The Korean Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) are seeking new ways to counteract long registration and market access timelines for healthcare products. Both agencies have been vigorously implementing new ways to get... Read More
In the Asia-Pacific (APAC) region, regulators are taking important steps to shape the future of artificial intelligence (AI) in medical technology. With that progress comes recognition of the usefulness and transformative potential of AI, and the necessity for new levels of oversight.... Read More
In early March, the Korean Ministry of Food and Drug Safety (MFDS) announced proposed amendments to the Standards for Medical Device Manufacturing and Quality Management. These amendments aim to speed up the process of granting compliance certification for medical devices. Under this... Read More
Korea’s Ministry of Health and Welfare announced today that a sweeping reform will change pharmaceutical pricing from March onwards. The reform will be called the “Measures to Improve Drug Pricing Systems to Reward Innovation and Strengthen Health Security”. The goal of the reforms will... Read More
The Korean Ministry of Food and Drug Safety (MFDS) plans to continue strengthening its support for innovative medical products, including new drugs, advanced biopharmaceuticals, and medical devices. The effort is meant to expedite the development and market release of innovative healthcare solutions. At a... Read More
On February 21, 2025, Korea introduced the Regenerative Medicine Law, which will enable patients suffering from serious, rare, or untreatable diseases to gain access to cell and gene therapies that are not yet fully approved for marketing. The law’s full title is ... Read More
On January 24, the Korean MFDS made public that it would put together and publish the world’s first Guideline for Approval and Review of Medical Devices Using Generative Artificial Intelligence (AI). To this end, the MFDS has formed a special group of... Read More
As mentioned in our earlier newsletter, Korea has implemented a new drug approval system to expedite drug approvals, which began on January 1, 2025. To do so, the MFDS has increased its fees by 50x to hire more staff, etc. However, the industry has complained... Read More
Artificial intelligence is transforming healthcare in Asia: improving the quality of care, facilitating operational efficiency, and increasing patient access. For example, the National University Health System (NUHS) in Singapore uses AI to accurately predict how long patients will stay in the hospital,... Read More
On November 21, Korea introduced the “Immediate Market Entry Medical Technology System,” a ground-breaking policy aimed at accelerating market entry for cutting-edge medical technologies. Before this system was initiated innovative devices could take up to 490 days to be approved. Under this new system, innovative... Read More