Publications on Korea
Pacific Bridge Medical has published numerous articles in leading trade journals pertaining to the rapidly growing medical market in Korea. Our consultants and researchers are constantly identifying pertinent new medical device and pharmaceutical regulations, trends, and other information. The published articles, reports, and webcasts below are free or for purchase.
Medical Device Registration in Korea: An Overview
Published by MPO Magazine
Korea is an important Asian destination for foreign medical devices. Its total medical device market in 2005 was about $2.5 billion. While this may seem low compared to China’s $5 billion, its health expenditure per capita in 2006 was $705, compared to China’s $61, according to the WHO. This means a greater proportion of the population can afford high-end medical treatment. Also, over 60% of its medical device market comes from imported products. Like Japan, though, potential sales are accompanied by a complicated regulatory environment. This article briefly describes the process of registering a product in Korea.
Medical Device Reimbursement in Korea
Published by Pacific Bridge Medical
The National Health Insurance (NHI) Act oversees all public health insurance in Korea. This Act covers the entire population and all citizens earning an income in Korea must contribute a percentage of their monthly salary. Today, the Korean government considers the medical device market to be a profi industry and therefore, often considers price reduction as an option. The Health Insurance Review Agency, responsible for reviewing reimbursement coverage/non-coverage and pricing applications from pharmaceutical and medical device companies, does not tend to appreciate the value of new technology and sometimes reduces prices at its own discretion. Therefore, medical device companies often consider reimbursement options carefully in Korea.
Regulatory Updates for Medical Devices in Asia (PDF)
Presented at the MD&M East Conference
This presentation provides information on the medical device regulatory environments for Japan, China, Taiwan, Hong Kong, Korea, Malaysia, Singapore, the Philippines and India. Some of the specific topics covered include Japan’s new Pharmaceutical Affairs Law (PAL) and Marketing Authorization Holder (MAH) System; the medical device registration process in China; and the reimbursement process in Taiwan.
Overview of Asia, Healthcare Markets and Regulatory Issues in the Region
Presentation at Regulatory Affairs Professional Society (RAPS) Conference
Despite sluggish economies in some countries, Asia still represents future growth opportunities in healthcare products. Over the next 20 years, Asian healthcare markets are expected to grow at a rate two and a half times that of the West. A rising standard of living throughout the region means patients will have the resources to acquire modern medical devices and pharmaceuticals. As the globalization of healthcare continues, regulatory practices for pharmaceuticals and medical devices will be further harmonized. This report examines emerging regulatory trends and issues in China, Japan, Hong Kong, India, Indonesia, Malaysia, the Philippines, Singapore, South Korea, Taiwan and Thailand.
2000 Regulatory Update: South Korea's Pharmaceutical Market
Published by Pacific Bridge Medical
Despite the damage from the Asian financial crisis, South Korea’s economy is moving ahead with a surge in imports and increased consumer confidence. The Korean pharmaceutical market is no exception to Korea’s economic boom. The Korean Ministry of Health and Welfare (MHW) has made a series of reforms and amendments to its pharmaceutical regulatory issues throughout 1999, 2000 and 2001, making it easier for foreign pharmaceutical companies to overcome the barriers of entering the Korean market. The MHW along with the Korean Food and Drug Administration (KFDA), have introduced several new laws and standards that will not only encourage drug imports, but also keep consumer safety in mind. This article discusses these specific revisions, amendments and additions to South Korea’s regulatory processes.
1999 Regulatory Update: South Korea's Medical Device and Pharmaceutical Markets
Published by Pacific Bridge Medical
As South Korea’s economy rebounds from the Asian financial crisis, its pharmaceutical and medical device markets are also rebounding due to increased demand and consumption. Part of the Korean government’s economic reforms include the deregulation of its markets and promoting of foreign investment. These liberalization reforms are supported by the Foreign Investment Protection Act, which puts an emphasis on maintaining and assisting foreign investment instead of controlling and regulating the market, and the Korean Food and Drug Administration (KFDA) under the Ministry of Health and Welfare (MOHW). This report examines the updates of medical device regulations, pharmaceutical regulations, reimbursement issues and the regulations on intellectual property rights in South Korea. Some of the key issues mentioned are testing requirements, safety data requirements, product license transfer rights, import regulations and distribution.
Regulatory Changes in the South Korean Medical Market: Medical Devices and Pharmaceuticals
Published by Pacific Bridge Medical
South Korea’s medical market is the third largest in Asia and is worth almost $11 billion. The Asian financial crisis sparked a government reform effort in Korea to liberalize its markets, allowing more foreign investment opportunities, especially in the medical market. The Ministry of Health and Welfare (MOHW) is striving to reform the regulatory environment for pharmaceutical and medical device imports, as well as guaranteeing international competitiveness in the Korean medical market. This article discusses the new regulatory framework system for medical devices and pharmaceuticals. Some of the key topics include approval requirements, registration, exemptions, licenses, pricing, labeling and clearances.
Changing Regulatory Climate Improves Korean Market for U.S. Companies
Published in Medical Device & Diagnostic Industry
Medical technology is developing at an unbelievable pace in Asia, possibly reaching an incredible 1520% annual growth rate over the next several years. Likewise, the South Korean market is expecting a boost in growth rates in the medical market due to new regulatory developments, allowing greater investment opportunities for US medical manufacturers. This article focuses on the specific new requirements and regulations for the Korean medical device market, including medical device classification, product testing and permission to export.
Opportunities in the South Korean Medical Market
Published in Clinica, a publication of PJB Publications, Ltd.
Healthcare systems are fast becoming national priorities for all Asian nations, as economies begin to experience high growth rates. In South Korea, the addition of hospitals and demand for expanded healthcare facilities are grounds for the increase of medical device imports. The lowering of import tariffs and lack of quality domestic production are also favorable factors for foreign firms hoping to export their products to Asia. Furthermore, technologically advanced medical equipment is badly needed, such as diagnostic imaging equipment and surgical/therapeutic laser equipment. The U.S., Japan and Germany are currently the top three suppliers for the Korean medical device market. This article examines the future prospects for foreign medical device manufacturers in the South Korean market.
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