The Korea Food and Drug Administration (KFDA) recently approved the first multinational clinical trial for a medical device. The device, the Nobori drug-eluting stent, is manufactured by the Terumo Corporation, an international medical device company headquartered in Tokyo, Japan. The trial involves... Read More
New IVD regulations are being developed throughout Asia. In Korea, before IVDs are permitted to enter the Korean medical market, these products require approval by the Korean Food and Drug Administration through a process similar to the pre-market approval (PMA) process for... Read More
The Korea Food and Drug Administration (KFDA) has continued its efforts on harmonization of medical device standards with the enactment of medical device Good Clinical Practice (GCP) regulations on July 14, 2005. Previously, GCP regulations were not established for medical devices in... Read More
In May 2005, a Memorandum of Understanding was signed by members of the World Health Organization (WHO), Korea Ministry of Health and Welfare (MOHW) and Korea Food and Drug Administration (KFDA), as a means of cooperating on chemical safety activities. Under the... Read More
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... Read More
Korea’s Ministry of Health and Welfare (MOHW) recently announced plans to deregulate a number of medical laws in hopes of boosting the country’s medical sector. The new bill, to be drafted by the end of 2005 and passed early in 2006, is... Read More
In Korea, the National Health Insurance (NHI) Act oversees all public health insurance. This Act covers the entire population and all citizens earning an income in Korea must contribute a percentage of their monthly salary. The Ministry of Health and Welfare (MOHW)... Read More
In June of this year, the Korean government released a plan to develop an industrial zone in Wonju, Korea, specializing in medical equipment. Even though the project does not officially begin until 2005, Wonju has already established a medical equipment development center,... Read More
The implementation of new information technology (IT) services in Korean hospitals enables patients to receive faster and more accurate diagnosis and treatment. These new IT services include the use of the Internet for remote diagnosis, teleconferencing, and the establishment of internal computer... Read More
A recent survey conducted by the Political and Economic Research Consultancy (PERC), a Hong Kong based research group, gave South Korea 5.88 points on a scale of 0 to 10 for intellectual property (IP) protection (0 being the highest level of IP... Read More