Medical Plastics Data Service Magazine March - April 2018

Table of

Contents Vol. 26

No. 1

Jan. - Feb. 2018

18 Cover Story

Challenges and Opportunities For Medical Disposables & Implants Industry in India Himanshu Baid, Managing Director, Poly Medicure Ltd. & Chairman-CII Medical Technology Division The removal of existing barriers for growth & innovative initiatives from government will ultimately lead to increased investment in the Indian Medical Devices Industry. All stakeholders can work together today to contribute for the future vision of “Affordable and quality healthcare to all.

Growth Dynamics For Indian Medical Device Industry • Three issues are of critical importance - unavailability of right quality raw materials & components, lack of skilled workers and capacity to implement quality needs.”

• New medical devices procurement guidelines propose to make 20-50% of components in India.”

23 Materials Bio-Compatible, Lightweight Polycarbonate Utilized in Respiratory Device Medical Polycarbonate lends its outstanding properties to achieve high performing yet portable medical device design…`

25 Global Trends The Asean Medical Device Market The region’s medical device market is expected to grow strongly and access to the market will improve in the coming years due to……..

29 AiMeD & Regulatory Updates • AIMED urges GoI to take policy decisions to boost 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

32 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’

33 Product Gallery • Cost-Effective Off-the-Shelf and Custom Tubing Solutions • Slide Clamps

16 Did You Know?

• About Serious Health Consequences Due to Faulty Tracheostomy Tube Sets

34 Events & Events Calender • • • •

Medical Manufacturing Asia 2018 : 29 – 31 August, 2018 Medicall : 27 – 29, July, 2018 Medicall : 21-23 September, 2018 15th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposables / Implants Industry 2018 : 26-27 October, 2018 • K 2019 : 16 – 23 October , 2019 Mar.-Apr. 2018

15

Did You Know ?

Flashback

?

Select Article Index

Jan. 2008 to Aug. 2008 • Opportunity for Innovation in Medical Device Industry Clusters (January – February 2008) • California Biomedical Industry (January – February 2008) • About Medical Device Innovation (January – February 2008) • Developments In Polymeric Materials For The Storage Of Blood And Blood Components (March April 2008) Dr. C.S.B. Nair, Smt. R. Vidya and Smt. P.M. Ashalatha, Terumo Penpol Ltd. • Medical Device Industry : Pros & Cons of E-Business (March April 2008)

About Serious Health Consequences Due to Faulty Tracheostomy Tube Sets.

What is tracheostomy ?

A tracheostomy is an artificial opening in the neck into the windpipe (trachea).

This opening is called a stoma. It allows air to go in and out of the lungs. It also allows any mucus to be removed. A small tube (the tracheostomy tube) is inserted through this opening. Breathing occurs through this tube. Thus it creates safe airway access and provide a pathway to remove fluid from the trachea and lungs.

• About Self-Expanding Plastic Stents Used In The Treatment Of Benign Esophageal Conditions (March – April 2008)

There are different types of tracheostomy tubes that vary in certain features for different purposes. These are manufactured by different companies.

Patient is given the tube that best suits his/her needs. The frequency of these tube changes will depend on the type of tube and may possibly alter during the winter or summer months.

• Medical Textiles : Emerging Opportunities (May – June 2008)

However, a specific type of tracheostomy tube will be the same no matter which company manufactures them.

• Plastics In Healthcare-Expanding Horizons (May – June 2008) Mr. Ravi Jalali, General Manager, Business Development - Polymers, Reliance Industries Ltd.

A commonly used tracheostomy tube consists of three parts: outer cannula with flange (neck plate), inner cannula, and an obturator. The outer cannula is the outer tube that holds the tracheostomy open.

• Molding & In-Line Assembly Automation For Medical Plastic Components (May – June 2008) Mr. Jignesh Bavishi, Hekuma GmbH (Neejtech India) • European Medical Device Vigilance System Guidelines (May – June 2008)

Incidents may occur when Tracheostomy Tube Set connector disconnect from the tracheostomy tube during use on a ventilated patient. If the connector detaches from the tracheostomy tube shaft during use, it can deprive the patient of adequate ventilation and would require immediate medical intervention including changing the tracheostomy tube and placing a new tube.

The use of affected products may cause serious adverse health consequences including oxygen deprivation, brain damage and death.

The FDA has identified this device as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. (https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm526022.htm)

• Heparin in Medical Devices Linked to 11 U.S. Deaths (May – June 2008) • Diabetes Disposables : Focus Insulin Delivery Systems (July – August 2008) • Bonding Medical Devices (July – August 2008) Mr. Barun Bharadwaj, Henkel Adhesives Technologies India Pvt. Ltd. • FDA 510(k) Process Provides Framework for Effective Medical Device Regulation (July – August 2008) • About The Economics of Prefilled Syringes (July – August 2008)

16

In a Nutshell....

“The only thing worse than being blind is having sight but no vision”

-Helen Keller

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

Mar.-Apr. 2018

Editor’s Desk

From the

This issue has focus on discussing Challenges and Opportunities for Indian Medical Device Sector particularly for Medical Disposables & Implants sub-sector.

In his article, Mr Himanshu Baid, Managing Director, Poly Medicure Ltd. & Chairman – CII Medical Technology Division, while critically analyzing needs of this Sector, has very rightly mentioned that : “The key issue remains that an import dependent economy cannot suddenly shift to indigenous manufacturing simply through driving policy decisions in a sector such as healthcare. To gradually transition from an import dependent to an export-oriented sector, the Government with all stakeholders, needs to come together to prepare and develop our medical technology ecosystem. To create such a healthy ecosystem in the near term, we will have to grant equal importance to imports and domestic manufacturing with a view to improve clinical outcomes and have continued access to global technology enabling a smooth transition.”

He has given indepth explanation for three Industry proposals : 1. Healthcare expansion by ramping up government spending on Healthcare.

2. Single window regulation for Medical Device related manufacturing 3. Economic incentives and rationalized duty structure.

He has also emphasized that, “Besides affordability of healthcare (which is currently 75 per cent out of pocket), the three pillars of medical technology remain safety, quality and efficacy of devices”.

The editorial article on “ Growth Dynamics For Indian Medical Device Industry” highlights – unavailability of right quality raw materials & components , lack of skilled workers and capacity to implement quality needs as issues of critical importance. The article also introduces a report for Mexico analyzing the “Roadmap for the Medical Device Industry” which suggests various “Supplier Development” activities. It also shares opinions of various Industry leaders on the subject as part of the previous survey carried out by “MEDICAL PLASTICS DATA SERVICE”.

We are also happy to mention that, “The Department of Pharmaceuticals” has proposed that the domestically sourced components have to contribute 25 – 50 % of the cost of medical devices procured by the government. “On draft of the proposed guidelines , created to give preference to products made in India, DOP has sought comments from all stakeholders”.

“AiMeD” has also urged Government to take policy decisions to boost Domestic manufacturing & to make healthcare affordable in India. In another such development, The quality council of India (QCI) alongwith UL has initiated efforts to further quality ecosystem in the country through standardization in Medical Devices also with an objective to “Build Brand India” in Medical Devices. One more positive development is the guidelines issued by the Union Health Industry for grouping Medical Devices in oder to streamline the application process for obtaining manufacturing or importing licence.

Along with the newly initiated column, “AiMED & Regulatory Updates”, this issue highlights Global Trends, Industry News, Materials, Products Gallery “Important Events as well as our regular enlightening column, ”Did You Know ?”.

