Publication: Accessing the Medical Devices Market in Egypt and Saudi Arabia: A Systematic Review of Policies and Regulations
Loading...
Files in English
2,563 downloads
Published
2016-06-15
ISSN
1743-4440
Date
2016-07-05
Editor(s)
Abstract
Despite the significant medical devices market size in Egypt and Saudi Arabia, information regarding policies and regulations for medical devices market access is highly deficient. The aim of this paper is to provide a systematic review on market access policies and regulations in both countries, to allow safe and timely access to medical technology. The following databases were searched: PubMed, Science Direct, Scopus, and Al Manhal Arabic database. Additionally, the web portals of regulatory authorities of both countries were searched. There are 34 records included in the qualitative synthesis of this review. Main findings include; adopted regulatory framework from reference countries, and interim main regulatory documents, In conclusion, the market access schemes are relatively structured. However, some recommendations are put forward to navigate towards a more comprehensive policy framework in both countries.
Link to Data Set
Digital Object Identifier
Associated URLs
Associated content
Other publications in this report series
Journal
Journal Volume
Journal Issue
Collections
Related items
Showing items related by metadata.
Publication A Labor Market Assessment of Nurses and Physicians in Saudi Arabia(World Bank, Washington, DC, 2021-09-22)Strengthening the health workforce in Saudi Arabia is central to ongoing reform efforts in the country and to the changing business priorities in the health sector and beyond. Saudi Arabia’s Vision 2030 aims to increase the size and performance of the Saudi health workforce to meet changing population needs and to achieve ambitious social and economic targets and goals. This book presents rigorous, empirical, and quantitative evidence to support national-level strategic planning efforts on human resources for health in Saudi Arabia. The book, a collaborative effort between the Saudi Health Council and the World Bank, is a first to anticipate and quantify projected future labor market imbalances of nurses and physicians in Saudi Arabia and to identify solutions to close those gaps. Drawing on the latest principles and modeling techniques in epidemiology and economics, the book forecasts future imbalances between epidemiological need and labor market supply and demand. It culminates in a set of policy recommendations to improve the availability, distribution, and performance of Saudi nurses and physicians. The book is expected to be of interest to health workforce planners and health systems researchers working in Saudi Arabia and beyond.Publication Tracing Labor Market Outcomes of Technical and Vocational Training Graduates in Saudi Arabia(World Bank, Washington, DC, 2022-01)This paper exploits a rich dataset from various administrative sources to study short- and medium-term labor market outcomes of vocational education and training graduates in Saudi Arabia. It examines five cohorts of graduates from institutes operated by the Technical and Vocational Training Corporation who are formally employed in the private sector. The outcome measures for the study are based on monthly earnings data from the private sector social insurance records covering up to five years after graduation for the first cohort. The analysis finds positive returns to technical and vocational education are sustained over time. However, program orientation and economic conditions at the time of graduation appears to impact wages. Furthermore, vocational education and training in Saudi Arabia is associated with higher job mobility after graduation from the program. Students’ mobility premium is enhanced by completion of the program, suggesting improved skills signaling and utilization contributing to higher returns to vocational education and training. The analysis identifies several challenges and opportunities to further improve outcomes of graduates, such as reducing the gender gap in labor market outcomes of female graduates and reducing the high incidence of vertical mismatch among graduates’ field-of-study selection and the occupations group in which they are employed.Publication Moving Up the Value Chain : A Study of Malaysia's Solar and Medical Device Industries(Washington, DC, 2011-07)This report responds to a request by the Government of Malaysia to examine how Malaysia can move up the value chain in the solar and medical device industries. Through the lens of long-term development, the overall growth performance of the Malaysian economy has been a resounding success story. The Commission on growth and development listed Malaysia as one of only 13 countries that registered sustained growth of 7 percent or more for a period of 25 years or longer. Much of this growth occurred on the back of a buoyant manufacturing sector, which was spurred by Malaysia's export-led industrialization model reliant on foreign direct investment (FDI). Multinational firms favored the country for its geographical location, political stability, reliable infrastructure, elastic supply of low-cost labor and attractive incentives. As a result of this success, Malaysia became the region's third-most open economy to trade, with the electrical and electronics (E&E) industry accounting at its peak for approximately half of all trade. Moving up the value chain concerns the process of shifting the productive activity of a nation, an industry or a firm into those goods and services that generate higher value added. Moving up the value chain is a highly complex undertaking it requires a fundamental reorientation towards innovation as the fundamental driver of growth, supported by a healthy level of investment in human and physical capital. This process should not be confused with simply producing the same mix of products more efficiently and neither should it be construed as implying a shift in focus towards anything high-tech. Moving up the value chain entails new, more complex, and more