The medical device industry in Korea has been growing rapidly. This growth is a testament to the quality and innovation of medical devices manufactured in Korea, which are increasingly being exported globally. A critical factor in determining the safety and efficacy of Korean devices is their adherence to Korean Good Manufacturing Practices (KGMP), as recommended by the Ministry of Food and Drug Safety (MFDS).

Renewing a medical device manufacturing license in South Korea is critical for ensuring the safety and efficacy of medical devices in the market. The renewal process can be complex and time-consuming. This guide provides tips to any company seeking to renew their medical device license, including criteria for renewal, how to fill in a medical device license application, common mistakes to avoid, and the consequences of non-renewal.

Digital therapeutics, also known as software-based therapies, have gained significant attention as an alternative treatment option for various chronic diseases. With improved patient outcomes, real-time monitoring, greater accessibility and flexibility as well as cost-effectiveness, digital therapeutics has revolutionized the healthcare sector, and worldwide health agencies are currently focusing on regulating this class of devices effectively.

Medical devices in South Korea are regulated by the Ministry of Food and Drugs Safety (MFDS), formally known as the Korean Food and Drug Administration (KFDA). MFDS requires all foreign manufacturers wishing to market their devices in South Korea to appoint a Korean License Holder (KLH) to register their devices with the MFDS. The current article answers the major questions posed by the device and IVD manufacturers to appoint a KLH.

The technological advancement is now an integral part of healthcare and Artificial Intelligence (AI) algorithms, along with other AI-powered applications supporting medical professionals in clinical settings. AI and Machine Learning (ML)-based Software as a Medical Device (SaMD) aid medical practitioners in decision-making for better patient care. South Korea’s Ministry of Food and Drug Safety (MFDS) has guidelines to regulate and monitor the use of AI and Big Data based medical devices.

With the vision of global device traceability, South Korea’s Ministry of Food and Drug Safety (MFDS) has suggested/mandated? a new Regulatory requirement, for incorporating Unique Device Identification system (UDI) on medical devices. Medical device registration and UDI are integrated procedures, and UDI is a prerequisite for establishing medical devices in the Korean market. To ensure patient safety, the MFDS introduced the Integrated Medical Device Information System (IMDIS) in 2016, a platform to regulate the traceability of medical devices in South Korea.

In a recent notification, the South Korean national health authority - Ministry of Food and Drug Safety (MFDS) announced that the Agency no longer requires the submission of full summary technical documentation (STED) files for the registration of high-risk (class IV) medical devices.