Tracked Medical Devices in South Korea: Traceability and Record Duties

1. Key takeaways

South Korea imposes tracking management (추적관리) duties on a set of high-risk, high-value or supply-chain-complex devices, known as tracked medical devices. The core requirement is to record a device all the way from the production end to the point of use: the relevant entities must record and report to the competent authority the item count, dates, users and other information.

• The commonly cited scope is 52 types, composed of two parts: about 48 types of devices implanted in the human body for 1 year or more, plus 4 types of life-sustaining devices that can be used outside medical institutions. This set of figures comes from authoritative industry reviews and prevailing interpretation, not read directly from the legal text, and is marked in this guide as a practical estimate; the specific list of types follows the list annexed to the current notice.
• The real difficulty of this duty lies not in understanding the principle but in the changeability of the list and the depth of the recorded information — the user field means an internal batch ledger will not suffice.

2. Legal basis

The following instruments frame the record and reporting duties for tracked devices and their supporting links.

Note: the total of 52 types and its composition (48 types implanted 1 year or longer plus 4 types of life-sustaining devices usable outside medical institutions) is a practical estimate drawn from authoritative industry reviews; the specific item list, determination criteria and reporting format follow the list annexed to the current notice.

3. Expert insights

Insight 1: writing the user into the record items determines how this duty lands.

Most distributors and internal ERP systems manage by customer — recording medical institutions or distributors. Tracking management requires recording users, which means the system must be able to answer which batch was implanted into which patient, when, and by whom. This layer of data can only be produced at the medical institution end, so companies must build a channel that returns data from the terminal.

Insight 2: the list of types changes, and a determination logic is more useful than memorising the list.

The figure of 52 types is a static snapshot, and types can be added or adjusted. The more valuable practice is to fix the determination logic: whether the product is implanted in the human body, whether the expected in-body residence time reaches 1 year, and whether it is a life-sustaining device usable outside medical institutions. Screening new models against these three questions is easier than re-checking the list every quarter and less prone to misses.

Insight 3: tracking management, UDI and distribution record reporting share one data foundation.

Since batches must be traced to users, the medical device standard code (UDI) identification is the natural index key, as described in the guide on the medical device standard code (UDI); the flow, return and recall category data likewise come from distribution record reporting, as described in the guide on distribution record reporting and supply details reporting. GRZAN recommends mapping the fields of the three systems once, so the same data is not entered three times and still inconsistent.

Insight 4: the real value shows at the recall end.

The purpose of tracking management becomes tangible when a device needs a recall or a batch problem occurs: if specific users can be located and notified in the shortest time, the recall scope can be appropriately narrowed. Conversely, without complete user data the recall can only be issued to the entire batch in full, at far greater cost and reputational damage.

4. Practical recommendations

• Replace memorised lists with determination logic. Establish the three screening rules, judge each new model before launch item by item, and retain the determination records.
• Use UDI as the primary key across systems. Index all tracking records by the UDI-DI and UDI-PI combination, avoiding the mismatches produced by reconciling on internal part numbers.
• Build a data return channel at the terminal. Agree with key medical institutions on the reporting deadlines and format of use registration, and provide a simple registration entry where necessary.
• Connect tracking data to the recall contingency plan. State directly in the recall plan the operational steps and time limits for locating the user list from the tracking ledger.
• Review alongside the other implant device duties. Compensation liability insurance and adverse event reporting apply at the same time; manage them together in one compliance file, with the insurance requirements described in the guide on medical device compensation liability insurance.

5. Verification checklist

• □ Whether the device is tracked: screen by the three determination rules and check against the current notice list; the determination is documented and re-checked whenever the list updates.
• □ Record item completeness: sample the latest record; it contains all three items — item count, dates and users.
• □ Index key consistency: compare UDI data with the numbering rules of tracking records; the two are mutually searchable with no duplicates or gaps.
• □ Terminal data channel: check the registration return agreements with medical institutions; written agreements exist and return data arrives on time.
• □ Consistency with distribution data: cross-check IMDIS flow data against the tracking ledger; quantities and timing agree and every discrepancy is explained.
• □ Recall linkage: check the locating steps in the recall plan; the user list can be generated within the time limit set in the plan.
• □ Currency of the type list: check the date of the last list verification; no more than one quarter before the verification date.

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team manages adverse event reporting and recall coordination with MFDS, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com