Archives

韩国食品药品安全部(MFDS)于2013年下旬公布了韩国医疗器械法案（MDA）的部分修订计划。该修正案拟于2014年中旬成为正式法规并在2014年底前生效。 在有关医疗器械部分的实施条例中，词条“用于体外诊断分析器械的试剂（reagent for in vitro diagnostic analysis device）”将被修改为“体外诊断产品（in vitro diagnostic product）”。这意味着包括试剂，以及所有用于体外诊断的用品都将被统一视为体外诊断产品（IVDs）进行管理。 除试剂以外的用品也被列为体外诊断产品意味着这些用品将被划归为医疗器械，需遵守医疗器械的法规和标准。现被列为药品的体外诊断产品需要在2014年底之前获取新的进口和生产批准。 三级和四级体外诊断产品需在一年内（2015年中旬之前）达到韩国医疗器械优良生产规范（KGMP）的标准。二级体外诊断产品有两年的时间（2016年中旬之前）达到KGMP的标准。若有体外诊断产品的标签或包装显示该产品不属于医疗器械，也需在一年内完成变更。 Read More

Korean hospitals are competing for dialysis patients, often offering free meals, transportation to and from the hospital, and even living expenses in an effort to capture government subsidies. The Korean government pays 90 percent of all dialysis costs, an average of $1,500... Read More

On October 1, Korea’s National Health Insurance Corporation expanded its coverage to include ultrasound scans for patients suffering from one of the so-called “four major diseases”: cancer, heart disease, cerebrovascular diseases and rare or incurable diseases. Under the new scheme, more than... Read More

Korea now exports as many medical devices as they import. According to a September 2013 report by the Korea Health Industry Development Institute, Korean medical device exports grew by almost 18 percent to reach $1.75 billion in 2012. Like Western medical device... Read More

At the end of June, Korea’s Ministry of Food and Drug Safety (MFDS) announced three major changes to the country’s Medical Device Act. The first requires that all Class IV medical devices undergo registration using the Summary Technical Document (STED) format starting... Read More

Demand for orthopedic devices is surging across Asia, as people there become older and wealthier. Sales of knee implants, hip implants, trauma devices and other orthopedic products have experienced double digit growth since the early 2000s. However, although half of the world's... Read More

The medical device market in Korea is growing quickly, at an annual average rate of 13.5 percent. It had a value of $3.9 billion in 2012, making it the third largest medical device market in Asia. Korea's medical device market is expected... Read More

In April 2013, the Korean Food and Drug Administration (KFDA) reported that for the first time ever, approval rates for domestically manufactured medical devices surpassed those for imported medical devices. In 2012, the total number of KFDA medical device approvals was 3,100.... Read More

Across Asia, rapid economic growth has fueled the growth of a new middle class. These people -- from China to India to Indonesia -- are spending more and more money on healthcare. Medical device markets across Asia have posted average growth rates... Read More

Rates of cancer have risen dramatically in Asia, where more than six million people are diagnosed with the disease every year. That number now accounts for 50 percent of new global cases. According to the World Health Organization (WHO), the occurrence of... Read More