Renewing a Korean Medical Device Licence — Five Years, and a Window 270 to 180 Days Out

Key takeaway — Korean approvals, certifications and notifications carry a five-year validity and must be renewed before expiry. The place accidents happen, though, is not the number five but the fact that the application deadline is a window, not a point: from 270 days to 180 days before the expiry date. Too late and too early both miss it. Current as of September 2026.

Approval is not the end of the matter

Something first-time applicants often miss: the certificate has an expiry date.

• Validity: five years
• Basis: Article 49 of the Medical Devices Act; Articles 62 and 62-2 of its Enforcement Rule
• Detail: Regulation on Renewal of Medical Device Manufacturing Approvals (MFDS Notice No. 2023-68, issued and effective 26 October 2023)

The scheme has two purposes — periodic re-examination of safety and performance after initial approval, and clearing out items that are not actually being manufactured or imported. The second purpose connects directly to the conditions below.

Scope — Class I notifications are included

	Content
In scope	Medical devices of all classes that have been approved, certified or notified
Excluded	Devices manufactured or imported solely for export; devices under conditional approval, certification or notification

A common misconception worth settling: Class I notifications are easy to assume are out of scope, but all classes are covered.

Class I is remembered as "file once and done" because the pathway is light. Post-issuance obligations, however, attach regardless of class — as with UDI registration and supply reporting, so with renewal. The obligations that follow a Class I notification are set out in the post-notification obligations guide.

The deadline — where this scheme goes wrong most often

The renewal application is filed from 270 days to 180 days before the validity period ends.

Read that again. It is a window, not a start date.

For an item expiring on 1 March 2027, the window runs roughly from June 2026 to September 2026. Not before, not after.

The typical failure modes:

• "Over a year left, we will get to it" — the responsible person changes, and by the time it resurfaces the window has passed
• "Surely filing before expiry is enough" — a month before expiry is already too late
• Several items with staggered expiry dates — without a register, they are missed one at a time

So the practice to adopt is simple: keep a register of expiry dates by item, and mark both D-270 and D-180 for each. Not one reminder — mark the opening and the closing of the window.

Renewal conditions — a record of trade matters

Renewal is not a matter of filing alone. There are conditions:

• No serious issue with the safety or performance of the device
• Diligent submission of the documents required for renewal
• A record of production or import for that device
• Diligent compliance with related legislation
• Conformity with other criteria set by the Minister of Food and Drug Safety

The third one calls for a judgment. Where an item has no production or import record, the scheme is designed to retire it.

So there is something the company has to decide before the window arrives: keep this item, or let it go. Companies that registered a broad line-up but trade only part of it find that renewal forces a review of the list. That is not necessarily bad news — maintenance carries cost.

Do not confuse renewal with change approval

They are different procedures.

	Renewal	Change
Trigger	Time has passed (five years)	The content has changed
What is examined	Whether it should continue	Whether the change is sound
Timing	270–180 days before expiry	When the change arises

A change to specification or manufacturing source is a change procedure, not renewal — see the change approval guide. Conversely, renewal arrives after five years even if nothing has changed.

Within the wider post-market picture

Renewal is not the only obligation that follows issuance.

• UDI registration and supply reporting — medical device integrated information system guide
• Change approval — when specification, manufacturing source or labelling changes
• Advertising review validity — reviewed advertising runs on its own three-year cycle (advertising review guide)
• Quality manager training — eight hours a year (quality manager guide)
• Maintaining KGMP — KGMP guide

Several obligations run on different cycles, so collecting them into one register makes them manageable.

Common mistakes

• Not knowing that approvals carry a validity period at all
• Assuming Class I notifications are out of scope
• Reading the deadline as "before expiry" and missing the 270–180 day window
• Not keeping expiry dates by item, and missing them one at a time
• Leaving items with no trade record in place without deciding
• Treating renewal and change approval as the same procedure

Before you start

• Compile approval, certification and notification dates and expiry dates for every item held
• Mark D-270 and D-180 on the calendar for each item
• Check whether any item is excluded (export-only, conditional)
• Check production and import records per item → decide whether to keep items without one
• Confirm the renewal document list in advance
• Consolidate renewal, change, UDI and training into one register despite their different cycles

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Renewal is calendar management if you learn about it early and an incident if you learn about it late. Send the list of approval dates for the items you hold, and we will map when each window opens and what to prepare — see free preliminary review.