CToabnletoef nts Vol. 23 No. 3 May-June 2015 22 Cover Story • Medical Device Manufacturing: Components Bonding and Joining Techniques - Medical devices in every aspect of their production demand highest level of quality. Reliability, and reproducibility. The assembly of sub components are also critical in manufacturing of Medical products. The bonding and joining technique must not interfere with the function or standards applied to Medical Device. The methods for joining plastics and composites can be divided into following major categories.......... 26 Manufacturing Policy • National Medical Device Authority (NMDA) - Recommended By Task Force To Strengthen “Make In India” Drive - The Department of Pharmaceuticals will within six months, bring a detailed proposal for creation of the National Medical Devices Authority with vision, mission, objectives, constitution……. 28 Product Gallery • New Kynar® Connectors from Qosina 31 Global Trends • Medical Disposables Market Worth $245 Billion By 2018 - Global medical disposables market will be dominated by 10 largest national markets, combining to absorb over two-thirds of the total value of global demand in 2018…….. Average annual growth in these markets will range from 3.6 percent in Japan to 15 percent in China. 34 Industry News • India Developing Federal Medical Device Surveillance System • Medical Devices Industry In India Underinvested: WHO • Imported Medical Devices Inflate Patient’s Bill • Gujarat Has Maximum Units Under Operation In Medical & Dental Instruments: Study 20 Did You Know? • About Welding of Thin Polymeric Films For Medical Applications 38 Events • Medical Fair India 2015 : March 11-13, 2016, Bombay Convention & Exhibition Center, Mumbai. • Medicall 2015 : July 31 & 1-2nd August, 2015, Chennai Trade Center. October 9 - 11, 2015, Bombay Convention and Exhibition Center, India. • Plastivision Arabia 2016 : January 10-13, 2016, Expo Center, Sharjah. • 13th National Conference And Technology Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016. 12-13 February, 2016, Ahmedabad. May - June 2015 19
Flashback ?YoDKuindow ? March 2003 About Welding of Thin Polymeric Films For Medical Applications From Editor’s Desk Nearly all thermoplastics can be used in film form as thin, soft, flexible, elastomeric materials Dear Readers, that can be folded or creased without damage. In selecting films for medical devices, The factors to be considered include cost, biocompatibility, sterilizability, mechanical toughness, The domestic medical device industry has advanced elasticity, optical clarity, leachability, barrier properties, drug interaction, and sealing and rapidly over the past twenty years since China started assembly characteristics. its economic reform policy in 1979. Presently, with 2900 medical device manufacturers, total output value Films most commonly used in the medical industry include high- and low-density polyethylene is USD 2 billion with a capacity to produce 12000 and polypropylenes , plasticized PVC, polyurethane elastomers, and breathable specialty specifications, 3500 varieties in 47 categories. By the films such as polyester. A clear understanding is required not only of a material’s properties, year 2000, total output value was expected to reach but also of how a particular welding process will affect it. USD 3.62 6.04 billion. Still the imported medical equipment and instruments The weldability of plastics is affected by various factors, including type of polymer; resin occupy 86 % of the total values meaning that China grade; presence of plasticizers, lubricants, and other additives; and moisture content. Thermal is a very promising market for the medical products. properties, molecular characteristics, and crystallinity of a polymer affect processing and film properties; additives influence extrusion and orientation processes and improve film Some of the favorable factors for the large potential properties; and reductions in the thickness of a film can lower costs and increase the area are release of import restrictions and development of obtained from a given weight of polymer yield per square meter. Medical & Hygiene Industry. This has resulted in increasing market demand for: In the 1970s, PVC became the material of choice for Band-Aids, and later the use of polymeric film patches in surgical draping became popular, replacing latex films. In the 1990s, the use • High & New Technology Medical Products of organ bags, drug-delivery patches, and breathable films for wound care increased • Physical Therapy & Household Healthcare Products dramatically, making films much in demand in the medical industry. However, health and • OEM Products environmental concerns about PVC and latex films have driven the development of alternative materials for these applications. The economy of China is the fastest growing in the world. In fact, it grew at an astonishing 8.1% in Thermoplastic polyurethane, is well suited for use in flexible medical products such as storage the previous quarter. and collection bags and other types of flexible containers and similar articles. China was also among the fastest growing Polyurethane films offer some important advantages over other films, including PVC. They markets for Indian exports during the 1990s, have similar welding characteristics to PVC, provide strength equal to PVC in a thinner film, according to the research house Center For contain no plasticizers, are sterilizable by either EtO or gamma radiation, and have good Monitoring Indian Economy (CMIE). Starting from alcohol resistance. Polyurethane films also can be readily sealed using radio frequency (RF) a low base of $48.7 million in 1991-92, exports welding techniques. from India to China have exploded to $925.7 million in 2001-02. The growth rate during the In a decade: a whopping 34.2% a year. Nutshell.... Pharmaceutical exports account for 9% of total exports to China. “I fear the day that technology will surpass our human interaction. CHINA MED 2003 will therefore, be an excellent opportunity to explore Chinese market. The world will have a generation of idiots.” This issue contains an important presentation by Dr. C.S.B. Nair regarding use of materials for artificial - Albert Einstein organs for replacement of human body parts and for the manufacture of various implants and devices, May - June 2015 which have revolutionised the healthcare system. This first part of the article introduces Pharmacopoeia requirements for materials for medical applications. The next issue will highlight differences in the requirements between Pharmacopoeia of different countries and also important criteria for medical devices required to guarantee their performance under actual use. This issue also features our regular columns : Global Trends, Industry News, Business Opportunities, important forthcoming events etc. 20
EDITOR D.L.PANDYA, B.E.(Chem), M.I.E. ASSOCIATE EDITOR FromDtheeEsdkitor’s Mr. Rahil Engineer, B.E. (Biomedical Eng.) Joining of plastics components is a practice of keen interest in the medical device industry. A large number of medical disposable EDITORIAL ADVISORY BOARD products are assembled using different joining and bonding methods. Medical Devices are becoming more complex and more Dr. TARANG PATEL sophisticated, both in performance specifications and structural complex city. Bonding M.B.B.S., M.Ch. (ONCO) of medical components involves a thorough understanding in design, material Cancer & Reconstructive Surgeon compatibility, performance testing, assembly methods and regulatory affairs. As the requirements for the components increases, so does the requirements for joining them. Mr. C. BALAGOPAL Considering the importance and interest to the industry, this issue gives a very Director - Enter Technologies Pvt. Ltd. comprehensive compilation of various methods of joining and bonding alongwith Chairman - Mobilexion Technologies Pvt. Ltd. applications, features and advantages as well as limitations for the commonly required techniques. Trivandrum National Medical Device Authority The task force, under the chairmanship of the Secretary, Department of Pharmaceuticals, Dr. DILIP H. RAIKER has recommended creation of an autonomous body. The draft National Medical Device Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Policy – 2015 recognised the need for strengthening make-in-India drive for