Clinical trials for low-risk medical devices, including medical artificial intelligence (AI), can now be conducted without the need for clinical plan approval from the MFDS. (Image courtesy of Yonhap)
SEOUL, Jan. 10 (Korea Bizwire) – The South Korean Ministry of Food and Drug Safety (MFDS) has announced that clinical trials for low-risk medical devices, including medical artificial intelligence (AI), can now be conducted without the need for clinical plan approval from the MFDS.
This change will also allow trials to be conducted outside of designated clinical trial institutions.
According to the revised Medical Devices Act, clinical trials that do not involve direct contact with research subjects, such as those analyzing patient medical data using AI, will no longer require prior approval from the MFDS.
This marks a significant shift from the previous regulations, where clinical trials, especially for medical AI that assists in diagnosis by analyzing patient data, required approval and were confined to specific institutions like university hospitals.
The amendment aims to streamline the approval process for medical AI and other low-risk medical devices, such as blood pressure monitors and thermometers used by chronic disease patients.
Recognizing that these patients typically receive care in local clinics and general medical practices, the revision allows these institutions to participate in clinical trials.
This initiative is part of the MFDS’s efforts to expedite the commercialization of medical devices and stimulate the development of new products.
Additionally, the amendment to the Cleansing and Hygiene Products Control Act allows manufacturers to seek secondary testing from different laboratories if they dispute the results of quality tests conducted by external institutions.
Other significant legislative changes include amendments to the Cosmetics Act, clarifying the requirement to list product names, ingredients, and expiration dates on external packaging, and the Narcotics Control Act to prevent self-prescription of narcotics by medical practitioners.
Lastly, the Special Act for the Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis was also passed, providing a basis for varying levels of product management depending on the severity of public health crises and the supply situation of medical products.
Kevin Lee (kevinlee@koreabizwire.com)
