On June 9, 2026, The Ministry of Food and Drug Safety (MFDS) of Korea has promulgated the Partial Amendment to the Medical Devices Act.
The purpose of the relevant partial amendment is to prevent confusion by revising the terminology from ‘orphan and urgently necessary medical devices’ to ‘urgently introduced medical devices,’ to clearly stipulate in the law matters concerning the designation and de-designation of urgently introduced medical devices, demand surveys, and the establishment of supply plans, and to designate the Korea Medical Device Safety Information Service as the entrusted agency for urgently introduced medical devices; and to prohibit advertisements that utilize virtual sounds, images, or videos generated by artificial intelligence systems that are difficult to distinguish from reality and are likely to mislead the public into believing that experts in the relevant field, such as doctors and dentists, are endorsing, designating, accrediting, recommending, instructing, or using the medical devices.
This Act shall take effect six months after the date of its promulgation.
Please refer to the attached document below.
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