79-25834850 Website : www.unikalindia.com E-mail: [email protected] • Web: www.jimitsurgicals.com Jan.-Feb. 2018 39

Manufacturer And Exporter Of a ISO 9001-2000 Quality Medical Devices wide range Of Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, REGISTERED Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, FIRM Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Wide Range Of Products : Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound The company Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical manufactures a wide range Cord Clamp etc... of Medical devices, which The company markets products its own brand name ANGELTOUCH. fall under the Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. 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 GMP PACK-EQUIP ISO - 9001-2008 Certified Company (Mfg. Packaging Machinery) S. Nath & Co. Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, Excellence in Quality CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Manufacturer & Exporter of Phone : 25855027 (M) 9825380739 Surgical Disposable Products since 1980 Works : IDEAL® 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. • Infusion Set • Blood Administration Set Jan.-Feb. 2018 • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Address S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] 40

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 ISO 9001:2008 CERTIFIED COMPANY MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS Address : • I.V. Infusion Sets Apex Medical Devices • Blood Administration Sets • Scalp Vein Set Plot No. 10/B, • Urine Collection Bags Shyam Ujjawal Indurstrial Estate, • Ryles / Feeding Tubes Opp. SBI Bank, Phase 1, G.I.D.C, Vatva, • Catheters and Tubes Ahmedabad-382445. Gujarat, India. • Surgical Gloves. Phone No. : +91-79 - 29701333 Contact : E-mail : [email protected] Mr. Bhavin Shah Website : www.apexmedicaldevice.com MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS Jan.-Feb. 2018 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 41

ISO 9001-2015 ISO 13485-2012 CE WHO GMP Range of Products • ECG Paper & ECG • Mount Catheter Accessories • “T” Recovery Kit • Breathing Circuit • ECG Paper Roll & Z • Ambu Bag Folding • Bain Circuit • 3 Ball Spirometer • Nasal Canula • Patient ID Belt • Oxygen Mask • Yankur Suction Set • Nebulizer Mask & • Nebulizer Chamber • Guidal Airways Nebulizer Compressor • B. P. Meter • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : [email protected] Customer Care No. +91 9898162576 & 7600020901 42 Jan.-Feb. 2018

Contents 2.11 Particulate Matter In Blood Bags 2.12 Complications Related To The Use Of Bone Cement Foreword 2.13 Failure Of The Tracheostomy Tube Preface to First Edition 2.14 Potential Cross-Contamination Linked To Haemodialysis Preface to Second Edition Acknowledgments Treatment 2.15 Complications Related To The Use Of Vascular Chapter 1 : Introduction to Medical Device 1.1 Medical Devices: Managing The Mismatch Haemostasis Devices 1.2 “Catheters”.... 2.16 Occluded Endotracheal Tubes 1.3 Self-Expanding Plastic Stents Used In The Treatment Of 2.17 Allergic Reactions To Medical Devices Containing Latex Benign Esophageal Conditions 2.18 IV Catheter-Associated Infections 1.4 A Combination Product 2.19 That Long Needles ‘Cut Injection Pain’ For Babies 1.5 Defining A Medical Device 2.20 Old Dialysis Filters Are Responsible For Kidney Patient Chapter 2 : Adverse Events . Injuries 2.1 Trends In Medical Device Adverse Events 2.21 About Failure of Endotracheal Tubes 2.2 How Easily Bacteria Clog The Medical Devices…!! 2.22 About Hospital Errors on Medical Tubing Killing Patients 2.3 Risk Management For Medical Devices 2.4 Complications Associated With Urological Devices 2.23 About Trends In Medical Device Adverse Events 2.5 Catheter Introducers – A Potentially Life Threatening Episode Chapter 3 : Applications 2.6 Human Factors Leading To Medical Device Adverse 3.1 PU Dressings Help Wounds To Heal Events 3.2 The Economics Of Prefilled Syringes 2.7 Luer Taper Fitting As Connectors In The Medical Industry 3.3 Coronary Drug-Eluting Stents 2.8 Problems With Transvaginal Surgical Mesh 3.4 Intravenous Infusion Sets ( IV Set ) In Anaesthesia Practice 2.9 Heparin In Medical Devices Linked To 11 U.S. Deaths 2.10 Preventing Dangerous Hemodialysis Catheter Chapter 4 : Regulations & Quality Issues Disconnections 4.1 Challenges Of Using Combination Products 4.2 FDA Regulations Regarding Medical Devices 4.3 About Modernizing Biocompatibility and Biological Risk Evaluation of Medical Device Materials

