Medical Plastics Data Service Magazine January - February 2018

Table of

Contents 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 biomedical 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

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Flashback Select Article Index

July. 2005 to Nov. 2007 • Engineering Adhesives For The Assembly Of Medical Devices (July-Aug 2005) Mr. Pradhyumna Ingle, Marketing Manager, Henkel Loctite India • Medical Device Manufacturing : Definition of Medical Device (Sept-Oct 2006) Dr. G.L. Jain - M. Sc (Chem.) Ph.D. (Bio-Med Engg.)

• Technology Event: Indo – Australian Conference - Biomaterials, Implants, Tissue Engineering & Regenerative Medicine (Sept- Oct 2006) • Polymeric Biomaterials : With Improved Biocompatibility And A Greater Range Of Applications (Sept- Oct 2006) • Medical Device Manufacturing : Understanding Important Issues (July-August 2006) Dr. G. L. Jain - M. Sc. (Chem) Ph.D. (Bio-med Engg.)

• Outsourcing of Medical Products to Asia (July–Aug 2006) • Why TPES (Thermoplastic Elastomers) can replace Thermoset rubbers in medical applications? (May-June 2006) (Mr. Manan Shah, Rubber Technologist) • Medical Device Innovations (May-June 2006) • Guidelines for Selection of Thermoplastic Elastomers for Medical Products (March- April 2006) Mr. Manan Shah, Rubber Technologist • Guidelines for Import and Manufacture of Medical Devices (March-April 2006) • General Medical Requirements for Thermoplastic Elastomers (Jan-Feb 2006) Mr. Manan Shah, Rubber Technologist • Medical Device Complaint Handling Practices (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 Eastern Europe (Jan-Feb 2006) • Indo-Australian Conference on Biomaterials Implants, Tissue Engineering & Regenerative Medicine (Nov- Jan 2007) • Seldinger Technique for Introducing Catheters Percutaneously into Vascular Channels (Nov-Dec, 2007)

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Did You Know ?

?

Improper Design or Use Of Blood Collection Devices Adversely Affect Accuracy Of Lab Test Results.

Improper design or use of blood collection devices can adversely affect the accuracy of laboratory test results. Vascular access devices, such as catheters and needles, exert shear forces during blood flow, which creates a predisposition to cell lysis. Components from blood collection tubes, such as stoppers, lubricants, surfactants, and separator gels, can leach into 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 devices are a potential source of pre-analytical error in laboratory testing. Accurate laboratory testing requires an understanding of the complex interactions between collection devices and blood specimens. Manufacturers, vendors, and clinical laboratorians must consider the pre-analytical challenges in laboratory testing.

In May 2017, the FDA advised Americans that Magellan's LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results and recommended that laboratories and health care professionals follow the FDA's recommendations concerning 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 composition of the rubber stopper of certain brand of blood collection tubes — specifically, tubes with lavender- or tan-colored tops — and advised customers to no longer use these types of tubes with Magellan’s blood lead tests..

During the investigation of the manufacturing facility, it was revealed that the company failed to comply with the good manufacturing practice requirements of FDA’s Quality System regulation including violations of device design validation requirements and failure to adequately review, evaluate, and investigate complaints.

BCTs consist of tube walls, rubber stoppers, lubricants, anticoagulants, separator gels, clot activators, and SFs, all of which can affect the quality of the specimens, accuracy and precision of laboratory tests Because BCTs function properly under most circumstances, many laboratorians are unaware of their complexity and limitations. A widespread surfactant (SF) problem revealed how these devices can adversely affect laboratory test results (7,8) and emphasized the importance of understanding device limitations. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3936985/ )

In a Nutshell....

“My worldview says that competition is the consumer's best friend.”

-Moshe Kahlon, Israeli Politician

Jan.-Feb. 2018

EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.

EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.)

Former Chief Manager(P), CIPET - Chennai ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. Vinny Sastri President, Winovia LLC, U.S.A. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, HCG Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G. S. BHUVANESHWAR Consultant, Medical Devices – Design, development, testing and quality management.

Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras.

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Editor’s Desk

From the

Medical Device Regulation Heeding to the Industry demands, the Government has now notified “Medical Device Rules 2017” as separate from Drugs. The CDSCO has also classified Medical Devices on the basis of risks. Association of Indian Medical Device Industry ( AiMeD ) under the leadership of Mr Rajiv Nath, Forum Coordinator had sought clarification and transition period implementation of Rules to permit smooth transition as detailed in his write up covered in this this issue.

The CDSCO has also published FAQs on their website for creating public awareness about the rules which have become applicable from Jan. 1, 2018. Few select FAQs and their replies are also included in this issue.

Year 2017 was remarkable with some of the very significant developments for the industry as summarized.

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 disruptive and when Good Officers leave suddenly, it’s disconcerting and not motivating for other officers. Let’s hope, the excellent initiatives taken by Shri Bhupendra Singh are carried forward by next incumbent & he tooearns the trust of consumers & Ethical Manufacturers and is transparent in decision making ISO 13485:2016 - Implications for the Supply Chain The ISO 13485 revision includes significant changes in number of important areas.

It provides greater emphasis on a risk-based thinking approach to compliance and an increased focus on supplier management.

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 wide supply chains”. “As such, quite a bit of information in the revision relates to purchasing controls and flow-down of requirements into the OEM’s supply base”.

“Suppliers certified to ISO 13485, should exercise due diligence and upgrade to the 2016 revision, particularly if they are categorized as critical suppliers.”

Under the column “Technology” this issue highlights important process development 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 You Know” are also included.

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However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.

Jan.-Feb. 2018

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Cover Story MEDICAL DEVICE RULE, 2017 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 smooth transition from D&C Rules to MDR 2017 and had Meetings with Additional Secretary, MOH&FW, Dr. R K Vats and Joint Drug Controller, Dr. V Somany who have been helpful.

Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AIMED) and Joint MD of Hindustan Syringes and Medical Devices Ltd (HMD)

To ensure Ease of Doing Business the following steps have been taken which will specially help anyone who has Drug Manufacturing License prior to 27th October 2017 or renewed prior to 27th October 2017.

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 requirement 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, additional 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 REGULATIONS, the Central Drugs Standard Control Organization, CDSCO has published Replies to the FAQs on Medical Device Rule, 2017 on the CDSCO website. While few select FAQs are reproduced below for the benefit of our readers, more detailed list of FAQs can be referred to on CDSCO 1. If a license is granted in Form 25 or Form 28 before or after publication of GSR 1337(E) dated 27.10.2017, what will be validity period of such licence?

• 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.

2. a) What will be status of application for renewal of licence issued in Form 25 or Form 28 which are pending for approval by licensing authority or central licensing approving authority on or after 27.10.2017? b) What will be the status of the application for grant of licence which are applied before 01.01.2018 but are still in process and not granted the licence?

• a) As per notification, GSR 1337(E), dated 27.10.2017, the Drugs and Cosmetic Rules, As per provisions in Rule 75 and Rule 76 the word “renewal” is omitted however, the licensee shall deposit licence retention fee and documents as per the provisions of Current Medical Device Rules 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 of the payment of applicable license retention fee. b) The application for grant of licence which are applied before

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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.

3.What will be the status of application for additional products on old existing licence in similar category, made before and after 01.01.2018 which are not yet issued?

• For inclusion of additional products on existing licence as per practices followed, additional fees and documents will have to be submitted as per current Medical Device Rules 2017.

4. For importing of raw materials or / components intended to be used for further manufacture of Finished Medical Devices under a valid manufacturing licence issued under the provisions of Drugs and Cosmetic Act and Rules thereunder, whether the importer needs to obtain the import license for such raw materials / components ?

• As per existing practices and circulars, in such cases, no import licence is required.

Note: The first four questions and answers applies to IVD’s also 5. By when will the revised Notified Medical Device listing be made available?

• As per Medical Device Rules 2017, (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i); (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and (iii) 15 classes of Medical devices notified from time to time Jan.-Feb. 2018

Cover Story under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) Government of India may notify more devices under section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 in due course of time which will be displayed on the CDSCO website.

7. What would be the transition timeline given to manufacturers and importers w.r.t grandfathering of already existing devices?

• If the device is already in the market and government of India notify the same under 3(b)(iv) of Drugs and Cosmetics Act, 1940 (23 of 1940) then the device will be regulated under the Medical Device Rules 2017.

9. What is the process for classification verification with CDSCO or notified body prior to submission?

• The Central Licensing Authority shall, classify medical devices referred to in Rule 2, based on their intended use and other parameters specified in the First Schedule. Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organization (CDSCO): Provided that the Central Licensing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device. CDSCO has already displayed the list of medical devices with classification, which is dynamic in nature.

10. In the event CDSCO considers any devices to be regulated beyond the notified devices as additional devices or as subset of device, what will be the process of regulating such device?

Jan.-Feb. 2018

•

The devices which are already notified or to be notified by Government of India shall be regulated as per Medical Device Rules 2017.

11. Will a list of products classified into Class A, B, C and D be released by CDSCO or the companies have to do a self-classification of the products as per their understanding of the definition of the risk factors?

• List of devices based on risk classification is published on the CDSCO website which is dynamic in nature.

12. If a manufacturing firm is complying with ISO/IEC standards, would it still need to follow BIS standards?

• (i) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time. (ii) Where no relevant standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organization for Standardization (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards. (iii) In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer’s standards. website at : http://www.cdsco.nic.in/writereaddata/ Updated%20%20FAQ%20MDR.pdf

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Cover Story 2017 in Review: Milestones in the Medical Device Revolution in India 2017 was another year that took the medical device revolution in the country to another level. Here are the most significant ‘medical device’ highlights that ensured that it remained at the top of the agenda from regulations to retaliations.

Medical Device Rules 2017 The year 2017 started with a big news in the industry when Medical Device Rules 2017 got published. The notification came a day after the Union Finance Minister mentioned during his Budget speech about forming new rules to regulate medical devices. This heeded the industry’s long standing demand to have medical device rules separate from drugs. The rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and have enhanced clinical trial norms as per International best practices. For the first time, certified agencies would be involved to audit the manufacturing units.

Subsequently, the National Regulatory Authority, CDSCO also came up with classification of medical devices. As per the Rules, 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 risk as Class B; moderate to high risk as Class C; and high risk as Class D. The State licensing authority will regulate Class A and Class B medical device and DCGI under the Union Government will regulate Class C and Class D medical device.

CDSCO with an aim to facilitate single window clearance for medical device and diagnostics industry, launched an online service for grant of import, manufacture, clinical investigation, sale and distribution licences of medical devices and diagnostics through ‘Sugam portal’. This shall also be in effect in line with Medical Devices Rules, 2017.

Global Forum on Medical Devices In May 2017, WHO headquarters in Geneva hosted the 3rd Global Forum on Medical Devices represented by 85 countries and their 650 dignitaries. The delegation from India was very well represented by the industry, government and quasi government institutions who in turn presented the work of their respective domains. The biggest news came during the closing ceremony when Indian delegates were invited on stage to announce the next Global forum in India. This would certainly help the government as well as the industry to enhance the growth of the medical device industry.

Price Caps This year most talked of topic in the industry was price cap on medical Devices. In February this year National Pharmaceutical Pricing Authority (NPPA) slashed coronary stent prices by as much as 85 percent and imposed price ceilings for all drug-eluting stents and bioabsorbable stents. The order on price caps were valid for a year and would be reviewed once again in February 2018. The matter was of grave concern for the US manufacturers, so much so that US trade representative (USTR) had to intervene and write to Union commerce minister and the Prime Minister’s principal secretary that the policy has created serious problems for US stent makers in India. The matter was also discussed during Prime Minister Narendra Modi’s visit to Washington in June.

