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.

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.