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
The Asia-Pacific Economic Cooperation (APEC) group recently declared a goal to align regulatory processes for medical devices and pharmaceutical products by 2020. APEC consists of 21 countries, including the US, China, Australia, and South Korea. The initiative is called the “Strategic Framework... Read More
The Korean Food and Drug Administration (KFDA) is in the process of changing its pre-approval system. The plan is to implement the new system partially within this year. The KFDA has presented a draft regulation of this change. Under the proposed new... Read More
The Korea Food and Drug Association (KFDA) recently revised the classification of six medicines. Two over-the-counter (OTC) drugs were re-categorized as prescription drugs, while two previously prescription drugs can now be sold at pharmacies OTC. Classifications of 11 other drugs... Read More
During the last decade, rates of cancer have increased dramatically in Asia. Asia accounts for nearly half of all new cancer cases in the world. Some cancers that are common in Western countries--such as lung, breast, and colorectal cancers--also are common in... Read More