Medical Plastics Data Service Magazine November - December 2018 by Medical Plastics Data Service

Table of

Contents Vol. 26

No. 6

Nov.-Dec.2018

COVER STORY National Medical Devices Council - Suresh Prabhu, Commerce and Industry Minister, Government Of India “Medical Device Industry will play a key role in the healthcare ecosystem and is indispensable in achieving the goal of health for all citizens of the country. The manufacturing and Trade in Medical Devices is growing steadily. National Medical Devices Council will give boost to domestic manufacturing and for exports”. Quality and Regulations of Medical Devices in India : A Glimpse - Dr T S Kumarvel, Founder Chairman, GLR Laboratories PVt Ltd., Chennai. “ India is seen as a key market for medical devices and diagnostic products. Considering the necessity of a strong regulatory system for medical devices, the government is working on a war foot to upgrade our systems to become globally visible and provide quality medical devices. “ Milestones in the Medical Device Revolution in India.

GLOBAL TRENDS Understanding Europe’s New Medical Device Regulation ( EU MDR ) - Sanjay Shah, Managing Director, Unikal Consultants - EU MDR will bring substantial changes to the way medical device manufacturers bring their devices to the European market. The new regulations seek to increase medical device safety and effectiveness in the EU market while……….. Global Forum On Medical Devices held in Visakhapatnam @ AMTZ - The theme of the WHO Global Forum was “ increasing access to medical devices”

36 39 20 35 Nov.-Dec. 2018

AiMeD & REGULATORY UPDATES • Industry Urges Centre To Change Definition Of Manufacturers In Guidance Document For Medical Devices • CDSCO Proposes To Add Surgical Gowns & Drapes To Notified Devices List As High-Risk Pacemakers, Defibrillators Stay Off Radar • Govt Plans To Use BIS Act To Regulate Medical Devices For Quality Control • Maha FDA Urges CDSCO To Place Intraocular Lenses Under NLEM To Prevent Overcharging* • Central Govt Plans 75% Trade Margin Cap On Imported & Domestic Medical Devices

INDUSTRY NEWS • • • • • •

WHO Supports Manufacturers from Developing Countries In Defining AD Syringes Indian Device Maker Meril Life Sciences Joins Big League With Artificial Heart Valve Technology Medical Compounds Company Expands TPE Range Peters Surgical Invests 5 Million To Expand India Plant HMD procures 2018 Good Design Award in Japan* (Ind News)

PRODUCT GALLERY • New Bonded Extension Lines

ARTICLE INDEX • Medical Plastic Data Service - 2018 Article Index

DID YOU KNOW? • About Compensation To Patients For Faulty Medical Devices

EVENTS CALENDER • India Pharma & India Medical Device 2019 : 18-19 February 2019, Bengaluru, Karnataka • Medical Fair India 2019 : 21-23 February, 2019, Delhi • Medicall 2019 : 8-10 March, 2019, Hyderabad • Medicall 2019 : 26-28 July, 2019, Chennai • K 2019 : 16 – 23 Oct., 2019, Germany

Nov.-Dec. 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. PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY :

Editor’s Desk

From the

COME 2019 – INDIAN MEDICAL DEVICE INDUSTRY – ALL SET TO CHANGE 2018 was an year of happenings for the Industry on all fronts : Regulations , Safety, Credibility , Affordability … and all for Industry, Regulators, Marketing Companies, Hospitals / Doctors and Patients. Last month, speaking at the Convocation ceremony in AIIMS, New Delhi, Hon. VicePresident of India, M Venkaiah Naidu rightly mentioned about the paradoxical situation in the healthcare sector in India. He mentioned that, “On the one hand, India is making rapid strides in medical tourism with the people from other countries coming to our country for a range of treatments - from liver transplant to knee replacement, however, the same treatment is out of reach for many Indians. We need to overcome this paradoxical situation by ensuring that treatment is affordable for all Indians” Of course, not only for the people at large but for all the stake holders of this “Sun Rise” sector, one of the focus sectors for Hon. Prime Minister’s “Make-In-India” Mission, it was high time that Medical Device Industry in India starts evolving. As rightly mentioned by Dr T.S. Kumarvel a very analytical article in this issue on “Quality and Regulations Of Medical Devices In India”, “we have taken too long to roll up our sleeves”. The article,” is a quick look at the metamorphosis of the Indian Medical Device Regulations, the past, the present and what the future holds”. But as he further mentioned, “Evolution is a slow process and so is our Medical Device Industry”. However, from the happenings of the 2018, we hope, “COME 2019 – INDIAN MEDICAL DEVICE INDUSTRY – ALL SET TO CHANGE” This issue highlights the various developments during the year starting from widening the product range defined as Medical Devices to revising the definition of a “Medical Device” manufacturer. It also includes preference to Indian Manufacturers in Government Procurement as also facilitating the Indian patients suffering from Faulty Medical Devices to help them get right and timely compensation for health problems caused by such products from companies making or importing them. The 4th Global Forum on Medical Devices organized in Dec. 2018 in Visakhapatnam @ AMTZ was dedicated to roadmap to develop standards, regulatory framework and increase access. Last , but the most important is the setting up of “National Medical Devices Promotion Council (NMDPC)” under the Department of Industrial Policy and Promotion (DIPP). It is expected that NMDPC will facilitate domestic manufacturers to rise to international level and discouraging unfair trade practices in import and lead India to an export driven market in the Sector. This issue includes these along with our regular columns Global Trends, Industry News, Regulatory Updates, Product Gallery, “Did You Know” etc .

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.

Nov.-Dec. 2018

Cover Story

National Medical Devices Council Set Up Under DIIP The Minister was speaking at the fourth WHO Global Forum on Medical Devices here on Friday at the Andhra Pradesh Medtech Zone. He said the medical devices industry (MDI) will play a key role in the healthcare ecosystem and “is indispensable in achieving the goal of health for all citizens of the country. The manufacturing and trade in MDs is growing steadily”. Prabhu said the national council will give a boost to domestic manufacturing and for exports. He said both the start-ups and MSMEs will also play a crucial role in the sector. The National Medical Devices Promotion Council (NMDPC) has appointed the Association of Indian Medical Device Industry (AiMeD) as a member of the Council. AiMeD has designated forum coordinator Rajiv Nath to represent it to the Council.

Suresh Prabhu

Elated Rajiv Nath said, “We are delighted and in high spirits to be a part of the newly established NMDPC. AiMeD had been seeking a council for the development of Indian medical devices for quite some time. We look forward to new opportunities to contribute in nation building by building a strong Indian medical device industry which is of utmost importance to address our national healthcare security concerns & economy.”

Commerce and Industry Minister, Government Of India

Nath thanked Suresh Prabhu, minister of commerce and industry for his encouraging offer to open a National Design Council and GEM Technical Centre at Kalam Institute of Healthcare Technology.

• To give a fillip to the medical device

The NMDPC will strengthen the Indian medical devices sector by facilitating domestic manufacturers to rise to international level and discouraging unfair trade practices in import and lead India to an export driven market in the sector.

sector, which is a sunrise sector, Union Minister of Commerce and Industry and Civil Aviation Suresh Prabhu announced the setting up of a National Medical Devices Promotion Council under the Department of Industrial Policy and Promotion (DIPP).