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Cover Story

Challenges and Opportunities For Medical Disposables & Implants Industry in India dependent to an export oriented market. The key issue remains that an import dependent economy cannot suddenly shift to indigenous manufacturing simply through driving policy decisions in a sector such as healthcare. To gradually transition from an import dependent to an export-oriented sector, the Government with all stakeholders, needs to come together to prepare and develop our medical technology ecosystem. To create such a healthy ecosystem in the near term, we will have to grant equal importance to imports and domestic manufacturing with a view to improve clinical outcomes and have continued access to global technology enabling a smooth transition.

With 17% of world population and a GDP growth rate of 7.2%, India is amongst the fastest growing economies of the world. The Indian healthcare sector grew at a rate of 18% from 2010 till 2016 and is expected to advance at a rate of 15% during 2016-20 to reach USD 280 billion by 2020.

With 1/6th of world’s population and a growing demand for healthcare services, India is also likely to witness a spur in the demand for allied technologies, medical devices, medical equipment and medical consumables which will aid in delivery of affordable healthcare. Medical Technology can be instrumental in shaping healthcare for all in India as it provides the opportunity to leapfrog over India’s longstanding healthcare challenges – accessibility, affordability and quality.

Current global medical technology market is around US$ 350 Billion.

Which is expected to grow to US$ 500 billion+ by 2025. The Indian market is among the top twenty in the world by market size, but its only 2% in value.

Industry proposes three thrust areas :

To gradually transition from an import dependent to an exportoriented sector, the Government with all stakeholders, needs to come together to prepare and develop our medical technology ecosystem.

1. Healthcare expansion by ramping up government spending on Healthcare:

The size of the Indian medical technology market is a key constraint for investment in India, particularly in local manufacturing.

On most healthcare metrics India has one of the lowest ratios, be it The Indian medical device sector doctors, per capita health care is expected to grow at a CAGR of spend as a percentage of GDP, or 15 % for next 4-5 years. Medical even hospital beds. The US$50 Technology can be instrumental in Himanshu Baid, billion opportunity for Medtech in shaping healthcare for all in India.

Managing Director, Poly Medicure Ltd. India can only be realized if • It plays a key role throughout the & Chairman-CII domestic demand is unlocked. patient’s care continuum – prevenMedical Technology Division Further - more, a significant part tive, diagnostic, as well as palliaof the demand generation opportive treatments tunity will be with the recently • It has positively impacted the healthcare delivery and patient announced Ayushman Bharat programme that aims to outcomes provide healthcare benefits for the 10 crore poor Medical Technology in India, like in several other countries families or around 40 per cent of the population. This makes in the world, is largely import dependent. Over 70 per cent the program the world’s largest government-funded health of high end medical devices and critical care equipment are care program. Every family will receive a benefit coverage up imported whereas large volume and comparatively low to to Rs 5 lakhs per year under the National Health Protection medium - end consumables, disposables and equipment’s Scheme, which is likely to cost the government around Rs are mostly locally manufactured.

1000-1200 as the premium of each family. The Government has urged the Indian Medical Devices Industry to brace for While the inverted duty regime is being touted as one of the meeting the demands of the ambitious health insurance primary reason for this imbalance over the years, the country’s scheme. The Government expects the Medical Devices Make in India initiative is being implemented through a ‘policy industry to double in next five years. With this clear approach push’ to encourage local manufacturing and shift from an import

18

Mar.-Apr. 2018

Cover Story ing domestic opportunity, all stakeholders are optimistic about the future of ‘Make in India’ and are expecting manufacturing investments to follow in the very near future.

We need to wait and watch how the government is going to fulfill the promise of bringing over 10 crore Below the Poverty Line (BPL) families under a health insurance scheme and enhanced health insurance cover up to 5 lakh. Funding such a large project in short term will be challenging.

2. Single window regulation for medical device related manufacturing: A Single window clearance for not only setting up the manufacturing facility but also for day-to-day operations would go a long way in addressing the primary concerns of investors in local manufacturing in India. Alignment of policy implementation across different state and national bodies will help reduce the challenges of running efficient operations in India.

Designating areas as Medical technology hubs is not enough.

The supporting infrastructure and desired talent needs to be put in place. When designating areas as hubs, the government needs to make sure the inbound and outbound clearances (e.g., customs) are streamlined, logistical challenges are addressed with sufficient Third Party Logistics (3PL) capacity and finally enough technical training is in the vicinity to provide trained manpower to the hubs.

3. Economic incentives and rationalized duty structure: It is important to create incentives to enhance the attractiveness of local manufacturing. As we know, the cost of capital in India today is high and traditional incentives such as capital subsidy and soft loans will help companies to consider investing in India. Finally, there is a need to establish appropriate duty structures for imported raw materials (to address the inverted duty structure challenges), which will encourage indigenous manufacturing.

For the medical devices industry, the recent budget was a disappointment. In 2016, the government had reduced the custom duty for some of raw materials to 2.5 per cent, but it was not done for in Vitro Diagnostic (IVD)s, which is a part of the sector. If the government really wants to “Make in India” they should have reduced the custom duty of all the raw materials used in the medical devices, including IVDs. The government announced a lot of measures to boost local manufacturing, but they are not implemented as yet. For example, the number of medical parks, which were announced in various states, is still a non-starter as none of them are opera-

tional. The projects are delayed in various states.

The medical devices industry is just like the automobile industry, as a lot of Research and Development (R&D) takes place. By allowing weighted tax deduction of upto 200 percent on R&D investments for the sector will promote innovation. Currently it is reduced to 150 per cent and further it is said to be reduced to 100 per cent.

Stakeholders need to take cognizance of the fact that it is not a desirable situation for a country with over a billion population to be 70 per cent import dependent on medical devices. Besides affordability of healthcare (which is currently 75 per cent out of pocket), the three pillars of medical technology remain safety, quality and efficacy of devices. At present, there is no nodal agency for assessing and evaluating technology in India.

The government should have a separate department under the Ministry of Health and Family Welfare (MoH&FW). The medical devices cater more to the healthcare than the pharmaceutical sector. Too many governing bodies with diverse requirements and standards, viz Department of Pharmaceuticals, Bio Technology, Telecommunications, Ministry of Environment and Forest, Ministry of Science and Technology, Ministry of Commerce, are hindrance to promotion of new technology. These affect ease of doing business as the decision making becomes slow. For the industry to grow and make it a hub, we need a nodal department which focusses on the segment.

Product performance reports are a globally accepted means of showing efficacy of medical technology, an aspect which has not found the same degree of importance in drafting policy and regulation. In other words, a onesize-fits-all approach may not work here and careful mapping of the medtech landscape is needed to identify the devices and equipment that are viable to making in India.

National Pharmaceutical Pricing Authority’s (NPPA) and Department of Pharmaceuticals are in discussion about categorization of medical devices into different segments for the purpose of fixing of trade margins. But the medical devices industry is continuing to be divided on the move of rationalization of trade margins. Rationalization of the price is necessary through an average pricing formula. The industry also suggests : • Transparent and evidence based pricing and reimbursement policies should be promoted • No arbitrary price control mechanisms should apply

Poly Medicure Ltd. Poly Medicure Ltd is one of the leading medical devices manufacturer and exporter from India with dominant position in medical consumables market over 20 years with focus on innovation, safety and quality and have a vision of a world with highest quality of healthcare is made available to all. POLYMED have 5 manufacturing facilities in India (3 facilities in Faridabad and 1 each in Jaipur and Haridwar), 2 facilities overseas (One facility in China – wholly owned subsidiary and One joint venture in Egypt.)

