Artificial intelligence (AI) is being implemented in many areas of medicine, such as patient-customized diagnosis. Growth in the artificial intelligence medical device (AIMD) field is expected in the coming years. Major countries are currently establishing systems and policies to gain a leading position in the medical artificial intelligence market. The Republic of Korea has initiated the Act on Nurturing the Medical Devices Industry and Supporting Innovative Medical Devices for the development of AIMDs and is implementing it preemptively. As a result, the country has achieved an effective strategy for coping with the COVID-19 pandemic, an increase in the number of AIMD approvals (85 approved as of September 2021), and the creation of a document pertaining to internationally harmonized guidelines on AIMD-related terms and definitions. However, in order to develop and activate more AIMD products, it is necessary to improve post-market management such as product change and quality control in addition to approval. Here, we review the current regulatory status of AIMD in the Republic of Korea and what needs to be improved for AIMD to be more developed and activated.
Keywords: AIMD; GMP; SaMD; artificial intelligence; diagnostic; medical device.