medical Former Chief Manager(P), CIPET - Chennai device industry. Based on this, Department of Pharmaceuticals has shortlisted various measures including formation of “National Medical Device Authority”. The draft lists ING LOUIS C. SUHUURMAN various salient features for the policy alongwith the incentives to the industry, provisions Formerly Sales Director for institutional framework as well as measures to improve affordability for the masses. COLPITT B.V., Holland The draft policy is uploaded on the Department’s web site inviting comments / suggestions from industry. Dr. A.V. RAMANI System for Medical Device Surveillance and Adverse Event Reporting Group Sr. Vice President (R&D), The TTK Group One more important development is regarding development of system for medical device surveillance and adverse event reporting by Government of India, the implementation of Dr. C.S.B. NAIR which to be co-ordinated by Sree Chitra Tirunal Institute Of Medical Sciences, Trivandrum. Director (R&D), Peninsula Polymers Ltd It is expected that the information gained from the monitoring system will help regulators make decisions and recommendations based on domestic use of medical devices. Dr. BHARAT GADHAVI As per the World Health Organisation, Indian Medical Device Industry is not only CEO, Medisurge Hospitals “underinvested” but also heavily import-oriented. The WHO recently announced formation of National Health Systems Resource Center (NHSRC), the first WHO collaborating Mr. A.S. ATHALYE centre in South East Asia Region. Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai This issue, along with the cover story, also includes other regular columns including industry news, global trends, product gallery, “Did You Know’ as well as information on Dr. SUJOY K. GUHA important industry events. B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. 21 IIT, Kharagpur Dr. G.S. BHUVANESHWAR Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India. Dr. J. V. Tyagi Consultant, Medical Device Certification PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: [email protected] Website:www.medicalplasticsindia.com Reg.No.GUJ-ENG-00446/23/ALL/TC/94 dt.3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-58 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. May - June 2015
Cover Story Medical Device Manufacturing: Components Bonding and Joining Techniques Medical devices whether temporary or permanent, used exter- may also require expensive or time-consuming disposal methods. nally or inside the body, are becoming more complex and more Most importantly, many toxic or dangerous materials cannot be sophisticated both in terms of their performance specification used in the manufacture of medical devices as they are going to and structural complexity. Medical devices have complex shapes be implanted in the human body. that cannot be molded directly. As a consequence, many devices currently used are multi-component and require methods of Nowadays, there are thousands of grades of polymers available assembly in their production. at the market for Medical Device Manufacturing. These cover a wide range of properties, from soft to hard, ductile to brittle, and Many types of medical devices are made of plastics which are weak to tough. The wide variety of polymers and polymeric required to be joined together in some manner. In these cases, composites makes it possible to select and even customize the the plastic parts may need to be separately made and joined to- material to specific application. gether. So, Joining and Bonding are critical steps in manu- facture of the components from polymers and polymeric As the requirements for the components increase, so do the composites which are used in manufacturing of Medical requirement of joining. Joints in Medical Device Manufacturing Devices. are necessary always when; part integration is impossible because of complexity and/or high cost, using different materials in the Medical devices in every aspect of their production demand same component, disassembly is highest level of quality. Reliability, required and repair of damage is reproducibility and the assembly needed. of sub components are also critical in manufacturing of Medical Joining is generally the final step products. Non-compatible in any fabrication cycle. The materials (e.g. Mix-matched effectiveness of joining polymers) used in the operation can have a large manufacture of medical devices influence on application of any pose difficulties in the assembly polymer or composite material process. The bonding and joining used in Medical Device technique must not interfere with production. the function or standards applied to Medical Device. Blood and gas filters, IV spikes, drug delivery systems, surgical One of the most prevalent tools, diagnostic cassettes, concerns when bonding materials fluidic devices, cardiometry for medical device manufacturing reservoirs, face masks, is how to get a strong bond implantable devices, insulin between mismatched substrate pumps, surgical gowns, blood surfaces. Generally, when donation kits, dialysis tubes, bonding like materials, there are disposable clothing, pump adhesives available that will cylinders, blood basins, sensor strongly bond the two surfaces at the interface of the substrates. components, dialysis systems, However, in many medical device manufacturing scenarios, the condiment dispensers and need to bond different materials with very dissimilar physical and blister packages, are some of the common Medical Products chemical properties frequently arises. For example, a reasonably and Components which are using Plastic Joining and rigid material such as polycarbonate (PC) may need to be bonded Bonding processes in their manufacturing. together to a more elastic polyethylene (PE) material. Since the chemical properties of these materials is quite different, they will The methods for joining plastics and composites can be divided tend to bond differently to various adhesives. A certain adhesive into following major categories: Mechanical Fastening, Adhesive may bond well to the PC, but not well, if at all, to the PE, and vice and Solvent Bonding, And Welding. versa. 1 Mechanical Fastening : There are methods to chemically treat the surface of one or both of the materials using primers, or other mechanical means to get Mechanical fastening has limited applications in Medical a strong adhesive bond. While many of these chemical methods Device assembly. Mechanical fastening presumes the use work quite well, they require the use of materials that may expose of additional parts such as polymeric screws, bolts and it the manufacturer to dangerous or toxic matter. Such materials involves the use of separate fasteners or it relies on integrated design elements such as snap fit or press-fit joints. Mechanical fastening can be used to join both similar and dissimilar materials. 22 May - June 2015
Cover Story The one advantage of Mechanical fastening is ease of Structural adhesives, in both liquid and tape formats, are disassembly. While, Disadvantages include reduced used in a growing number of medical applications as aesthetics, poor hermetic sealing and increased inventory. replacements for mechanical fasteners. 