• “We are glad government is taking

serious steps to make India a global robust hub for medical devices manufacturing and fulfilling government's ambitious mission of making quality healthcare affordable for common masses,” - Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), Jt. MD, Hindustan Syringes & Med. Ltd., Faridabad

• "Time has come for the medical tech-

nology sector to have an exclusive promotion council that will safeguard the interests of the patients, industry and all stakeholders," - Himanshu Baid, Chairman, CII Medical Technology Division (CII MTD)

Nath further pointed out that the way Pharmaceuticals Export Promotion Council of India (Pharmexcil) was successful in promoting the Indian pharmaceutical industry, we are similarly hopeful that NMDPC will help realise our vision for India to be among the top 5 medical devices manufacturing hubs worldwide as the Council will spearhead the policy needs to accelerate the manufacturing of medical devices in India and end the 70-90% import dependence forced upon us and an import bill of over Rs. 31,000 crore. The Indian market at retail and institutional level is estimated to be at over Rs. 70,000 crore (US$ 10 billion). “We are glad government is taking serious steps to make India a global robust hub for medical devices manufacturing and fulfilling government's ambitious mission of making quality healthcare affordable for common masses,” concluded Nath. The Prime objectives of the National Medical Devices Promotion Council are : • Act as a facilitating and promotion and developmental body for the Indian medical devices industry. • Hold periodic seminars, workshops to deliberate on various parameters for inclusion in the industrial and trade policies in medical devices. • Identify redundant processes and render technical assistance to the agencies/departments concerned in order to simplify the approval processes involved in medical device industry promotion and development. • Enable entry of emerging interventions and support certifications for manufacturers to reach levels of global trade norms and lead India to an export driven market in the sector. • Support dissemination and documentation of international norms and standards for medical devices, by capturing the best practices in the global market and facilitate domestic manufacturers to rise to international level of understanding of regulatory and non-regulatory needs of the industry. Nov.-Dec. 2018

Cover Story • Drive a robust and dynamic Preferential Market Access (PMA) policy, by identifying the strengths of the Indian manufacturers and discouraging unfair trade practices in import; while ensuring pro-active monitoring of public procurement notices across Indian to ensure compliance with PMA guidelines of DIPP/DoP. • Undertake validation of Limited Liability Partnerships (LLPs) and other such entities within MDI sector, which add value to the industry strength in manufacturing to gain foothold for new entrants. • Make recommendations to government based on industry feedback and global practices on policy and process interventions to strengthen the medical technology sector including trade interventions for related markets. "Time has come for the medical technology sector to have an exclusive promotion council that will safeguard the interests of the patients, industry and all stakeholders," said Himanshu Baid, Chairman of the CII Medical Technology Division (CII MTD) in a statement. He said that this council will provide anchorage and an environment for conducive growth for this sector. "We are looking forward to seeing strong Indian presence in the global medtech map in the next few years," he added. CII MTD is an industry association comprising of over 50 major domestic and global medical device companies.

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

The council is aimed at boosting manufacturing, attract investments and promote exports of the fast-growing sector. (Ref : www.thehindubusinessline.com / www.pharmabiz.com / www.medicalbuyer.co.in / www.moneycontrol.com)

Website : www.ivcannulaindia.com Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India.

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 Nov.-Dec. 2018

Cover Story

Quality and Regulations Of Medical Devices in India : A Glimpse Evolution is a slow process and so is our

medical device industry and its regulation. We are evolving! and hope it’s for the sake of good. Well, that’s an optimistic way of establishing the fact that we have taken too long to roll up our sleeves, as far as medical devices are concerned. This article is a quick look at the metamorphosis of the Indian medical device regulations, the past, the present and what the future holds.

Dr. T. S. Kumarvel Founder Chairman, GLR Laboratories Pvt. Ltd., Chennai

Considering the necessity of a strong regulatory system for medical devices, in particular, the government is working on a war foot to upgrade our systems to become globally visible and provide quality medical devices. Hopefully, the introduction of the Medical Device Rules, 2017 may provide some relief to this burning issue.

India, the fourth largest medical devices market in Asia is estimated to demonstrate a growth of a whopping $50 billion by 2025. This shows the enormous potential that this sector holds and is proficiently tapped by the international pharma giants. India is seen as a key market for the medical devices and diagnostic products. In a span of seven years, there has been a spurt of growth in the Indian medical device market with a compound annual growth rate of 15.8%. However, unlike the rest of the world, lack of stringent regulations made it easy for the big manufacturers to market their products in India. This is one reason why nearly 75% of the medical devices marketed in India are imported hands down. Are all these imported devices safe and of good quality? Now, that’s a million-dollar question. About 4700 Indian patients received faulty hip implants supplied by one of the famous pharma giants even after it

was recalled in other countries in 2010. What was reported as a massive failure, earned a huge amount of money in India. How could this even happen? Are we being treated as guinea pigs? And what happened to the moral responsibility of the manufacturer? Well, the answer clearly lies in the lack of defined regulations in India for handling medical device failures with no legal provisions for compensating patients. The rise in the number of serious adverse events related to medical devices from 40 in 2014 to 556 in 2018, shows the negligence by the ministry and the handicap of our regulations in this industry. As of now, there is no system in India for handling compensations for injured or dying patients due to a faulty medical device. However, according to a recent DTAB meeting, proposals are on the way to insist the manufacturing or importing companies that supplies the faulty product, to pay the compensation to the patient’s or their family. As per the proposal, the vindictive pharma company which supplied the faulty hip implants was insisted to pay a lump sum of ¹ 2 million to each patient as compensation. Considering the necessity of a strong regulatory system for medical devices, in particular, the government is working on a war foot to upgrade our systems to become globally visible and provide quality medical devices. Hopefully, the introduction of the Medical Device Rules, 2017 may provide some relief to this burning issue. This critical document, which was drafted way back in 2006, was released in 2017 and was in effect from January 2018. The reason for this delay could have been the change in the government and all the political bureaucracies. Finally, there is this 241page document which really has some meaningful rules to regulate medical devices in India. The remarkable part being that, it has been framed based on international standards (Global Harmonized Task Force standards), so it will certainly have an impact on the quality of the medical devices and their acceptance in the Nov.-Dec. 2018

Cover Story international forum. A critical component of this regulatory compliance is that, it monitors the adverse events and reports them. This is now being managed through the Materiovigilance Programme of India which was launched in 2015. Will MDR 2017 can help in dealing with corporate misconducts? Well, the Indian regulations for medical devices is slowly being streamlined. Earlier only 23 of the many devices marketed in India were regulated. The Drugs Technical Advisory Board in its recent meeting, added some more devices including, all implantable medical devices, bone marrow cell separators, defibrillators, dialysis machines, CT scan equipment, MRI equipment, PET equipment, X-ray machines. The CDSCO, which is the apex body, aims to make this addition a dynamic process and all manufacturers are advised to be on the lookout if their devices are listed. If a medical device that has already been marketed in India is added to this list of regulated devices, the applicant needs to provide evidences of safety, performance and effectiveness. According to the MDR 2017, medical devices are classified into A, B, C and D, where A and B are low risk devices, C and D are high risk devices. The state licensing authority shall be the issuing authority for the A and B class of devices, while the Central licensing authority issues license for the C and D class devices. An amendment to the MDR 2017 rules was made to accommodate this device-class specific issuance of licenses. Also, the fee (Rs. 1000/-) has been applied to each category of the medical device instead of each distinct device. This would add up to the cost for registration of devices that have multiple components falling under different categories. In contrast to the rest of the world, where, the manufacturer classifies his device according to the nature of contact and contact duration, in India, the regulatory body would classify the device based on its intended use, invasiveness, duration of contact, presence of a therapeutic component, presence of medicinal product/biological derivatives. In addition, the accessories would be classified separately from the main device. In a combination device, the rule would apply for each individual device. For the C and D classes of devices, the manufacturing site shall be inspected within a period of 60 days from the application to verify QMS compliance. Subsequent to this, an inspection report shall be issue with recommendations and observations, based on which the government shall approve or reject the license of a given product within 45 days. This procedure is similar to the one that exists in the Europe. Furthermore, all the devices are required to conform their performance standards set by the BIS or ISO or IEC or any other pharmacopoeial standard. The safety