Poly Medicure has spent Rs. 60 crore on the new green field project at IMT Faridabad, another 50-60 crore will be spent on the capacity expansion, automation and new products to be launched. Polymed produces over 100 different types of medical devices, the category ranges from Infusion Therapy, Central Venous Catheter, Blood Management System, Surgery and Wound Drainage, Anesthesia, Urology and Dialysis. With 98% percent of products of the renal care imported, the company will launch portable artificial kidney dialyser, which will help in continuous blood cleansing. A filter developed indigenous in India will help decrease the cost and more people will be able to afford it.

Mar.-Apr. 2018

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Cover Story • Recently Government broadened Medical Device definition to attract FDI. – delinked with D&C Act – (Same should apply for Rules & Regulations) The industry welcomes CDSCO’s recent notification on waving off ADC/NOC condition of export consignments to all countries.

This was a long standing demand of domestic manufacturers.

This waiver of ADC/NOC will reduce the procedures for export clearance from the port where shipments were getting delayed for requirement of additional paper work. This is an important step taken by CDSCO to accelerate exports and reduce bottle necks for domestic manufacturers.

Also, the Ministry of Environment and Forest notified last month exclusion of Blood Bags from Bio Medical Waste Management

Rules. The rules suggested phase out use of chlorinated plastic bags and gloves. The industry is concerned as there is no alternative to some of the chlorinated bags (Urine Bags, Drainage bags etc.).

The removal of existing barriers for growth & innovative initiatives from government will ultimately lead to increased investment in the Indian Medical Devices Industry by domestic and global players alike, whether in the form of local manufacturing, fostering Research & Development and Innovation, partnerships for skill development, among other things.

All stakeholders can work together today to contribute for the future vision of “Affordable and quality healthcare to all”.

Growth Dynamics For Indian Medical Device Industry The Medical Device Industry Medical Devices are an extremely diverse group of products. This covers very simple applications suchas first-aid bandages, tongue depressors, walking frames and plastic tubing, to more complex devicessuch as implanted cardiac and neurological devices, robotic surgical systems, and magnetic resonanceimaging devices.

The industry is characterised by high interdisciplinary with extremely high innovation dynamics. MedicalDevices firms rely strongly on research, technology and engineering and thus require a wide-rangeof skill sets such as medical and technical skills. Both high-technology solutions and basic or frugal supplies characterise the industry.

The Medical Devices industry is globalised and specific parts of the final product are delivered in differentplaces of the world. The industry is specifically sensitive to copycats and firms are careful in notbeing copied by others or overseas. This is why the different industry segments in the value chainoften do not trust each other, which is a barrier to information sharing and collaboration.

Challenges The key challenges of the industry include the move to value-based health care, where the emphasisis on solutions, security and affordable costs; increasing global pressure on healthcare costs, growingregulatory reforms and scrutiny to numerous issues, including the processby which products gain marketing approval; and resource constraints.

Medical Device Industry Value Chain

Regulations influence businesses to a large extent, which have to comply with complex regulatory,customs, health safety and security regulations and are responsible for meeting requirements such aslabelling, packaging or post-sales monitoring. Regulation is an important driver behind innovations andcross-industry trends.

On the downstream we find the customers such as hospitals, laboratories, doctors’ consultancies and thepatients themselves, and other actors such as logistical companies, medical equipment stores,pharmacies,other retailers and insurance companies.

A Make in India for Medical Device Industry

If Indian Medical System needs to get some sort of independence, Make in India approach needs to become deep rooted in the Indian Medical Devices Industry. Interestingly the range is also huge, as compared to medicinal products. However, medical devices industry of India is miniscule in comparison with global production, with disproportionate reliance on imports and indigenous manufacturing being mostly Make in India inirestricted to products in the lower end of the technology value chain. With such high dependence tiative assumes of imports, not surprisingly, they contribute nearly paramount impor25 per cent of an average treatment cost. While tance, not only to the per capita spending on Medical Devices in India is the lowest among BRIC countries, it reduce technology represents a sizeable growth opportunity.

gap but also to reducethe cost of treating illness.

But there are challenges.

The medical devices value chain ranges from research, technology and development, raw materials /component / sub-asemblymanufacturing, assembly, distribution, to marketing, sales and post salesservices. Diverse interactions characterise the industry depending on the type of product.

Central actors are medical technology companies and manufacturers (eg. responsible for machining, packaging or sterilising the product). Manufacturers are suppliers of specific parts (eg. original equipmentmanufacturers), engineering firms, software companies, clinical trial organisations, and certifying bodies.

Upstream actors include research institutions, private research laboratories involved in testing, Thedominant disciplines of this

20

industry are biomedical, automation, process design, product design, qualityengineering but often they are also related to the pharmaceutical or chemical industries.

Thus, a Make in India initiative assumes paramount importance, not only to reduce technology gap but also to reduce the cost of treating illness. But there are challenges.

Three issues are of critical importance unavailability of right quality raw materials& components, lack of skilled workers and capacity to implement quality needs.

Despite sufficient human capital in the country, the industry faces the problem of inadequacy of the available skilled and trained manpower in both quantitative and qualitative terms. However, we would like to highlight only one important bottle neck here.

Access to critical raw materials: Quality of critical raw materials / components is not up to the mark in India. Hence a number of critical raw materials are required to be imported in order to Mar.-Apr. 2018

Cover Story meet international product quality requirements. However the high import duty on these raw materials / components as well as high costs of low volume imports results in high cost of assembling in India which in turn turns out as a non-viable exercise.

technology base in India.”

India.

providers play a key role in enabling the device industry. He also feels that, “Government needs to financially support service providers in these supply chain areas who could form a supplier backbone.”

As per Mr C. Balagopal, if effective steps are taken for various issues discussed earlier in this debate, it will lead to the development of Indian Medical Device Industry. It will also create the necessary conditions for development all along the supply chain Substituting imported parts / components with that could starting from basic raw materials, intermediate be manufactured by Indan Companies (as components, sub contracting/ vendoring, done by “Medical Device Three issues are of outsourcing of processes like sterilizaIndustry Clusters” in other developing countion, testing, warehousing, transportation etc. tries) would promote growth of the sector critical importance along with a greater transfer of technology Supporting the need for strong supply chain, Mr - unavailability of in design , development and advanced manuAjay Pitre cited the case of aerospace industry. right quality raw facturing processes in the country . Products The similarity as per him is because of both have / components quality standardizations and materials& comporeliability requirements of highest order. He also the standardization in the components further says that , “The other area where specialnents, lack of manufacturing processes and facilities ized supply chains have contributed to the skilled workers including appropriate regulatory norms (not device industry has been in the field of packagthe same as finished products but appropriand capacity to ing. Validation requirements for medical device ate for raw materials/components manufacsterile packaging are extremely stringent and the implement quality turing) will contribute significantly towards advancements in packaging materials and needs. thegrowth of Medical Device Industry in conversion technologies made by service A report on the “Roadmap for the Medical Device Industry” in Mexico by “ProMexico” ( www.promexico.gob.mx ) has identified “Supplier Development” as major focus area and suggested the following : “Supplier Development must take into account the significant gap in the sector’s supply chain, which will not have capabilities from other sector to convert and that start by creating national companies in these niches or attracting companies from other regions and developing strategic alliances with Mexican companies. The TRM work group identified the following main projects : • Creation of a supplier integration program.

