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
To learn more about how we can help you obtain a DMF in Korea, please contact us. According to the Korean MFDS, all APIs used for medicinal products that require pharmaceutical equivalence should be registered as DMFs in Korea. For the DMF... Read More
While robotic surgical devices have penetrated much of the US and Europe, future growth is expected to be strongest in Asia. It is estimated that Asian surgical robotic sales will hit $10 billion in 5 years. Asia’s quickly aging population and the... Read More
While AI used in Healthcare is most prevalent in the US and China, a market research firm “Insights10” projects growth in this sector from $0.1 billion in 2022 to $2.11 billion by 2030 in Korea. The growth is fueled by the Korean... Read More
According to a recent market research report by Triton Market Research, Asia’s CDX market was valued at $1.4 billion in 2022 and is likely to grow to $3.85 billion by 2030 with a CAGR of 13%. While CDX growth has already accelerated... Read More
Korea is gearing up to expand its own homegrown domestically produced medical device business. The country is hoping to develop and export more of its own medical devices internationally. In an effort to do this, a few weeks ago, Korea’s MFDS outlined... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) has announced that all RWE can be used as clinical data to expedite the registration of medical devices in Korea that utilize digital technology like AI, Big Data, and some software applications. The MFDS... Read More
Drug prices in Korea, like other markets around the world, have seen drug price erosion. Korea’s MOHW, earlier this year, established a private-public working group to discuss increasing reimbursement for innovative drugs. The goal of the Korean group is to foster new... Read More
Last month, officials from Korea and the US issued a Memorandum of Cooperation (MoC) on AI used in medical and healthcare products. According to the MoC, the two countries will try and harmonize regulations on AI medical products. The Korean government also... Read More