Nov.-Dec. 2018

of a medical device is generally demonstrated through a set of biological tests to say that it is “biocompatible”. These are in vitro and/or in vivo tests that are carried out in accordance with international standards (ISO 10993). Very few laboratories in India are proficient in conducting biocompatibility tests for medical devices. However, this expertise can certainly be expanded. With respect to the registration of the medical devices, all approvals are time bound so that innovative products are brought to the market to reach the patients promptly and those that do not comply are given a chance to improve and get qualified. The license, once issued for a device, is permanent, however, a renewal fee must be paid every five years to keep the license active, failing which the license may stand cancelled. Any changes in the material of construction, design affecting quality, intended use or indications for use, performance, stability, sterilization method, shelf life, domestic manufacturer name or site are to be submitted for approval by the licensing authority. Minor changes are to be notified to the authority within 30 days of implementation. In addition, clinical investigations require prior approval according to the new MDR. Importing or manufacturing investigational medical devices for conducting clinical trials require prior approval from the authority. The medical device industry is included in the “Make in India” campaign. This will open up new business avenues and lure Foreign Direct Investment up to 100% through the automatic route. Proposals for financing common facilities and prioritizing domestic manufacturers as the first choice of sourcing medical devices by government agencies are underway. These moves are encouraging and many medical device manufacturers have begun their exploration on this, however, import duties would still be a bottleneck. It is evident that there is a long agenda for the Indian Government in the medical device sector and it certainly involves a lot of time and resources. Given the infancy of the MDR 2017, the corporate master plays in this market cannot be totally eliminated, however, it is certainly a beginning of an end to this unpalatable medical tourism. No wonder, we are still toddling in this industry as far as our regulations are concerned. Nevertheless, it is a brave move that is worth appreciating! While preventing the diseases is the core objective of any country, preparing a battalion for any catastrophe is what a country does and in the case of medicine, the making of good quality medical devices – the battalion – is the biggest challenge. On an optimistic note, these new regulations will upgrade the quality of the medical devices. Hopefully, this move will take India towards betterment in the medical device industry, providing safe and efficacious devices in the near future.

Cover Story Milestones In The Medical Device Revolution In India Here are the most significant ‘medical device’ highlights that ensured that it remained at the top of the agenda from regulations to retaliations. • Government broadens medical device definition to attract FDI • New medical devices procurement guidelines to make specific percentage of components in India • Niti Aayog’s plan for comprehensive trade margin regulation of medical devices • Materiovigilance Programme of India (MvPI) Issues Draft Guidance Document • Compensation for faulty hip implant patients in India • Implant Files • National Medical Device Promotion Council • 4 More Medical Devices to Be Regulated • WHO Global Forum on Medical Devices • India’s first essential diagnostics list https://health.economictimes.indiatimes.com/news/ medical-devices/2018-in-review-milestones-in-themedical-device-revolu-tion-in-india/67282915

REQUIRED Medical Device Company In Good Running Condition We are looking for a small manufacturing unit on long lease or outright in Ahmedabad or near Ahmedabad for manufacturing of Medical devices as per CDSCO regulations. Must have all the approvals for manufacturing licences from state and central government. Contact : Ms. Dimple Sitpura – 9372778449 email your details on dsitpura@gmail.com

Nov.-Dec. 2018

Global Trends

Understanding Europe's New Medical Device Regulation - MDR 2017/745

Sanjay Shah, Managing Director Unikal Consultants, Ahmedabad • • • • •

Why MDR replaces MDD/93/42 What are the key changes of the regulation? What is the scope of the regulation? How will EUDAMED and other databases change? Factors to consider when timing your transition to the MDR, and...

You've probably heard that Europe's well-established medical device regulations are about to change. And you probably have a lot of questions. What do these changes mean and how will they affect your company? Europe's new Medical Device Regulation (MDR) will bring substantial changes to the way medical device manufacturers bring their devices to the European market, and how they maintain compliance throughout the product's life cycle. Why MDR?

The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. It has brought in a fundamental revision in 2017 to better identify medical devices products and improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed). Similar to the FDA’s UDI, EU MDR will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation. The new regulations seek to increase medical device safety and effectiveness in the EU Market while addressing weaknesses revealed in the implementation of Medical Device Directives by several medical device manufacturers. The MDR and IVDR also are a response to technical and scientific developments that are quickly shaping the medical device industry. What will new MDR intend to achieve? Until now, different European countries have interpreted and implemented the directive in different ways. By revising the directive EU MDR will enforce: • Stricter pre-market control of high-risk devices at an EU level • The inclusion of certain aesthetic products which present the same characteristics and risk profile as equivalent medical devices e.g. contact lenses • A new risk classification system for diagnostic medical devices based on international guidance • Improved transparency through the establishment of a comprehensive EU database of medical devices (Eudamed) • Device traceability through the supply chain from its manufacturer through to the final user including importer, distributor Nov.-Dec. 2018

• An EU-wide requirement for an 'implant card' to be provided to patients containing information about implanted medical devices • the reinforcement of the rules on clinical data and clinical studies on devices • Manufacturers to collect data about the real-life use of their devices • Improved coordination between EU Member States

The main reasons behind this change** Problems with diverging interpretation of the current Directives as well as the incident concerning fraudulent production of the PIP silicone breast implants highlighted weaknesses in the legal system in place at the time and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Such problems should not occur again and the safety of all medical devices available in the EU has to be strengthened. Moreover, revision of the legislation was necessary to consolidate the role of the EU as a global leader in the sector over the long-term and to take into account all technological and scientific developments in the sector. The new regulations will ensure: • a consistently high level of health and safety protection for EU citizens using these products • the free and fair trade of the products throughout the EU • that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years • Also refer to Factsheet for Manufacturers of Medical Devices in EU guidance document

COMPLIANCE DATES • New MDR and IVDR regulations were approved in March 2017 by the European Council and in April 2017 by the European Parliament. Both regulations entered into force on May 26, 2017; new rules will apply starting May 26, 2020, for MDR, and May 26, 2022, for IVDR. MDR NOVELTIES: Overview of New Requirements EU Regulation 2017/745 on Medical Devices Structure of MDR – Fact Sheet • Recitals 101 • Articles 123 • Annexes 17 Annexure : • I General Safely and performance Requirements (GSPR)

Global Trends • • • • • • • • • • • • • • • •

II Technical Documentation III Technical Documentation on PMS IV EU Declaration of conformity V CE Marking VI Registration and UDI VII Requirements for Notified Bodies VIII Clarification rules IX Full QMS and Technical documentation X Type Examination XI Product Conformity QA XII Certificates issued by Notified Bodies XIII Custom –made devices Xiv Clinical Evaluation and PMCF XV Clinical investigations XVI Products with no medical purpose XVII Correlation table with MDD

Information Pending • Implementing / Delegated Acts (Art. 52) - Minimum frequency of unannounced audits & sample checks - (Annex IX) frequency and sampling basis of class lIa and llb technical documentation. - The physical, lab or other tests to be carried out by NBs for sample tests, assessment of technical documentation and type examination - For UDI, will be introduced over 1-5 years determined by product risk • Common Specification (Art. 9) - General safely and Performance requirements - Technical documentation - Clinical evidence and post market follow up - Clinical Investigation - Devices without a medical purpose

Definition of Medical Device revised as follows: • ‘Medical device’ means any instrument, apparatus, appliance, software implant regent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: - Diagnosis, prevention, prediction, prognosis, treatment or alleviation of disease - Diagnosis, monitoring, treatment, alleviation of or compensation for, an inquiry or disability - Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state - Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations. And which does achieve its principal intended action by pharmacological Immunological or metabolic means in or on the human body, but which may be assisted in its function by such means.

