MDREX Newsletter

2024.4.5.

Notification from MDREX Regarding the Enactment and Implementation of the Digital Medical Products Act

The Digital Medical Products Act was newly enacted on Jan. 23, 2024 and is scheduled to be effective on Jan. 24, 2025 (for Digital Medical/Health Support Devices, to be effective on Jan. 24, 2026). Operated by the Ministry of Food and Drug Safety (hereafter the MFDS), the Act is a newly enacted legislation for the new management of “Digital Medical Devices (e.g. AI SaMD, Robots, Wearable Devices, etc.)" previously managed by the existing Medical Device Act, “Digital Fusion Pharmaceuticals” which combine pharmaceuticals and digital medical devices or digital medical/health management support devices, and “Digital Medical/Health Support Devices (part of the existing wellness products)” which have been used for health management using vital signs.

According to the Act, digital medical devices with a low risk are exempt from Investigational Device Exemption (IDE) requirements previously required by the Medical Device Law, and by newly implementing the system for excellent management system certification, it is specified that medical device manufacturing companies that have received certification for excellent management are to be partially exempt from the document requirements (e.g. technical documents categorized as corporate secrets or confidential information, etc.) for KGMP certification and approval/certification. In addition, the whole Application Programming Interface (API) used in software development is to be certified and registered, to adopt a system which allows for exemption of related documents during the stage of approval for finished products using the registered API.

Moreover, for “Digital Fusion Pharmaceuticals” that have combined pharmaceuticals and digital medical devices or digital medical/health management support devices, in addition to the New Drug Approval (NDA) for manufacturing and sale pursuant to the existing Pharmaceutical Affairs Act, the KGMP, safety and performance documents, clinical trial documents, etc. for digital products that are used in combination or together are required to be submitted. It is worth noting that, for products that are used in combination with pharmaceuticals such as digital therapeutics (DTx), obtaining performance certification is essential even if the DTx in question is classified as a digital device/health management support device.

Finally, for wellness products that measure vital signs or analyzes everyday habits to be used for health management (e.g. apps, etc.), an autonomous system for product listing and excellent performance certification has been implemented. For products that received an excellent performance certification according to the autonomous system, the use of MFDS certification mark is permitted in product marking and advertisements, and a system has been provided so that certified products can be disclosed via the MFDS website. Also, for products that have not received the excellent performance certification, it has been regulated so that the MFDS can implement immediate order of sale suspension/recalls via collection inspections in cases where performance findings different from that which have been advertised are found.

If you would like counsel regarding Digital Medical Products, etc., feel free to contact MDREX (pro@mdrex.co.kr) at any time. MDREX provides reasonably priced consulting services to help your company’s products smoothly enter the Korean market.

Thank you