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2016 Top Markets Report Medical Devices A Market Assessment Tool For Us Exporters
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Author :U. S. of Commerce Publisher :Createspace Independent Publishing Platform ISBN 13 :9781542347471 Total Pages :56 pages Book Rating :4.3/5 (474 download)
Book Synopsis 2016 Top Markets Report Medical Devices a Market Assessment Tool for U.s. Exporters by : U. S. of Commerce
Download or read book 2016 Top Markets Report Medical Devices a Market Assessment Tool for U.s. Exporters written by U. S. of Commerce and published by Createspace Independent Publishing Platform. This book was released on 2017-08-08 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: Industry & Analysis' (I&A) staff of industry, trade and economic analysts devise and implement international trade, investment, and export promotion strategies that strengthen the global competitiveness of U.S. industries. These initiatives unlock export, and investment opportunities for U.S. businesses by combining in-depth quantitative and qualitative analysis with ITA's industry relationships
Book Synopsis Economics of the Pharmaceutical and Medical Device Industry by : Ramesh Bhardwaj
Download or read book Economics of the Pharmaceutical and Medical Device Industry written by Ramesh Bhardwaj and published by Taylor & Francis. This book was released on 2024-08-01 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive examination of the pharmaceutical and medical device industry, including analysis of its current trade and innovation strategies. Opening with a survey of the global pharmaceutical and medical device industry, Bhardwaj outlines the growing trade and trade interdependence among countries in the global supply chain. He adopts a trade competitiveness approach to analyze patterns of product specialization and examines the drug discovery process and its challenges in translating bioscientific knowledge into lifesaving products. Bhardwaj argues that further economic integration, collaborative R&D, and digital technologies may help accelerate productivity and address global challenges of escalating drug costs, neglected tropical diseases (NTDs), and pandemic risks. The book also considers how the industry may further green its supply chain, and thus contribute to SDG Goals 3 (Good Health and Wellbeing) and 12 (Responsible Consumption and Production), before closing on a review of China and India, major players who have the potential to become drivers of low-cost medical products and innovations. With its evidence-based analysis, this book will be of great interest to researchers in pharmaceutical studies, supply chain management, global health, and health economics, as well as policymakers and professionals interested in the global issues facing the industry.
Book Synopsis Medical Devices Market Opportunities for U. S. Small and Medium-Sized Enterprises by : U S Department of
Download or read book Medical Devices Market Opportunities for U. S. Small and Medium-Sized Enterprises written by U S Department of and published by CreateSpace. This book was released on 2014-12-03 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book - the first in a planned series of ExportMED books on developing markets - describes and analyzes trends, key issues, and events in Brazil's medical devices sector, to assist U.S. small- and medium-sized enterprises (SMEs) in making educated business decisions about entering that market. The book examines the medical devices industries, including its domestic medical devices and diagnostics market and the best market opportunities and sales prospects for U.S. SMEs. The book also considers economic, cultural, and political factors influencing Brazil's medical devices market. Finally, the book provides information on market entry requirements and strategies for SMEs, and U.S. Department of Commerce and other resources to help U.S. firms in their market entry endeavors. Appendices list useful contacts in the United States and Brazil, as well as recent statistics for medical devices exports to Brazil and further information about Brazilian medical devices associations.This book is based on market research and analysis undertaken in Brazil in 2002-03, including several trips by the OMMI Director Jeffrey Gren, Medical Devices Team Leader Richard Paddock and International Trade Specialists Jay Biggs and Kimberly Shaw. Mr. Gren and Mr. Paddock interviewed government officials, industry trade associations, industry analysts, and government officials in Brasília and São Paulo, Brazil. U.S. Commercial Service (USCS) market specialists in Brazil attended these interviews and actively supported this work. Supplemental information gathered from on-site interviews and a review of available literature are also included in this book. Ms. Shaw attended the ABPVS International Regulatory Conference in Recife, Brazil, from September 3 - 5, 2003. In the body of the book, Brazilian terms are presented in English translation, accompanied occasionally by the original Portuguese words in parenthesis. A glossary of terms and abbreviations is provided for quick reference.
Book Synopsis OECD Development Pathways Production Transformation Policy Review of Egypt Embracing Change, Achieving Prosperity by : OECD
Download or read book OECD Development Pathways Production Transformation Policy Review of Egypt Embracing Change, Achieving Prosperity written by OECD and published by OECD Publishing. This book was released on 2021-07-08 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: Egypt is one of Africa’s industrial heavyweights. Transforming the country's economy to sustain job-rich and sustainable growth are pivotal steps in its march towards prosperity. Today’s search for new development models, accelerated by the unfolding of the COVID-19 pandemic, calls for shifting up a gear in raising Egypt’s industrial capabilities to compete in an industry 4.0 and agro 4.0 landscape. The Production Transformation Policy Review (PTPR) of Egypt uses a forward-looking framework to assess the country's readiness to embrace change. This includes an analysis of the game-changing potential of the African Continental Free Trade Area (AfCFTA) and perspectives on agro-food and electronics (i.e. what in Egypt is referred to as part of the engineering sector), as well as identifying priorities for future reforms. This review is the result of government-business dialogue, and benefited from peer learning from Italy and Malaysia. It also resulted from international and multi-stakeholder knowledge sharing through a dedicated Peer Learning Group (PLG) and the OECD Initiative for Policy Dialogue on Global Value Chains, Production Transformation and Development.
