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
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
As mentioned in our October newsletter, the Korean MFDS drug review time is significantly longer than in other global markets. To help solve this problem, the MFDS is planning a new program in January to increase its drug review fees from about... Read More
In October 2024, Singapore’s Health Sciences Authority (HSA) updated its Guidance on Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers. From October 1, 2024, evidence demonstrating GMP compliance is mandatory for all new or generic drug applications and minor variations... Read More
Drug reviews in Korea take a lot longer than in other advanced global markets. The current MFDS review time is about 420 days, and the new plan is to reduce this to 295 days. To do this, the MFDS is going to... Read More
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