2 Adhesive Bonding And Solvent Bonding : Solvent Bonding In Adhesive Bonding, an adhesive is placed between the This method uses a solvent to fuse two plastics together. parts to be bonded where it serves as the material that joins Simple in principle and simple in use. Solvent bonding is the part and transmits the load through joint. Adhesive inexpensive and very fast. However this method demands the bonding involves the use of a polymeric adhesive, which use of thermoplastic which will dissolve to fuse together. The undergoes a chemical or physical reaction, for eventual joint application of a solvent at the bond lines induces sufficient formation. mobility for the polymer chains to interdiffuse. Because the solvent must strongly plasticize the polymer surface, this Adhesive bonding is well regarded in the industry because it joining technique is primarily applied to glassy amorphous does not have the health and safety issues that solvent thermoplastics, such as polycarbonate (PC), acrylic (AK) and welding has. In addition, adhesive bonding does not require Polystyrene (PS) resins. the high capital equipment costs as do ultrasonic or vibration welding. These techniques have found wide use by virtue of their low cost and adaptability to high speed production. In addition No one adhesive technology can fulfill all requirements in adhesive and solvent bond provide a relatively uniform bonding disposable medical devices. A balance of adhesive distribution of stresses over the assembled areas and high properties is needed to assure successful bonding of strength to weight ratio. medical devices. The types of adhesives commonly used for medical device assembly include cyanoacrylate, light- Solvent Bonding is only for joining of amorphous curable cyanoacrylate, light-curable acrylics, epoxies, thermoplastics, whereas adhesive bonding can be used with urethanes and dual ultraviolet (UV)/moisture curable almost any plastic also Joints with large, induced gaps cannot silicones. be secured via solvent bonding. Many medical devices, including reusable surgical 3 Welding (Fusion Bonding) : instruments like endoscopes and laparoscopes, are assembled using a variety of biocompatible adhesives. Many medical devices can be joined without consumable These adhesives must be able to tolerate repeated adhesives or fasteners. Although snap and press- sterilization cycles that may include steam autoclaving, fit applications are the least expensive options, they are often chemical treatment, and radiation Anaerobic sealants, not permanent or secure enough. When that is the case, cyanoacrylates, light-curable acrylics, and silicones are used welding is often the best solution. in diverse lifesaving applications ranging from automotive air-bag sensors to catheters and blood oxygenators. In welding, heat is applied to melt the polymeric material at contacting surfaces enabling through intermolecular diffusion and polymeric chains entanglement process to form a joint. Welding processes for Medical Device assembly are often categorized and Identified by the heat method that is used. All processes can be divided into two major categories: External Heating and Internal Heating. Internal heating methods are further divided into two categories: internal mechanical heating and internal electromagnetic heating. External Heating method relies on convection and/or conduction to heat to the weld surface. These processes include hot tool, hot gas, extrusion, implant induction and implant resistance welding. Internal mechanical heating methods rely on conversion of mechanical energy into heat through surface friction and intermolecular friction. These Processes include ultrasonic, vibration and spin welding. Internal Electromagnetic heating methods rely on absorption and conversion of electromagnetic radiation into heat. These processes include infrared, laser, radio frequency and microwave welding. It is important to understand and compare different methods in order to determine which may be best for a given application. Some of the popular plastics welding methods for Medical Devices are presented here. May - June 2015 23
Cover Story Ultrasonic Welding size considerations. Laser welding still has relatively high capital costs,faster cycle The ultrasonic welding process is used quite commonly for times come with higher capital costs also the process is medical devices because its strengths nicely complement sensitive to part fit-up. the requirements of medical device assembly. Economics Plasma Processing : often favor ultrasonic welding because cycle times are typically The medical device industry is highly regulated which demands very short. In ultrasonic welding, high-frequency vibrations reliable and reproducible components and manufacturing generate heat at the interface of the parts to be joined, melting processing. Bonding mismatched plastics can be challenging the plastic and creating a strong bond. Ultrasonic Welding is for engineers and technicians in medical device manufacturing, very popular technique for fusion and bonding of even when the proper adhesives are utilized for maximum thermoplastics and thermoplastic components. adhesion results. Low temperature gas plasma can be a simple, safe, This technique is efficient, non-contaminating and requires inexpensive, and powerful alternative to prepare materials for no consumables. It produces a clean weld site with highly bonding for the manufacture of medical devices. Plasma uniform joint quality, providing exceptional performance, processing is an excellent choice for increasing the surface consistency and reliability. Ultrasonic welding is often used energy of polymers enabling more wettable surfaces. in mass production because the welding times are relatively A Number Of Other Techniques Are Used For Joining & short (often less than 1 s).Ultrasonic welding is a flexible Bonding : technique that can also be used for small lot size production Hot gas welding, Speed tip welding, Extrusion welding, – as long as the fixtures are designed to be flexible. It is Contact welding, Hot plate welding, High-frequency welding, applicable to both amorphous and semi crystalline Injection welding, Ultrasonic welding, Friction welding, Spin thermoplastics. However, Limitations includes; high capital welding, Laser welding, Solvent welding and plasma & running cost of equipment and poor gap filling. processing are some of the commonly used techniques. The applications, important features and the limitations for each RF Welding technique is summarised in the attached table. Radio Frequency (RF) welding, which is also often referred Congratulations to as “dielectric welding” is a process that relies on internal heat generation by dielectric hysteresis losses in for the good website you have developed thermoplastics with polar side groups. It is most commonly used to weld PVC bladders, such as intravenous Your site, Medical Plastic Data Service, has been drip bags for the medical industry. RF welding has the selected as one of Biomet.net’s Top 5 sites. advantages that it is a relatively fast process with typical cycle times ranging from less than 1s to 5s. It also does not require The biomaterials network (Biomat.net) periodically dis- any special joint designs and produces welds that are tinguishes selected internet sites, based on their top relatively appealing cosmetically.RF welding is almost general quality, mainly their scientific value and sutability exclusively used for welding thin sheets or films. Thickness to internet browsing. usually ranges from 0.03 to 1.27 mm (0.001 to 0.050 in), depending on the material and application. Jose Paulo Pareira Editor of Biomet.net University of Porto Portugal The limitation of RF welding is due to the fact that a strong electric field must be generated and this can only be achieved when the welding electrodes are brought together in close proximity (0.03 to 1.27 mm). Another limitation of the process is that the materials being joined must have the proper electrical properties. Common applications include blister packs for packaging and medical applications such as IV bags and Urine Bags. Laser Welding When welding seams in the micrometer range are required, there is only one economical solution – laser plastic welding. Laser welding is a vibration-free, particulate-free, and, in most cases, flash-free process that is nearly silent.Other aspects make this joining technique additionally interesting for medical applications, such as: flexible production options, stress-free processing, very fine process control and hygienic high-precision processing chains – all assuring high quality and profitability.The process is nearly independent of part- 24 May - June 2015