• Consolidation of a National Supplier Development Council for the Health Sector.

• Promotion of sector events that allow the presentation of structural projects to opinion leaders.

• Replication of the R&D Investment Program by bid purchases model (YSSEMYM).

• Implementation of the Supplier Development Program in companies that are affiliated to the chambers and with government tractor companies.

• Promotion of the national development of high specialty medical devices.

Role and Importance Of Supply Chain ( Raw Materials / Components / Semifinished Products etc. including services) For the Growth Of Indian Medical Device Industry.

Emphasizing on warehousing requirements, Mr Himanshu Baid mentioned that, “higher Volume products should be centralized so that they can be easily distributed to various parts of the country. Warehouses with proper storage facilities should be created in each District for storage of products to ensure efficient distribution to smaller healthcare centres. Al so this will ensure shorter delivery times. Public Private Partnerships will definitely make this more affordable.”

Share of Medical Device Companies involved in one or more phases of Medical Device manufacturing process : Global and Indian Scenario As per a 2014 report on “ Production , Research And Innovation In The Medical Device Industry in Italy”prepared by “Assobiomedica Research Centre ( CSA )” - “56% of companies are involved in distribution, 40% in production and 4% in services” . …” Overall, there are 243 companies that target their activity on one ormore phases of the medical device manufacturing process: 10% are involved in design or prototyping,70% manufacture components or semi-finished products, 32% manufacture accessories or finishedproducts and 20% intervene in the final phases of the manufacturing process and are involved inassembly, sterilisation, labelling or logistics.”

Medical Plastics Data Service interacted with the leaders of the Indian Medical Device Industry and compiled their opinions on “Indian Medical Device Industry 360 degree View”. The leaders opined on the role and importance of supply chain as follows (Detailed report attached.) : “A strong supply chain supports the Medical Device Industry to improve Global Competitiveness. As shared by Mr KishorKhanna, A positive approach will be collaboration with the industry and academia to develop indigenous manufacturing base of all possible materials required by the industry. Not only input material but also the availability of high tech machinery essential for moulding, extrusion and assembly is not at par with other countries. A synergetic approach is required where the industry, academia and government work towards developing the Mar.-Apr. 2018

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Cover Story New medical devices procurement guidelines propose to make 20-50% of components in India NEW DELHI : The Department of Pharmaceuticals has proposed that domestically sourced components have to contribute to 25-50% of the cost of medical devices procured by the government, depending on the category of the device.

A draft of the proposed guidelines, created to give preference to products made in India, has sought comments from all stakeholders by April 5.

At the same time, the proposed guidelines lack measures to help the local industry grow and imposes conditions that may hurt the quality of medical devices procured through these tenders, claimed a lobby group of domestic firms in the sector.

The guidelines also may not be possible to implement for highend, critical products for which there is currently no ecosystem available to manufacture locally, according to two lobby groups representing several multinational medical device firms.

Domestically sourced components have to contribute to at least half the cost of medical disposables and consumables and

40% of the cost of implants in order for the device to be eligible for procurement, according to DoP’s draft. Local content should contribute to 25% of the cost of medical electronics, hospital equipment, surgical instruments and diagnostic reagents/in-vitro diagnostics, according to it.

DoP has prescribed the requirements based on its current understanding of the medical devices market in India, according to the draft. At the same time, it also said it is in the process of collecting “accurate and reliable” data on criteria like the total capacity and production of various categories of devices in the country.

Purchase preference shall be given to local suppliers by all procuring entities, stated the draft. https://economictimes.indiatimes.com/industry/healthcare/ biotech/pharmaceuticals/new-medical-devices-procurementguidelines-propose-to-make-20-50-of-components-in-india/ articleshow/63372115.cms

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 22

Mar.-Apr. 2018

Materials Bio-Compatible, Lightweight Polycarbonate Utilized in Respiratory Device Medical technology continues to advance by leaps and bounds but bringing life-saving products to market requires more than medical breakthroughs: it also requires materials that can meet the rigorous challenges these applications demand. Polycarbonate resins and blends developed by Covestro help bring medical and healthcare applications to life.

Imagine not being able to climb stairs or stand and wash dishes without getting winded. Unfortunately this is a common reality for individuals suffering from respiratory conditions. Ventilators can help reduce the work of breathing by unloading the ancillary respiratory muscles, but are often bulky and heavy, creating additional user limitations.

A better solution by reducing the overall size of the ventilation system to support patient mobility and independence will be the desire from chronic respiratory disease patients.

US respiratory OEM Breathe Technologies Inc. selected medical Makrolon® from Covestro to achieve the R&D goals for their Non-Invasive Open Ventilation System (NIOV).

The main properties of Makrolon® 2858 polycarbonate are : • Medium viscosity • Easy release • Medical device grade • Available in transparent and opaque colors • Suitable for ETO and steam sterilization at 121 °C • Biocompatible according to many ISO 10993-1 test requirements Makrolon® polycarbonate from Covestro helps Breathe Technologies Inc. achieve the high-performing yet portable device design.

The Breathe NIOV System is a one-pound, non-invasive mechanical ventilator that can be used in home and institutional settings. Breathe Technologies explains that the device utilizes novel venturi principle technology in a comfortable facial interface that can be worn while talking and exercising.

The patient interface and air/oxygen path components utilize injection-molded Makrolon® 2858. This grade is suitable for ETO and steam sterilization at 121 Deg C and is biocompatible according to many ISO 10993-1 test requirements, making it an ideal choice for medical devices. Makrolon® 2858 also features easy release and medium viscosity and is available in transparent and opaque colors. The device components made of Makrolon® are intricate in design and require optimal functionality for patient safety.

OEM : Breathe Technologies Inc. Supplier : Covestro Application : Breathe Non-Invasive Open Ventilation (NIOV) System Product : Makrolon® 2858 Medical Makrolon® polycarbonate from Covestro lends its outstanding properties and light weight to help Breathe Technologies Inc. achieve the high-performing yet portable device design.

The Breathe NIOV System has received five 510(K) clearances from the U.S. FDA for use with compressed oxygen or compressed air for home and institutional use, and includes invasive and noninvasive circuits.

The needs are real, and the ideas to meet those needs are here…

Covestro helps them materialize.

Local Contact : Covestro India: pcsproductservices@covestro.com www.covestro.in

About Covestro : With 2017 sales of EUR 14.1 billion, Covestro is among the world’s largest polymer companies. Business activities are focused on the manufacture of high-tech polymer materials and the development of innovative solutions for products used in many areas of daily life. The main segments served are the automotiveconstruction, wood processing and furniture, and electrical and electronics industries. Other sectors include sports and leisure, cosmetics, health and the chemical industry itself. Covestro has 30 production sites worldwide and employs approximately 16,200 people (calculated as full-time equivalents) at the end of 2017.

Mar.-Apr. 2018

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®

Alpha Medicare and Devices Ltd.

(taking care…Since1984)

Manufacturers & Exporters of Disposable Medical Devices

GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests.

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 24

Mar.-Apr. 2018

Global Trends THE ASEAN MEDICAL DEVICE MARKET The region’s medical device market is expected to grow strongly and access to the market will improve in the coming years due to a number of factors : 1. Size of middle class in the region is rapidly expanding. Asian Development Bank expects this group to grow from 24% of the total population in 2010 to 65% by 2030.

Additionally, demographic trends such as population aging and urbanisation, is expected to fuel demand for better quality healthcare, and contribute to the expansion of Southeast Asia’s medical device market.