skill-intensive activities in the manufacturing of products; it requires conducting these at world-class standards of quality, productivity and competitiveness; and, as long as higher value is created, it does not matter whether these final products are low-tech, medium-tech or high-tech. This study is as much a process as a product. This report is the outcome of the study. The report sets out a conceptual framework, examines the global industry context, analyzes Malaysia's position in the global value chain, identifies industry opportunities and bottlenecks, and suggests policy adjustments. This study is however more than just a report. The study is also accompanied by a process of capacity building to train policymakers and industry participants in global value chain analysis, so that this work can be updated, extended, and replicated to other industries. The study also constitutes an attempt to promote a novel way of thinking about identifying and seizing value chain opportunities in ways that emphasize bottom-up, decentralized, collaborative and consultative approaches.Publication Strengthening the Pharmaceutical System in the Kingdom of Saudi Arabia(World Bank, Washington, DC, 2020)This document presents the major issues that were discussed in the process of working towards the development of a new medicines policy in Saudi Arabia, examining current national practice in light of international practices and experiences. The document is designed to foster discussion and help inform the development of a new national medicine policy. A detailed accounting of the evidence informing policy choices to be highlighted in an updated medicine policy are presented in Part I of this discussion paper; a proposed new National Medicine Policy itself is presented in Part ll. A new Medicine policy, once finalized and approved, will need to be implemented in a highly dynamic environment and must therefore allow for flexibility. It will need to be followed by the implementation of regulations, closely monitored, and adapted as necessary over time.Publication Financial Sector Assessment Program Update : Saudi Arabia - Basel Core Principles for Effective Banking Supervision(World Bank, Washington, DC, 2011-09)This assessment of Saudi Arabian Monetary Agency's (SAMA) compliance with the basel committee's core principles for effective banking supervision was conducted by a mission to Saudi Arabia during April 9-20, 2011. The assessment was carried out as part of a Financial Sector Assessment Program (FSAP) update undertaken by the International Monetary Fund (IMF) and the World Bank at the request of the Saudi authorities. The authorities requested that the assessment of compliance be conducted using only the essential criteria in the methodology. This assessment was based on a review of laws, regulations, policies and practices in place at the time. The financial system is subject to risks reflecting the openness of the economy and dependence on the hydrocarbon sector, as well as the size of the market. Saudi Arabia implements International Financial Reporting Standards (IFRS) for banks and insurance companies and is served by the major accounting firms. There has been no need to provide emergency liquidity assistance (ELA) to any bank in recent years. The conditions in which SAMA will provide ELA would be determined on a case-by-case basis, as will the terms on which such ELA will be provided.
Users also downloaded
Showing related downloaded files
Publication Business Ready 2024(Washington, DC: World Bank, 2024-10-03)Business Ready (B-READY) is a new World Bank Group corporate flagship report that evaluates the business and investment climate worldwide. It replaces and improves upon the Doing Business project. B-READY provides a comprehensive data set and description of the factors that strengthen the private sector, not only by advancing the interests of individual firms but also by elevating the interests of workers, consumers, potential new enterprises, and the natural environment. This 2024 report introduces a new analytical framework that benchmarks economies based on three pillars: Regulatory Framework, Public Services, and Operational Efficiency. The analysis centers on 10 topics essential for private sector development that correspond to various stages of the life cycle of a firm. The report also offers insights into three cross-cutting themes that are relevant for modern economies: digital adoption, environmental sustainability, and gender. B-READY draws on a robust data collection process that includes specially tailored expert questionnaires and firm-level surveys. The 2024 report, which covers 50 economies, serves as the first in a series that will expand in geographical coverage and refine its methodology over time, supporting reform advocacy, policy guidance, and further analysis and research.Publication Digital Progress and Trends Report 2023(Washington, DC: World Bank, 2024-03-05)Digitalization is the transformational opportunity of our time. The digital sector has become a powerhouse of innovation, economic growth, and job creation. Value added in the IT services sector grew at 8 percent annually during 2000–22, nearly twice as fast as the global economy. Employment growth in IT services reached 7 percent annually, six times higher than total employment growth. The diffusion and adoption of digital technologies are just as critical as their invention. Digital uptake has accelerated since the COVID-19 pandemic, with 1.5 billion new internet users added from 2018 to 2022. The share of firms investing in digital solutions around the world has more than doubled from 2020 to 2022. Low-income countries, vulnerable populations, and small firms, however, have been falling behind, while transformative digital innovations such as artificial intelligence (AI) have been accelerating in higher-income countries. Although more than 90 percent of the population in high-income countries was online in 2022, only one in four people in low-income countries used the internet, and the speed of their connection was typically only