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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

A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More

Overview of the MFDS The Ministry of Food and Drug Safety (MFDS), formerly recognized as the Korean FDA, is the regulatory authority responsible for overseeing safety matters related to a wide range of products, including drugs, medical devices, food, functional food, and... Read More