Book Synopsis Ensuring Quality to Gain Access to Global Markets by : Martin Kellermann
Download or read book Ensuring Quality to Gain Access to Global Markets written by Martin Kellermann and published by World Bank Publications. This book was released on 2019-04-09 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a modern world with rapidly growing international trade, countries compete less based on the availability of natural resources, geographical advantages, and lower labor costs and more on factors related to firms' ability to enter and compete in new markets. One such factor is the ability to demonstrate the quality and safety of goods and services expected by consumers and confirm compliance with international standards. To assure such compliance, a sound quality infrastructure (QI) ecosystem is essential. Jointly developed by the World Bank Group and the National Metrology Institute of Germany, this guide is designed to help development partners and governments analyze a country's quality infrastructure ecosystems and provide recommendations to design and implement reforms and enhance the capacity of their QI institutions.
Book Synopsis A Basic Guide to Exporting by : Jason Katzman
Download or read book A Basic Guide to Exporting written by Jason Katzman and published by Skyhorse Publishing Inc.. This book was released on 2011-03-23 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Here is practical advice for anyone who wants to build their business by selling overseas. The International Trade Administration covers key topics such as marketing, legal issues, customs, and more. With real-life examples and a full index, A Basic Guide to Exporting provides expert advice and practical solutions to meet all of your exporting needs.
Book Synopsis Medical Device Regulations by : Michael Cheng
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Book Synopsis National Trade Estimate ... Report on Foreign Trade Barriers by : United States. Office of the U.S. Trade Representative
Download or read book National Trade Estimate ... Report on Foreign Trade Barriers written by United States. Office of the U.S. Trade Representative and published by . This book was released on 1997 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis China's Changing Trade and the Implications for the CLMV by : Mr.Koshy Mathai
Download or read book China's Changing Trade and the Implications for the CLMV written by Mr.Koshy Mathai and published by International Monetary Fund. This book was released on 2016-09-01 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: China’s trade patterns are evolving. While it started in light manufacturing and the assembly of more sophisticated products as part of global supply chains, China is now moving up the value chain, “onshoring” the production of higher-value-added upstream products and moving into more sophisticated downstream products as well. At the same time, with its wages rising, it has started to exit some lower-end, more labor-intensive sectors. These changes are taking place in the broader context of China’s rebalancing—away from exports and toward domestic demand, and within the latter, away from investment and toward consumption—and as a consequence, demand for some commodity imports is slowing, while consumption imports are slowly rising. The evolution of Chinese trade, investment, and consumption patterns offers opportunities and challenges to low-wage, low-income countries, including China’s neighbors in the Mekong region. Cambodia, Lao P.D.R., Myanmar, and Vietnam (the CLMV) are all open economies that are highly integrated with China. Rebalancing in China may mean less of a role for commodity exports from the region, but at the same time, the CLMV’s low labor costs suggest that manufacturing assembly for export could take off as China becomes less competitive, and as China itself demands more consumption items. Labor costs, however, are only part of the story. The CLMV will need to strengthen their infrastructure, education, governance, and trade regimes, and also run sound macro policies in order to capitalize fully on the opportunities presented by China’s transformation. With such policy efforts, the CLMV could see their trade and integration with global supply chains grow dramatically in the coming years.
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Book Synopsis Importing Into the United States by : U. S. Customs and Border Protection
Download or read book Importing Into the United States written by U. S. Customs and Border Protection and published by . This book was released on 2015-10-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Book Synopsis World Development Report 2020 by : World Bank
Download or read book World Development Report 2020 written by World Bank and published by World Bank Publications. This book was released on 2019-11-19 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: Global value chains (GVCs) powered the surge of international trade after 1990 and now account for almost half of all trade. This shift enabled an unprecedented economic convergence: poor countries grew rapidly and began to catch up with richer countries. Since the 2008 global financial crisis, however, the growth of trade has been sluggish and the expansion of GVCs has stalled. Meanwhile, serious threats have emerged to the model of trade-led growth. New technologies could draw production closer to the consumer and reduce the demand for labor. And trade conflicts among large countries could lead to a retrenchment or a segmentation of GVCs. World Development Report 2020: Trading for Development in the Age of Global Value Chains examines whether there is still a path to development through GVCs and trade. It concludes that technological change is, at this stage, more a boon than a curse. GVCs can continue to boost growth, create better jobs, and reduce poverty provided that developing countries implement deeper reforms to promote GVC participation; industrial countries pursue open, predictable policies; and all countries revive multilateral cooperation.
