Change Approval, Change Certification and Change Notification for Medical Devices in South Korea

Key takeaway — A licence is a snapshot of the device as it stood at review. When the device changes, the snapshot has to be updated, and the reviewer asks a single question: "does this change affect safety or performance?" If it does, you file a change approval, change certification or change notification. If it does not, a minor change report is enough. Most of the accidents in practice start when a company answers that question in its own favour.

A change follows the track the product came in on

The first principle of change management is simple. A notified product files a change notification, a certified product files a change certification, an approved product files a change approval. Whatever track the device took to reach the market, it stays on that track for changes. If the differences between the three routes are unfamiliar, start with the overview of notification, certification and approval.

There is one bypass: the minor change report. Changes that do not affect performance or safety, and that MFDS (Ministry of Food and Drug Safety, formerly KFDA) has listed in the annexes to the Regulation on Approval, Notification and Review of Medical Devices, can be reported within a set deadline instead of going through prior review. A regulatory amendment at the end of 2023 widened the scope — label design and the external design of components, among others — and set out the decision flowchart in more concrete terms.

A practical read on each type of change

Type of change	Usual treatment	What to watch
Adding a model (model name)	Often subject to review	Turns on the equivalence argument against the existing model. Where specifications diverge sharply, it is effectively a new review
Change of raw material	Likely review if the part contacts the body	Biological safety data in the ISO 10993 series may need to be revisited
Change or addition of manufacturing site	Subject to review + KGMP (Korean Good Manufacturing Practice) implications	Not a "notice." The single most common misconception
Change in performance or structure	Subject to review	Re-examine every affected test, not just the part that changed
Software change	Depends on impact	Screen and UI edits may qualify as minor; algorithm or functional changes point to review
Labelling change	Often qualifies as minor	Changes the intended use or performance claims tell a different story

The word "usual" recurs in that table for a reason: the same category of change can land differently depending on the device and the substance of the change. A colour change is the textbook minor change, but if the part in question contacts the body, the first question is whether a material change comes with it.

Software and labelling are the two areas where judgements most often diverge. On the software side, changing the font or layout of a measurement display is a completely different proposition from adjusting a parameter in the measurement algorithm or adding a new analytical function. The former lends itself to an argument that performance is unaffected; the latter touches the very evidence of performance that was verified at registration, so treating it as a review track is the safe call. Bug fixes are not automatically safe either. If the fixed defect relates to a performance or safety function, record the impact analysis and decide on that basis — software change management records in the IEC 62304 sense are exactly what supports the judgement here. If a diagnostic or analytical algorithm is the core of your product, read the reviewer's perspective in the SaMD approval guide alongside this.

Labelling works the same way. Moving a logo or refining a packaging design has real room to qualify as a minor change, but shortening a precaution or broadening how an indication is expressed goes straight to the intended-use review. The gap between "we just tidied up the wording" internally and "the claim has changed" from the reviewer's chair is a regular source of trouble.

Review required vs minor change — the logic that separates them

The starting point is not memorising a list but asking a question: does this change touch the safety and performance evidence that was reviewed at registration? If it does, that evidence — the technical documentation — has to be updated and reviewed. If it does not, a report is enough.

In practice, a three-step approach is the safe one.

Step 1 — Check the annex. Start with the list of minor-change items in the annexes to the Regulation on Approval, Notification and Review of Medical Devices, together with the decision flowchart. If your change is expressly listed, proceed by report.

Step 2 — Cross-check the underlying evidence. If it is not listed, or the position is unclear, look at the technical documentation and test reports submitted at registration and ask whether this change alters the conclusion of any of them. If even one is affected, you are on the review track.

Step 3 — Confirm in advance when it is borderline. Treating an unclear change as "probably minor" is the single most dangerous move. A finding of undeclared change brings administrative action — suspension of sales, recall — and puts every unit already in distribution in question. A change procedure is a matter of days or months; an undeclared change is a matter of the business.

How a minor change report actually runs

Once you have settled on minor change, the procedure itself is straightforward. Through the electronic civil complaint portal for medical devices you call up the approval, certification or notification number for the item, select the changed particulars, and file the report with a before-and-after comparison table and supporting evidence attached. When the report is accepted, the change is reflected in the particulars recorded on the licence (certificate or notification receipt), and your labelling and internal quality documents then have to be aligned to the same content.

Two cautions. First, the minor change report is an obligation with a deadline. Assuming that "there is no review, so there is no rush" and missing the deadline is a common mistake. Second, acceptance of the report does not transfer responsibility for the judgement. Where an item that was in fact subject to review has been reported as a minor change, it can later be treated as an undeclared change — so keep a documented record of how you assessed the item against the annex before filing. MFDS publishes a guidance document for applicants on minor change reporting that sets out the scope, the filing method and frequently seen errors; it is worth a read before your first report.

Miss the KGMP link and you have done half the job

Change management has a quality system track running alongside the licence track. Relocating or expanding a manufacturing site normally triggers a GMP change audit, and adding a new product group at an existing site triggers an additional audit. For an importer switching overseas manufacturing sites, a full KGMP audit of the new site may be required. The product-group scheme and the audit structure are set out in the KGMP guide.

Sequencing matters. A change of manufacturing site is not "file the change approval, then import once it clears" — it is a project whose whole timeline, KGMP preparation included, has to be designed at the contract stage. For changes that carry a review, budgeting a period comparable to a new registration is the realistic approach, and the extent to which the new site's test reports will be accepted is worth checking in advance against the guide to using foreign test reports.

The importer's problem — overseas sites change quietly

What makes change management uniquely hard for imported products is that the change happens abroad, not in Korea. The manufacturer swaps a board because a component went end-of-life, updates the software, improves the packaging specification — and frequently does not tell the Korean importer any of it. When the product that arrives differs from the Korean licence, the importer carries the responsibility whether or not it knew.

So monitoring has to be built as a system, not left to individual diligence. Three mechanisms are the practical minimum. First, put an obligation to give advance notice of specification changes into the supply contract. Second, name a person and a procedure for receiving and reviewing the manufacturer's change notifications, so that a notice does not arrive and sit unread. Third, run a periodic reconciliation — at least annually — between the particulars on the licence and the actual product and latest specification sheet. Specification changes often coincide with a revision of the manufacturer's CE technical documentation or a certificate renewal, so using those moments as the trigger for a check is efficient. Problems also surface late at customs, where the declared information and the physical goods no longer match, so manage this together with the flow described in the import and customs guide.

Common reasons for rejection or deficiency letters

• Describing only the changed part and omitting the other items the change affects (performance and safety testing)
• Insufficient equivalence comparison against the existing model when adding a model
• Submitting biological safety data based on the old material even though the raw material changed
• A change of manufacturing site filed without running the KGMP audit in parallel, stalling the procedure
• Filing several accumulated changes at once, breaking the chain between change history and supporting evidence
• Reporting as a minor change when the package in fact contained items subject to review

Checklist before you file

• Change specified in writing (what changes, why, and how)
• Cross-checked against the minor-change list and decision flowchart in the annexes
• Affected items listed from the technical documentation and test reports filed at registration
• Manufacturing site change or addition confirmed → need for a GMP change or additional audit assessed
• For an overseas site change, a plan in place to obtain test reports and quality documents for the new site
• Internal controls ensuring only the existing specification is manufactured or imported until the change completes
• History reviewed for past changes that were never reported

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It is barely an exaggeration to say that change management is entirely about determining, early and correctly, which track a change belongs on. Send us a change plan or a before-and-after specification comparison and we will assess both the review requirement and the KGMP implications in a free pre-review.