Controversy has arisen between US drug manufacturers and the Korean government regarding the reform of South Korea’s national health insurance system and its affects on drug pricing. Proposals have been made by Korea’s Health Ministry to implement a new reference pricing system... Read More
Before medical devices can be manufactured or sold in South Korea, it must first obtain the approval of the Korea Food & Drug Administration (KFDA). Through a system of testing, the KFDA would reject or approve the manufacture or sale of a... Read More
Less than two years ago, the Korean government significantly revamped rules governing the prescription and sale of pharmaceuticals in that country. Prior to the reform, distinct roles between those who prescribed and sold drugs were not clearly defined. Doctors and pharmacists could... Read More
The Korea Food and Drug Administration (KFDA) requires that all medical devices sold in Korea receive approval prior to market entry. In the past, if the foreign manufacturer was exporting to Korea, KFDA regulations stipulated that a local distributor, not the foreign... Read More
All medical devices sold in Korea must obtain approval from the Korea Food & Drug Administration (KFDA) before they may be sold and marketed in that country. The Medical Devices & Radiation Health Department of KFDA is charged with the inspection and... Read More
With 2000 sales over US$1 billion and demand for medical devices predicted to grow by 10% in 2001, South Korea is Asia’s second largest medical device market, after Japan. Imports from the United States increased nearly 60% in 2000 to US$308 million... Read More
The US Trade Development Agency (TDA) estimates that developing countries in Asia will spend over $6 billion on healthcare technology over the next five years. There are at least 25 large-scale healthcare technology projects either underway or on the drawing board in... Read More
Last summer, the Korean government put into service a new law, the “National Health Insurance Act,” which, among other things, significantly changed Korean government policy regarding reimbursement of medical devices. Government approval of the listed coverage and price is required before a... Read More
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... Read More
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)... Read More