Cover Story Techniques Used For Joining and Bonding Applications Features and Advantages Limitations Mechanical Blood Collection Immediate Easy to use Removable Tolerance Specific, Difficult to Offer stress Fastening Not suitable for automate concerntration Tubes Full Strength smaller components Syringes, Catheters, Oxygenators and Even Stress Joins dissimilar Longer Set Up and Prior Surface Adhesive Surgical distribution, Fills materials, Easily automated Processing Time, preparation is Can cause Welding contamination equipment such large gaps Aesthetically Requires fixture required as Endoscopes acceptable time and Laparoscopes Catheters, Health and safety Membrane Solvent Oxygenators, Low cost and High strength Fast Process issues, Harmful for Not usable on Solvent Can cause Bonding Microfluidic adaptability to to weight ratio operators because thermosets,Poor stress cracking of the fumes that devices high speed gap filling production. are generated Ultrasonic Respiratory Filters, Most widely used Does not Fast, clean, Cannot be used on Ultrasonic High capital costs Welding Blood Filters, method due to introduce any efficient and Thermosetic vibrations can and Tooling costs Catheters, clean weld and repeatable process Cannulas, produce high additional Plastic, Plastics damage for fixtures are Luers,Trocars, strength joints materials such as must be compatible electric compo- high Masks, Blister consistently Packs adhesives into nents the device Vibration Surgical Capability of Capable of Not usable on High capital costs, Welding instruments, welding more producing strong, Surface preparation Plastics must be Thermosets Capital expenditure Filters, I-V units, than one part at a and special tooling pressure-tight not required, rigid/flat,Must have Bedpans, time joints and also Adaptable to either flat or slightly are required Insulated trays works with multi- automation curved interfaces plane surfaces Spin Valves,Fluid filters, Joins circular Ease Of Assembly, Provides fast cycle Suitable for parts Spin welding can Limitation to Welding Flow diverters, parts under Simple and highly times with a circular joint generate Circular Areas Surgical trocars pressure with a energy efficient RF circular, spinning line only particulates only Welding process motion IV bags, One of the most Disposable widely used Relatively fast and Does not require Material Must have Material must For limited joint hospital products, methods, Energy Efficient, any special joint a relatively high have a relatively Complexity and Exclusively used Typical cycle time designs or solvents dielectric constant high dielectric loss Component size Blister packs, for welding thin less than 5 sec and adhesives Blood and Urine Bags sheets Infrared Instrument panels Particularly Non-contact Suitable for Temperature Higher tooling and Process may welding and Filter appropriate for process, Joints Complex curved control requires maintenance costs create smoke and Assemblies higher-tempera- are free from constant current (requires infrared tures processing contamination joints fumes platen) Hot plate Filter cartridges, For Complex For parts having Higher joint Higher power Require Warm-up Higher tooling welding artificial joints, geometries, irregular shape, or strength and Cost- consumption braces and splints large/multiple curved or internal (required for time (Preheating) costs small parts and effective walls heaters) parts Laser Microfluidic Useful when High Speed, Precision, Laser welding High Capital cost Welding Sensor, PTCA Micrometer Shorter Cycle cleanliness, and plants are of Equipments and Mainly Restricted catheter, Micro range is required time, Particle-free expensive High maintenance To flat shapes only Atomizer and Cell High speed culture Flask processing Production cost Plasma Microtiter Suitable for Suitable for Improved lubricity Processing Plates chemical- resistant Bonding mis- and surface materials matched plastics adhesion May - June 2015 25
Manufacturing Policy National Medical Device Authority (NMDA) - Recommended By Task Force To Strengthen “Make In India” Drive The Drugs and Cosmetics (Amendment) Bill, 2015 for providing competition, access foreign markets, and find new business a separate chapter for regulation of the complete range of medical partners abroad. devices is now under legislative process. g Search, collect, collate and analyze relevant data. h Promote, co-ordinate and issue guidelines for the development Besides, the others issues facing the Indian medical device of risk assessment methodologies and monitor, conduct and industry include training and capacity building programme, forward messages on the risks associated with medical interaction with medical device regulators, policy to promote local devices to the Central Government, State Governments and manufacture of Medical devices, granting subsidies and other enforcement agencies. incentives and promoting higher education relevant to medical i Promote networking of national and international organizations devices industry to bring fresh talent and techniques into research within and outside India with the aim of facilitating scientific and development. There does not exist a single nodal authority co-operation, coordination of activities, exchange of for medical device industry. information, implementation of joint projects and exchange of expertise. Recognizing this policy deficit, the Government constituted a Task j Take all such steps to ensure that the public, medical Force under the chairmanship of the Secretary, Department of professionals and interested parties receive rapid, reliable, Pharmaceuticals (DoP) to address issues relating to the objective and comprehensive information through appropriate promotion of domestic production of high end medical devices methods and means. and pharmaceutical manufacturing equipment in the country. The k Promote general awareness as to medical device safety and Task Force in its report released by Honourable Minister of medical device standards. Chemicals and Fertilizers on 08.04.2015 had made a set of l Undertake any other task assigned to it by the Central recommendations for the promotion of the Medical device Government. industry. Objective: ii The Government on the recommendations of NMDA, subject The National Medical Device Policy-2015 has the objective of to availability of Budgetary resources, may consider all or an strengthening the Make in India drive in Medical device sector appropriate mix of the following incentives for both Greenfield by reducing the dependence on imports and setting up a strong and Brownfield units: base for Medical devices especially those having critical implications in terms of affordability and availability for patients. a Preference in government procurement may be considered for medical devices which are being manufactured in India Salient Features: with an additional preference for medical devices manufactured under MSME sector. i An autonomous body “National Medical Device Authority” b R&D by agencies like ICMR, DBT, CSIR, DIETY & DoP should (NMDA) to be created under the Department of be supported/ coordinated through the single window Pharmaceuticals; which may be headed by an officer of the facilitating body. rank of Additional Secretary/ Joint Secretary to the Government of India. c Low cost funding like interest subsidy to MSME The Authority shall have a Member Secretary of the rank of d Concessional power tariff for up to 5-10 years Joint Secretary/ Director; two eminent medical practitioners; e Provide seed capital, viability gap funding and co-fund start- two eminent medical device technologists or scientists; and Secretary General of Quality Council of India (exofficio). The up projects Authority shall. f Support commercialization of innovations g Provide longer term view (10 years window) for 200 % weighted a Provide a single window mechanism to the industry with an objective of promotion of the medical device industry to make tax deduction on approved expenditure on R&D as the the country not only self-reliant but also a global hub of gestation period in high in this industry. production and innovation in medical devices. h Tax/ duty structure to be designed to promote local manufacturing of quality medical devices and diagnostic b Be responsible for setting up and managing, through equipment appropriate corporate body/ SPV, Medical Devices Mega i Minimum/ zero duty on the import of raw materials and Parks of approximately 500 hectares and above, of various manufacturing equipments for production of medical devices. specialisations in the vicinity of Centres of Excellence. j Restrictions on import of second hand diagnostic equipment/ tools c Create benchmarks as per international best practices and k Higher taxes after 5-7 years of usage for imported second update all the stakeholders on global development. hand devices l Incentivize and promote exports in the medical devices sector. d Develop knowledge networks with partners from industry. e Identify and prevent creation of unnecessary and unjustified Institutional Framework: technical barriers to trade especially by new or changing • Medical device testing centers to be set up preferably in the technical regulations. PPP mode - Common medical device testing facilities can be f Support and prepare indigenous businesses to face 26 May - June 2015