MDR scope expands on MDD to include: • Devices manufactured using tissues or cells of human origin or their Derivatives, which are, or are rendered, non-viable • Devices for control or support of conception • Product for cleaning, disinfecting or sterilising devices • Device incorporating nano materials • Invasive device re: body orifices, intended to administer medicines by inhalation. • Substances applied to skin / introduced via a body orifice and

absorbed or locally dispersed • Active therapeutics with an integrated diagnostic function • Products without an intended medical purpose : (aesthetic products) (annex XVI) - Contact lenses, fillers, equipment for removing/reducing /destroying adipose tissue/surgically invasive products to modify anatomy or fix body parts. - Equipment for brain stimulation by electric current, magnetic or EM fields to modify neuronal activity in the brain - Equipment emitting high intensity EM radiation for skin resurfacing. Tattoo or hair removal, other skin treatment • Distance sales of diagnostic or therapeutic services (Art.6) • Active implantable devices.

Out of scope: • Specifically ATMP – Regulation (EC) 1394/2007 • Other products that contain or consist of viable biological material or viable organisms including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product • Food (EU) Regulation – 178/2002

Definitions: • Accessory for a medical device: an article which, whilst not being itself a Medical device, is intended by its manufacturer to be used together with one or several particular medical devices to specifically enable the MD(s) to be used in accordance with its/ their intended purpose(s) or to specifically and directly assist the medical functionality of the medical Device(s) in view of its/their intended purpose(s) • Intended purpose : the use for which a device is intended a/c the data supplied by the manufacturer on the label, in the IFU or promotional or Sales materials or statements as specified by the manufacturer in the clinical evaluation. • Manufacture....Market the device under its name or trademark Few examples of new requirements which are critical to the manufacturers’ are as follows in brief:

Technical Documentation • Strategy for regulatory compliance • Risk management plan per product • Clinical evaluation plan - Clinical development plan • Clinical Evaluation reports • Summary of clinical safely and performance (SSCP) class III and implantables • PMS plan including PMCF plan • PMS report (Class I) • Periodic safety update report (Class IIa, IIb, III) • PMCF reports A specific requirements for creating and updating information is relating to European Database on Medical Devices: “Eudamed” • Secure, web-based portal, using an internationally recognised nomenclature, available free of charge, as a central repository for information exchange between competent authorities, the commission and other parties. - Different levels of access to NBs, economic operators, the public • To improve transparency and availability of information • To enable identification and traceability of device on the market Nov.-Dec. 2018

Global Trends • Full, audited functionality due by 25 March 2020 (MDR Art. 34)

detailed information on implementation.

References in this article are taken from Author’s attending workshops and various articles/guidance/information available on the web. Special thanks to ‘Obelis’ EAR Services for inputs from their presentations. European Union website and their links provide

** © European Union, [2018] Reuse is authorised provided the source is acknowledged. The reuse policy of European Commission documents is regulated by Decision 2011/833/EU (OJ L 330, 14.12.2011, p. 39).

Specific details on various articles of MDR will be discussed in future series of articles like clinical evaluation requirements and clinical equivalence, PMCF, labelling, risk management, classification changes, UDI, conformity assessment, responsibilities of Importers, distributors, authorized representative, appointment of Person Responsible for Regulatory Compliance, notified bodies and their roles, DOC and like as per the various articles of MDR.

Global Forum On Medical Devices Held In Visakhapatnam @ AMTZ Developing global standards on essential devices and ensuring their adherence is still some way off. The theme of the 4th World Health Organisation (WHO) Global Forum on Medical Devices (GFMD) was “increasing access to medical devices”. Why should access to devices matter? Because as of 2008, in the 60th World Health Assembly, a resolution was passed recognising the importance of medical devices for healthcare delivery, responding to emergencies and keeping populations safe. The 4th Global Forum on Medical Devices was dedicated to precisely this – the roadmap to develop standards, regulatory framework and increase access. Organised in Vishakhapatnam, at the Andhra Med Tech Zone (AMTZ), from December 13 to 15, it was

attended by 100 countries and curated by the WHO’s Essential Medicines and Health Products division, which leads this work globally. Below are some highlights from the forum. • Preparing to deliver essential diagnostics • Setting technical specifications • Medical device donation and ethics • Absence of adequate NGOs/Civil Society coalitions • Complete silence on knowledge transfer and technology transfer https://thewire.in/health/a-step-closer-to-making-medical-devicesmore-accessible

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 Nov.-Dec. 2018

0434

Industry News WHO Supports Manufacturers from Developing Countries In Defining AD Syringes If the change in definition of AD syringes by International Organisation for Standardisation (ISO) was implemented , more than 60 per cent of the existing World Health Organisation (WHO) performance, quality and safety (PDS) designs would have been disqualified despite being auto-disable, which would have adversely impacted global immunisation campaigns and supply security. Furthermore, the revision would have favoured a few MNCs and put syringe makers from the developing world in jeopardy. Manufacturers from Indonesia, Bangladesh, Pakistan and Kenya have joined hands with the Indian industry, led by Hindustan Syringes and Medical Devices Ltd, in opposing the move with the active backing of the WHO, an ISO committee member who attended the meeting told Pharmabiz on condition of anonymity. Thanks to their concerted and determined effort, the ISO Technical Committee has decided not to go ahead with the proposed revision of ISO 7886-3 Standard of AD syringes for fixed-dose immunisation at its recent meeting in San Jose, California. Currently, the ISO defines ‘auto-disable’ syringe as any syringe with a mechanism that disables it automatically in course of

giving a full dose of injection either at start of an injection, during the injection or by the end of the injection. A four-member expert sub-group of Working Group 11 (WG11) that was looking into the review of ISO 7886- 3 Standard of AD syringes had opted to redefine them and limit them to those designs which had the mechanism to activate the AD function at the beginning of injection and the change was incorporated in the initial Committee Draft of the standard. If the change was implemented, those few manufacturers who produced the newly defined type would have got a huge competitive edge. It is interesting to note that two of the four-member expert panel were from Becton Dickinson and Terumo, producers of the defined type of AD syringes. The ISO decision is a big relief for India and many other nations. A major part of the Indian immunisation campaign and many tenders at national and regional levels in countries such as China, Indonesia, Nigeria, Vietnam, Bangladesh, Pakistan and Saudi Arabia are dependent upon local manufacturers with AD syringes which are not necessarily activated at the beginning of injection. http://pharmabiz.com/NewsDetails.aspx?aid=112774&sid=1

Indian Device Maker Meril Life Sciences Joins Big League With Artificial Heart Valve Technology Meril last month received an approval from Indian drug regulator Central Drugs Standard Control Organization (CDSCO) for commercialization of Transcatheter Aortic Heart Valve Replacement, which will be sold under the brand name Myval. Meril Life Sciences, India's top medical device maker, is all set to launch an indigenously developed and manufactured artificial aortic valve that regulates the blood flow in the heart. Meril last month received an approval from the Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) for commercialisation of Transcatheter Aortic Heart Valve Replacement (TAVR), which will be sold under the brand name Myval. Meril not just developed the valve but the entire technology to replace the valve through a minimally invasive surgery on the

lines of angioplasty. Headquartered in Vapi, Gujarat, India, the company got CDSCO nod on the basis of almost three years of clinical study in India. "All patients are doing well post procedure and during follow-up. This novel Myval technology is associated with Zero new pacemaker implantation rates post procedure which is an important benefit for the patient already treated for valve replacement," Meril said. Pacemaker is an additional device that may be placed post TAVR procedure. https://www.moneycontrol.com/news/trends/current-affairstrends/maharashtra-has-27963-persons-affected-with-aidsminister-3242071.html