However the move was very well taken by the Indian manufacturers, it was also reported in the Economic Times that some of Private equity firms are now approaching the Indian manufacturers for investments. Later this year, continuing its agenda, NPPA capped prices for orthopaedic knee implants aswell in a move to

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make medical devices more affordable. Year 2018, will be a year to watch out for which would clarify further course of action to make medical devices more affordable.

Maximum Retail Price Later this year amendments to the Legal Metrology (Packaged Commodities) Rules, 2011 took place which are also applicable to regulated medical devices effective from 1st January 2018.

It was reported that consumers at large were facing difficulty as prices of devices were sold according to the paying capacity of the consumer. Even after capping of MRP many companies were not displaying the same. Also there are important declarations other than MRP that need to be displayed, are brought into the purview of declarations to be made under the rules. Further, these rules provide that every package shall bear the name, address, telephone number, e-mail address of the person who can be or the office which can be contacted, in case of consumer complaints.

1st World Conference on Access to medical products and International Laws for trade and health In the context of 2030 agenda for Sustainable development, Ministry of Health & Family Welfare, Indian Society of International Law and World Health Organisation hosted the 1st World Conference on Access to Medical Products and International Laws for Trade and Health. The conference was inaugurated by the Union Health Minister himself. The objective of the conference was to exchange knowledge and expand understanding on contemporary issues in international trade law, research and innovation for access to medical products.

Kalam Institute of Health Technology Named after the 11th President of India, an institute dedicated for medical technology came up in Vishakhapatnam. The institute is funded by the Department of Biotechnology, Government of India with the aim to identify critical gaps in medical technology and suggest the government to do focused spending on such areas. It shall also help bridge the gap between academic research and industrial market access, by auctioning of patents and prototypes available with government funded academic research institutions. KIHT shall broadly function on Innovation & Market Access, Enabling Technology Transfer, and Research & Development Support.

Accomplishments under National Health Mission (NHM) As per the achievements of Ministry of Health & Family Welfare during the year 2017 published under Press Information Bureau, many technology intensive programs have flourished. In order to increase access to better healthcare services, some of these programs have been implemented under Public Private Partnership (PPP) mode.

Under the Pradhan Mantri National Dialysis Program, access to Dialysis services have been increased to 219 districts with 2039 dialysis machines. These dialysis services are free for patient Below Poverty Line (BPL) and at a subsidised rate to other patients. Under NHM’s Free Diagnostic services Rs. 759.10 Crore have been approved to 29 sates/UTs to provide these services free for all. In order to ensure a sustainable model, Government of India is also supporting states for Biomedical Equipment MainJan.-Feb. 2018

Cover Story tenance Program (BMMP) and for provisions for radiation safety.

BMMP, which is one of the biggest medical equipment maintenance program globally.

Asian Harmonisation Working Party This year India embraced the opportunity to host the 22nd conference on Asian Harmonisation Working Party (AHWP) at New Delhi. The five day conference conducted by Central Drug Standard Control Organisation (CDSCO) under Ministry of Health & Family Welfare and Federation of Indian Chambers of Commerce and Industry (FICCI) focussed on Capacity Training, technical Workshops, technical committee meeting and the 22nd AHWP Annual Meeting. This year’s edition of the programme focussed on ways to harmonize the medical device regulations in the Asian and other regions. It also focussed on major regulatory and policy updates in the medical device sector and the initiatives taken by the Government of India in the Medical Device Sector.

Standards and Quality With Medical Device Rules (MDR), 2017 notified, accreditation bodies under Quality Council of India have also become very active in the domain of medical device. NABCB has been identified as an accreditation body for the certification bodies which will be designated as the Notified bodies (NB) by the Central Licensing bodies. These NBs will undertake assessment of Quality Management System for manufacturers of Class A and B category devices. In this regard NABCB has formulated a task force to finalise the audit requirements based on MDR, 2017.

Meanwhile, National Accreditation Board for Testing and

Jan.-Feb. 2018

Calibration Laboratories (NABL) under Quality Council of India has also announced a national level awareness program on accreditation of Medical Device Calibration to be held on 11th and 12th of January 2018 at AERB campus, Mumbai. NABL would also launch ‘specific criteria for Medical devices calibration discipline’ at this event.

Medical Device Parks After Andhra Pradesh, this year Telangana too inaugurates a medical device park with a claim to be country’s biggest. On the day of inauguration itself, the Telangana government had handed over land to about 14 medical devices manufacturing companies. The Telangana Park would work closely with Indian Institute of Information Technology Hyderabad (IIIT-Hyderabad) for medical technology. To weed out the financial constraints for the development in the park, an accelerator seed fund has also been proposed.

With Medical Parks also planned in Gujarat and Maharashtra; emphasis on excellence in Research and Development (R & D), the medical devices industry in India is poised to grow.

The author is the Senior Consultant, Healthcare Technologies (Medical devices) at National Health Systems Resource Centre, Ministry of Health & Family Welfare, Government of India which is a WHO collaborating center for priority medical devices & health technology policy. https://health.economictimes.indiatimes.com/news/medicaldevices/2017-in-review-milestones-in-the-medical-devicerevolution-in-india/62250639

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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 strengthening 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 Innovations and Performance Excellence of individuals and organisations, contribute to the betterment and economic wellbeing of the society.

Recognising these aspects, Plastindia Foundation instituted the program Plasticon Awards in the year 1997, for 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-

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preneurship. The winners and runner-ups of each category are selected by an independent panel of jury, who again, are achievers and pioneers in their respective fields.

Offered across a spectrum of 23 categories (16 for innovations and 7 for recognising outstanding performers), these awards cover the widest spectrum of the plastics industry.

An acclaimed and independent jury, who are brands in their own right, make sure that the 'best' is truly the best.