Manufacturing Policy notifying a separate Medical Devices Prices Control Order (MDPCO). set up by government in major medical device manufacturing • A separate division may be created in National hubs to facilitate testing/ evaluation of medical devices. Pharmaceuticals Pricing Authority for pricing of the devices by Recurring expense can be borne by the industry. suitably amending the resolution constituting NPPA. • Designate “Centres of Excellence” (CoE) for supporting Implementation: product development and validation- The centers having existing requisite facilities and expertise for different In the first phase, the Department of Pharmaceuticals will within categories of medical devices (Example: Department of six months, bring a detailed proposal for creation of the National Electronics and Information Technology (DEITY), Bureau of Medical Devices Authority with vision, mission, objectives, Indian Standards (BIS), Indian Institute of Technology, Madras constitution, Head Quarters and likely budgetary allocation for (IIT-M), Indian Institute of Technology, Delhi (IIT-D), Indian appraisal and approval of the competent authority. Institute of Science, Bangalore (IISc-B), Central Institute of Plastics Engineering (CIPET), Defence Research and The Department of Pharmaceuticals will come up with separate Development Organization(DRDO). These Centres of proposals for amending the Essential Commodities Act, amending Excellence would support: the scope of functions of NPPA, and the National Medical Devices Pricing Policy. • Product development - design and prototyping • Validation and certification of the medical use of devices Department of Pharmaceuticals has invited comments / • Adopt, implement and advocate policies on efficacy and suggestions on the draft National Medical Device Policy - 2015 which is uploaded on their website, safety testing www.pharmaceuticals.gov.in. • Strengthen a Made in India marking (BIS) specific to Medical www. medicalplasticsindia.com devices in line With International standards like CE and FDA THE ONLY INDIAN PORTAL SITE ON MEDICAL PLASTIC / • Set up a Skill Development Committee under National DEVICES TECHNOLOGY AND TRADE Medical Devices Authority with representatives from Medical devices industry, academia (NIPERs) and Healthcare Sector SHAILESH SURGICAL Skill Council (HSSC) under National Skill Development Council (NSDC), which would: Leading Manufacturers and Exporters of Surgical Disposable Products a Identify skill gaps and reduce shortages b Design curriculum and explore possibilities for on-line/ e- PRODUCTS MANUFACTURED learning modules to meet specific requirement of medical ISO 9001 • I.V. INFUSION SETS device segment • SCALP VEIN SETS c The committee would engage with HSSC affiliated Vocational REGISTERED • BLOOD ADMINISTRATION SETS Training Providers as well as potential ITIs, Polytechnic and • BLOOD DONER SET other institutes for skill development 0434 • URINE COLLECTION BAG d Set up satellite training campus around manufacturing hubs • RYLES/FEEDING TUBES for skill upgrading • DISPOS ABLE SYRINGES & NEEDLES e Liaise across the Medical devices industry for job • DISPOSABLE GLOVES placements. • SURGICAL DRESSINGS f Provide counseling to candidates seeking skill development • ADHESIVE TAPES and address issues like student loan, scholarships, job • PLASTER OF PARIS placements etc. • FORMULATIONS • Since the medical devices sector is highly innovation and technology intensive, it is recommended to create a system Office: where Industry may place/ make available their IP in non- L-8, “Manhattan” core activities available to the exchange which may help Near Lion’s Hall, Mithakhali, Ellisbridge, technological up-gradation of the sector. Ahmedabad-380 006, India Phone: (91-079) 26420281, 26440236 • Set up/ promote Incubation centers through appropriate incentive structure/ cost sharing. Such centers would 27 address gaps in capabilities within R&D infrastructure, testing calibration etc. Affordability: • Separate price control for medical devices- The medical devices may be included as separate entry in the list of commodities controlled under the Essential Commodities Act. • The Government may announce a separate policy enunciating the principles for regulating the prices of identified medical devices and implement the same by May - June 2015
Product Gallery New Kynar® Connectors from Qosina Edgewood, components are Autoclave, E-Beam, EtO, Gamma and Steam sterilization compatible. Qosina offers an array of barbed NY –June 17, luers in various sizes and materials including ABS, nylon, polycarbonate, polypropylene and PVC. In addition, Qosina 2015- Qosina carries a variety of Tygon®, C-Flex®, and silicone tubing. is pleased to Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and pharmaceutical announce the industries including connectors, luers, caps, clamps, adapters, clips, valves, needle hubs, stopcocks, hemostasis addition of an valves, tuohy borst adapters, swabs and spikes. Qosina operates an ISO 9001 and ISO 14001 registered facility. extensive line Qosina offers low minimums and short lead times. Call our of Kynar® Customer Specialists to request a sample, obtain our latest catalog or place an order via phone +1(631) 242-3000, fax Connectors +1(631) 242-3230 or e mail [email protected]. Visit us at www.qosina.com to see our latest products. Custom sourcing ( # 11 3 9 0 - services are available through our extensive network. 11404), in Contact: QOSINA Ryan Edwards stock and 150-Q Executive Drive, Edgewood, NY 11717 ready for Phone: +1 (631) 242-3000 Fax: +1 (631) 242-3230 immediate Email: [email protected] d e l i v e r y. Configurations include female luer lock to barb, non- vented female luer lock cap, female luer lock to female luer lock, male luer lock to barb, and non-vented male luer lock cap. Barbs are offered in a variety of sizes including, 1/16, 3/32, 1/8, 5/32, 3/16, and 1/4 inch. Kynar® (PVDF) is a tough engineering thermoplastic with a balance of physical and chemical properties, and is used in applications requiring the highest purity, strength, and resistance to solvents. These natural colored ® Alpha Medicare and Devices Ltd. (taking care…Since1984) Manufacturers & Exporters of Disposable Medical Devices GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. • Exporting our products to almost more than 23 countries. ISO 13485 : 2003 Contact : 0434 Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : [email protected] 28 May - June 2015
VIRTUE CERTIFICATION SYSTEMS PVT. LTD We are a leading Consulting organization providing an integrated services with We are entrusted with the responsibility to manage in India on focus on project technology : behalf of the world renowned accredited certification Body G2S Italy, ASCE (E) from IASPL & ACS Registrars – UKAS Quality Management System as per Accredited. ISO 9001, ISO 13485, Medical Devices We are involved on the certification activities in the following CE marking as per MDD/93/42, FDA areas : 510k, Audit, Documentation, training • ISO 9001:2008 - QMS and c-GMP. • ISO 14001:2004 – EMS • OHSAS 18001:2007 – OHSAS Sanjay Y .Shah – Owner Promoter • ISO 22000:2005 – FSMS • ISO/IEC 27001:2005 – ISMS M : +91 98240 17850 • ISO 13485 : 2003 – QMS for Medical Devices • ISO 30000 – Ship Building & Repairing Obelis European • CE Marking • GMP Authorized Representative Center (O.E.A.R.C) based in We have collaboration with European Notified Body for CE Mark- Brussels, Belgium since 1988 is one of the largest ing & SA 8000 certifications. Regulatory Centers in Europe, assisting non-European We have assisted over 6500 clients all over the country, as an manufacturers’ successful endeavors into Europe. expansion plan we also require well qualified personnel’s in vari- ous districts to conduct the audits and provide after sale services, F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. for Business Associates kindly apply for your location with com- Tel. : +91 79 66090225 E-mail : [email protected], [email protected] plete details. Business Plan preferred. Website : www.unikalindia.com For further details OR clarification pleases contact : CE & ISO 9001 – 2008 Certified Company Virtue Certification Systems Pvt. Ltd. AMIGO SURGI CARE PVT. LTD. “Virtue House” 28, Defence Co-Op Society, Nr. Navrachana School, Manufacturer of Sama Road, Vadodara – 390008. Gujarat. Disposable Medical Devices & Ph. : 91-265 – 2794158 / 98250 43523 Email: [email protected] OR [email protected] Surgical Products: Products I.V.CANNULAS / B.T.SETS / I.V.SETS / • Flexible Packaging Material SURGICAL LATEX GLOVES / CORD • Paper Pouch CLAMPS / URINE BAGS / MEASURE • Aluminium Foil • Foil Seal VOLUME SETS ETC. • Ribbon Pack Pouch Manufacturers / Exporters / Hospital Suppliers Contact : Dealer are requested to Jignesh Patel : +91 94265 25388 Contact : +91 90163 36699 Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) Kavya Packaging (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : • [email protected] E-mail : [email protected] • [email protected] May - June 2015 Website : www.ivcannulaindia.com www.amigo-india.com Plant Address Plot No. 780, Near Canera Bank, Rakanpur (Santej) - 382721. Gujarat, India. 29