a small fraction of that in wealthier countries. As businesses in technologically advanced countries integrate generative AI into their products and services, less than half of the businesses in many low- and middle-income countries have an internet connection. The growing digital divide is exacerbating the poverty and productivity gaps between richer and poorer economies. The Digital Progress and Trends Report series will track global digitalization progress and highlight policy trends, debates, and implications for low- and middle-income countries. The series adds to the global efforts to study the progress and trends of digitalization in two main ways: · By compiling, curating, and analyzing data from diverse sources to present a comprehensive picture of digitalization in low- and middle-income countries, including in-depth analyses on understudied topics. · By developing insights on policy opportunities, challenges, and debates and reflecting the perspectives of various stakeholders and the World Bank’s operational experiences. This report, the first in the series, aims to inform evidence-based policy making and motivate action among internal and external audiences and stakeholders. The report will bring global attention to high-performing countries that have valuable experience to share as well as to areas where efforts will need to be redoubled.Publication Global Economic Prospects, June 2025(Washington, DC: World Bank, 2025-06-10)The global economy is facing another substantial headwind, emanating largely from an increase in trade tensions and heightened global policy uncertainty. For emerging market and developing economies (EMDEs), the ability to boost job creation and reduce extreme poverty has declined. Key downside risks include a further escalation of trade barriers and continued policy uncertainty. These challenges are exacerbated by subdued foreign direct investment into EMDEs. Global cooperation is needed to restore a more stable international trade environment and scale up support for vulnerable countries grappling with conflict, debt burdens, and climate change. Domestic policy action is also critical to contain inflation risks and strengthen fiscal resilience. To accelerate job creation and long-term growth, structural reforms must focus on raising institutional quality, attracting private investment, and strengthening human capital and labor markets. Countries in fragile and conflict situations face daunting development challenges that will require tailored domestic policy reforms and well-coordinated multilateral support.Publication The Container Port Performance Index 2023(Washington, DC: World Bank, 2024-07-18)The Container Port Performance Index (CPPI) measures the time container ships spend in port, making it an important point of reference for stakeholders in the global economy. These stakeholders include port authorities and operators, national governments, supranational organizations, development agencies, and other public and private players in trade and logistics. The index highlights where vessel time in container ports could be improved. Streamlining these processes would benefit all parties involved, including shipping lines, national governments, and consumers. This fourth edition of the CPPI relies on data from 405 container ports with at least 24 container ship port calls in the calendar year 2023. As in earlier editions of the CPPI, the ranking employs two different methodological approaches: an administrative (technical) approach and a statistical approach (using matrix factorization). Combining these two approaches ensures that the overall ranking of container ports reflects actual port performance as closely as possible while also being statistically robust. The CPPI methodology assesses the sequential steps of a container ship port call. ‘Total port hours’ refers to the total time elapsed from the moment a ship arrives at the port until the vessel leaves the berth after completing its cargo operations. The CPPI uses time as an indicator because time is very important to shipping lines, ports, and the entire logistics chain. However, time, as captured by the CPPI, is not the only way to measure port efficiency, so it does not tell the entire story of a port’s performance. Factors that can influence the time vessels spend in ports can be location-specific and under the port’s control (endogenous) or external and beyond the control of the port (exogenous). The CPPI measures time spent in container ports, strictly based on quantitative data only, which do not reveal the underlying factors or root causes of extended port times. A detailed port-specific diagnostic would be required to assess the contribution of underlying factors to the time a vessel spends in port. A very low ranking or a significant change in ranking may warrant special attention, for which the World Bank generally recommends a detailed diagnostic.Publication Global Economic Prospects, January 2025(Washington, DC: World Bank, 2025-01-16)Global growth is expected to hold steady at 2.7 percent in 2025-26. However, the global economy appears to be settling at a low growth rate that will be insufficient to foster sustained economic development—with the possibility of further headwinds from heightened policy uncertainty and adverse trade policy shifts, geopolitical tensions, persistent inflation, and climate-related natural disasters. Against this backdrop, emerging market and developing economies are set to enter the second quarter of the twenty-first century with per capita incomes on a trajectory that implies substantially slower catch-up toward advanced-economy living standards than they previously experienced. Without course corrections, most low-income countries are unlikely to graduate to middle-income status by the middle of the century. Policy action at both global and national levels is needed to foster a more favorable external environment, enhance macroeconomic stability, reduce structural constraints, address the effects of climate change, and thus accelerate long-term growth and development.