Starting this December, advertisements that use artificial intelligence (AI) to generate virtual figures resembling real doctors or medical experts to recommend or endorse medical devices will be strictly banned in South Korea. Violators will face up to three years in prison or fines of up to 30 million won.
The Ministry of Food and Drug Safety (MFDS) issued a legislative notice on the 14th for a proposed revision to the Enforcement Rule of the Medical Devices Act. The update follows statutory amendments to the Medical Devices Act enacted on June 9 and establishes detailed administrative guidelines alongside updated procedures for emergency-imported medical devices and clinical trials.
Strict Criteria for AI-Generated Endorsements
The ban specifically targets advertisements utilizing AI-generated audio, images, or video that are difficult to distinguish from actual footage and create the false impression that a medical professional or expert is guaranteeing, recommending, or using a specific medical device. The provision officially takes effect on December 10.
While misleading expert endorsements were already prohibited under existing law, the June amendment explicitly added AI-generated "fake experts" to the list of prohibited practices. The proposed enforcement rule outlines the operational standards regulatory authorities will use during day-to-day oversight.
Overhauling Emergency Imports and Expanding Clinical Trials
The government is also overhauling the emergency-import medical device system, which supplies unapproved foreign medical devices to domestic patients with rare or intractable diseases when no local alternatives exist. The revised enforcement rule details the criteria for designating or removing emergency-import items, as well as the procedures for conducting demand surveys and managing distribution. The Korea Medical Device Safety Information Institute will oversee the importation, supply, and survey operations.
Additionally, the revision broadens the network of medical institutions eligible to participate in clinical trials. Currently, trials for medical device approval must be conducted at MFDS-designated institutions. Under the new rule, regional clinics and hospitals in areas lacking designated facilities may participate in clinical trials under the supervision of a primary designated institution, subject to Ministry approval. The government is also refining its pre-review system to clarify procedures for confirming product classification prior to formal approval applications.
