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
The country of South Korea is one of the world's leading economies -- the 15th largest by GDP in 2012, and the fourth largest in Asia. In 2011, the Korean medical device market had a value of $3.9 billion, according to the... Read More
Beginning August 31, 2012, the Korean Food and Drug Administration (KFDA) will require medical device manufacturers in Korea to disclose more product information to the public. The KFDA has prepared a guideline on information that needs to be disclosed for medical devices.... Read More
Korea’s Food and Drug Administration (KFDA) and Indonesia’s National Agency of Drug and Food Control (NADFC) recently signed a memorandum of understanding (MOU) on safety and quality standards. This is the first inter-country MOU signed by the Indonesian NADFC. Prior to this... Read More
In April 2012, the Korean FDA (KFDA) made significant changes in its Medical Device Act, which stipulates regulations for medical devices. The revised Medical Device Act improves transparency and predictability for medical device approval. Within the Medical Device Act, the KFDA released... Read More