Labeling Standards for Digital Medical Devices to Be Clarified

MFDS Revises Guidelines to Resolve Labeling Confusion

The Ministry of Food and Drug Safety announced on June 10, 2026, that it had revised the 'Guideline on Labeling for Digital Medical Devices' to address difficulties in labeling requirements for products that have been converted from conventional medical devices to digital medical devices under the Digital Medical Products Act, which came into effect last year.

As some stakeholders raised concerns about challenges in the field due to differences in labeling and management systems for 'converted products' by company, the Ministry actively reflected industry opinions gathered through the 'Medical Device Approval and Review Communication Group' meeting held in April and prepared a revised guideline to improve regulations.

The main revision clarifies the eligible products and the period for which previously certified or reported digital medical devices are allowed to use the former labeling content, specifying that this is permitted until January 23 of next year.

Considering the characteristics of digital medical device software, the guideline specifies that the version information and date of manufacture should be indicated as the 'distribution date of the current software version,' and the serial number should be noted as the 'distribution date of the first produced software version.' Alternatively, companies may flexibly indicate these details in accordance with their own GMP systems.

Taking into account the intangible nature of software products, the guideline clearly states that, in accordance with the Digital Medical Products Act, information about digital medical device software should be provided via the company's website, within the software user interface, through subscriber email, or in other similar ways.

To ensure transparency and the consumer's right to know regarding products using artificial intelligence (AI) technology, the guideline provides explanations and examples about the AI learning methods, information on training data, and the range of expected performance.

The Ministry of Food and Drug Safety stated, "We expect this guideline revision to resolve difficulties in the field for the industry and to contribute to the growth of the digital medical device market and enhanced quality competitiveness," adding, "We will continue to provide a variety of support to ensure the stable implementation of related systems."

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