In recent years, South Korea has implemented a comprehensive Unique Device Identification (UDI) system for medical devices, aiming to enhance patient safety, improve traceability, and align with global standards. As of 2025, understanding and complying with the Ministry of Food and Drug Safety (MFDS) UDI requirements is essential for manufacturers and importers seeking to market medical devices in the Korean healthcare sector. 

What is UDI System?

The UDI system in South Korea was introduced to establish a standardized method for identifying medical devices throughout their distribution and use. This initiative enhances the ability to trace devices, facilitates prompt recalls, and reduces medical errors. The MFDS oversees the implementation and regulation of the UDI system, ensuring that all medical devices are accurately identified and registered. 

What is the purpose of UDI? 

The Ministry of Food and Drug Safety (MFDS) introduced the Unique Device Identification (UDI) regulation to address several important issues within the medical device industry. One of the main objectives is to minimize medical errors that occur when healthcare providers use the incorrect device. The regulation also facilitates the quick identification of medical devices, particularly for tracking distribution details as required under the Medical Device Act’s Article 31-2. 

A significant advantage of the UDI system is its ability to manage device recalls and market corrections swiftly, ensuring that any safety concerns can be addressed in a timely manner. It also enables manufacturers to effectively resolve issues with their devices by clearly identifying individual products. Additionally, the regulation promotes more effective communication between manufacturers and the MFDS regarding device identification. 

The MFDS requires the creation of an integrated medical device information system (IMDIS), which efficiently records and manages critical device-related data, including approval, manufacturing, importation, distribution, and use. 

Each medical device is assigned a unique number within the UDI system, linking it to a database that contains comprehensive information about the product. This number identifies the labeler and the specific characteristics of the device. The UDI must appear on the device packaging and/or be directly marked on the device itself, in both human-readable format (HRI) and barcode or RFID form. 

In South Korea, domestic manufacturers and importers must submit their UDI Device Identifier (UDI-DI) to the IMDIS before distributing the product. The system requires them to enter the device identifier (DI) and general production identifiers (PI), but not the specific identifiers for each unit produced. 

Key Components of the UDI System 

The UDI system comprises two main elements: 

1. UDI Code: A unique alphanumeric code assigned to each medical device, which includes: 

• Device Identifier (DI): The DI is a unique code that identifies the specific model or version of a medical device. It is part of the UDI and is assigned by the manufacturer. The DI remains constant for a specific version of the device throughout its lifecycle. 

• Production Identifier (PI): The PI provides additional information about the device*, such as the lot or batch number, serial number, expiration date, and manufacturing date. The PI can change based on the specific device unit and its production attributes. 

*Class I devices do not require the PI as part of the UDI. 

2. UDI Database (UDID): A centralized database where manufacturers and importers must register their devices’ UDI information. This database enables the MFDS and healthcare providers to access detailed information about each medical device. 

3. UDI Labelling: The UDI must be displayed on the device packaging and, when possible, directly on the device itself, particularly for reusable devices intended to be used multiple times. This display should appear in both human-readable form (text) and machine-readable form (barcode or RFID). These measures ensure that the device can be easily identified and tracked, whether by humans or automated systems, maintaining traceability and compliance throughout its lifecycle. 

Role of Application Identifiers (GS1 AIs) 

Application Identifiers (AIs) are numeric or alphanumeric codes used in GS1 barcodes to provide additional information about a product. These identifiers are essential for tracking and managing products throughout the supply chain. 

Here are some common GS1 Application Identifiers (AIs) used in the PI of a UDI: 

• AI (10): Lot/Batch Number 

• AI (11): Production Date (YYMMDD) 

• AI (17): Expiration Date (YYMMDD) 

• AI (21): Serial Number 

These identifiers help ensure accurate tracking and traceability of medical devices, enhancing patient safety and regulatory compliance. 

Under Article 4, Paragraph 2 of the Regulation on the Unique Device Identifier (UDI) as per MFDS Notification No. 2023-67, a UDI must be regenerated if any of the following changes occur: 

1. Transfer of product license (excluding business license) for a domestic manufacturer. 

2. Changes to the packaging unit. 

3. Modifications related to product disposal or sterilization. 

As outlined, certain changes to device packaging may necessitate the assignment of a new UDI. The MFDS emphasizes the importance of maintaining device identification throughout distribution and use. If changes are made to the packaging, the company must provide a valid rationale for not issuing a new UDI. Additionally, the company’s change management process must account for and track changes across the entire packaging level and the device itself. 

