By: Ames Gross and Catherine Matacic
February 8, 2013
Published by Pacific Bridge Medical
The country of South Korea is one of the world's leading economies -- the 15th largest by GDP in 2012, and the fourth largest in Asia. In 2011, the Korean medical device market had a value of $3.9 billion, according to the Korean Food and Drug Administration (KFDA). It is expected to grow 10 - 15 percent annually through 2018. To cope with a growing medical device market, the KFDA amended the countrys Medical Device Act in April 2011. Changes include a restructuring of the pre-market approval process, an acceptance of more foreign clinical data, the reclassification of in-vitro diagnostics (IVD) products into the medical devices category, and the introduction of a new certification system for Korea Good Manufacturing Practice (KGMP). Changes went into effect throughout 2012 and are still being implemented in 2013.
Webcast by Pacific Bridge Medical
Pacific Bridge Medical presents Managing Asian Cultural/Business Diversity, a 2008 webcast/webinar on cross-cultural issues for Western companies doing business in Asia.
By: Ames Gross and John Minot
November 1, 2007
Published in RA Focus
This report helps medical device manufacturers and distributors better understand how to source from Asia. Topics covered include: how to identify manufacturers, how to perform due diligence, what to look for during factory visits, contract negotiations, regulatory requirements, logistics, quality control, and other issues related to the sourcing equation. This report will also offer advice on how to avoid and troubleshoot problems and pitfalls that may arise in the course of the sourcing process, as well as information about insurance, payment arrangements, freight forwarding, and customs.
Furthermore, we will include Microsoft Excel spreadsheet templates on CD-ROM with this report that will facilitate your transportation and shipping decisions when dealing with multiple SKUs being shipped in one container.
By: Ames Gross and John Minot
January 1, 2007
Published by Medical Product Outsourcing 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.
By: Ames Gross and Rachel Weintraub
July 1, 2005
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.
By: Ames Gross
August 1, 2001
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.
By: Ames Gross
August 1, 2000
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.
By: Published by Pacific Bridge Medical
July 1, 1999
Ames Gross
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.
By: Ames Gross and Gayatri B. Koolwal
July 1, 1998
Published in Medical Device & Diagnostic Industry Magazine
Despite its currency crisis, Asia still offers manufacturers many opportunities.
Asia's recent currency crisis has caused some U.S. medical device companies to wonder whether there is still a market for their products and services. Concern has risen that Asians have lost their purchasing power, meaning a decrease in U.S. exports to Asia and an unstable economic environment in which to invest. However, not all manufacturers have fled the region. Several companies feel that the crisis has opened new opportunities for manufacturing in Southeast Asia.
By: Ames Gross
July 1, 1998
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.
By: Ames Gross and Pat Dyson
April 1, 1996
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.
By: Ames Gross
April 1, 1994
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.
By: Ames Gross
October 1, 1993
Published in Medical Industry Executive
This article is an overview of business opportunities for medical product manufacturers in the Asia Pacific region. Topics include Japan's import requirements, registration procedures, and the keiretsu system; Chinas slow decentralization of its healthcare system; the market growth of Indonesia, Thailand, Malaysia, Korea, Singapore and Taiwan; and business relationships between Western and Asian partners.
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