Medical Compounds Company Expands TPE Range A medical compounds company will expand its thermoplastic elastomer (TPE) compounds range for healthcare and other applications. Colorite, a Tekni-Plex business, is adding 12 grades to its TPE formulations which will be used for IV therapy and medical devices. Heath Schmid, director of business development at Colorite, said: “Changes in regulations and market conditions are prompting

medical device manufacturers to look for solutions via other materials. The Cellene TPE compound line is ideal for medical device manufacturers and others looking for alternatives to PVC, phthalate-plasticized compounds and various rubber materials. The line expansion will assist in reducing the development cycle and provide manufacturers with greater options to obtain the durometer rating required for their applications.” https://www.medicalplasticsnews.com/news/medical-compounds-company-expands-tpe-range/

Peters Surgical Invests •5 Million To Expand India Plant Peters Surgical, which has presence in 90 countries, is also open to more acquisitions in India Three years after having acquired a controlling equity stake in

Gurgaon-based Stericat, French medical devices company Peters Surgical SAS has invested over •5 million to expand its existing manufacturing facility in India. Peters Surgical, which has presence in 90 countries, is also open to more acquisitions in Nov.-Dec. 2018

Industry News India. “We want to enrich our portfolio of products,” said Thierry Herbreteau, CEO Peters Surgical. “We believe we have to do more and more and if you buy a quality partner and make it a part of your journey, it works very well.” Rajeev Das, CEO, of Peters Surgical’s India operations, said: “We are open to acquisitions, it could be products, companies, distribution channels, depending on the market we address…where we want to expand our portfolio. We we want to move into new markets…we are dynamic and open. These are strategic plans, we don’t have numbers at this point in time, but we are evaluating and seeing what are the strategic areas.”

While, the company has increased its production capacity to 33 million surgical sutures a year, it also plans to manufacture products such as surgical clips, single-use instruments for laparoscopic surgery, surgical meshes and tissue glues at its Manesar facility in Haryana. Founded in 1926, Peters Surgical is the second-largest wound care company in France. https://www.ifcci.org.in/news/n/news/peters-surgical-investseur5-million-to-expand-india-plant.html

HMD procures 2018 Good Design Award in Japan* ( Ind News ) Recently Hindustan Syringes & Medical Devices Ltd (HMD) became the first set of Indian Manufacturers of Disposable Medical Devices to achieve MDSAP certification

to presence of a protection device SipClip which encapsulates the tip of the used needle, when introducer needle is extracted from the Catheter.

Hindustan Syringes & Medical Devices Ltd (HMD), one of the largest manufacturers of Disposable Syringes in the World and the largest for Auto Disable syringes has been awarded the prestigious ‘2018 Good Design Award’ for HMD’s Safety IV Cannula - Cathy Sipclipearning recognition in the category of Medical Care Products at the Good Design Award 2018 hosted by the Japan Institute of Design Promotion in Japan.

The Good Design Award was founded in 1957 as the Good Design Product Selection System (or G Mark System), by the Ministry of International Trade and Industry (the current Ministry of Economy, Trade and Industry). It is the only system in Japan to comprehensively evaluate and recommend design and the G-Mark carries substantial International Prestige.

The auto protection technology of Safety I V Cannula Cathy SipClip is designed to provide Involuntary Activated Safety due

Nov.-Dec. 2018

https://www.biospectrumindia.com/news/74/11961/hmdprocures-2018-good-design-award-in-japan.html

Industry Urges Centre To Change Definition Of Manufacturers In Guidance Document For Medical Devices In order to support indigenous medical device industry, the Association of Indian Medical Device Industry (AiMeD) has urged the Centre to change the definition of manufacturers in the Guidance Document for Medical Devices.

it is supplied under the person's name, whether or not it is the person, or another person acting on the person's behalf, who carries out those operations” isstated being incorrectly defined, says Rajiv Nath, forum coordinator, AiMeD.

According to the industry body's contention, the suggested definition of manufacturer of a medical device as per Clause 1.6.6 of the Guidance Document for Medical Devices will encourage Pseudo Manufacturing and is against basic tenets of Make in India campaign.

In a letter addressed to Indian Pharmacopoeia Commission (IPC), AiMeD says that “the manufacturer of a medical device is the person who is responsible for the design, production, packaging and labeling of the device before it is supplied under the person's name, whether or not it is the person, or another person acting on the persons behalf, who carries out those operations” in the clause 1.6.6 of the Guidance Document for Medical Devices, it will encourage pseudo manufacturing, which should be made illegal and is harming actual manufacturers. If we equate mere partial processing like packing, labeling, etc. with the real production, that is at least assembly of components, then it will just encourage the importers to bring the finished goods in un-sterile or bulk packed form from abroad where the Government gives enough subsidies and incentives and do this process to be termed as manufacturer.

The body has proposed the following definition which says, “Manufacturer is a person, an enterprise, or an entity who himself makes a product through a process involving raw materials, components, or sub-assemblies, usually on a large mass production scale with different operations divided among different workers and fulfills the following conditions that minimum local content be 50 per cent in medical disposables and consumables, 25 per cent in medical electronics, hospital equipment and surgical instruments, 40 per cent in implants and 25 per cent in diagnostic reagents or intravenous diagnostics (IVD).” A similar definition of manufacturer is also adopted in the historic legislation of the Central Goods and Services Act, 2017, which states that as per Section 2 (72) “manufacture” means processing of raw material or inputs in any manner that results in emergence of a new product having a distinct name, character and use and the term “manufacturer” shall be construed accordingly.” “As per the definition in the guidance document,“The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labeling of the device before

According to the Federation of Indian Chambers of Commerce and Industry (FICCI) Medical Device Committee, “The manufacturer of a medical device should also include fully owned subsidiary of an offshore manufacturer, one who provides warranty/annual maintenance contract (AMC)/comprehensive maintenance contract (CMC) in case of equipment, responsible for materiovigilance reporting/FCA/recall and impart product training/demonstration of products.” http://pharmabiz.com/NewsDetails.aspx?aid=111969&sid=1

CDSCO Proposes To Add Surgical Gowns & Drapes To Notified Devices List As High-Risk Pacemakers, Defibrillators Stay Off Radar The step was proposed at a meeting headed by the Director General of Health Services in October to discuss implementation of decisions taken by the Committee of Secretaries on Technical Textiles. The national drug regulator is currently weighing the proposal and has already sought inputs from industry stakeholders. Earlier this year, the CDSCO had decided to bring a set of medical devices under the purview of Section 3 (b) (IV) of the Drugs and Cosmetics (D&C) Act 1940 to increase reliability. Once a medical device is notified, manufacturers and importers will have to get the national drug regulatory body’s nod to sell these products in the Indian market. These devices are defined as ‘drugs’ under the D&C Act for the purpose of price and quality control and regulated using the Medical Device (MD) Rules 2017. Though the MD Rules came into force early this year, only 23 devices are regulated by the health ministry through its licensing authorities as of now, leaving the door open for unscrupulous firms selling products of dubious origin. The apex drug regulator’s latest measure to regulate surgical

gowns and drapes has left industry experts disappointed. “While we welcome the initiative to add gowns and drapes to the list of notified devices, deploying limited regulatory resources in our country for a relatively low-risk device while a high-risk defibrillator and pacemaker can continue to be imported (mainly) or manufactured (by a few) without regulations will have a detrimental impact,” Association of Indian Medical Device Industry (AiMeD) forum coordinator Rajiv Nath told Pharmabiz. Instead of adhoc item-by-item addition to the notified list, the domestic manufacturers had suggested a list of 38 medical device categories to be regulated on priority basis, considering the higher proportion of risk. However, their suggestions remain largely ignored. “We hope the ministry and the CDSCO will immediately call an emergency meeting of Medical Devices Experts Advisory Group (MDR-EAG) whose membership constituency we had recommended to them. It’s a folly to continue relying solely on drugs experts to plan regulations for medical devices which have a totally different engineering technology. NitiAayog, Drug TechniNov.-Dec. 2018

cal Advisory Board and the CDSCO can deliver more useful results by getting better guidance from a well-meaning and well

informed MDR –EAG,” AiMeD forum coordinator pointed out. http://pharmabiz.com/NewsDetails.aspx?aid=112566&sid=1

