Korea Leads Development of International Standards for 'AI Medical Devices'

The Ministry of Food and Drug Safety announced on the 20th that South Korea will lead the development of the international standard for "Performance Evaluation Procedures for AI·Machine Learning (ML)-Based Medical Devices," which was proposed by Korea to the International Electrotechnical Commission (IEC) Technical Committee on Medical Electrical Equipment (IEC/TC 62) and has been approved.

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The IEC, established in 1906, is an international organization that coordinates standards and specifications across countries in fields such as electricity, electronics, telecommunications, and nuclear power. Among these, Technical Committee 62 (TC 62) on medical electrical equipment handles standards related to electrical and mechanical safety, risk management, validation, and data security of medical electrical device products.

AI·ML-based medical devices are products that integrate cutting-edge technologies expected to lead the future market. With the international standard development led by Korea, it is anticipated that our products will gain significant support when entering the global market. Accordingly, the government has been providing active support.

Korea will act as the team leader in a project team (PT8) involving international medical device standard experts from the U.S. Food and Drug Administration (FDA), China National Institutes for Food and Drug Control (NIFDC), and others to develop the international standard. The development is expected to take approximately three years.

Chae Gyu-han, Director of the Medical Device Safety Bureau, stated, “Based on our experience in establishing international common guidelines in the AI medical device field and domestic guideline preparation, we actively led the advisory group activities of the Software, Networks, and AI Group (SNAIG) under IEC/TC 62, resulting in Korea leading this international standard development.” He added, “As technology advances, the importance of technical standards will continue to grow. We will strive to ensure that our standards become international standards by promptly developing standards for software medical devices applying AI and ML.”

This content was produced with the assistance of AI translation services.