The main regulatory body in charge of overseeing medical devices in South Korea is the Korea Food & Drug Administration (KFDA) established in 1996. Through the Medical Devices & Radiation Health Department, the KFDA performs inspections and quality assurance as well as... Read More
South Korea’s Ministry of Finance and Economy recently announced their plans to develop five Special Economic Zones (SEZs) throughout the country. The plan is part of the Korean government’s endeavor to attract greater foreign investments into the country. Besides special tax incentives... Read More
Slowing economies have not stopped Asian countries from moving ahead with medical device regulatory reforms. Asian consumers demand high-quality healthcare products, making it worthwhile for American manufactures to be active in the region. Procedures and practices vary according to country. This article... Read More
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