Manufacturer And Exporter Of a ISO 9001-2000 Quality Medical Devices wide range Of Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, REGISTERED FIRM 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 Wide Range Of Products : Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical The company Cord Clamp etc... manufactures a wide range of Medical devices, which The company markets products its own brand name ANGELTOUCH. fall under the Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. main domains of : Expertise & Experience : Infusion Therapy, – OEM/Contract Manufacturing. Transfusion Therapy, – Supply of Components for Medical Devices. Dialysis, Gastroenterology, Urology, Anesthesia, ANGIPLAST and Surgery. Private Limited Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: [email protected]/[email protected] Website : www.angiplast.com 30 May - June 2015
Global Trends Medical Disposables Market Worth $245 Billion By 2018 World medical disposables demand to increase 6.6% annually blood borne infections during surgery. New polymer and through 2018 and reach nearly $245 Billion. The upgrading and bioengineered tissue sealants are decreasing the length of many enforcement of infection prevention standards, coupled with an surgical procedures and are promoting the faster recovery of expanding volume of hospital, surgical and outpatient procedures, postoperative patients. Drug delivery is another fast growing will promote overall gains. application for disposable medical supplies. New and improved Global medical disposables market will be dominated by the United safety engineered prefillable and hypodermic syringes and IV States, China, Japan, Russia, Germany, France, Brazil, India, Italy catheters have substantially lowered the risk of accidental staff and the United Kingdom, who will comprise the 10 largest national and patient needlesticks before and after medication injections. markets, combining to absorb over two-thirds of the total value of Innovations in prefilled inhalers and transdermal patches are global demand in 2018. During the forecast period, average annual expanding the range of chronic conditions adaptable to cost growth in these markets will range from 3.6 percent in Japan to 15 effective self-treatment. In addition to drug delivery, innovations percent in China. Among the major disposable medical supply in disposable medical supplies are enabling patients to perform product segments, dialysis disposables will post the fastest other health care functions themselves, including urinary drainage, increases in global demand based on an expanding prevalence and chronic wound management. of end-stage renal disorders and the high frequency of therapeutic Demand for disposable medical supplies in the United States, requirements. Segments projected to command average or better Western Europe, Japan, and most other developed countries will worldwide revenue growth include incontinence goods, infusion expand at a below average pace as their medical delivery systems and hypodermic devices, nonwoven products, respiratory supplies are well established, meet the health care needs of most residents and devices, sterilization supplies, and various other offerings such and have already adopted stringent infection prevention standards. as urinary catheters and accessories, first aid kits, ostomy By contrast, growth in Brazil, Russia, India, China and many other appliances, transdermal patches and waste disposal supplies. emerging economies will exceed the world average as health care Advances in disposable medical supplies are contributing sectors are expanded, modernized, and adapted to formal infection significant improvements to the safety and outcome of patient prevention protocols. procedures. Products such as Level 4 microbial resistant surgical (Ref: http://www.reportsnreports.com/market-research/medical-devices/ ) gowns and drapes have reduced the risk of spreading air and May - June 2015 Shree Dye Stuff Manufacturer of PVC Compound, (Surgical Grade, Molding & Tubing) According to the customer requirment • Flexible PVC tubing grade compound • Flexible PVC moulding grade compound • Flexible PVC tube for I.V. Set, S.V. Set, X-ray opeque tube and Oxygen tube. • Flexible PVC compound for Urine bag roll Contact Pragnesh Shah C-3 TPS 88, bharat Small Scale Industrial Area, B/h Gujarat Offset, Narol - Vatva Road, Ahmedabad - 382 445 Mobile : +91 98246 49740, +91 93761 82700, +91 90168 13881 E-mail : [email protected], [email protected] Our First Priourity is Customer Satisfaction 31
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Industry News India Developing Federal Medical Device Surveillance System The Indian government is developing a reporting forms and studying how to do to The article alludes to the global metal-on- system of medical device surveillance and causality assessments. metal hip debacle, which left a stream of adverse event reporting, dubbed the injured patients in its wake, and Materio-vigilance Programme of India. The government has devoted about $15 demonstrates the dangers of other million to setting up surveillance programs countries’ reliance on the FDA and It will be run out of 10 Indian medical for pharmacovigilance, biovigilance, and European regulators. schools, led by the Sree Chitra Thirunal haemovigilance, as well as medical device Institute of Medical Sciences and monitoring, or materiovigilance. The plan to create an adverse event Technology in the South Indian city of reporting and post-market monitoring Thiruvananthapuram, according to Indian Among emerging markets, India is one of system comes in the context of a federal news outlet Pharmabiz.com. The Indian the most accepting of new devices because proposal to create a separate medical Pharmacopoeia Commission, located near it has many modern, privately run hospitals, device regulatory regime. In India, they are New Delhi, will play a coordinating role, as and lacks a strict process for device currently regulated as drugs, in spite of the well as the Central Drug Standard Control regulation or approval. myriad differences between the two sets of Organization, the country’s equivalent to the products. FDA. But this move shows the Indian government is looking to increase its oversight of a med Mr. Varun Saxena In addition, a proposed World Health tech market worth $3.1 billion annually. The FierceMedicalDevices Organization center for crucial medical information gained from the monitoring devices and health technology policy would system will help regulators’ make decisions 25 May 2015 provide technical support, according to the and recommendations based on domestic - See more at: http://novamedica.com/ article. use of devices. China is also implementing systems to gather domestic data in the form media/theme_news/p/ Currently, a committee formed to implement of more invasive local clinical trials, which 2579#sthash.Ca9eXJPN.dpuf the program is designing adverse event would be required as a condition for device (Ref: http://novamedica.com/media/ approval. theme_news/p/2579 Medical Devices Industry In India Underinvested: WHO NEW DELHI: The ambitious ‘Make in India’ Health Technology Policy. Its works includes framing of technical campaign of Prime Minister Narendra Modi specifications for technologies procured throws up opportunities for growth of This was announced by the WHO Country under National Health Mission, best domestic medical devices industry, which office for India in collaboration with the practices for technology life-cycle is not only “underinvested” but heavily Health Ministry and NHSRC yesterday. This management and maintenance, secretariat import-oriented at present, the World Health is the first WHO collaborating centre in for assessment and uptake of innovations Organisation (WHO) has said. South East Asia Region, the Health Ministry into public health systems among others, statement said. the statement said. “There is a need for appropriate and applicable health care technology in India. Menabde also handed over the designation PTI Mar 21, 2015, 08.40PM IST Our medical devices industry is of WHO collaborating centre (Ref: http://articles.economictimes underinvested and heavily import-driven at commencement at NHSRC to Health .indiatimes.com/2015-03-21/news/ present. secretary B P Sharma. 