On January 9, 2024, the Ministry of Food and Drug Safety (MFDS) announced that two amendments to the Medical Device Act had passed the plenary session of the National Assembly. The amendments exempt clinical trials with low- risk device from Investigational Device Exemption Approval and allow clinical trials to be conducted at non-designated sites (first and second-tier hospital, clinic, etc.). The amendments are expected to be revised and promulgated in January, 2024 at earliest.

 

In this context, low-risk clinical trials refer to trials that do not involve direct contact with subjects. Instead, they examine medical data, such as medical records and images, to produce results. These trials are often used in the development and approval of innovative medical devices, such as Digital therapeutics and SaMDs, that utilize Artificial Intelligence-based algorithms.

Therefore, it is expected that this revision will not only allow innovative medical devices to be approved and enter the market quickly but also help revitalize related industries.

* In the case of the U.S. FDA, Investigational Device Exemption is determined by dividing devices into SR (Significant Risk) and NSR (Non-SR) devices based on the degree of risk. This is the first time such system has been introduced in Korea.

 

Furthermore, clinical trials are currently limited to be conducted only at designated clinical institutions with Good Clinical Practices (GCP) conditions and approval from the Ministry of Food and Drug Safety. There are currently about 180 designated institutions, that are mostly tertiary hospitals. However, with this revision, it is anticipated that clinical trials may be conducted at hospitals and clinics under supervision of clinical institution, expanding the range of institutions eligible to conduct clinical trials.

 

If have any questions about the above changes on regulation regarding Clinical trials, please contact MDREX (pro@mdrex.co.kr) at any time.

 

Thank you.