2. Penetration of medical devices into ASEAN is still relatively low, thus, there is much room for growth and market expansion. The heterogeneity of the ASEAN market allows medical device companies to adopt different market strategies and provides ample room for device segmentation.

3. Another important consideration for medical device companies entering the ASEAN market is the lack of domestic competition in the region. Overall, ASEAN is a net importer of medical devices. Vietnam for example, currently imports 90% of all the medical devices used in the country.

Country Profiles Singapore Well-positioned to ride medtech wave • Singapore has the most advanced economy in the region and has an established public healthcare system. Along with its strong intellectual property protection, existing research infrastructure and educated workforce, Singapore makes a strong choice for foreign device companies looking to establish a foothold in the region.

• In attracting foreign medical device manufacturers, the government has launched a series of incentive schemes, including tax-relief and training grants. From 2000 to 2015, the value-add of Singapore's medtech manufacturing grew from S$800 million, or 0.6 per cent of the country's gross domestic product, to S$3.5 billion.

• As part of the Research, Innovation and Enterprise (RIE) 2015 plan, the government established Sector Specific Accelerators (SSA) to identify, invest and grow start-ups in strategic but nascent sectors, such as medical and clean technology. A total of S$70 million has been committed under the SSA Programme to encourage the formation and growth of start-ups in medical technology.

Malaysia • A middle-income country with a per capita healthcare spending of US$457.

Its medical device market is valued at more than US$1.9 billion. Domestic healthcare spending has more than doubled in value since 2005.

• Malaysia has a rapidly growing healthcare sector and aims to move up the value chain in medical device manufacturing. The country is also a major producer of rubber-based medical devices, and produces a significant portion of the world’s surgical gloves, catheters, amongst others.

Thailand • Medical device market continues to grow rapidly.

The country’s per capita healthcare spending is US$360, up from $113 in 2004. Growth of the healthcare sector is forecasted to be 10%, as opposed to GDP growth of less than 2%. The medical device sector is currently worth more than US$1.1 billion.

• Thailand’s local medical device manufacturers are focused on the production of low-tech basic devices like syringes, test kits and surgical gloves. The Thai government has made some efforts to attract foreign manufacturers by promising corporate tax exemptions for a number of years. Health tourism is a major industry, with Bangkok serving about 30% of health tourists coming to Asia.

MEDICAL MANUFACTURING ASIA 2018 : Delivering solutions for the future of medtech Mark your calendar for the 4th Manufacturing Processes for Medical Technology Exhibition and Conference from 29-31 Aug 12 Jan 2018 – Innovative medical technology is an increasingly important driver for delivering efficiencies in the global healthcare system. Through advances in medical technology, precision engineering, micro-manufacturing processes, and IT, medical devices and solutions have become more sophisticated, accurate and effective. As a specialist exhibition on manufacturing processes for medical technology, the 4th edition of MEDICAL MANUFACTURING ASIA will focus on new manufacturing technology and automation which play vital roles in driving innovation and operations. The upcoming edition will highlight companies that cover the spectrum of additive manufacturing or 3D printing technologies, imaging and diagnostic imaging solutions, as well as nano manufacturing and automated solutions.

As Singapore continues to grow its medtech presence on the world stage, with a sizeable number of complex scientific instruments already designed and manufactured here, the 3-day exhiMar.-Apr. 2018

bition strongly reflects Singapore’s focus on moving upstream to not just production but also value engineering. For companies keen on engaging global medtech companies and see Singapore

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Global Trends as an ideal base to develop products for the Asian region, MEDICAL MANUFACTURING ASIA 2018 provides a highly relevant springboard.

MEDICAL MANUFACTURING ASIA 2018 comes against a dynamic backdrop which sees the Asia Pacific medtech market expected to surpass the European Union by 2020 as the world’s second largest medtech market after the United States1, while on the global front, the medtech sector is expected to grow 5% or more annually through to 2022, to reach nearly US$530 billion2.

With Singapore’s positioning as Asia’s top location for medtech and home to over 30 globally-recognised medtech companies, MEDICAL MANUFACTURING ASIA 2018 continues to attract a highly international exhibitor base coming mainly from Asia and Europe and a trade visitor base that is predominantly represented by the medical devices and instruments, medical and healthcare, and electrical and electronic sectors from around the region.

Complementing the exhibition is the half-day forum on High-technology for Medical Devices where exhibitors will present and share latest developments and trends on the global and domestic fronts and market opportunities for medtech products from Europe. Organised by IVAM Microtechnology Network, the German-based international association has an extensive membership with companies in the fields of microtechnology, nanotechnology, advanced materials, and photonics.

MEDICAL MANUFACTURING ASIA 2018 is also synergistically co-located with the region’s leading medical and healthcare exhibition, MEDICAL FAIR ASIA – thus providing an end-to-end solutions and business sourcing platform across the entire value chain for the medical, healthcare, medical manufacturing and

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medtech sectors. Jointly organised by SPETA (Singapore Precision Engineering and Technology Association) and Messe Düsseldorf Asia, the exhibition is modelled after the No.1 global trade fair in the medtech sector, COMPAMED, held in Düsseldorf, Germany.

The 4th edition of MEDICAL MANUFACTURING ASIA is fast gaining traction as the region’s leading specialist trade exhibition for the medtech and medical manufacturing sectors. Following the success of the 2016 edition, the exhibition welcomed 200 companies from 18 countries, and 5,420 trade visitors from 52 countries. For booth space booking and more information on MEDICAL MANUFACTURING ASIA 2018, please visit www.medmanufacturing-asia.com.

About Messe Düsseldorf Asia Messe Düsseldorf Asia is a subsidiary of Messe Düsseldorf in Germany, one of the world’s leading trade fair organisers, responsible for organising more than 20 global No. 1 exhibitions in various industries including medicine and health, specifically MEDICA, COMPAMED and REHACARE INTERNATIONAL held in Düsseldorf, Germany. With extensive expertise in organising trade fairs in Southeast Asia, Messe Düsseldorf Asia has developed a portfolio of numerFor more information on the exhibition, please contact : Press Contact : Exhibitor Contact : Melvin Chye Daphne Yeo Marketing & Communications Executive Senior Project Manager Tel: (65) 6332 9652 Tel: (65) 6332 9682 melvin@mda.com.sg daphne@mda.com.sg

Mar.-Apr. 2018

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 Mar.-Apr. 2018

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

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Mar.-Apr. 2018

AIMED urges GoI to take policy decisions to boost Domestic Mfg & to Make Healthcare Affordable in India 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 • AiMeD welcomes FDI in manufacturing by overseas manufacturers but not in form of Import based Pseudo 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 Manufacturing of these importer/ overseas manufacturers lobbies claiming to be Indian Industry.

1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 • India needs to Learn from China who succeeded to drive FDI into manufacturing by manoeuvres of 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345 Preferential Market Access , Non Tariff Barriers and punishing boldly errant Cos doing unethical marketing.

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New Delhi, 9th April, 2018: The government has been taking measures to control prices of medicines and some devices like coronary stents etc. over last two years. This has been a welcome move. However, much more needs to be done and in a more planned manner in place of a piecemeal approach. To begin with, we need to understand that price control or MRP capping is important but a small step in making healthcare affordable in the long run.

"There is an urgent need for an integrated and calibrated development policy to put ‘Make In India’ initiative in medical devices sector in top gear and reduce high import dependency on foreign made devices in order to promote indigenous manufacturing of drugs and devices which would go a long way in making healthcare affordable." said Mr Rajiv Nath, Forum Coordinator, (AIMED) Association of Indian Medical Device Industry.