60346504_1_health-ministry-national- “But with the current ‘Make in India’ Noting that prioritising medical devices and health-mission-nata-menabde) campaign, there is a huge opportunity for health technology in the country is an growth and expansion of the medical device “important agenda” item, Sharma said that industry. This would highly improve the it is critical to have the specifications in place access of essential medical devices and for the medical devices and equipments that health care technology to patients in India,” are already procured and WHO Representative to India, Nata used in the system. Menabde, was quoted as saying in a Health Ministry statement. “There is also need for dedicated medical devices testing laboratories to ensure the She said this during an event to formally safety and efficacy of these devices,” he announce the commencement of National said. Health Systems Resource Centre (NHSRC), as the WHO collaborating centre The division of healthcare technology and for Priority Medical Devices and innovation at NHSRC has been working in the area of health technologies and related policy interface. 34 May - June 2015
Industry News Imported Medical Devices Inflate Patient’s Bill It has been noted that using imported high- towards developing a more self-reliant diseases and thus bring down the patients’ end medical devices in complex disease country in manufacturing high-end medical bills considerably. management highly inflates a patient’s bill. devices.” “To be self-reliant, the government can help Around 75 per cent of the bill is incurred by us by creating industry-friendly the usage of imported devices. In Stating that the Indian medical device infrastructure and giving us subsidies,’’ comparison, India-developed low-end industry is developing very fast, he noted noted Mr. Gurmit Singh Chug, managing devices currently constitutes only 5 per cent that the cost benefit that Indian director, Translumina Theraputics. of a patient’s bill. manufactures are offering is immense. “India has always been considered to The expenditure and our dependence on “Indian doctors have been using it for the manufacture low-end and low-cost products imported medical devices can be curbed if past 15 years and they opine that the with no clinical evidence to prove their the government allows Indian manufactures products’ standards have evolved to match efficacy. This now holds untrue. A drug- to start producing high-end medical devices, international quality. There was a ray of hope eluting stent manufactured in India called noted senior cardiologists from across the in India for affordable stents when former YUKON PC was reported to be equally safe country. They have gathered at the three- President of India Dr. A.P.J. Abdul Kalam and efficacious by three acclaimed day National Interventional Council came out with a stent called Kalam-Raju international journals, namely the Journal organised by the Cardiological Society of Stent that could be manufactured for Rs. of American College of Cardiology, India, which will conclude today. 5,000 to Rs. 7,000. This stent was never European Heart Journal and patronised and plans to further do research Dr. Praveen Chandra, chairman, and improve the stent were shelved. In India, EuroIntervention ,’’ he added. interventional cardiology, Medanta Heart U.S. multinationals dominate with more than Updated: April 5, 2015 07:49 IST Institute, also the organising secretary of the 70 per cent market share with a price range (Ref: http://www.thehindu.com/news/ conference said: “For the first time in a of Rs. 45,000 to Rs. 1.20 lakh per stent,’’ he cities/Delhi/imported-medical-devices- medical conference in India, we have said. inflate-patients-bill/article7069663.ece) facilitated doctors and industry from India to interact on a common platform and have Manufactures, too, add that India has discussion to work closely and purposefully the potential of making high-end medical devices for the management of complex Gujarat Has Maximum Units Under Operation In Medical & Dental Instruments: Study The State, However, Ranked 4th With 8.2% Share In Total Output and dental instruments and supplies in “Growth of medical goods’ exports to the country by Assocham. India is expected to continue as a result Gujarat accounted for highest share of Of the total number of 65 factories in of our burgeoning middle class, growing over 18 per cent in terms of total number medical and dental instruments and medical tourism industry, swelling private of 316 factories operating in the medical supplies segment in Gujarat, 58 such sector healthcare investment, aging and dental instruments and supplies factories were under operation as of population and heightened government sector across India, according to the 2011-12. commitment to provide health services sector specific analysis undertaken by the to the rural population,” noted a study Associated Chambers of Commerce and However, with an output worth just about titled ‘Indian Medical Devices Industry: Industry of India (Assocham). Rs 439 crore, Gujarat is ranked fourth The way ahead,’conducted by with a meagre 8.2 per cent share in the Assocham. “Gujarat also had the highest share of total output worth about Rs 5,300 crore over 19 per cent in total number of 338 of medical and dental instruments and “As currently much of the medical devices factories in the sector of medical and supplies sector generated across India. in India are imported therefore, going dental instruments and supplies,” The state, however, had third highest forward it is imperative for India to focus according to analysis of the state-wise share of 10.1 per cent in terms of direct on development of domestic distribution of manufacturers of medical employment generated by medical and manufacturing capabilities for ensuring dental instrument factories operating the nation’s health security,” said DS throughout the country. Rawat, secretary general of Assocham while releasing the findings of the Clocking a compounded annual growth chamber’s study. rate (CAGR) of over 15 per cent, imports of medical devices and equipments in He further added that “Absence of a clear India is likely to cross $4 billion mark by and consistent regulatory framework, lack 2018-19 from a level of about $2.3 billion of adequate incentives and funding for as of 2013-14, as per Assocham. manufacturing devices, absence of May - June 2015 35
