Over the last 20 years, Western medical device makers have had a boom in device exports to Asia. During that time, most Asian countries’ populations have gotten wealthier, seen more government investment in healthcare, seen new, more and advanced healthcare insurance programs... Read More
Drug reimbursement significantly lags drug approval in Korea. This has led to many innovative drugs being approved but not reimbursed for a long time. While the Korean government has made efforts to shorten the reimbursement period over the last 10 years, drug... Read More
Korea Drug Reimbursement Update 2024 Korea is taking significant steps to improve the accessibility and affordability of innovative medications, with a particular focus on treatments for cancer and rare diseases. The government has recently implemented a series of reforms designed to streamline... Read More
Recently, South Korea has been making significant progress in transforming its approach to healthcare, specifically through the integration of AI and digital technologies in medical devices. The Ministry of Food and Drug Safety (MFDS) is at the forefront of these efforts and... Read More
According to a recent announcement by Korea’s Ministry of Food and Drug Safety (MFDS), AI medical devices with reduced risks can be registered without the MFDS’ clinical trial requirement. In addition, for other AI medical devices that do require a local clinical... Read More
This article was originally published on MedTech Intelligence. Companion diagnostics (CDx) plays a pivotal role in personalized medicine—one of the fastest-growing areas of medicine. Regulation of CDx is fairly well established in Western countries, but the East is not far behind. Here... Read More
Korea has been at the forefront of the development of healthcare AI and digital products. Accordingly, the Korean MFDS tried to incorporate regulation changes to accommodate these new and innovative technologies. Today, in Korea’s National Assembly, three important regulatory reforms are being... Read More
As mentioned in our July Pacific Bridge Newsletter, Korea plans to increase drug reimbursement for innovative, cancer and rare disease drugs. This reimbursement increase has been confirmed in the recently released Seoul National University R&DB Research Foundation report. In addition to better... Read More
Korea is currently the 10th largest drug market in the world. While in the past, Korean drug companies mostly made generic drugs, today, they are making new chemical and biological products. Korean drug companies and foreign drug companies looking to sell their... Read More