As a first step, the government may consider granting tax / duty incentives and Price Preference in public procurement among other things to protect and promote domestic manufacturing.

Simultaneously, price control measures should be undertaken.

As of now, only coronary stents and some orthopaedic devices are being considered. But, the list needs to be expanded to include more devices.

Some price control measures that could be undertaken are : • Tax Based Measures Government should introduce an Innovative Tax Structure of stalling Artificial Inflation of MRP e.g.1% GST Cess on MRP to have a disincentive to importers and manufacture from labelling device with excessive MRP. Consider this option for Devices not Notified as Drugs.

• Trade Margin Rationalisation : AiMeD has proposed to DoP to fix the trade margin to a maximum of 50-100% (depending upon value) between import landed price / Ex Fcy price and MRP. If DoP accepts our formula, after consulting with AHPi and IMA it will provide tremendous savings to consumers as MRP will be substantially reduced.

• MRP Capping (This is the least favoured option if above 2 are proven non effective) Make in India of medical devices is already suffering and following MTAI recommended formula will make Indian Mfg at a further competitive disadvantage - GoI needs to take policy decisions to give strategic advantage to domestic Mfg while safeguarding consumers or India will remain 70-90% import dependent. Only when it will be advantageous to manufacture in India only then will these importer / Overseas manufacturers move manufacturing to India to retain market share and gain from that competitiveness created .

India needs to Learn from China who succeeded to drive FDI Mar.-Apr. 2018

into manufacturing by manoeuvres of Preferential Market Access, Non Tariff Margins and punishing boldly errant Cos doing unethical marketing.

AiMeD welcomes FDI in manufacturing by overseas manufacturers but not in Import based Pseudo Manufacturing of these importer/ overseas manufacturers lobbies claiming to be Indian Industry.

Private healthcare providers have been profiteering from Medical Products Margins in attempt to cross subsidize easily comparable procedure costs to inflate overall treatment costs, leading to very high out- of- pocket cost of healthcare. At 60%, India's out-of-pocket expenditure on health is one of the highest in the world and has lead to many bankruptcies..

"Isn't Imports a trading activity so if we talk about Rationalisation of Trade Margins it has to include Imports, you can't have importers having over 200% Margin as was indicated in NPPA report on Catheters &Guidewires and the whole supply chain have only a 35-50% Trade Margin!" Asked Rajiv Nath , Forum Coordinator of AiMeD. "Everyone in a supply chain has intermediate costs and value addition - so what value addition importers are doing and the question is what's a rational margin for them ?

Why those intermediate costs like R&D are not part of the Import landed price ? To avoid custom duties ?

This proves our point why FDI has hurt Indian Mfg as earlier Distributors used to import from overseas manufacturers at their standard price that included R&D costs and Market Creation and development costs built into the import price .

After the Subsidiary of the overseas MNC displaced the Distributor they started importing at lower Transfer Pricing to reduce impact of Customs Duty and started booking their market development and Market Creation costs in Indian subsidiary which in most cases have an opaque balance sheet of a private limited company. FDI was not used to put up factories but finance inventories, build warehouses and finance market expansion many times at cost of existing manufacturing capacity of other existing indigenous players" he explained.

www.medicalplasticsindia.com

The Only Indian Portal Site On Medical Plastics/ Devices Technology And Trade 29

New guidelines for medical device grouping to streamline licensing The Union health ministry has issued a set of comprehensive guidelines for grouping medical devices which is expected to streamline the application process for obtaining manufacturing or import licence. The norms will come in handy for individuals or companies applying for a licence and are aimed at regulating medical devices industry in the country on par with international standards.

The guidelines, prepared in accordance with the Medical Devices Rules, 2017, categorise medical devices into six brackets -- Single, Family, IVD Test Kit, System, IVD Cluster and Group. An applicant is allowed to group medical devices having same or similar intended uses or commonality of technology and submit a single application for a licence to manufacture or import it.

According to the notification, a single medical device is a product sold as a distinct packaged entity and does not meet the criteria for other specified categories. It may be sold in a range of package sizes but must be licensed separately. Even if the devices are a part of a Group, it must be licensed separately before it is sold in the market, the guidelines say.

For instance, condoms are sold in packets of 3, 10 or 16 but can be licensed as a single medical device application. However, if a company that assembles a first aid kit decides to supply each of the devices in the kit individually, each product supplied separately must be licensed as a single medical device.

A medical device Family is a collection of products from the same licence holder, have same risk classification class, have a common intended use, have the same design and manufacturing process and their variations should be within the scope of the permissible variants.

and cannot be considered as members of a Family.

Regarding In Vitro Diagnostics Test Kit, the guidelines state that it is a device that consists of reagents or articles which are from same licence holder, intended to be used in combination to complete a specific purpose, sold under single proprietary test kit name and compatible when used as a test kit. An In-Vitro Diagnostics Kit does not include the instruments such as analysers needed to perform the test.

By way of illustration, an Enzyme Linked Immunosorbent Assay (Elisa) Test Kit, used to check presence of Human Immunodeficiency Virus (HIV) infection, may contain controls, calibrators and washing buffers. All the reagents and articles are used together to detect HIV and therefore can be licenced as Test Kit. These reagents and articles can be supplied separately as replacement items for that particular test kit.

A set of medical devices belongs to the System category if they are intended to be used in combination to complete a common purpose, compatible when used as a system and are sold under single proprietary system name.

An In Vitro Diagnostics Cluster comprises a number of in-vitro diagnostics reagents or articles which are from same licence holder, of a common methodology, are sold under single proprietary name and are compatible when used as a test kit.

A medical device Group is a collection of two or more products, supplied in a single package by same license holder, may have different proprietary names and intended purposes. They might be designed and sold by different licence holders.

The collection of medical devices in a Group may differ in the number and combination of products, while maintaining the same proprietary name and intended purpose. To give an instance, a first aid kit consisting of medical devices such as bandages, gauzes, drapes and thermometers, when assembled together as one package, can be licenced as a Group.

To give an example, spherical contact lens with additional features of UV protection can be licenced as part of a Family, as this feature does not affect the basic design or manufacturing of the lens. But contact lenses are available as toric lens and spherical lens. These products have different intended purposes and (March 21, 2018 http://pharmabiz.com/NewsDetails.aspx?aid=107907&sid=1) performances. They are designed and manufactured differently 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345678901234567890123456789 1234567890123456789012345678901212345678901234567890123456789012123456789012345678901234567890121234567890123456789012345678901212345678901234567890123456789

Govt invites proposals from labs for testing medical devices, IVDs as per new MD rules Government has invited proposals from all NABL accredited laboratories in the country which are having capacity and capability for testing and evaluation of the medical device including in vitro diagnostics (IVDs) to be notified as central medical device testing lab in accordance with the new Medical Device Rules (MDR) 2017 which came into effect from January 1, 2018.

central medical device testing lab for the purpose of testing and evaluation.

According to the government notification dated 31st January, 2017, all the testing labs may get registered with Central Drugs Standard Control Organization (CDSCO) and also inform details about their activities.

Further, Rule-19 in chapter-III, of Medical Device Rule, 2017, prescribes that the Central Government may, by notification, may also designate any laboratory having facilities for carrying out test and evaluation of medical devices including in vitro diagnostics medical device, as central medical devices testing laboratory with the provision that no medical device testing laboratory, shall be so designated unless it has been duly accredited by the National Accreditation Board for testing and calibration laboratories (i.e. NABL).

