Medical AI Clinical Trials Can Be Conducted Without MFDS Approval

Clinical trials for medical devices with low risk of harm to clinical trial subjects, such as medical artificial intelligence (AI), can now be conducted by institutions other than clinical trial institutions without approval of the clinical trial plan from the Ministry of Food and Drug Safety (MFDS).

On the 9th, the MFDS announced that seven bills under its jurisdiction, including the amendment to the "Medical Device Act" containing this provision, passed the plenary session of the National Assembly and are expected to be amended and promulgated as early as this month.

According to the amended Medical Device Act passed that day, clinical trials that do not involve direct contact with research subjects but analyze subjects' medical data to produce results, such as medical AI, will no longer require clinical trial plan approval from the MFDS. Clinical trials can also be conducted at places other than clinical trial institutions, such as corporate-affiliated research institutes.

Medical AI is a medical device that analyzes patient data to assist medical staff in diagnosis. Previously, clinical trials had to be conducted only at designated clinical trial institutions such as university hospitals after obtaining clinical trial plan approval from the MFDS.

Additionally, clinical trials for low-risk medical devices such as blood pressure monitors and thermometers for chronic disease patients like those with hypertension and diabetes have been improved to allow general medical institutions, such as local clinics where these patients usually receive treatment, to participate in clinical trials.

The MFDS explained that this is to establish a foundation for the rapid commercialization of medical devices and to help revitalize related industries. On the same day, the plenary session also passed the amendment to the Hygiene Products Control Act, which allows manufacturers of hygiene products to request inspections from other testing institutions if they object to the results of self-quality inspections conducted by outsourced external testing agencies, and the amendment to the Cosmetics Act, which clarifies that the name, ingredients, and expiration date of cosmetics must be indicated on external packaging.

Furthermore, the amendment to the Narcotics Control Act, which prohibits medical professionals handling narcotics from self-prescribing or administering narcotics to themselves, so-called "self-prescription," was also approved.

The MFDS also explained that the Special Act on Medical Products for Public Health Crisis Response, which provides a basis for differentiating the level of product management according to the severity of public health crises and the supply status of medical products, passed the plenary session.

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