This year, the NA audit of the MOHW and MFDS was conducted on October 12-13, 2023. In the field of medical devices, several lawmakers publicly questioned the Minister of Health and the head of the Food and Drug Safety Administration, highlighting issues and proposing solutions. Among the issues that are likely to affect the medical device industry, two key items have been selected and are shared below.

1. Impact of New Medical Technology Evaluation and Regulation on Digital Therapeutic Device Market Growth:

• Representative Gang Gi-yoon of the conservative party raised concerns about the delayed market entry of digital medical devices (including Digital Therapeutics) commonly referred to as the "future industry" due to the traditional medical device evaluation/approval process as per the Medical Act.
• Unlike pharmaceuticals, which can be sold immediately as non-reimbursable products upon approval by the MFDS, medical devices are subject to additional evaluation, causing delays in market growth.
• Representative Gang emphasized that the clinical data reviewed during MFDS approval and the clinical data reviewed during medical device technology evaluation are not significantly different, urging for harmonization of these two processes to allow non-reimbursable use after MFDS approval.
• Minister Cho Kyu-hong of the MOHW explained that legislative amendments are necessary, and he pledged efforts to improve regulations.

2. Low Causality Investigations Despite 7,534 Reports of Medical Device Side Effects in 5 Years:

• In 2018, the Medical Device Act was revised to allow the government-designated causality investigators to examine the causes of side effects reported in medical devices.
• Representative Choi Hyun-sook of the conservative party pointed out that despite 7,534 reported cases of side effects in the five years following the amendment, only 26 cases had causality investigations conducted by designated investigators.
• Currently, there are 58 individuals designated by the government to conduct causality investigations. According to Medical Devices Act Article 43-5, causality investigators are authorized to investigate the causes of side effects related to medical devices at manufacturers, importers of medical devices, and medical institutions.
• In response, the head of the MFDS pledged to conduct more proactive investigations into major side effect cases and cases requiring causality investigation in the future.

Considering the feedback received during the NA audit, the MOHW and MFDS are expected to propose regulatory improvements in the digital medical device market in 2024. Given that digital medical devices cover a wide range of sectors, waiting for regulatory amendments may be more time-consuming than proactively entering the Korean market by initiating product license and commercial efforts under the current structure. If you have any questions or concerns about the above information, please feel free to contact us at MDREX (pro@mdrex.co.kr).

   Thank you.