Similarly those labs, who are willing to get designated as medical device testing laboratories under said rules shall communicate their details about which medical device or IVDs can be tested at their laboratories along with persons involved in the testing.

This information is being sought in light of MDR-2017 and those labs which are found suitable may officially be designated as

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In this regard, it is also required to get such laboratories registered under Rules 81 to Rule 86 of Chapter X of MDR-2017, if they are involved in medical device and IVDs testing on behalf of the stakeholder.

(March 9, 2018, http://pharmabiz.com/NewsDetails.aspx?aid=107686&sid=1 )

Mar.-Apr. 2018

Gujarat FDCA sends draft notifications to state govt for approval to implement new Medical Devices Rules In order to implement New Medical Devices (MD) Rules 2017 in an effective manner, the Gujarat Food and Drug Control Administration (FDCA) has sent draft notifications to the state government for approval to designate notified bodies and officers for oversight of medical devices units under the current regulatory framework.

Gujarat has the maximum number of 250 licensed medical devices units which include both low risk and high risk devices.

New MD Rules 2017 effective from January 1, 2018 cover not only medical devices but also in vitro diagnostics, disinfectants, surgical sutures, ligature, condoms, bandages, etc. It sets new standards for manufacturing and use of medical devices. As per the new rules, manufacturers are expected to adhere to stringent quality management system, while carrying out manufacturing of medical devices.

The state regulator is also planning to conduct workshops to sensitise drug inspectors on newly notified medical device rules 2017.

Meanwhile, Maharashtra Food and Drug Administration (FDA) is also awaiting notifications from the Central Drugs Standard Con-

Mar.-Apr. 2018

trol Organization (CDSCO) on the categorisation of medical devices for implementation of New Medical Devices (MD) Rules 2017.

The Central Licensing Authority will notify medical devices based on four classes i.e Class A, Class B, Class C and Class D depending on the risk involved.

Once notified, compliance to the new medical devices rules will be implemented with the help of medical device officers designated by the central and state governments for the purpose.

Medical Devices Rules 2017 were notified last year and is into effect since January 1, 2018. Industry and legal experts however have been raising some of the contentious issues related to compliance to guidelines which have not been finalised as yet and timelines for its effective compliance.

One such issue is related to the guidelines on essential principles of safety and performance as stipulated in Rule 6 of MD Rules, 2017, which has not been notified as yet and hence the concern is that the companies might not have the time to comply with it as the rules has already come into effect. The subjects included post grant compliance, data protection, product recalls and product liabilities among others.

(March 29, 2018, http://pharmabiz.com NewsDetails.aspx?aid=108068&sid=1 )

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Industry News QCI, UL team up with govt and industry to spur robust quality ecosystem to build 'Brand India' in medical devices Our Bureau, Bengaluru Friday, March 16, 2018, 15:30 Hrs [IST] The Quality Council of India (QCI) and UL, an independent, global safety science company have brought together government agencies and industry associations to further the quality ecosystem in the country through standardization in medical devices.

Chaired by the Ministry of Commerce and moderated by the Quality Council of India and UL, the Standards Roundtable saw active participation of government agencies such as the National Accreditation Board for Testing and Calibration Laboratories (NABL) and the Telecommunication Engineering Centre (TEC), and 16 industry associations representing diverse sectors, as well as premier industry bodies such as the Confederation of Indian Industries (CII) and Associated Chambers of Commerce and Industry of India (Assocham).

A critical agenda of the Standards Roundtable was the draft Indian National Standards Strategy (INSS) released by the Ministry of Commerce recently. The draft INSS focuses on, among other objectives, ‘using standards as an enhancer for competitiveness in the domestic and international markets’ and ‘adopting best practices in standardization, conformity assessment and technical regulations, and creating an integrated infrastructure,

roadmaps and institutions for their effective management’.

While India today has more than 19,000 standards, around 5,000 of them are updated and about 135 are mandated for regulation.

A phased approach to increase the level of regulation to match other comparable markets will give the domestic industry the right impetus to compete on global as well as domestic scale.

Commenting on the first-of-its-kind effort by the Government to devise a comprehensive Standards strategy, Anil Jauhri, CEO, National Accreditation Board for Certification Bodies, India said, “The Government is actively pushing the Standards agenda, and hopefully, with the draft INSS, where the roles of each stakeholder are clearly defined, we can create an action plan to further standardization in India with greater participation from the industries.”

Other strategic discussions in the event under the theme, “Accelerating Standards Development For Building Brand India” centered around speeding up the process of creating domestically relevant, technologically sound, science-based and globally harmonized standards that can foster better safety, sustainability and healthy outcomes for the country. Experts reiterated the need for the industry to proactively support the standardization program of the Bureau of Indian Standards (BIS). http://pharmabiz.com/NewsDetails.aspx?aid=107828&sid=2

Hindustan Syringes and Medical Devices gets ‘India Design Mark’ Hindustan Syringes and Medical Devices Limited (HMD), which today exists as the country’s leading manufacturer of SMART (auto disable) syringes, was recently granted the most significant distinction ‘India Design Mark’ by the India Design Council.

It has been granted the ‘India Design Mark’ for its recently introduced product ‘Safety Cathy IV Cannula” which is used for drug delivery. It was given this after having successfully completed the evaluation by the jury during an award ceremony in Coimbatore.

The India Design Council exists as an autonomous body under Ministry of Commerce and Industry Government of India.

The India Design Mark is a design standard, which symbolises excellence in form, function, quality, safety, sustainability and innovation and communicates that the product is usable, durable, aesthetically appealing and socially responsible.

It needs to be understood the Safety IV Cannula , used for giving infusion of drugs, has a protective device “SAFETY SIP CLIP” which encapsulates the tip of the used needle when introducer needle is extracted from the Catheter; Post Cannulation.

The “Safety Sip Clip” prevents accidental needle stick injury, provided that general effective and safe working procedures and precautions are maintained during its use and disposal.

The award was announced by Pradyumna Vyas, Member Secretary, India Design Council in the presence of eminent personalities associated with public and private healthcare, government establishments and healthcare consultancies.

“While this is a prestigious recognition for us at HMD to make the quest for the India Design Mark more popular the procurement officer in Private & Public Healthcare need to give a preference to Medical Devices with the Design to encourage Manufacturer to invest in Quality & Design,” said Pradyumna Vyas, Member Secretary, India Design Council, on the occasion.

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Reacting to this granting of ‘India Design Mark’, Rajiv Nath, Joint Managing Director of Hindustan Syringes and Medical Devices Ltd (HMD), said, “We are delighted to be honoured by the most significant recognition for our safety IV Cannulas assuring excellence in aspect of design, quality and safety.

“Our product samples were evaluated by the Jury of India Design Mark. The Jury was satisfied with the uniqueness and benefits of the Design of our product and the India Design Mark is awarded to HMD.” It may be noted that the India Design Mark aims to use the design as strategic element for business excellence, to promote design as a tool for innovation and economic competitiveness in industry and to promote the concept of environment friendly designs.

Rajiv Nath also stressed that the Government urgently needs to deploy “Safety I V Cannulas” to Limit HIV & Hepatitis Epidemics in the Country and to protect Healthcare workers from accidental needle stick injuries while treating infected patients.