Govt Plans To Use BIS Act To Regulate Medical Devices For Quality Control With an aim to ensure quality and efficacy of medical devices in the country, the Central government is planning to use the Bureau of Indian Standards (BIS) Act to regulate all devices until it comes out with an independent medical device law. The announcement to this effect was made by Union minister of state for health and family welfare Ashwini Kumar Choubey at global conference on medical devices in Visakhapatnam recently as he acknowledged the threat to patients health from unsafe unregulated medical devices and need for quality control measures. Once the proposal gets approved, devices will have to be registered under the quality parameters prescribed under

Medical Devices Rules, 2017 and other standards set by the BIS certification from January 1, 2020. The medical device market in the country at retail and institutional level is estimated to be over Rs.70,000 crore (US$ 10 billion). Currently, there is no comprehensive law in the country to regulate the medical devices industry. Though an exclusive Medical Device Rules came into effect from January this year, most of the devices are still regulated as “drugs” under Drugs and Cosmetics Act. http://pharmabiz.com/NewsDetails.aspx?aid=112951&sid=1

Govt May Hike Custom Duty On Medical Devices By 15-20% To Boost Indigenous Production The Central government is actively considering a proposal to increase custom duty on medical devices by 15-20% to promote indigenous manufacture of medical devices. The announcement to this effect was made by Union minister of state for health and family welfare Ashwini Kumar Choubey at global conference on medical devices in Visakhapatnam recently. At present the domestic medical device industry is suffering from the onslaught of cheap imports from the countries like China who subsidises their export by 17% through various means. The existing manufacturers are converting into importer/trader as they find it cheaper to import than manufacture in India with lots of other hassles. To promote local medical device industry that will subsequently reduce India's heavy reliance on import, Association of Indian Medical Device Industry (AiMeD) had sought reasonable tariff protection. The Association has suggested that current basic import tariff of 0% to 7.5% needs to be raised to 15% for medical devices and on their components to be 5%, next year 7.5%. Now after the announcement of Union minister of state for health minister, the ministry is seriously looking into its suggestion.

Unless the Indian manufacturers get level playing field and visible benefit to manufacture in India in comparison to the imports, nobody will venture out to this tedious job of putting together men, machine and capital for manufacturing of medical device in India, which is a dream and mission of Prime Minister. “If government can boost manufacturing of mobile phone & consumer electronics by levying 20% to 15% duty and for automotive, bicycles & motorcycles, we request for medical device, similar tariff protection clauses,” said Rajiv Nath, forum coordinator, AiMed. Earlier Department of Pharmaceuticals (DoP) had consented to AiMed's tariff rationalization proposal and forwarded the same to department of revenue for consideration. In budget (Finance Bill) the custom duty was increased from 7.5% to 10% but same day in the evening, the notification stated it at 7.5%. “We were informed by DoP & department of Industrial Policy & Promotion that department of revenue is awaiting clarification/ response from Union health ministry to DoP's proposal. With the health ministry actively considering our tariff rationalization proposal, we expect a positive response,” he added. http://pharmabiz.com/NewsDetails.aspx?aid=112912&sid=1

Maha FDA Urges CDSCO To Place Intraocular Lenses Under NLEM To Prevent Overcharging* Maharashtra Food and Drug Administration (FDA) has submitted its study report on the overcharging of intraocular lenses at the point of care to the Central Drugs Standard Control Organisation (CDSCO). The purpose of the study is to bring intraocular lenses under the National List of Essential Medicines (NLEM) to protect patients from being overcharged in hospitals. Intraocular lenses which falls under the ambit of notified devices and widely used in cataract surgeries are being overcharged 10 times higher than the market price at the point of care. Consumers are charged Rs. 8,000 for a brand of intraocular lens which has a landing cost of Rs. 800. Nov.-Dec. 2018

After the National Pharmaceutical Pricing Authority (NPPA) capped the prices of cardiac stents, Maharashtra FDA, the legal metrology department and non-government organisations (NGOs) have been demanding a price cap on implants like intraocular lenses. Intraocular lenses (IOLs) are medical devices that are implanted inside the eye to replace the eye's natural lens when it is removed during cataract surgery. IOLs also are used for a type of vision correction surgery called refractive lens exchange. http://pharmabiz.com/NewsDetails.aspx?aid=112969&sid=1

Central Govt Plans 75% Trade Margin Cap On Imported & Domestic Medical Devices In a bid to protect patients from being fleeced by exorbitant 1000%3000% mark up on maximum retail prices (MRP) of medical devices, the central government is considering a proposal to bring down prices of the devices by putting 75% trade margin cap on the first point of sale of imported and local devices. The announcement to this effect was made by Union minister of state for health and family welfare Ashwini Kumar Choubey on the sidelines of global conference on medical devices in Visakhapatnam recently. At present, only few devices-- cardiac stents, drug eluting stents, condoms, intra uterine devices, knee implants have been brought under price control thus leaving thousands of devices out of price control. Welcoming this, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) stated that 75% trade margin cap on the first point of sale of both imported as well as domestic devices will benefit patients and encourage ethical manufacturing and marketing of devices. http://pharmabiz.com/NewsDetails.aspx?aid=113053&sid=1

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 Nov.-Dec. 2018

Press Release Announces the Addition of Four New Board Members Ronkonkoma, NY, USA, November 14, 2018—Qosina Corp. and its Qosmedix division are pleased to announce the appointment of four new board members: Pat Alesia, Robert Beckman, Ari Hoffman and Bruce Williams. The new members join the existing board of Stuart Herskovitz, Janis Herskovitz and Scott Herskovitz.

ISO 13485 and ISO 14001 certified, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, visit the company’s newly redesigned e-commerce website at www.qosina.com, or call +1 (631) 242-3000.

Stuart Herskovitz, Qosina’s founder and chairman of the board, said, “We are delighted to welcome these talented leaders to our board of directors. Their combined industry expertise, operational leadership and proven track record of profitability will help propel Qosina and Qosmedix into the next stage of growth.”

Qosmedix is an ISO 9001 and ISO 14001 certified global supplier to the cosmetic, skin care, spa and salon industries. Founded on the concept of maintaining hygienic practices during beauty consultations, the company has expanded to provide an array of high quality products that offer convenience and value to its customers. The vast inventory includes brushes, swabs, applicators, disposable spa wear, jars, bottles and more. For assistance with sample requests, orders or customization inquiries, please contact a customer specialist by phone: +1 (631) 2423270, fax: +1 (631) 242-3291, or email: info@qosmedix.com. Ask to receive the latest catalog, or visit www.qosmedix.com to view the complete product line. Qosmedix is a division of Qosina, a leading international supplier of components to the medical and pharmaceutical industries.