Compliance Requirements 

To comply with the MFDS UDI regulations, manufacturers and importers must: 

• Labelling: Ensure that the UDI code is affixed to the device’s label or packaging in both human-readable and machine-readable formats (e.g., barcodes). 

• Direct Marking: For reusable devices intended to be reprocessed and used multiple times, a permanent UDI mark must be applied directly to the device. 

• Registration: Submit the UDI data to the MFDS’s Integrated Medical Device Information System (IMDIS) before the product enters the Korean market. 

Implementation Timeline 

​South Korea’s Ministry of Food and Drug Safety (MFDS) has implemented a phased approach to the Unique Device Identification (UDI) system for medical devices, as part of its commitment to enhancing patient safety and device traceability. The UDI system was introduced in stages, starting with the highest-risk devices and progressing to lower-risk categories. The implementation timeline was as follows: 

• Class IV (High-Risk Devices): Compliance required by July 2019. 

• Class III: Compliance required by July 2020. 

• Class II: Compliance required by July 2021. 

• Class I (Low-Risk Devices): Compliance required by July 2022. 

This phased approach allowed manufacturers and importers to gradually adapt to the UDI requirements, ensuring a smooth transition and compliance across all device categories.​ As of 2025, all medical devices across all classes must comply with UDI requirements to be marketed in South Korea. 

Benefits of the UDI System 

The implementation of the UDI system offers several advantages: 

• Enhanced Traceability: Improved tracking of medical devices throughout their lifecycle. 

• Efficient Recalls: Streamlined identification and removal of defective or harmful devices from the market. 

• Reduced Errors: Decreased likelihood of medical errors related to device misidentification. 

• Global Alignment: Harmonization with international UDI standards facilitates easier access to global markets. 

Conclusion  

South Korea’s Unique Device Identification (UDI) system is a key step in improving medical device safety, traceability, and regulatory oversight. By assigning unique identifiers to devices, it enhances monitoring throughout their lifecycle and ensures better patient safety. Compliance with the UDI system streamlines regulatory processes and helps with device recalls when necessary.  

OMC Medical can assist with the entire UDI registration process, including medical device classification, registration, obtaining UDI codes, ensuring proper labeling, and submitting required data to the MFDS. With our expertise, you can ensure compliance with South Korea’s evolving regulations.

FAQs 

1. What is Korea’s UDI system for medical devices? 

Korea’s Unique Device Identification (UDI) system is a regulatory framework implemented by the Ministry of Food and Drug Safety (MFDS) to improve the traceability, safety, and management of medical devices. It requires manufacturers and importers to assign a unique identification code to each device and register it in a centralized database. 

2. Who needs to comply with the UDI requirements in Korea? 

All medical device manufacturers, importers, and distributors selling devices in South Korea must comply with the UDI requirements. 

3. Which issuing agencies are recognized by MFDS? 

The MFDS recognizes: 

• GS1 

• HIBCC 

• ICCBBA 

4. Do imported medical devices need UDI compliance? 

Yes, all medical devices sold in Korea, whether manufactured locally or imported, must comply with UDI regulations. 

5. What happens if a device is not UDI-compliant? 

Non-compliance can result in regulatory actions, including delays in product approvals, restrictions on market entry, or penalties imposed by the MFDS. 

6. Can I use the same UDI for different devices? 

No, each medical device model must have its own unique Device Identifier (DI). However, multiple devices from the same batch may share the same Production Identifier (PI). 

7. How does UDI help with recalls and safety monitoring? 

UDI allows faster and more accurate identification of faulty or unsafe devices, making recalls and post-market surveillance more efficient. 

8. How can OMC Medical assist with UDI compliance? 

OMC Medical provides expert guidance on UDI registration, regulatory compliance, and labelling requirements for medical devices in South Korea. Our team ensures a smooth compliance process, helping you navigate MFDS regulations effectively.