“We have been exporting millions of our Safety I V Cannuls to Sweden, Norway, Denmark and other European Countries but (we) are challenged by the discerning Indian doctors who demand quality. The Design Mark should help us gain confidence and trust of those doctors as we did for our Ribbon Packed DISPOVAN Syringes,” said PardeepSareen, Chief of Marketing, at HMD. HMD is the most prominent and key player in India and abroad in the manufacturing and supply of Syringes, Needles, I.V.Cannulas, Safety I.V.Cannulas, Surgical Blades, Safety Scalpels, Scalpvein Sets, Nonreusable (AD)Syringes, Blood collection tubes and blood collection systems etc. etc. http://ehealth.eletsonline.com/2018/03/hindustan-syringes-andmedical-devices-gets-india-design-mark/ Mar.-Apr. 2018

Product Gallery Qosina Provides Cost-Effective Off-the-Shelf and Custom Tubing Solutions Ronkonkoma, NY, USA, April 5, 2018—Qosina offers a wide selection of in-stock tubing for prototyping and largescale production requirements. The high-quality, medical-grade tubing is competitively priced, conveniently packaged in small coils and available in a diverse range of sizes and materials including PVC, silicone, FEP, HDPE or DEHP-free PVC. Qosina also carries platinum-cured silicone tubing, which can withstand repeated compression, and peroxide-cured silicone tubing for increased resilience and durability.

Qosina’s off-the-shelf tubing solutions include popular brands such as Tygon®, PharmaFluor® and C-Flex®.

Additionally, Qosina customizes tubing to exact specification with cut-to-length, multi-lumen and multi-layer configurations, along with custom durometers, sizes, colors and materials. Qosina also provides medical tubing sampling kits for all project needs.

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’s Slide Clamps Remain an Integral Part of the Company’s History Ronkonkoma, NY, USA, March 9, 2018—Since Qosina’s inception in 1980, the company has consistently stocked its core product, the slide clamp. It was the first component Qosina ever sold and remains one of its top-selling product lines.

In its first catalog nearly 40 years ago, Qosina featured six unique slide clamps.

Through the years, the company has altered its slide clamp offering, adding new, innovative parts and removing obsolete ones. However, Qosina has consistently carried five of its original six slide clamps, proving that these components can stand the test of time.

Qosina’s inexpensive and ergonomic slide clamps are used to control the flow of fluid in a line. They feature a graduated opening through which the tube passes, and when the tube is pushed into the narrow end of the opening, it clamps off, reducing or shutting off the flow of fluid.

Qosina carries approximately 50 off-the-shelf slide clamps in an assortment of colors, sizes and configurations, including open-

Mar.-Apr. 2018

jaw and closed. Customizable options are available as well.

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

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Events MEDICAL FAIR INDIA continues on course for growth

Quality and quantity of visitors makes for high spirits among exhibitors MEDICAL FAIR INDIA, India’s No. 1 Trade Fair for Hospitals, Health Centres and Clinics, impressively continues its rate of growth and keeps pace with the positive trend in the industry.

This conclusion can be drawn from the successful course of MEDICAL FAIR INDIA 2018 in Mumbai. 16 – 18 March saw 12,350 trade visitors come to the Bombay Convention & Exhibition Centre to learn from 551 exhibitors about innovations for health care and current trends.

“This means that the number of visitors has gone up yet again by 15% compared to the event at the same location two years before. In interviews exhibitors said they were very satisfied with the quality of visitors and their demands,” explains Thomas Schlitt, Managing Director at Messe Düsseldorf India, and adds: “Rising incomes, population growth and increasing health consciousness all result in steady market growth and a call for improved health care. This is also reflected by the development of MEDICAL FAIR INDIA. It is not only a platform for supply and demand. It is also about joint ventures for product development, manufacturing and sales.”

Since there are currently only about 60 national medical device technology producers, the majority of products and technologies for medical needs are imported. This opens up excellent business opportunities for multi-national vendors. At the same time, there is a need for them to closely cooperate with Indian partners so as to rise to the challenges specific to the Indian market in an optimal way. Underlining this on behalf of many exhibitors, Simon Bensassi, International Sales Director of Surgival from Spain, said: “This was the first time we have participated at MEDICAL FAIR INDIA. We have reached many high-quality visitors. What was especially important to us was gaining insights into the Indian market. Who are the decision- makers? What about the government and what about pricing? How much is invested and where?

These were questions we had interesting conversations about.”

Brian Krawczyk, Director of Global Business Development at VIA Global Health (USA), also believes his company has achieved the aims it set itself for participation at the trade fair: “To us this was an extremely useful event for finding good distribution partners in India.” John Mason, Sales Director at Seers Medical (Great Britain), shares his view: “There was a very good mixture of visitors from both private and public health care. Visitors come from all over the country. We will also be taking part in MEDICAL FAIR INDIA 2019 in New Delhi.”

Also taking positive stock was the Brazilian manufacturers’ association ABIMO. Karina Yamamoto (Trade Promotion Coordinator) emphasised: “The Indian market is developing at warp speed and it is very important for us to get a foot in the door here and learn to understand the market. In addition to Indian visitors we also succeeded in making contacts in Bangladesh, China and even Saudi Arabia and the United Arab Emirates.”

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Again, the integral programme components of the trade fair made MEDICAL FAIR INDIA 2018 even more attractive for visitors.

Worth mentioning here is CLIN LAB INDIA, a conference with exhibition organised by Scherago and Messe Düsseldorf India; in terms of content it focuses on molecular diagnostics, point-ofcare applications and immune-biological laboratory medicine. The increasing digitalisation of medicine was centre stage at the ‘International Conference on Digital Health and Medical Equipment’

by Voice of Healthcare and the Lounge Area ‘FTR4H’ (Future for Health) played a prominent role within the trade fair as a platform for the creative start-up community. Here the discussions related to presentations and brief lectures revolved around sounding out the market relevance and maturity of innovations and placing young entrepreneurs with potential business partners.

MEDICAL FAIR INDIA is held alternately at venues in Mumbai and New Delhi every year. Focal ranges include: medical products and medical device technology, laboratory technology and diagnostics, equipment and furnishings plus furniture for hospitals and health centres and the global trend areas of Health IT and Mobile Health solutions, to name but a few themes.

The target group encompasses decision-makers from the medical field (such as physicians and medical professionals), hospital managers as well as representatives from the medical trade and industry. Due to its spectrum of topics covered the event is equally attractive for architects and building planners, for enterprise consultants or for the scientific and research community.

The next MEDICAL FAIR INDIA http://www.medicalfair-india.com. will be held from 21 to 23 February 2019 – in keeping with the schedule – in New Delhi, at the Pragati Exhibition Center.

Contact : Messe Düsseldorf India Pvt. Ltd. Love Bhardwaj Project Manager Tel: +91(0)11-4855-0061 E-mail: BhardwajL@md-india.com

Events Calender • Medical Manufacturing Asia 2018 4th Manufacturing Processes for Medical Technology Exhibition and Conference Date : August 29 – 31, 2018 Venue : Marina Bay Sands Singapore • Medicall India’s Larges B2B Medical Equipment Exhibition Date : July 27 – 29, 2018 Venue : Chennai Trade Center, Chennai, India • Medicall India’s Larges B2B Medical Equipment Exhibition Date : September 21-23, 2018 Venue : Pragati Maidan, New Delhi, India • 15th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposables / Implants Industry 2018 Date : October 26-27, 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 Mar.-Apr. 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

Mar.-Apr. 2018

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

E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com 35

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

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

ISO 9001-2000

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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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 Mar.-Apr. 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 Mar.-Apr. 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 37

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

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Mar.-Apr. 2018