Change Management: From Item-by-Item Prior Approval to a Negative List System

1. Key takeaways

Change management in Korea is governed by MFDS Public Notice No. 2022-52 (effective July 29, 2022): 2 procedures, change approval and change notification, with a 15-working-day change review period for Class 2 devices. The current Enforcement Rule is Prime Minister Decree No. 2127 (partially amended and effective July 1, 2026); the processing period under Article 17, Paragraph 2 remains within 20 days.

• The Enforcement Rule amendment bill was pre-announced on March 3, 2026, proposing a negative list system: only new manufacturing sites, intended use, principle of operation and raw materials – 4 categories significantly affecting safety and effectiveness – would retain prior approval; other changes would be self-recorded under a change self-assessment and management procedure filed with the initial licence application. Per a search on the National Law Information Center, as of October 29, 2026 the bill had not been formally promulgated and the system remains proposed.
• Companies must still file under the two current procedures; once promulgated, the switching moment falls on the initial licence application date: filed then, it opens the self-management channel and most changes no longer wait instance by instance; not filed, the channel stays closed.
• The same bill also proposes shortening the condition fulfilment confirmation period from 20 days to 10 days for KGMP-conditioned licences, and expanding the recall standard to non-conformity with licensed test specifications; not formally promulgated as of October 29, 2026, and the current period remains within 20 days.

2. Legal basis

The instruments below cover the pending bill, current procedures, statutory review periods and KGMP obligations. Regulatory information verified as of October 29, 2026.

Change categories versus procedures. The current procedure against the proposed one, not yet in effect.

3. Expert insights

The proposed negative list system moves the review action from after the change to before the licence. It moves review to before the licence; once in force, waiting time drops significantly, but a documented system must be built upfront. Not formally promulgated as of October 29, 2026, yet its shape is clear and preparation can start now. GRZAN breaks it into 4 mandatory modules – identification and grading rules, evaluation methods and judgment criteria, record formats and retention periods, reviewer and approval authority; missing any, it is not executable.

The 4 retained categories overlap heavily with the six SE comparison elements; one set of technical judgments should serve both documents. New manufacturing sites, intended use, principle of operation and raw materials overlap heavily with intended use, mechanism of action and raw materials among the six comparison elements in Article 22: Substantial equivalence documentation – how to select the comparison device. Written independently, the same judgment would exist in two contradicting versions when traced. GRZAN keeps one technical judgment worksheet; the comparison table and change grading table both derive from it.

Self-assessment does not mean deciding by yourself; the records are what gets inspected (proposed basis). Self-recorded management means the company executes under the procedure it submitted, and the authority inspects against it. The more principled the wording, the smaller the interpretation room. GRZAN pre-sets judgment examples for common change types – packaging quantity changes, minor software version updates, like-for-like supplier replacement – writing the outcome into the annex to remove execution-layer discretion (practical estimate: the list follows the product structure).

Faster conditional licence confirmation and the recall standard expansion are two faces of the same bill – neither has landed. The bill proposes shortening the KGMP-conditioned licence confirmation period from 20 days to 10 days, changing cash and scheduling rhythm, not technical requirements. Not formally promulgated as of October 29, 2026, and Article 17, Paragraph 2 remains within 20 days – the licence-first, KGMP-later route must still be scheduled on the within-20-days basis, or a gap opens at the waiting-for-reply step. KGMP audit types and the 3-year validity are in Article 16: KGMP certificate – scope, audit types and 3-year validity. The same bill also expands the recall standard to non-conformity with licensed test specifications, likewise not yet promulgated; once in force, a self-management change without a synchronized update of the licensed test specification would also constitute a recall ground – so keep the specification ledger in step with change records from now, see Article 26: Application and exemptions of Korean medical device standard specifications.

4. Practical recommendations

• File under the two current procedures, while preparing the change self-assessment and management procedure. Change approval and change notification still apply; keep the procedure as a standby for filing with the initial licence application once in force; filing later means returning to approval change by change.
• Pre-judge the red-line list against the 4 proposed retained categories. New manufacturing sites, intended use, principle of operation and raw materials always go through prior approval under the proposed direction, outside self-management.
• Pre-set judgment examples for common changes. Write the conclusions for high-frequency changes into the annex to narrow execution-layer discretion (practical estimate).
• Link change records to the master technical document. Change records trigger master document and UDI data updates; UDI data must be modified within 10 days of the change.
• Keep the specification ledger in step with change records. Judge every change against the licensed test specifications first; changes touching specifications must be updated in the licence documents.
• Track the bill as a package for promulgation. It covers change management, condition fulfilment confirmation, ex officio revocation and the recall standard, was not formally promulgated as of October 29, 2026, and the current basis remains Article 17, Paragraph 2, within 20 days. The item-by-item timetable is in Article 49: Korean medical device regulatory updates 2026.

5. Verification checklist

• □ Change self-assessment and management procedure: ready before promulgation, filed with the initial licence application after promulgation, traceable to acceptance.
• □ All 4 modules of the procedure present: identification and grading, evaluation methods, record formats, authority settings; none missing.
• □ Red-line list: the 4 proposed retained categories sit outside self-management, always prior approval.
• □ Judgment examples: conclusions for common changes in the annex; high-frequency changes all pre-judged (practical estimate).
• □ Record trail: sample change and approval records; records contain the evaluation process, reviewer and date.
• □ Technical document synchronization: change records match the master document version numbers.
• □ Specification ledger synchronization: changes touching licensed test specifications updated in the licence documents.
• □ Promulgation status: confirmed not formally promulgated as of October 29, 2026; current basis Article 17, Paragraph 2, within 20 days.

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 prepares MFDS-compliant technical dossiers, coordinates KGMP documentation, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com