Industry News medical devices’ specific legislation, output generated across 25 operating BS Reporter | Ahmedabad May 14, 2015 Last Updated at 20:58 dearth of trained workforce for factories in medical and dental IST maintenance of medical devices, instruments and supplies segment in the (Ref: http://www.business-standard insufficient financing and lack of co- state.While Haryana had highest share of .com /article/companies/Gujarat -has- ordination between diverse stakeholders over 25 per cent in terms of direct maximum-units-under-operation-in- medical-dental-instruments-study- are certain key constraints faced in employment generated by medical and 15051400642_1.html) establishing this industry in India.There is dental instruments’ manufacturers across a need for infrastructure creation for India followed by UP (11.6 per cent). setting up green-field medical devices and In its study, Assocham has suggested that equipment parks” Government needs to expedite the Over 18,100 people were employed in process of relaxing FDI policy for cash- 316 factories under operation in medical starved medical devices sector attract and dental instruments and supplies more investments and boost domestic sector in India producing a total output manufacturing. “FDI inflow is expected to worth over Rs 5,300 crore as of ASI spur research and development (R&D) survey of 2011-12, highlighted the and manufacturing innovations, in turn Assocham study. increasing the efficiency and Maharashtra had second highest share effectiveness of medical devices,” it said. in of over 12 per cent in the total number It has further recommended to encourage of factories in the aforesaid sector while innovative financing mechanisms and Uttar Pradesh (UP) had the second funding sources and to establish a large highest share of 10.4 per cent in total scale medical devices capital fund to number of factories under operation invest in needed, viable, medical devices followed by Maharashtra (10.1 per cent). development and commercialisation, Karnataka alone had over one-fourth besides the fund would also support a share with over Rs 1,360 crore worth of national medical devices network. SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • Regulators / Cord Clamp • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • PP Mucas Container • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 SANIDHYA ENTERPRISE Office : 28/29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (F) 22731656 (M) 9825474789 E-mail : [email protected] 36 May - June 2015
PACK-EQUIP National Healthcare (Mfg. Packaging Machinery) An ISO 9001 : 2008 Company 91, Avnish Society, Opp. Pavitrakunj Society Manufacturing & Exports of CTM Cross Road, Amraiwadi Medical Disposables : Ahmedabad-380 026 I.V. Set, B.T. Set, Urine Bag, Phone : 25855027 (M) 9825380739 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 : [email protected] Website: nationalhealthcare.in ISO : 13485 : 2012 JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 & CERTIFIED COMPANY Manufacturers & Exporters of Disposable Medical Devices Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, Dressings etc. Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850 E-mail: [email protected] • Web: www.jimitsurgicals.com May - June 2015 37
Events AN ISO 13485-2012 CE certified Company Events Calender Manufacturer & Exporter of Medical • Medical Fair India 2015 Disposable Devices & Surgical 22st International Exhibition and Conference Products Date: 11-13 March, 2016 Venue: Bombay Convention & Exhibition Center, Range of Products : Mumai. • Infusion Set • Blood Administration Set • Medicall 2015 • Measure Volume Set 13th Edition Medicall 2015 • Urine Collecting Bag Date : 31st July, 1st & 2nd August 2015 • Urine Collecting Bag - Uro Meatry Venue : Chennai Trade Centre • Respiratory Exerciser • Twin Bore Nasal Oxygen Set 14th Edition Medicall 2015. • Oxygen Face Mask Date : 9th - 11th October, 2015. • Nebulizer Kit Venue : Bombay Convention and Exhibition Center • Vaccum Suck Suction Set • Latex Surgical Gloves • Plastivision Arabia 2016 • Umblical Cord Clamp Region’s Leading Plastics Event Date: 10-13 January, 2016 Contact Yogesh Patel Venue: Expo Center, Sharjah. M. : +91 98241 21383 • 13th National Conference And Technology Exhibition on MEDICARE DEVICES Indian Medical Devices & Plastics Disposables / Implants Industry 2016. 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, Date: 12-13 February, 2016 C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Venue: Ahmedabad Management Association, Ahmedabad-380 026. Gujarat (India) Phone 079-2585 5711 Ahmedaad. E-mail : [email protected] Website : www.medicaredevices.com Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : Corresponding Address: HINDUSTAN SURGICAL HINDUSTAN SURGICAL Hasmukhbhai B. Patel Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, 23, Manav Mandir Bungalows, Village - Pithai - 387630. Taxshilla Colony, Ta.: Kathlal, Dist. Kheda, Gujarat. Old Aradhana School Circle, Email : [email protected] B/h Ramannagar, Sukhipura, Website : www.hindustansurgical.com Maninagar, Ahmedabad - 380008 Tele/Fax : (O) ++91-25440223 Email : [email protected] Cell :9824060964 38 May - June 2015
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: 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 : [email protected] • [email protected] Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double Swivel Mount) • Endotracheal Tube Holder With Bit • Ventilator Circuit • Ventilator Circuit with Single Water Block Oxygen Therapy Products Trap(Adult, Pediatric, Neonatal) • Inflatable Anaesthesia Mask • Nasal Cannula • Ventilator Circuit with Double Wa- • Anaesthesia Mask Silicon ter Trap(Adult, Pediatric, Neonatal) • Breathing Filters(HME & BVF) • Trachostomy Tube With Cuff • Oxygen Mask Breathing Filters • Resuscitator(Ambu Bag) Airovent T-Humidifier • Anaesthesia Circuits (Mapleson D, • Endotracheal Tube Holders • Multi flow Venturi Mask Mapleson F, Bain Circuit with APL Valve) • Yankaures Suctions Systems • Single Dial Venturi Mask • Stylet • Guedel Airway • Airovent T-Humidifier • High Concentration Mask • Nasopharyngeal Airway • Dialflow Regulator • Nebulizer Set • Laryngeal Mask Airway • Airopap Full Face Mask • Nebulizer Chamber • Mallaeble gum Bougie • Close Ventilation Suction System • Incentive Spirometer • 3 Ball Spirometer • Three-way Stopcock • Extension Tubing for Infusion Systems • Pressure Monitoring Line Contact : Anil Gupta +91-90999 15731 Anaesthesia Circuits Incentive Spirometer Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, High Concentration ET Holder with Bite Expandable Catheter Goregoaon (E), Mumbai - 400 063, INDIA. Mask Block Mount Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : [email protected] [email protected] • Web : www.airwayssurgical.com May - June 2015 41
GMP MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS ISO - 9001-2008 Certified Company • I.V. Infusion Sets • Blood Administration Sets S. Nath & Co. • Scalp Vein Set • Urine Collection Bags Excellence in Quality • Ryles / Feeding Tubes • Catheters and Tubes Manufacturer & Exporter of • Surgical Gloves. Surgical Disposable Products since 1980 Contact : IDEAL® Mr. Bhavin Shah • Infusion Set MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS • Blood Administration Set • Urine Collection Bag 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi • Urine Specimen Container Mill, Narol - Isanpur Highway, Narol, • Umblical Cord Clamp Ahmedbad-382405. (India) Phone : (O) 079- Address 25733318 (R) 079-25430211 (M) +91-9825018952 S. Nath & Co. Email : [email protected], [email protected] B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Website : www.mescosurgical.com Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] Venus manufacturers PVC COMPOUNDS according to the customer requirements of BASIL manufacturers PVC COMPOUNDS ac- strength, flexibility, x-ray traceability, transpar- cording to the customer requirements of strength, flexibility, x-ray traceability, transpar- ency, colour and extraction resistance. ency, colour and extraction resistance. VENUS MEDICAL DISPOSABLE are pa- tronized by Health Care Industries For BASIL POLYMERS are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible Extrusion Grade PVC Compounds • Flexible PVC Tube For I.V.Set, S.V.Set, X-Ray • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set.X-Ray Opaque Tubes • L. D. Tube For Carman Cannula Opaque Tubes • P. P. Stick For Urinbag. • Flexible PVC Layflate Film For Medical PVC Bags • Henging Tube For Urinebag • RF Welded Medical Bags for I.V. Fluid, Enema etc. • DEHP free Medical Grade PVC Compound Venus • Injection Moulded Parts like PVC Chambers, Roller MEDICAL DISPOSABLE Clamp, Adapter etc. for I.V.Set and other Medical Disposable Products. 15/a, Bhagirath Estate, Vibhag - 3, Jawaharnagar, B/h. Indiranagar, Amraiwadi, Ahmedabad–380026. BASIL POLYMERS Phone (F) : 079-22749329 3-B, Verdan Exclusive, Near Stadium Petrol Pump, (R) : 079-26621269 P. O. Navjivan, Navrangpura, Ahmedabad – 380014. Mobile : 098240 32063 Phone : 079-26565981 - 82 - 83 E-mail : [email protected] Mobile : 9909036411 / 9824045178 May - June 2015 E-mail : [email protected] www.basilpolymers.com 42
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