South Korea MFDS Medical Device Classification

South Korea regulates medical devices through the Ministry of Food and Drug Safety (MFDS). The MFDS, formerly known as the Korea Food and Drug Administration (KFDA), oversees the safety and efficacy of medical devices in the country. Similar to other regulatory authorities, the MFDS has implemented a classification system for medical devices to categorize them based on their intended use and level of risk. While specific details may have evolved since my last update, the classification system generally consists of several classes, each with its own regulatory requirements.

The MFDS classifies medical devices into four risk-based categories, ensuring that each product undergoes the appropriate level of regulatory scrutiny before entering the South Korean market. This classification helps determine the requirements for technical documentation, clinical data, quality management system (QMS) compliance, and product testing. By aligning its framework with global regulatory standards, the MFDS aims to enhance patient safety, support innovation, and streamline the approval process for both domestic and international manufacturers. 

This structured classification system also helps manufacturers understand the exact regulatory pathway required for market entry in South Korea. Higher-risk devices typically require more rigorous clinical evidence and conformity assessments, while lower-risk devices follow a simplified review process. By clearly defining these requirements, the MFDS supports faster, more predictable approvals and improved compliance for medical device companies.