Book Synopsis Textiles and Apparel by : United States Tariff Commission
Download or read book Textiles and Apparel written by United States Tariff Commission and published by . This book was released on 1968 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Exporting Through Intermediaries: Impact on Export Dynamics and Welfare by : Parisa Kamali
Download or read book Exporting Through Intermediaries: Impact on Export Dynamics and Welfare written by Parisa Kamali and published by International Monetary Fund. This book was released on 2019-12-27 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt: In many countries, a sizable share of international trade is carried out by intermediaries. While large firms tend to export to foreign markets directly, smaller firms typically export via intermediaries (indirect exporting). I document a set of facts that characterize the dynamic nature of indirect exporting using firm-level data from Vietnam and develop a dynamic trade model with both direct and indirect exporting modes and customer accumulation. The model is calibrated to match the dynamic moments of the data. The calibration yields fixed costs of indirect exporting that are less than a third of those of direct exporting, the variable costs of indirect exporting are twice higher, and demand for the indirectly exported products grows more slowly. Decomposing the gains from indirect and direct exporting, I find that 18 percent of the gains from trade in Vietnam are generated by indirect exporters. Finally, I demonstrate that a dynamic model that excludes the indirect exporting channel will overstate the welfare gains associated with trade liberalization by a factor of two.
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Book Synopsis Trade in Counterfeit and Pirated Goods by : Piotr Stryszowski
Download or read book Trade in Counterfeit and Pirated Goods written by Piotr Stryszowski and published by . This book was released on 2016 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study offers unique up-to-date analysis of the impact on global trade of counterfeit and pirated products, known as "fakes" by the general public. Using statistical analysis and drawing on a global dataset covering almost half million customs data on seizures, the study estimates the huge share of international trade commandeered by counterfeit and pirated goods. In 2013, international trade in such products represented up to 2.5% of world trade, or as much as USD 461 billion. This is the equivalent of the GDP of Austria, or the combined GDP of Ireland and the Czech Republic. Above all, it highlights that right holders, governments and the formal economy as a whole suffer from significant economic and social losses. It also gives an idea about the potential financial revenues collected by criminal networks that are behind such trade.^More specifically, counterfeit and pirated products amounted to up to 5 % of imports in 2013 in the European Union, or as much as EUR 85 billion (USD 116 billion). This suggests that the relative impact of counterfeiting is twice as high for a group of developed countries, such as the EU, than it is for the world as a whole. The scope of the phenomenon appears to be greater than a decade ago. Back in 2008, a previous OECD study estimated that counterfeit and pirated goods accounted for up to 1.9 % of world imports, or up to USD 200 billion, relying on the best data and more limited methods available at that time. In the context of today's revival of international trade in the global economy, there is no shortage of opportunities for counterfeiters and criminals. Counterfeit and pirated trade is a major threat to any modern, knowledge-based economy. Counterfeiting and piracy matter in an innovation driven global economy.^Intellectual property (IP) is a key value generator for firms, helping them succeed in competitive markets. At the macroeconomic level, IP protection and enforcement is one of the main drivers of innovation, which contributes to long term economic growth. Given the fundamental economic importance of IP, counterfeiting and piracy must be directly targeted as a threat to sustainable IP-based business models.
Book Synopsis FDA Regulation of Medical Devices by : Judith A. Johnson
Download or read book FDA Regulation of Medical Devices written by Judith A. Johnson and published by CreateSpace. This book was released on 2012-07-06 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt: On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30, 2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the House on May 30, 2012). The following CRS reports provide overview information on FDA's processes for approval and regulation of drugs: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul; CRS Report RL33986, FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul; CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson; CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson. (Note: The rest of this report has not been updated since December 28, 2011.) Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved medical devices and, at the same time, prevent devices that are not safe and effective from entering or remaining on the market. Medical devices regulation is complex, in part, because of the wide variety of items that are categorized as medical devices; examples range from a simple tongue depressor to a life-sustaining heart valve. The regulation of medical devices can affect their cost, quality, and availability in the health care system. In order to be legally marketed in the United States, many medical devices must be reviewed by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by overseeing medical products, including devices. FDA's Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device review. CDRH activities are funded through a combination of public money (i.e., direct FDA appropriations from Congress) and private money (i.e., user fees collected from device manufacturers) which together comprise FDA's total. User fees account for 33% of FDA's total FY2011 program level and 15% of CDRH's program level, which is $378 million in FY2011 including $56 million in user fees. FDA's authority to collect user fees, originally authorized in 2002 (P.L. 107-250), has been reauthorized in five-year increments. It will expire on October 1, 2012, under the terms of the Medical Device User Fee Act of 2007 (MDUFA), Title II of the FDA Amendments Act of 2007 (FDAAA, P.L. 110-85). FDA requires all medical product manufacturers to register their facilities, list their devices with FDA, and follow general controls requirements. FDA classifies devices according to the risk they pose to consumers. Premarket review is required for moderate- and high-risk devices. There are two paths that manufacturers can use to bring such devices to market. One path consists of conducting clinical studies, submitting a premarket approval (PMA) application and requires evidence providing reasonable assurance that the device is safe and effective. The other path involves submitting a 510(k) notification demonstrating that the device is substantially equivalent to a device already on the market (a predicate device) that does not require a PMA. The 510(k) process results in FDA clearance and tends to be much less expensive and less time- consuming than seeking FDA approval via PMA.