“We are confident Qosina and Qosmedix will benefit greatly from the guidance of the new members due to their business acumen and expertise,” said Scott Herskovitz, president and CEO of Qosina. “Their experience across global markets will undoubtedly add a valuable perspective to our board.” Mr. Alesia is the former senior vice president, CFO and chief administrative officer of Griffon Corporation (NYSE: GFF), where he was employed for nearly 40 years. After his retirement in 2013, he commenced serving Griffon Corporation in a consulting role. In 2015, Mr. Alesia formed Alesia Consultants, lending his vast experience in finance, accounting, compliance, risk management and cyber security as a strategic consultant to other corporate clients. Mr. Beckman has served in corporate and industry leadership for several decades and has supported the growth and development of a wide range of global healthcare companies. He formed The Channel Group, an advisory business that provides support to global healthcare companies. Mr. Beckman also was a founder of BIO and NYBIO, where he served as chairman and in board leadership positions. Mr. Hoffman is currently the CEO of Scotch & Soda USA and has been a fashion industry executive for over 30 years, working at leading brands including Yves Saint Laurent, Christian Lacroix, St. John, Lacoste, GANT and Benetton. He has been ranked on the fashion industry’s Power 100 list and served on the retail advisory board of NYC and Co. Mr. Williams’ professional background crosses many end-product markets and a wide variety of product applications, the majority being with healthcare OEMs. Mr. Williams’ previous roles include engineering manager, vice president of sales and marketing, COO and CEO during his tenure with Value Plastics, Inc. 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, Nov.-Dec. 2018

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

Qosmedix Danielle Venticinque +1 (631) 242-3270 dventicinque@qosmedix.com

Events Calender

Medical Fair India 2019 25th International Exhibition and Conference 21-23 February, 2019 Venue : Pragati Maidan, New Delhi, India Medicall 2019 - Hyderabad India’s Largest & No. 1 Medical Equipment Exhibition 8-10 March, 2019 Venue : Hitex Exhibition Center, Hyderabad, India Medicall 2019 - Chennai India’s Largest & No. 1 Medical Equipment Exhibition 26-28 July, 2019 Venue : Chennai Trade Centre, Chennai, India K 2019 The World’s No. 1 Trade Fair for Plastics and Rubber 16 - 23, October, 2019 Venue : Dusseldofr, Germany

Product Gallery Qosina Adds New Bonded Extension Lines To Its Inventory Ronkonkoma, NY, USA, November 6, 2018—Qosina is pleased to introduce five new bonded, off-the-shelf extension lines (part #s 33066-33070). Each of these extension lines are unique in that they are designed with a combination of components. Four of the sub-assemblies include both female and male luer locks, and one contains a stopcock. All five are assembled with female and male caps and various tubing lengths. Other components include a slide clamp, pinch clamp or hydrophilic filter. These easy-to-use, cost-effective extension lines provide added flexibility to gravity and infusion sets. Because they are pre-assembled, they aid in reducing time to market in the development and production phases. Qosina also offers a wide selection of bonded, high pressure, insert-molded and high durometer extension lines, and can provide custom configurations to meet exact specifications. Qosina will be showcasing its new extension lines, in addition to thousands of stock components, at booth 8AL16

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

during the Compamed trade show at Messe Düsseldorf in Düsseldorf, Germany, November 12-15. 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

India Pharma & India Medical Device 2019 18-19 February 2019, Bengaluru, Karnataka

A flagship annual event of the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers and the Federation of Indian Chambers of Commerce and Industry (FICCI).

Biggest names in the Indian pharmaceutical and medical devices industry will come together on a common B2G platform to deliberate with the Government, drug regulatory agencies, pricing regulators and WHO on key policy changes required for the growth of the pharma and medical devices Industry. Drug regulators from US, European Union, United Kingdom, Mexico, Russia, Singapore, Indonesia, Vietnam, China, Uzbekistan, Argentina, Brazil, Ghana, Nigeria, Bangladesh and Sri Lanka are expected to take part in the event

Nov.-Dec. 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 Serious Health Consequences Due to Faulty Tracheostomy Tube Sets 2.2 Improper Design or Use Of Blood Collection Devices Adversely Affect Accuracy Of Lab Test Results 2.3 Failure of Endotracheal Tubes 2.4 Hospital Errors on Medical Tubing Killing Patients 2.5 Trends In Medical Device Adverse Events 2.6 How Easily Bacteria Clog The Medical Devices…!! 2.7 Risk Management For Medical Devices 2.8 Complications Associated With Urological Devices 2.9 About Trends In Medical Device Adverse Events 2.10 Catheter Introducers – A Potentially Life Threatening Episode 2.11 Human Factors Leading To Medical Device Adverse Events 2.12 Luer Taper Fitting As Connectors In The Medical Industry Nov.-Dec. 2018

2.13 Problems With Transvaginal Surgical Mesh 2.14 Heparin In Medical Devices Linked To 11 U.S. Deaths 2.15 Preventing Dangerous Hemodialysis Catheter Disconnections 2.16 Particulate Matter In Blood Bags 2.17 Complications Related To The Use Of Bone Cement 2.18 Failure Of The Tracheostomy Tube 2.19 Potential Cross-Contamination Linked To Haemodialysis Treatment 2.20 Complications Related To The Use Of Vascular Haemostasis Devices 2.21 Occluded Endotracheal Tubes 2.22 Allergic Reactions To Medical Devices Containing Latex 2.23 IV Catheter-Associated Infections 2.24 That Long Needles ‘Cut Injection Pain’ For Babies 2.25 Old Dialysis Filters Are Responsible For Kidney Patient Injuries 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 Compensation To Patients For Faulty Medical Devices 4.2 Balancing Product Development Effectiveness with Regulatory Compliance 4.3 Modernizing Biocompatibility and Biological Risk

Evaluation of Medical Device Materials 4.4 Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices 4.5 Effect of Medical Device Quality Performance on Business Performance 4.6 Challenges Of Using Combination Products 4.7 FDA Regulations Regarding Medical Devices Chapter 5 : Markets & Emerging Trends 5.1 Drug / Device Combination Products & ASEAN Markets 5.2 Implants As The Fastest Growing Application For Medical Plastics 5.3 What Global Medtech Manufacturers Need To Copy From India And China 5.4 India’s Success In Developing Its Own Health Related Technologies 5.5 The WHO Report On Medical Devices And Equipment 5.6 Humanitarian Use Medical Devices (Huds) 5.7 The Ageing Population In Europe 5.8 About Implants As The Fastest Growing Application For Medical Plastics 5.9 Challenges Of Using Combination Products 5.10 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 What is a Medical Grade Polymer? 7.2 Using Medical Polymers Reduce Hospital-Acquired Infections 7.3 Advanced Medical Polymer For Treating Diabetic Patients 7.4 The “Medical Grade “ Polymer Dilemma 7.5 Why “PEEK” offers success for the manufacture of medical parts 7.6 Polymers To Restore The Sound Of Music? 7.7 Conductive Plastic Which May Preserve Eyesight...!! 7.8 UHMWPE Fibers 7.9 Engineered Medical Coatings Advancing The Performance Of Medical Devices 7.10 Intelligent Materials To Revolutionise Surgical Implants 7.11 Medical Device Coatings 7.12 Why You Should Not Use PVC Tubing In The O2/ Aircircuit If You Are Using Forane

Chapter 8 : Manufacturing : Technologies & Trends 8.1 Why Clean Room Is Important -- For Medical Plastics Manufacturing 8.2 Best Practices to Ensure Good Supplier Management 8.3 Welding Of Thin Polymeric Films For Medical Applications 8.4 When To Consider Outsourcing Medical Device Manufacturing To A Contract Manufacturer? 8.5 Health Technology Assessment (HTA) 8.6 Ultrasonic Welding For Assembling Of Medical Components 8.7 Filters In Intravenous Filter Sets 8.8 Hypotension And Bedside Leukocyte Reduction Filters 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

