MDREX Newsletter

2024.9.24.

MDREX, Co-hosting Online Seminars Focusing on “Considerations in reimbursement listing upon implementation of Digital Medical Products Act”

As the Digital Medical Products Act was newly enacted on January 23, 2024 and will go into effect on January 24, 2025, the Ministry of Food and Drug Safety announced a legislative notice concerning its subordinate statues, namely Enforcement Decree and Enforcement Rules of the Digital Medical Products Act, on July 31, 2024. Accordingly, the industry is increasingly interested in the regulations applicable to “digital medical devices (e.g., AI SaMD, Robotics, Wearable Devices, etc.)”, “digital combination products (e.g., products that combine drugs and digital medical devices or digital medical/health management support devices, such as DTx)” and “digital medical/health support devices (wellness products, etc.)” managed by the said act, as well as matters to consider when registering them with reimbursement.

For this reason, MDREX plans to hold two seminars in collaboration with KMDIA (Korea Medical Device Industry Association) and APACMed (Asia Pacific Medical Technology Association) as scheduled below. We would like to extend our invitation for you to join!

Should you like consultation with regards to the Digital Medical Products Act and others, please contact us via email (pro@mdrex.co.kr). We at MDREX provide support for your market entry at a reasonable fee.

Thank you