Jan.-Feb. 2018

Technology Medical Components Cleaning by Vapour Degreasing Medical Device manufacturing needs cleaning of Components before use, whether plastic injection-moulded parts, or sub-assemblies made from stainless-steel or other materials. This is essential to avoid serious quality implications including the bioburden risk. As medical devices are evolving into more compact and complex components, cleaning becomes more and more difficult. Perfecting and validating a cleaning method that works effectively on the intricate parts of medical components is vital to ensure patient safety. Vapour degreasing offers a simple, proven and reliable answer to cleaning processes within the medical manufacturing industry.

Bioburden : Huge Issue In The Cleaning Process Bioburden can be a huge issue within the cleaning process, especially if the cleaning method uses aqueous technologies.

Using aqueous-based cleaning systems not only instigates a bioburden risk, but it also generates a waste water stream that requires expensive treatment. Higher temperatures also are required for effective cleaning, which means more energy is used which can have a significant effect only on the environment and also on the pocketbook.

There are many conditions that can cause bioburden, but water is a primary growth medium for bacteria. Even trace amounts of moisture in hard-to-reach locations can encourage the growth of bacteria, compromising the ability to properly sterilise the device.

Therefore, it is important to remove water from the cleaning process to minimise this threat. If it is not properly addressed it can result in increased complications during the validation of the product.

A solvent-based cleaning process is a non pyrogenic environment. This feature alone significantly reduces the risk of bioburden. Solvents dry very quickly and completely leaving no residues on parts after they exit the vapour degreaser. Solvents also do not require additional mechanical action (high pressure sprays or air knives) or increased temperatures to be effective.

The process offers an easy way for engineers to validate bioburden issues out of the manufacturing process. Lastly, solvent cleaning has very high throughput because the cleaning is fast and the finished devices are ready for processing immediately 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 components with complex geometries. The process also successfully satisfies the performance requirements needed within the medical device industry and the regulatory regimes in different countries. 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/

Covestro’s Developes New Tougher Medical -Grade PC

Oncology drugs aggressively attack cancer but they can also affect the medical devices through which they travel.

It is very important materials , particularly , those used to make connectors , withstand the aggressive solvents found in these drugs.

The medical-grade polycarbonate developed by “ Covestro”, typically used to moldluer and IV connectors , combines durability, chemical resistance and transparency.The material also features structural integrity to allow for thin-walled designs and dimensional stability during the shipping and storage process. https://www.plasticstoday.com/medical/covestro-s-newmedical-grade-pc-tougher-rest/130505310658221

Teleflex Medical Launches New Suture Technology to Reduce Tissue Strangulation Teleflex Medical has created a new suture technology that may reduce tissue strangulation and a cutting effect in situations where tissue pull-through is a risk.

The technology, called Force Fiber Fusion, is a two-in-one construct that goes from a round suture to a flat braid center segment and back to round suture. It is made from ultra-high molecular weight polyethylene (UHMWPE) and is strong, durable and lubricious.

Force Fiber Fusion sutures are braided using a continuous process that makes seamless transitions between each of the segments. It has a lower knot profile with an average knot height that is 1/4 the size of similar sutures on the market. The centers of the flat portions of the suture are also 38% thinner than similar sutures.

The sutures are cleared for approximation and ligation of soft tissues, including in allograft tissue for orthopedic procedures, in the U.S. Force Fiber Fusion sutures also come in sizes 1 to 5 and have a variety of colors and patterns to choose from. The widths, lights and patterns can be customized. https://www.medicaldesignandoutsourcing.com/teleflexmedical-suture-technology-reduce-tissue-strangulation/

Jan.-Feb. 2018

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Technology Needle-Free Injection Device Developed by MIT After using the device, patients can input how they’re feeling into the app. A digital image of the body is available so patients can spinout A new needle-free injection device could help reduce the pain and worry for patients needing multiple injections.

input which joints still hurt after using Prime. Doctors can then check patients’ adherence levels and satisfaction to potentially adjust treatment.

Prime can inject drug doses at a specific skin depth, something which other jet-injection devices don’t currently do. For instance, the device could have a high-pressure injection for drugs needing to breach the skin or a low-pressure injection to deliver drugs to the surrounding tissue.

Patients suffering from chronic diseases often require numerous injections of drugs but due to associated pain and anxiety, some patients stop adhering to treatments. The FDA and Centers for Disease Control currently estimate adherence rates for injected biologics somewhere between 40% and 70%.

Now, a spinout from MIT has developed a device to take away the worries of needle injections, shorten administration time and improve adherence.

Portal Instruments has developed a jet-injection device that delivers medicine through the skin with little to no pain. The device, Prime, is the size of an electric razor and includes a connected app that tracks medicine doses and enables patients and doctors to see their progress. Prime works by having drugs being loaded into a single-use, disposable vessel, which is then fired at high pressure through the device’s nozzle.

Portal Instruments has now landed a commercialisation deal for Prime with the Japanese pharmaceutical company, Takeda.

Portal Instruments will work with Takeda’s Entyvio drug as a potential candidate for administration through Prime. The drug is an antibody for people with ulcerative colitis or Crohn’s disease.

The company is set to receive an initial payment and could possibly earn milestone payments of up to $100 million.

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 collaboration 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 interact. 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 mpdsadvt1@gmail.com, medicalplastics@gmail.com 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.

ISO 13485 : 2003 • Exporting our products to almost more than 23 countries.

Contact : Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : contact@alphamedicare.com

0434

: Attention :

MEDICAL PRODUCTS MANUFACTURERS FOR

Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact :

Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India.

Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com Jan.-Feb. 2018

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National Healthcare An ISO 9001 : 2008 Company

Manufacturing & Exports of Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.

Injection Moulded Medical Components and Extended Tubes : I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.

Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in

AN ISO 13485-2012 CE certified Company Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp

Contact Yogesh Patel M. : +91 98241 21383 MEDIC ARE DEVICES

8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : bhagwatimedicaredevices@gmail.com Website : www.medicaredevices.com

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An ISO & CE certified Company

AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / MEASURE VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN SET / CANNULA FIXATOR ETC.

Only Manufacturer of IV CANNULA in GUJARAT Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Mobile : 0091-9825057180 Tel.: 0091-2764-268249 E-mail : amigo.surgicare@gmail.com Website : www.ivcannulaindia.com Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India.

AVAILABLE PRE USED SYRINGE MANUFACTURING EQUIPMENT Moulds : 2, 3, 5, 10ml Syringe Printing Machine : 2/3, 5, 10ml Syringe 4 Parts Assembly Machine : 2/3, 5, 10ml Contact : 7895648113 pawantiwari1978@gmail.com

Jan.-Feb. 2018

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 time that ISO 13485 reflected that evolution. The global standard for medical device quality management systems recently underwent its first revision since 2003, and it contains a number of changes that must be taken into account by medical device manufacturers and their critical suppliers. And, yes, there is a deadline: Companies must show compliance to ISO 13485:2016

by March 1, 2019. That might seem a ways off, but Notified Bodies have a lot on their plate right now, and audits are taking longer than ever before. PlasticsToday checked in with Garth Conrad, Vice President, Quality, at C. R. Bard, now part of BD, to learn more about how the revision affects the medical manufacturing space.

on the component they are producing or material or service they are delivering. It will be a little different for everybody.” Contract sterilizers would be considered critical suppliers, for example, and that classification could apply to a plastics processor to whom production is being outsourced, added Conrad.

“There are three things I would focus on in the revision,” said Conrad: The approach to risk management, greater convergence with FDA CFR Part 820 and supply-chain management.

Procrastination is not a viable strategy, even if the compliance deadline seems fairly distant. Auditors and Notified Bodies are stretched very thin right now, according to Conrad. Not only are they dealing with the ISO 13485:2016 revision, they are also wrapped up with MDSAP compliance, which is set to start next January, and the European Union’s Medical Device Regulation.

“That’s further out—2020 to 2022—but the amount of work associated with that is immense,” said Conrad. “In our experience, the response time for audits and the certification update process has been 25 to 50% longer than in the past.”

Previously, ISO 13485 essentially compartmentalized risk management activities around product development and post-market complaints. “The revision comprehensively takes risk management and applies it throughout the controls of a quality management system,” said Conrad. “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.

ISO 13485:2016 also integrates “more of the flavor of what you see in FDA CFR Part 820 in terms of requirements,” said Conrad.

“Regulators around the world are beginning to converge to a more common set of requirements and expectations.” The European Union’s new Medical Device Regulation (MDR), which starts to go into effect in 2020, was influenced by the breast implant scandal, in which a French manufacturer of implants was found to be using non-medical grade silicone. As a result, the MDR includes a number of safeguards that were absent in the Medical Device Directive, which it replaces. “ISO 13485:2016 was drafted a little before then, but it did capture some of [the same] expectations,” said Conrad.

The third foot of this three-legged stool is supply chain management. “Regulators understand that the majority of medical devices are not made by OEMs, who have deep and wide supply chains,” said Conrad. “As such, quite a bit of information in the revision relates to purchasing controls and flow-down of requirements into the OEM’s supply base.”

For companies marketing medical devices in Europe this can be a do-or-die situation. After March 1, 2019, OEMs may not use components manufactured by suppliers that are not in compliance with ISO 13485:2016 until the non-compliance issue has been resolved. It is imperative for any medical device manufacturer doing business in countries that recognize CE marking to monitor the progress of their suppliers in obtaining ISO 13485:2016 certification.

As a final note, Conrad offered three key considerations for companies implementing the ISO 13485 revision.

First, it’s important to “perform a thorough gap assessment comparing the revised standard to your internal controls. That will set you on the right path for the things you need to do.”

Second, compliance is the beginning, not the end, of the process. “If you’re using the standard as a minimum compliance item and that’s all you do within your company, you’re missing the bar in terms of what the standard is trying to do, which is to drive a culture of improvement within your business. Use it as a guideline, but don’t stop there. Continue to improve the systems and processes you have.”

And the third thing is to do it now, stressed Conrad. “If you have gaps, you will have time to fix them before the compliance deadline.” https://www.plasticstoday.com/medical/iso-13485-revisionwhat-it-means-medical-device-oems-and-their-supply-chains/ 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 certificate,” explained Conrad. “Critical supplier classification is based Jan.-Feb. 2018

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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 (AIMED) has teamed up with the Andhra Pradesh MedTech Zone (AMTZ) and Quality Council of India (QCI) to form the Indian Biomedical Skill Consortium (IBSC).

MD & CEO, AMTZ and Dr. Ravi P. Singh, secretary general, QCI.

The development of biomedical skill sector in India received a major boost and the objective of the initiative is to understand and analyse the methodology of existing certification/licencing for clinical engineers or biomedical equipment technicians by institute / association in various countries and prepare a module to benefit Indian biomedical engineering professionals.

“The move will help develop skill programs in the areas of medical devices and related areas that full fill the required manpower to hospitals, medical equipment companies and manufacturing industries. This will benefit the manufactures/industries by making available skilled manpower very easily who are well trained as per the requirements. It will also create more job opportunities for our engineers across the globe. It will enhance the competitiveness and profitability of Indian medical device industry,” he added.

The proposed Skill Cell will be hub for both national and international BME students and engineers to learn and gain in-depth knowledge on all medical devices, calibration and relevant areas. IBSC will give recognition to Indian biomedical engineers based on their years of experience, education and competency levels. This will benefit to approximately two lakh biomedical engineers in India and 6,500 or more fresh graduates annually.

International candidates are also eligible to take this exam.