Nov.-Dec. 2018

January 2017 to December 2017 Column

Content

Column

Content

November-December 2018

Events

• Jigish Doshi elected as President of Plastindia Foundation for 2018-21 Ravish Kamath takes over as Vice President and Jayesh Rambhia as Treasurer

Cover Story

• National Medical Devices Council • Quality and Regulations of Medical Devices in India : A Glimpse Global Trends • Understanding Europe’s New Medical Device Regulation ( EU MDR ) AiMeD & Regu- • Industry Urges Centre To Change Definition Of Manufacturers In Guidance Document For Medical Devices • CDSCO Proposes To Add Surgical Gowns & Drapes To Notified Devices List As High-Risk Pacemakers, Defibrillators Stay Off Radar • Govt Plans To Use BIS Act To Regulate Medical Devices For Quality Control • Maha FDA Urges CDSCO To Place Intraocular Lenses Under NLEM To Prevent Overcharging* • Central Govt Plans 75% Trade Margin Cap On Imported & Domestic Medical Devices Industry News • WHO Supports Manufacturers from Developing Countries In Defining AD Syringes • Indian Device Maker Meril Life Sciences Joins Big League With Artificial Heart Valve Technology • Medical Compounds Company Expands TPE Range • Peters Surgical Invests •5 Million To Expand India Plant • HMD procures 2018 Good Design Award in Japan* (Ind News) Product Gallery • New Bonded Extension Lines Article Index • Medical Plastic Data Service - 2018 Article Index Did You Know? • About Compensation To Patients For Faulty Medical Devices

September - October 2018 Cover Story

• Event Highlights : The 15th National Conference and Technology Exhibition on “Indian Medical Devices & Plastics Disposables / Implants Industry 2018” supported by major leading industry associations as well as Government, Regulatory, Export Promotion and Research Organizations. Conference Theme : “Medical Device Sector : Making India Globally Competitive” • Building Manufacturing Capabilities for Medical Devices in a Developing Country - India, a case study • Plastics For India’s Medical Devices And Pharmaceutical Packaging Vital Role in the Design of Safe Treatments AiMeD & Regu- • MoU to foster cooperation in Manufacturing of Hi tech latory Updates Medical Equipment in India between South Korea's Busan Techno Park Healthcare Technique Division & Aimed • AiMeD recommends tariff protection & quality assurance for access to indigenous medical products by 2030 • Medical device sector seeks price preference in public tenders to boost domestic manufacturing Product Gallery • Now Carries Unique TPE-Coated-Stem Check Valves Nov.-Dec. 2018

July – August 2018 Cover Story

• Clean Room Environment For Medical Devices – ISO 14644 • Injection Moulding Machines For Clean Room Applications • Simplifying Setting-up Of Plastic Processing Clean Room Materials • Polymer Compounds For Medical Devices Manufacturing • Design Control : Importance and Regulatory Aspects Global Market • Medical Polymers, Medical Injection Molding, Medical Insights : Snapshots Device Contract Manufacturing. PVC Hospital Waste Recycling AiMeD & Regu- • Mitsubishi expanding Indian footprint with PVC business latory Updates acquisition • Covestro Strengthens its Global Film Production • AMTZ sets up Centre for Bio-Materials Testing • India, US move a step closer : Trade Issues including Medical Devices Product Gallery • New Closed Male Luer Lock Valves / New Line of Tyvek® Sterilization Supplies • Qosina Unveils a New Line of Tyvek® Sterilization Supplies Did You Know? • Why Clean Room Is Important For Medical Plastics Manufacturing

May – June 2018 Cover Story

• Material Selection for Injection Molded Medical Parts • Unique Properties Make Polymers Suitable to Medical Tubing Applications Technology • Polymeric PDC Technology: An Integrated Approach To Autoinjector Design Global Trends • Enteral Feeding Devices Market Worth 3.19 Billion USD by 2022 AiMeD & Regu- • AiMeD terms new MD procurement policy a lost opporlatory Updates tunity to promote indigenous manufacturing of medical devices • CDSCO Proposes To Include All Implantable medical devices & other high end equipment under the category of 'drugs’ as Medical Devices • Health ministry identifies 10 exclusive centres to report serious adverse events as part of MvPI Industry News • Govt Proposes Over Rs 460 crore Support for Development of Pharma Sector (including Medical Devices) • KIHT Ties Up With JBI To Boost Research In Medical Devices & Diagnostics • CTP Expands To Meet Local Medical Market In India Product Gallery • Gamma-Stable, Large-Bore Tuohy Borst Adapters Event • Medical Design & Manufacturing (MD & M) East : Event Report • Medical Manufacturing Asia 2018 the Springboard to billion dollar ASEAN Medtech Market

Column

Content

Did You Know? • About What is a Medical Grade Polymer?

March – April 2018 Cover Story

• Challenges and Opportunities For Medical Disposables & Implants Industry in India • Growth Dynamics For Indian Medical Device Industry Materials • Bio-Compatible, Lightweight Polycarbonate Utilized in Respiratory Device Global Trends • The Asean Medical Device Market AiMeD & Regu- • AIMED urges GoI to take policy decisions to boost latory Updates Domestic Mfg & to Make Healthcare Affordable in India • New guidelines for medical device grouping to streamline licensing • Govt. invites proposals from labs for testing medical devices, IVDs as per new MD rules • Gujarat FDCA sends draft notifications to state govt for approval to implement new Medical Devices Rules Industry News • QCI, UL team up with govt and industry to spur robust quality ecosystem to build 'Brand India' in medical devices • Hindustan Syringes and Medical Devices gets ‘India Design Mark’ Product Gallery • Cost-Effective Off-the-Shelf and Custom Tubing Solutions • Slide Clamps Did You Know? • About Serious Health Consequences Due to Faulty Tracheostomy Tube Sets

January – February 2018 Cover Story

• Medical Device Rule 2017

Column

Content

• Frequently Asked Questions On Medical Device Rule, 2017 Rewards & • Dr. S Eswara Reddy Appointed As New DCGI Recognitions • Award For “Outstanding Contribution For Image Building Of Plastics” To D L Pandya, Editor & CEO, Medical Plastics Data Service at Plasticon Awards 2018 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 Global Trends • 13485 Revision: What it Means for Medical Device OEMs and their Supply Chains 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 Product Gallery • Revolutionary PenBlade® Safety Scalpels • Line of Stopcocks Did You Know? • Improper Design or Use Of Blood Collection Devices Adversely Affect Accuracy Of Lab Test Results

Nov.-Dec. 2018

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

: 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 42

Nov.-Dec. 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

Nov.-Dec. 2018

Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com 43

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

Nov.-Dec. 2018

AVAILABLE

AN ISO 13485-2012 CE certified Company Manufacturer & Exporter of Medical Disposable Devices & Surgical Products

PRE USED SYRINGE

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

MANUFACTURING EQUIPMENT Moulds : 2, 3, 5, 10ml Syringe Printing Machine : 2/3, 5, 10ml Syringe 4 Parts Assembly Machine : 2/3, 5, 10ml

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

Contact : 7895648113 pawantiwari1978@gmail.com

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 Nov.-Dec. 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 45

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 46

Nov.-Dec. 2018

Medical Plastics Data Service Magazine November - December 2018

Articles inside

GLOBAL TRENDS

INDUSTRY NEWS

EVENTS CALENDER

PRODUCT GALLERY

AiMeD & REGULATORY UPDATES

COVER STORY