Item Renewal in South Korea: The Five-Year Medical Device Certificate Cycle

1. Key takeaways

Article 49 of the Medical Devices Act, as amended by Act No. 17248 — promulgated April 7, 2020 and effective October 8, 2020 — established the comprehensive 5-year item renewal (품목갱신) system: all six certificate types, covering manufacturing licence, manufacturing certification, manufacturing notification, import licence, import certification and import notification, must be renewed every 5 years. The previous belief that one approval lasts indefinitely no longer holds from that date.

• Renewal is not a formalistic certificate exchange; the law sets three substantive gates. First, only devices actually manufactured or imported during the validity of the licence may apply for renewal. Second, items with serious safety or effectiveness problems are not renewed. Third, items for which documents are not submitted within the prescribed time are not renewed. Fees must also be paid, and devices exclusively for export and similar cases are subject to separate exceptions.
• On timing, note in particular: taking October 8, 2020 as the starting point of the 5-year cycle, the first batch of new certificates obtained after that date enters the first concentrated expiry window from October 2025. Shifting the 5-year cycle forward, the number of renewals to handle within 2026 will only increase. The common practice of submitting 180 days before expiry is marked in this guide as a practical estimate; the actual acceptance start point is subject to what the competent authority announces at the time.

2. Legal basis

The following instruments define the renewal cycle, the qualifying requirements and the supporting certificates.

Note: the widely adopted practice of submitting 180 days before expiry is an industry operating position, not stated directly in the legal text, and is marked in this guide as a practical estimate; the fee amounts follow the current notices, and this guide does not list specific figures.

3. Expert insights

Insight 1: the renewal system clears dormant items out of the market — a mandatory health check for product line management.

Article 49 requires the renewal object to be a device actually manufactured or imported during the licence validity. The practical effect is that stockpiled items held with an approved certificate but no shipments do not qualify for renewal when they expire. GRZAN recommends using the first expiry window to run a product line inventory and converge the number of licences to the real business plan — every certificate retained adds one more set of 5-year-cycle fees and ancillary duties.

Insight 2: the three non-renewal situations are all concentrated eruptions of earlier management gaps.

Serious safety or effectiveness problems, late submission, and failure to meet the actual manufacture or import requirement look independent but all point to gaps in daily management. The third deserves emphasis: missing the prescribed submission time is itself grounds for non-renewal, meaning a missed window is not recovered by supplying one missing document — the application may have to start again from the first document.

Insight 3: the first concentrated expiry window stacks three timelines.

The 5-year item renewal cycle, the 3-year validity of the KGMP certificate, and the 10-day duty to modify device standard code (UDI) data after changes are usually owned by three different departments. When the three fall in the same year, missing any one affects the other two — an expired KGMP certificate directly drags on licence-type renewals, as described in the guide on the KGMP certificate; UDI data inconsistent with the licence information will trigger a demand for correction before the renewal review proceeds.

Insight 4: the renewal review looks not at the present but at what happened over the 5 years.

Foreign regulatory status, adverse events and change records all enter the field of view — exactly the material scope of re-evaluation under Article 9 of the Medical Devices Act, as described in the guide on the re-evaluation system. GRZAN’s judgement: preparing the renewal package as a small-scale re-evaluation is far safer than treating it as form filling.

4. Practical recommendations

• First take a full inventory of the six certificate types. List the certificates by the six categories of manufacturing/import crossed with licence/certification/notification, marking the effective date and expiry month of each, forming a single source of truth.
• Slice the renewal window into half-year segments. Use a point 6 months before the expiry month as the internal control start point, leaving buffer over the externally circulated 180-day position, and order submissions by document readiness.
• Use the first window to make product line trade-offs. For items with no actual import record during validity, assess the cost of simply giving up renewal rather than spending budget on products unlikely to launch.
• Align KGMP and UDI status at the same time. Mark each item’s KGMP certificate validity and UDI data update date on the same sheet, correcting any desynchronisation first, as described in the guide on the medical device standard code (UDI).
• Have the licence holder submit on a consolidated basis and retain receipts. Import-type renewals are executed by the Korean licence holder; state document provision deadlines and receipt-archiving duties in the agreement, and include completion evidence in the annual compliance file.

5. Verification checklist

• □ Legal basis and timing: verify Act No. 17248 (promulgated April 7, 2020, effective October 8, 2020); the deadline conclusion is traceable to Article 49 and the effective date is indeed October 8, 2020.
• □ Certificate inventory: check certificate by certificate across the six types; nothing is missing and every certificate has an effective date and expiry month.
• □ Actual manufacture/import records: sample shipment and import records within validity; every item applying for renewal has actual transaction flow during validity.
• □ Non-renewal risk: screen item by item against the three situations; no unresolved serious safety or effectiveness issues, and documents submitted within the prescribed time.
• □ KGMP status: check certificate validity and the periodic review application date; KGMP is valid for class 2 to 4 renewals and the application was filed 90 days before expiry.
• □ UDI data consistency: compare IMDIS data with licence information; changes were modified within 10 days and no inconsistencies remain.
• □ Submission lead time: check the internal start point against the practical estimate; scheduling runs backwards from the expiry month with lead time no shorter than the 180-day practical estimate.
• □ Evidence archiving: check submission receipts and fee payment vouchers; receipts and vouchers are complete and filed in the annual compliance file.

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