1. Background information
The Middle East, one of the world's most developed economies, offers unique opportunities and challenges for multinationals operating in the medical device industry. While the gap between some economies in the Middle East remains large, most countries are showing a sustainable growth in many areas of medical technology, such as interventional cardiology. This increase was mainly attributable to a significant increase in the population, increased health-care expenditures, rich hydrocarbon wealth, per capita income growth, increased coverage of health-care indicators, a higher middle class population, and a growing burden of lifestyle-related diseases (diabetes, obesity and cardiovascular disease).
2. Regulatory regime
Turkey, Saudi Arabia, UAE as the three major medical devices in the Middle East market, and governments to promote the development of medical market to take corresponding measures for medical devices, pharmaceutical companies and other enterprises to create new opportunities. For medical devices, most countries in the Middle East have their own monitoring and approval systems at different stages of development, mainly responsible for regulation. And the countries of the Middle East have obvious differences in law, administration and economic performance. Industry insiders point out that the volatility and opacity of the political environment in the region are other major obstacles for multinationals to enter the market.
Despite the challenges facing the market for medical devices in the Middle East, significant progress has been made in recent years in regulating regulations consistent with global norms. The International Medical Equipment Regulatory Forum (IMDRF), established under the strong framework of the Global Coordination Task Force (GHTF), is working to harmonize equipment regulation and simplify the regulatory relationship equipment companies between the Middle East countries and international health-care providers. This will have a positive impact on cooperation between these countries and foreign equipment manufacturers.
3. Challenges and Opportunities
Turkey, the largest market for medical devices in the Middle East, offers an exciting opportunity for foreign equipment manufacturers, but the issue of regulation and reimbursement at different levels remains a domestic challenge. Turkey recognized the CE certificate, so European companies have a slight advantage. To enter the Saudi Arabian market, multinationals must pass the Saudi Food and Drug Administration (SFDA) approval process.
Local companies in the Middle East are mainly engaged in manufacturing low-end consumables or as distributors of foreign companies, while high-end medical devices are usually imported from U.S., European or East Asian multinationals. Equipment from the United States, Japan, the Netherlands, Switzerland, France and Germany has been widely accepted in the Middle East, and equipment in Eastern Europe, China and South Korea is occupying the market with price advantages.