South Korea’s Digital Medical Product Classification and Registration

By Sora Lee

What products are subject to the DMPA?

The Digital Medical Products Act (DMPA) applies to medical devices and in vitro diagnostic medical devices (IVDs), which also include or use qualifying digital technologies (e.g., AI, intelligent information/robot technologies, high-performance computing technology or virtual convergence technology). A digital medical product, per the DMPA, only needs to be compliant with the DMPA. 

Background on DMPA

The DMPA requires manufacturers of digital medical devices to secure the Digital Korea Good Manufacturing Practice (Digital K-GMP) (background, insights), identify the appropriate product code and risk class and submit regulatory documents to register the product.

Both the seven-character product code and risk classification are important parts of the process and only finalized during the registration process. The National Institute of Medical Device Safety Information (NIDS) reviews the class specified by the manufacturer for Class I and II devices, and Ministry of Food and Drug Safety (MFDS) reviews whether the class specified by the manufacturer is appropriate for Class III and IV devices. A preliminary review of the product code and risk classification is possible, though it requires an official query to MFDS (55 working days, and fees). 

DMPA classification of digital medical products

Digital medical products are classified according to Article 7, Paragraph 2, Annex 4 of the Regulations on Classification and Grading of Digital Medical Products: based on intended use, functions, and potential risks to the human body.

If a medical device qualifies as a digital medical product and consists of embedded software and standalone software, the highest applicable classification determined under subparagraph A or B applies to the digital medical product. 

DMPA classification: Digital medical devices with embedded software

The classification of a digital medical device with embedded software follows the classification of the medical device hardware. However, if the device includes one or more embedded digital medical device software functions, the higher of either the hardware classification or the classification of each embedded software function applies. 

The medical device hardware is classified according to its intended use, in accordance with the criteria set forth in Subparagraph 2(a) or 2(b) of Annex 1 of the Enforcement Regulations of the Digital Medical Products Act. 

The functions of embedded digital medical device software are classified by function, applying mutatis mutandis the criteria shown in the table below.

DMPA classification: Standalone digital medical device software 

The classification of standalone digital medical device software follows the classification of its function. If the software has more than one function, the highest classification among those functions applies. 

The classification of each function of standalone digital medical device software is determined by considering the intended use, taking into account the medical situation or patient condition, the impact on healthcare, and the level of direct or indirect harm in case of performance degradation or malfunction, in accordance with criteria a)-c) below. The level of harm in the event of performance degradation or malfunction is not considered if the classification is determined as Class I based on the medical situation or patient condition and impact on healthcare. If the final classification exceeds Class IV, it is classified as Class IV. Classification cannot be downgraded from Class II to Class I. While this requirement is specified only for standalone digital software, it appears to apply to embedded software as well.

DMPA classification: Applicable to embedded software and standalone software

The following information is provided to classify the embedded software and standalone software. Note that this classification is based on International Medical Device Regulators Forum (IMDRF) guidance. 

1. Medical situations or patient conditions are categorized as critical/life-threatening (death may occur immediately or within 24 hours without immediate intervention), serious (severe disease) or non-serious (other conditions).
2. Impact on healthcare is categorized as treatment/rehabilitation (including disability assistance/relief and narcotics addiction rehabilitation), testing, diagnosis, support for medicinal products, clinical management guidance (e.g., prediction, prevention), information provision/management (monitoring) and others. 
3. The level of direct or indirect harm in case of performance degradation or malfunction is classified based on the severity of harm that may affect patients, users or others due to software failure, design defects or potential defects arising during use, as follows: possibility of death, possibility of injury (serious or minor), or no possibility of injury or physical harm. In this case, risk management factors (including risk control measures considering users and use environments) in accordance with Annex 1, Subparagraph 5 of the Regulation on Approval, Certification, Notification, Review, and Evaluation of Digital Medical Products and the Quality Management System for Manufacturing of Digital Medical Devices are comprehensively considered. 

Concluding remarks 

With the DMPA, the registration of digital medical products has become significantly more complex and challenging. Once a medical device or IVD is categorized as a digital medical product per the DMPA, that becomes the primary applicable legislation and the manufacturer must secure the Digital K-GMP, determine the seven-character product code and identify the risk classification. The risk classification is based on the IMDRF software guidance documents. Our next Regulatory Update discusses the regulatory documents for the registration submission. 

Based on Emergo by UL's experience with digital medical product regulations, we can support manufacturers with Digital K-GMP compliance, product code identification, risk classification and registration activities.