Regulations on Unique Device Identification (UDI) Management in South Korea (MFDS)

South Korea’s Ministry of Food and Drug Safety (MFDS) issued MFDS Notice No. 2019-46 (established June 12, 2019) to define the details of what medical device manufacturers and importers must register in the national UDI system, including the scope of required information, registration procedures, and update rules. MFDS also publishes this regulation as part of its official English regulatory resources. ([mfds.go.kr][1])

1) Purpose and legal basis

The notice exists to operationalize the UDI-related obligations under the Medical Devices Act and its Enforcement Rule, by specifying:

• what UDI/device information must be registered,
• who must register it,
• and the method and procedures for registration. ([eLaw][2])

2) Who must register, and where

Medical device manufacturers and importers (including for imported devices, information on foreign manufacturers) are required to register prescribed information in the UDI System, via electronic means such as the Internet, when they release a device that has been licensed, certified, or notified.

3) What must be registered in the UDI System

The regulation groups mandatory registration items into three buckets.

A) UDI information (identification + barcode standard)

Manufacturers/importers must register:

• UDI-DI (Device Identifier), and
• the barcode labeling system used (choose from GS1, HIBCC, ICCBBA).

B) Product information (packaging, control, safety flags, licensing, tracking)

Required product-level fields include (selected highlights):

• total quantity in packaging
• for standalone software, software version
• management format: lot/serial/manufacture date/expiry date
• sterile status and (if applicable) sterilization requirement and sterilization method (e.g., autoclave, EO gas, etc.)
• whether it is a national health insurance benefit item and (if applicable) benefit code
• fatal warnings/contraindications flags (e.g., latex, DEHP/phthalates for fluid sets, MRI safety)
• implantable, single-use
• item name, class, license/certificate/notification number and date, product/model name
• whether subject to tracking; and set/composite device component item name/class

C) Manufacturer/importer information (including foreign manufacturer details)

Required company-level fields include:

• UDI management contact (phone/email)
• manufacturer/importer name and addresses, including contracted manufacturer (if any), and for imports the foreign manufacturer’s name/address

4) Optional information you may register (when needed)

The regulation allows (but does not require) additional fields such as:

• storage conditions,
• distribution/handling conditions,
• URL for further product description including electronic IFU (e-IFU),
• package DI,
• customer service desk information.

5) Exemptions: when some items can be skipped

If certain information is already linked through MFDS’s license information system, the notice allows exemptions from registering:

• some product information items (the notice references items (j) through (s) within the product list), and
• certain manufacturer/importer information items (the notice references items (b) through (f) within the company list).

6) Updates, confidentiality, and governance

Registering changes

When specified registered information changes, manufacturers/importers must register the changes in the UDI System within 10 days after the date of change (the notice points to defined subsets of product and contact information).

Confidentiality obligations

Anyone who learns confidential manufacturer or product information (company secrets) through their work must not disclose it or use it for non-business purposes.

Re-review cycle

The regulation’s validity is to be reviewed every three years (from January 1, 2019; by Dec 31 of every third year) with improvement measures taken as needed.

7) Phased enforcement timeline (by device class)

The addenda specify phased entry into force:

• Class IV: July 1, 2019
• Class III: July 1, 2020
• Class II: July 1, 2021
• Class I: July 1, 2022

This phased approach is also reflected in the Enforcement Rule’s addenda for provisions tied to UDI-related requirements. ([eLaw][2])

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Practical compliance tips (sponsor/manufacturer checklist)

• Decide your issuing agency format early (GS1 vs HIBCC vs ICCBBA) and ensure your UDI-DI and labeling match.
• Map internal PLM/ERP fields to MFDS UDI data fields (sterility, sterilization method, warnings like latex/DEHP/MRI safety, implantable/single-use).
• For imported devices, prepare foreign manufacturer identifiers/address data and UDI contact ownership.
• Put a change-control trigger in your QMS to ensure UDI updates are filed within 10 days when relevant fields change.
• If you publish e-IFU, register the URL (optional) and maintain version control so the URL remains valid over time.

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Q&A

Q1. What exactly must be registered for the UDI itself?

At minimum, the UDI-DI and the selected barcode labeling system (GS1/HIBCC/ICCBBA).

Q2. Are software-only medical devices covered?

The notice explicitly calls out that for standalone software, the software version must be registered as part of product information.

Q3. What if my device is sterile or needs sterilization before use?

You must indicate whether it is sterile, whether it requires sterilization before use, and (if yes) the sterilization method from the listed options (e.g., autoclave, EO gas).

Q4. How quickly do I need to update the UDI system when something changes?

For specified fields, changes must be registered within 10 days after the change date.

Q5. Is there any relief if MFDS already has my information in another system?

Yes—where certain information is linked through MFDS’s license information system, parts of the registration may be exempted as described in the notice.

Q6. When did UDI requirements start applying to each class?

They were phased in from July 1, 2019 (Class IV) through July 1, 2022 (Class I).

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References

• Regulations on Unique Device Identification Management, Etc.* (MFDS Notice No. 2019-46).
• MFDS official English regulations listing. ([mfds.go.kr][1])
• Korea Law (KLRI e-Law): Enforcement Rule of the Medical Devices Act (shows phased enforcement provisions). ([eLaw][2])