The Korean Ministry of Food and Drug Safety (MFDS) has made a major overhaul to its disclosure policies regarding Good Manufacturing Practice (GMP) inspection outcomes. The MFDS will now disclose results in full, instead of in the past, just issuing heavily redacted... Read More
A draft bill has been introduced in Korea to increase the scope of devices that can receive a designation as “innovative medical devices“. Innovative devices are those that would enhance the convenience and quality of diagnosis and treatment. At present, only devices with enhanced safety... Read More
Japan’s Ministry of Health, Labor, and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) celebrated the tenth anniversary of their Memorandum of Cooperation with Korea’s Ministry of Food and Drug Safety (MFDS). For the last ten years, the agencies have... Read More
While China has dominated the headlines for new drug research and out-licensing to Western pharmaceutical companies, and will continue to do so in the future, Korea, too, is entering the new drug game. While historically Korean drug companies have mainly focused on making... Read More
Korea is quickly expanding the use of AI in its drug regulatory and safety systems. Korea’s Ministry of Food and Drug Safety (MFDS) will start applying AI in drug review work starting next year as part of a wider attempt to innovate its regulatory... Read More
Registering a medical device in Korea involves navigating a stringent regulatory process governed by the Ministry of Food and Drug Safety (MFDS). While much has been written about Korea’s classification system and regulatory pathways, one critical aspect often overlooked is the documentation... Read More
Securing Korea Good Manufacturing Practice (KGMP) certification is a key regulatory milestone for medical device registration in Korea. The KGMP system, overseen by the Ministry of Food and Drug Safety (MFDS), ensures that medical devices are consistently produced and controlled according to... Read More
Western drug companies are demanding improvements to Korea’s “Innovative Company” criteria. Up until now, the Korean government has been choosing innovative firms every two years. Since the program started, there have been 49 designated innovative drug companies, but only 4 of these were... Read More
The Korean Ministry of Food and Drug Safety (MFDS) has introduced a new initiative focused on three aspects: organoid alternatives to animal testing, legal framework for CDMOs, and the acceleration of GMP inspections. First, the Bio Future Development Council will establish regulations... Read More
Introduction In the fast-paced medical device industry, product quality is essential to guaranteeing patient safety and public confidence. Across the world, regulatory bodies have established stringent quality systems to manage and enforce standards throughout the life cycle of a device. In Asia,... Read More