4.4 About Regulatory Science Priorities For Assuring Safety, 8.2 When To Consider Outsourcing Medical Device Effectiveness, Performance and Quality of Medical Manufacturing To A Contract Manufacturer? Devices 8.3 Health Technology Assessment (HTA) 4.5 About Effect of Medical Device Quality Performance on 8.4 Ultrasonic Welding For Assembling Of Medical Business Performance Components 4.6 About The “Medical Grade“ Polymer Dilemma 8.5 Filters In Intravenous Filter Sets 8.6 Hypotension And Bedside Leukocyte Reduction Filters Chapter 5 : Markets & Emerging Trends 8.7 About Best Practices to Ensure Good Supplier 5.1 What Global Medtech Manufacturers Need To Copy From India And China Management 5.2 India’s Success In Developing Its Own Health Related 8.8 About Welding of Thin Polymeric Films For Medical Technologies 5.3 The WHO Report On Medical Devices And Equipment Applications 5.4 Humanitarian Use Medical Devices (Huds) 5.5 The Ageing Population In Europe Chapter 9 : Packaging & Sterilization 5.6 About Implants As The Fastest Growing Application For 9.1 Determining Breathable Area Of Sterilization Package? Medical Plastics 9.2 Packaging Failures: The Largest Source Of Sterility 5.7 About Challenges Of Using Combination Products Recalls 5.8 About Drug / Device Combination Products & ASEAN 9.3 Sterilization Of Plastics Markets 9.4 Using Steam For Sterilization 9.5 Packaging Combination Products (Medical Devices) Chapter 6 : Innovation & Product Developments 9.6 How Different Sterilisation Methods Were Developed? 6.1 High Impact Frugal Innovations In India 9.7 The Importance Of Keeping Premixed IV Bags Covered 6.2 Medical Device Innovation In Their Plastic Overwraps 6.3 Replacement Cornea Makes Clear Difference 6.4 First Medical Device Derived From New Class Of Chapter 10 : Healthcare Practices, Procedures & Techniques Biopolymers: Absorbable Suture Product 10.1 Safe Injection And Safety Practices 6.5 Remote Monitors For Medical Devices 10.2 Prevention Of Catheter-Related Infections 6.6 Silicon Sensors For Use In Catheters 10.3 Dialysis Procedure 6.7 Phatik Intraocular Lenses 10.4 Five Steps To Safer Healthcare 6.8 Temporary Artificial Heart 10.5 Healthcare Supply Chain 6.9 Coatings For Blood-Contacting Devices 10.6 The “Distribution Channel” For Hospitals 6.10 Knowledge Management 10.7 The Reuse Of Single-Use Devices 6.11 Why The Great Scientist APJ Abdul Kalam Developed Orthosis Callipers Weighing Just 300 Gms ! Chapter 11 : Environment, Waste management & Safety 6.12 Why I.V. Administration Sets Require In-Line Filters? Concerns 6.13 Balancing Product Development Effectiveness with Regulatory Compliance 11.1 PVC : The Environmental Perspective For Health Products Chapter 7 : Materials : Medical Polymers, Biopolymers & Other Materials 11.2 Establishing A Healthcare Plastics Recycling Program 11.3 Healthcare Plastics Recycling 7.1 Polymers To Restore The Sound Of Music? 11.4 Shared Responsibility For Medical Device Safety And 7.2 Conductive Plastic Which May Preserve Eyesight...!! 7.3 UHMWPE Fibers Performance 7.4 Engineered Medical Coatings Advancing The 11.5 Safeguarding Cardiac Guide Wires To Avoid Breakage 11.6 Infectious Hospital Waste Performance Of Medical Devices 11.7 Safety Of Healthcare Professionals 7.5 Intelligent Materials To Revolutionise Surgical Implants 11.8 Vinyl And The Environment? 7.6 Medical Device Coatings 7.7 Why You Should Not Use PVC Tubing In The O2/ Chapter 12 : Industry, Government Research & Academic Institutiona Aircircuit If You Are Using Forane 7.8 Why “PEEK” offers success for the manufacture of 12.1 Sterilization Packaging Manufacturers Council 12.2 Pediatric Medical Device Institute medical parts 12.3 The Center For Devices And Radiological Health (CDRH) 7.9 About Advanced Medical Polymer For Treating Diabetic 12.4 The US Healthcare Industry Patients About the Author 7.10 About Using Medical Polymers Reduce Hospital-Acquired Product and Subject Index Infections References Chapter 8 : Manufacturing : Technologies & Trends 8.1 Welding Of Thin Polymeric Films For Medical Applications