Korea passes basic AI law at plenary session, laying the foundation for the use of reliable AI equipment

The draft of the Basic Act on Artificial Intelligence (AI) was passed at the National Diet plenary session on December 26, 2024. The AI Basic Act was enacted after collecting many opinions over the four years since it was first proposed in July 2020.
The law aims to lay the foundation for the use of highly reliable AI. It is scheduled to come into force in January 2026. It is not expected that the law will enact any additional safety regulations for AI medical devices.
As a result, AI medical devices made by Korean manufacturers are expected to comply with the Digital Medical Products Act. The Digital Medical Products Act, enacted in January 2024, will come into effect on January 24, 2025.
This law is the first in the world to be divided into three areas: digital medical devices, digital convergence medicines, and digital medical and health support devices.
According to the Ministry of Food and Drug Safety, there are approximately 800 types of products in South Korea that are subject to regulation under the Digital Medical Products Act.
According to the law, AI medical devices will be given a classification code and will be managed differently from existing medical devices. For example, updates to AI medical devices are possible continuously due to their characteristics.
The change will not be permitted within a separately specified scope, but will be made in accordance with a change management plan submitted in advance. The application of AI technology stipulated in the Artificial Intelligence Management Act will be based on the awareness of consumers.
The Digital Medicine Act includes measures such as making it mandatory and establishing a risk management system.