IBSC proposes to develop an equivalence system of value-based assessment covering educational training, work experience and competency possessed by practitioners of biomedical engineering skills. To facilitate this a large number of assessment centres are being planned across several states in India where competency test on key bio-medical engineering skills could be undertaken by practitioners of bio-medical engineering from mechanical, electronic, electrical, health, IT, clinical and allied engineering subjects. The outcome - a competency score - shall be framed on parity with other such professional bodies in other countries.

This equivalence score will help the Indian biomedical skill pool to gain formal recognition and acceptance of their experience and knowledge in other countries.

The tripartite memorandum of understanding (MoU) was signed

by Rajiv Nath, forum coordinator, AiMED, Dr. Jitendar Sharma,

According to Nath, healthcare industry is one of the major source of economy to our nation, this industry needs well trained and skilled engineers particularly in medical devices areas.

Earlier a CT Scan manufacturer in India could not depute his engineer to EU or US to install, commission or service his equipment as his Indian employed engineer was not qualified. Now with this competency certification and international agreements we expect to have we will be able to support our exports as the above issue is acting as a non-tariff trade barrier, said Dr Sharma.

Along with representatives from AMTZ, QCI and AIMED, the first meeting of IBSC had representation from Kalam Institute of Health Technology (KIHT), IIT Guwahati (IIT-G), Indian Institute of Science (IISc), Christian Medical College (CMC), Central Scientific Instruments Organisation (CSIO), Healthcare Sector Skill Council (HSSC), Society for Applied Microwave Electronics Engineering & Research (SAMEER), Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Panjab University, BSI Group, Australian Trade and Investment Commission (Austrade), TÜV Rheinland India and Phoenix Medical Systems. http://pharmabiz.com/NewsDetails.aspx?aid=107359&sid=1

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 the government to provide tax breaks to medical device R&D centres under the transfer pricing act to boost investment in innovation based in-house capabilities centres.

In its pre-budget recommendations for Union Budget 2018-19, the association said: "The government needs to provide tax holiday to medical device R&D centres under the transfer pricing act to boost investment in high innovation-based in-house capabilities centres."

"We also demand tax incentives for the industry for developing global patents from India and tax deduction on income made by individuals or a company for rewards earned on patent development or licensing of patents," it added.

MTaI further requested that Safe Harbour guidelines be provided for pharmaceutical companies who are manufacturing and exporting the product as contract manufacturer/loan licensee.

Jan.-Feb. 2018

There are many companies dealing in manufacturing and export of generic pharmaceutical drugs under contract manufacturing arrangement. There are major litigations on account of margins that the contract manufacturer should have earned by transfer pricing cell of income tax department. The Central Board of Direct Taxes (CBDT) has notified the Safe Harbour rule covering sectors like IT/ITES, KPO and auto component manufacturers prescribing desirable margins to avoid litigations under transfer pricing regulations.

Considering that weighted deductions and tax holidays are being phased out, MTaI recommended that the corporate tax rates should also be reduced for large companies in line with the government's objective to widen the tax base and make these companies globally competitive. MTaI also raised concerns over high custom duties on medical devices. There was a significant increase ranging 50-60 per cent on medical devices. This has adversely impacted costs for these products in India where the

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Industry News government agenda is to provide low cost healthcare available to masses.

economies like Singapore, Malaysia, Hong Kong and Indonesia,” the association said.

This is especially important in view of the fact that a significant 67-70 per cent of healthcare spends is through private spending and there exists a wide gap in local manufacturing of high quality medical devices.

The association has also urged the government to reduce Minimum Alternative Tax (MAT) rate to 15 per cent and amend Section 115JAA to provide that in case of an amalgamation, where the amalgamating company has carry forward MAT credit, the provisions of said section 115JAA would apply and the amalgamated company would be eligible to set off and carry forward the MAT credit of amalgamating company.

“We strongly recommend to restore the import duty rates on medical devices to earlier rate of 5 per cent import duty where 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 devices in the range of 5-15 per cent to promote domestic manufacturing, Association of Indian Medical Device Industry (AiMeD) said today.

The current slab is 0-7.5 per cent, it said. "The government has rightly revised custom duty on Electronics to up to 20 per cent recently to maintain the investment climate, and same is sought for Medical Electronics where import dependency is 90 per cent," AiMeD Forum Coordinator Rajiv Nath told PTI. He said nominal import duty on critical items is not protectionism but sound 'Make in India' economics.

The industry body urged the government to introspect as to why, even after three years of the 'Make in India' campaign, the

medical device manufacturing is still floundering.

On its expectations from the Union Budget (2018-19), AiMeD said the medical devices sector expects, "extension of inverted duty tariff rationalisation to medical electronics & diagnostics".

It also urged the government to expedite buy Indian policy drafted

by Department of Pharmaceuticals which is pending with Ministry of Health & Family Welfare.

AiMeD also asked the Department of Pharmaceuticals to accelerate trade margin capping proposal in the range of 50- 100 per cent, depending on the cost of the devices. https://economictimes.indiatimes.com/industry/healthcare/ biotech/healthcare/domestic-medical-device-makers-seek-hikein-basic-custom-duty/articleshow/62458778.cms

PolyOne to Begin Thermoplastic Elastomer Production in India Feb 9, 2018 CLEVELAND, Feb. 7, 2018 /PRNewswire/ — PolyOne Corporation (NYSE: POL) today announced it expects to begin production of thermoplastic elastomers (TPEs) this summer at its existing facility in Pune, India. PolyOne currently produces color and additive concentrates and engineered polymer solutions at the Pune facility. Adding TPE production enables the company to support customers in the country even more quickly and with a broader portfolio of domestically manufactured materials.

