South Korea’s Digital Medical Product Classification and Registration

By Sora Lee

Background on Digital Medical Products Act  

As discussed in our initial Regulatory Update,  the Ministry of Food and Drug Safety (MFDS) has enforced the Digital Medical Products Act (DMPA). Now that we have over a year of experience with the DMPA we share insights related to the Digital K-GMP (background, insights), as well as identification of the appropriate product code, risk classification, and registration process. 

Background on classification under the Digital Medical Products Act  

The rapid development of software and AI technologies has led to the emergence of digital medical devices with increasingly diverse and complex characteristics. Because these products may have multiple intended uses or evolve through software updates and AI learning processes, the conventional medical device classification system based on predefined intended uses has limitations in appropriately categorizing such products and identifying their associated risks. Therefore, a separate classification framework for digital medical devices was introduced.

Regulations on product code and classification of digital medical products

Under the Digital Medical Products Act (DMPA), the manufacturer and/or importer should identify the appropriate product code and proposed classification based on detailed classification and grading criteria for digital medical products. A new seven-character alphanumeric product code is introduced for digital medical devices.

The product code and classification are finalized during the registration process. False or incorrect product codes or classification may result in a request for supplementary information or rejection during the review process.

This article focuses on product code identification.  

Background on DMPA product code

Article 6, Paragraph 2, Annex 3 of the Regulations on Classification and Grading of Digital Medical Products describes the product code. Each digital medical product is assigned to a seven-character product code based on the intended use, technology and product form. In this product code, the first two characters represent the primary intended use, the following three characters represent the technology type, and the last two characters represent the form of the product.  

The product code for a digital medical device product group is generated based on the characteristics of a representative product selected to represent the product group.  

DMPA product code intended use

The first character of a digital medical device is assigned based on the primary intended use, and the second character is assigned based on the detailed characteristics of the products under each primary intended use.

DMPA product code technology type

The third to fifth characters for digital medical devices are recorded sequentially from “A” to “E” according to the types of digital technologies in the device.

If only one digital technology is used, the fourth and fifth characters are marked as “X.” If only two digital technologies apply, the fifth character is marked as “X.” If four or more digital technologies apply, the fifth character is marked as “P.”  

DMPA product code product form

The sixth character for digital medical devices is assigned based on the fundamental digital technology, and the seventh character is assigned according to the form of the digital medical device.  

Concluding remarks  

With the separation of software medical devices (SaMD and SiMD) under the Medical Device Act and In Vitro Diagnostic Medical Device Act, the compliance of digital medical products has become significantly more complex and challenging.

Based on Emergo by UL's expertise, we can assist with assigning the appropriate seven character product code. The product code is one critical step in the registration process. Our next articles will discuss classification and the submission of regulatory documents.