“This investment at our facility in Pune answers customers’ de-

sire for a domestic supplier able to offer expertise in color, engineered materials and thermoplastic elastomers,” said Craig Nikrant, president, Specialty Engineered Materials, PolyOne. “We are the only global company to offer all of these domestically produced materials in India. Customers benefit from shorter lead times due to domestic production, and also from our global network of polymer science expertise.” https://plastics.com/plastic-news-business-materials-polyonebegin-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 Medichemicals 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 emergIndian 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 ambitious in India and we look to create a material and profitable specialty chemical business through our new greenfield plant for healthcare packaging. While this plant may not fall in the specialty chemicals category in the traditional sense, but it is cer-

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consistent quality is the hallmark of our offerings to the customers” http://www.plastemart.com/news-plastics-information/inauguration-of-clariants-new-healthcare-packaging-plant-in-cuddaloretamil-nadu-/48375 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 components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development.

Qosina is ISO 9001, ISO 13485 and ISO 14001 registered, and

operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products, visit www.qosina.com or call +1 (631) 242-3000.

Contact : Qosina Corporation, Rachelle Morrow, +1 (631) 242-3000 rmorrow@qosina.com

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-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development.

Qosina isISO 9001, ISO 13485 and ISO 14001 registered, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn aboutQosina’s full component offering, which includes thenewest products, visit www.qosina.com or call +1 (631) 242-3000.

Contact : Qosina Corporation, Rachelle Morrow, +1 (631) 242-3000 rmorrow@qosina.com

www.medicalplasticsindia.com

The Only Indian Portal Site On Medical Plastics/ Devices Technology And Trade Jan.-Feb. 2018

Events Calender • Medical Fair India : 24th International Exhibition And Conference Date: March 16-18, 2018.

Venue: Goregaon (East), Mumbai • Medical Manufacturing Asia 2018 4th Manufacturing Processes for Medical Technology Exhibition and Conference Date : August 29 – 31, 2018 Venue : Marina Bay Sands Singapore • 15th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposables / Implants Industry 2018 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

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SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • 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 : sanidhya.ent@gmail.com 38

Jan.-Feb. 2018

ISO : 13485 : 2012

We are a leading Consulting organization providing an integrated services with focus on project technology :

Quality Management System as per ISO 9001, ISO 13485, Medical Devices CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training and c-GMP. Sanjay Y .Shah – Owner Promoter M : +91 98240 17850

Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe.

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

F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : unikal@unikalindia.com, unikal@hotmail.com Website : www.unikalindia.com

Jan.-Feb. 2018

Tele : +91-79-25835567, +91-79-25834850

E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com 39

Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking

ISO 9001-2000

Manufacturer And Exporter Of a wide range Of Medical Devices Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests.

Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical Cord Clamp etc...

The company markets products its own brand name ANGELTOUCH. Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. Expertise & Experience : – OEM/Contract Manufacturing.

– Supply of Components for Medical Devices.

ANGIPLAST Private Limited

REGISTERED FIRM Wide Range Of Products :

The company manufactures a wide range of Medical devices, which fall under the main domains of : Infusion Therapy, Transfusion Therapy, Dialysis, Gastroenterology, Urology, Anesthesia, and Surgery.

Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India.

Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com

GMP ISO - 9001-2008 Certified Company

S. Nath & Co. Excellence in Quality Manufacturer & Exporter of Surgical Disposable Products since 1980

IDEAL® • Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Address

S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India.

Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com

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PACK-EQUIP (Mfg. Packaging Machinery) Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, CTM Cross Road, Amraiwadi, Ahmedabad-380 026.

Phone : 25855027 (M) 9825380739 Works : 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026.

Jan.-Feb. 2018

Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block • Ventilator Circuit • Inflatable Anaesthesia Mask • Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff • Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems • Breathing Filters(HME & BVF) • Airovent T-Humidifier • Resuscitator(Ambu Bag) • Dialflow Regulator • Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer • Stylet • 3 Ball Spirometer • Guedel Airway • Three-way Stopcock • Nasopharyngeal Airway • Extension Tubing for Infusion • Laryngeal Mask Airway Systems • Mallaeble gum Bougie • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : airwaycorporation@rediffmail.com info@airwayssurgical.com • Web : www.airwayssurgical.com

High Concentration Mask

Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount

MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

ISO 9001:2008 CERTIFIED COMPANY

•

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

Address :

Apex Medical Devices Plot No. 10/B, Shyam Ujjawal Indurstrial Estate, Opp. SBI Bank, Phase 1, G.I.D.C, Vatva, Ahmedabad-382445. Gujarat, India.

Phone No. : +91-79 - 29701333 E-mail : apexmedical@live.in Website : www.apexmedicaldevice.com Jan.-Feb. 2018

4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com 41

ISO 9001-2015 ISO 13485-2012 CE WHO GMP

Range of Products • ECG Paper & ECG Accessories • ECG Paper Roll & Z Folding • Nasal Canula • Oxygen Mask • Nebulizer Mask & Nebulizer Compressor • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter

• • • • • • • • • • •

Mount Catheter “T” Recovery Kit Breathing Circuit Ambu Bag Bain Circuit 3 Ball Spirometer Patient ID Belt Yankur Suction Set Nebulizer Chamber Guidal Airways B. P. Meter

Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026.

M. : 9898162576 • E-mail : lifeoline2011@yahoo.com Customer Care No. +91 9898162576 & 7600020901

42

Jan.-Feb. 2018

Contents Foreword Preface to First Edition Preface to Second Edition Acknowledgments Chapter 1 : Introduction to Medical Device 1.1 Medical Devices: Managing The Mismatch 1.2 “Catheters”....

1.3 Self-Expanding Plastic Stents Used In The Treatment Of Benign Esophageal Conditions 1.4 A Combination Product 1.5 Defining A Medical Device Chapter 2 : Adverse Events .

2.1 Trends In Medical Device Adverse Events 2.2 How Easily Bacteria Clog The Medical Devices…!!

2.3 Risk Management For Medical Devices 2.4 Complications Associated With Urological Devices 2.5 Catheter Introducers – A Potentially Life Threatening Episode 2.6 Human Factors Leading To Medical Device Adverse Events 2.7 Luer Taper Fitting As Connectors In The Medical Industry 2.8 Problems With Transvaginal Surgical Mesh 2.9 Heparin In Medical Devices Linked To 11 U.S. Deaths 2.10 Preventing Dangerous Hemodialysis Catheter Disconnections

2.11 Particulate Matter In Blood Bags 2.12 Complications Related To The Use Of Bone Cement 2.13 Failure Of The Tracheostomy Tube 2.14 Potential Cross-Contamination Linked To Haemodialysis Treatment 2.15 Complications Related To The Use Of Vascular Haemostasis Devices 2.16 Occluded Endotracheal Tubes 2.17 Allergic Reactions To Medical Devices Containing Latex 2.18 IV Catheter-Associated Infections 2.19 That Long Needles ‘Cut Injection Pain’ For Babies 2.20 Old Dialysis Filters Are Responsible For Kidney Patient Injuries 2.21 About Failure of Endotracheal Tubes 2.22 About Hospital Errors on Medical Tubing Killing Patients 2.23 About Trends In Medical Device Adverse Events Chapter 3 : Applications 3.1 PU Dressings Help Wounds To Heal 3.2 The Economics Of Prefilled Syringes 3.3 Coronary Drug-Eluting Stents 3.4 Intravenous Infusion Sets ( IV Set ) In Anaesthesia Practice Chapter 4 : Regulations & Quality Issues 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, Effectiveness, Performance and Quality of Medical Devices 4.5 About Effect of Medical Device Quality Performance on Business Performance 4.6 About The “Medical Grade“ Polymer Dilemma Chapter 5 : Markets & Emerging Trends 5.1 What Global Medtech Manufacturers Need To Copy From India And China 5.2 India’s Success In Developing Its Own Health Related Technologies 5.3 The WHO Report On Medical Devices And Equipment 5.4 Humanitarian Use Medical Devices (Huds) 5.5 The Ageing Population In Europe 5.6 About Implants As The Fastest Growing Application For Medical Plastics 5.7 About Challenges Of Using Combination Products 5.8 About Drug / Device Combination Products & ASEAN Markets Chapter 6 : Innovation & Product Developments 6.1 High Impact Frugal Innovations In India 6.2 Medical Device Innovation 6.3 Replacement Cornea Makes Clear Difference 6.4 First Medical Device Derived From New Class Of Biopolymers: Absorbable Suture Product 6.5 Remote Monitors For Medical Devices 6.6 Silicon Sensors For Use In Catheters 6.7 Phatik Intraocular Lenses 6.8 Temporary Artificial Heart 6.9 Coatings For Blood-Contacting Devices 6.10 Knowledge Management 6.11 Why The Great Scientist APJ Abdul Kalam Developed Orthosis Callipers Weighing Just 300 Gms !

6.12 Why I.V. Administration Sets Require In-Line Filters?

6.13 Balancing Product Development Effectiveness with Regulatory Compliance Chapter 7 : Materials : Medical Polymers, Biopolymers & Other Materials 7.1 Polymers To Restore The Sound Of Music?

7.2 Conductive Plastic Which May Preserve Eyesight...!!

7.3 UHMWPE Fibers 7.4 Engineered Medical Coatings Advancing The Performance Of Medical Devices 7.5 Intelligent Materials To Revolutionise Surgical Implants 7.6 Medical Device Coatings 7.7 Why You Should Not Use PVC Tubing In The O2/ Aircircuit If You Are Using Forane 7.8 Why “PEEK” offers success for the manufacture of medical parts 7.9 About Advanced Medical Polymer For Treating Diabetic Patients 7.10 About Using Medical Polymers Reduce Hospital-Acquired Infections Chapter 8 : Manufacturing : Technologies & Trends 8.1 Welding Of Thin Polymeric Films For Medical Applications

8.2 When To Consider Outsourcing Medical Device Manufacturing To A Contract Manufacturer?

8.3 Health Technology Assessment (HTA) 8.4 Ultrasonic Welding For Assembling Of Medical Components 8.5 Filters In Intravenous Filter Sets 8.6 Hypotension And Bedside Leukocyte Reduction Filters 8.7 About Best Practices to Ensure Good Supplier Management 8.8 About Welding of Thin Polymeric Films For Medical Applications Chapter 9 : Packaging & Sterilization 9.1 Determining Breathable Area Of Sterilization Package?

9.2 Packaging Failures: The Largest Source Of Sterility Recalls 9.3 Sterilization Of Plastics 9.4 Using Steam For Sterilization 9.5 Packaging Combination Products (Medical Devices) 9.6 How Different Sterilisation Methods Were Developed?

9.7 The Importance Of Keeping Premixed IV Bags Covered In Their Plastic Overwraps Chapter 10 : Healthcare Practices, Procedures & Techniques 10.1 Safe Injection And Safety Practices 10.2 Prevention Of Catheter-Related Infections 10.3 Dialysis Procedure 10.4 Five Steps To Safer Healthcare 10.5 Healthcare Supply Chain 10.6 The “Distribution Channel” For Hospitals 10.7 The Reuse Of Single-Use Devices Chapter 11 : Environment, Waste management & Safety Concerns 11.1 PVC : The Environmental Perspective For Health Products 11.2 Establishing A Healthcare Plastics Recycling Program 11.3 Healthcare Plastics Recycling 11.4 Shared Responsibility For Medical Device Safety And Performance 11.5 Safeguarding Cardiac Guide Wires To Avoid Breakage 11.6 Infectious Hospital Waste 11.7 Safety Of Healthcare Professionals 11.8 Vinyl And The Environment?

Chapter 12 : Industry, Government Research & Academic Institutiona 12.1 Sterilization Packaging Manufacturers Council 12.2 Pediatric Medical Device Institute 12.3 The Center For Devices And Radiological Health (CDRH) 12.4 The US Healthcare Industry About the Author Product and Subject Index References