Three Market Entry Pathways for Medical Devices in South Korea

1. Key takeaways

Korea has only three premarket market-entry pathways, and the single variable that separates them is device class. Class 1 devices go through item notification, received by the National Institute of Medical Device Safety Information (NIDS), with a statutory review period of 5 working days and an official fee of KRW 85,000. Class 2 devices go through item certification, in which a designated review organization reviews the technical documents, with an initial period of 25 working days and 15 working days for changes, and official fees of KRW 2,400,000 and KRW 1,800,000 respectively. Class 3 and Class 4 devices go through item approval, reviewed directly by the Ministry of Food and Drug Safety (MFDS), with 55 working days where no clinical trial is required and 70 working days where one is, and official fees of KRW 561,000 and KRW 1,338,000.

The sequence of determination must not be reversed: first confirm whether the product falls under the Medical Device Act, the In Vitro Diagnostic Medical Devices Act, or the Digital Medical Products Act, then assign the class according to the classification criteria in Annex 1 of the Enforcement Rule. Once the class is fixed, the pathway, the receiving body, the review period, and the fees are all fixed at the same time. What a company can optimize is the structure of its documentation and the timing of submission; it cannot choose freely among the three pathways.

GRZAN refers to this step in project assessment as “pathway lock”, and it is the baseline for all subsequent timeline and budget calculations. Any delivery commitment given before the pathway is locked cannot be treated as executable.

2. Legal basis

The pathway system rests on the following instruments, cited here with their official numbers, publication dates, and operative provisions.

Statutory review periods and official fees (per the Enforcement Rule annex)

3. Expert insights

The naming difference between the three pathways reflects a difference in review intensity. Item notification, item certification, and item approval correspond in Korean to sin-go, in-jeung, and heo-ga, with review intensity rising in that order. Notification is primarily a formality check, certification centers on technical document review, and approval adds clinical data and the professional assessment performed inside MFDS. GRZAN advises companies not to read item notification through the lens of the Chinese-style filing concept: notification is likewise a route to lawful market authorization, and its outcome carries the same subsequent change management, item renewal, and post-market obligations.

Class 2 is the only class with an institutional split. Class 2 devices are certified by a designated review organization by default, but four situations must be redirected to MFDS: products requiring a clinical trial report, digital health related devices such as telemedicine systems, novel devices not defined by the nomenclature and classification rules, and devices combined with drugs. Products of the same class can differ by months in real timeline depending on whether they fall into these four situations. GRZAN recommends running a four-item self-check immediately after class determination, because it changes not only the reviewing body but also the communication channel and the rhythm of deficiency responses.

The level of official fees does not reflect the level of technical difficulty. The initial Class 2 certification fee of KRW 2,400,000 is higher than the KRW 561,000 charged for Class 3 or 4 approval without a clinical trial, yet the latter requires a full technical dossier and usually clinical data as well, so the actual effort is far greater. Official fees are charged by class and by whether a clinical trial is needed; they are administrative charges and do not correspond to technical difficulty. GRZAN estimates workload from the composition of the dossier, not from the official fee, when preparing budgets.

Pathway determination must come after the applicability determination. In vitro diagnostic devices have been governed since 1 May 2020 and digital medical devices since 24 January 2025 by their own dedicated statutes. If an IVD or a digital medical product is classified under the class table of the Medical Device Act, the pathway determination is wrong from the first step, and the error is often only discovered at the acceptance stage, by which time the technical documents have already been compiled for the wrong pathway.

4. Practical recommendations

• Write the three-step conclusion of applicability, class, and pathway into a written record. Cite the supporting provision at each step so it can be used in deficiency responses and internal review, preventing an oral judgment from being overturned mid-project.
• Run an extra four-situation self-check for Class 2 products. The result directly changes the receiving body, so keep the checklist on file.
• Schedule by pathway, not by project. Multiple items in one project should each be estimated separately at 5, 25, and 55/70 working days, then add documentation preparation and deficiency-response time.
• Book official fees and service costs separately. They follow different bases; merging them overstates budgets for Class 2 products and understates budgets for Class 3 and 4 products.
• Output the pathway conclusion together with the item-group split. The item-group split affects the number of submissions and the workload of later changes and UDI data maintenance, so settle it during pathway lock.

5. Verification checklist

• □ Product applicability — cross-check against Article 2 of the Medical Device Act, Article 2 of the In Vitro Diagnostic Medical Devices Act, and the scope of the Digital Medical Products Act; standard: clearly assigned to one of the three categories with no unresolved overlap.
• □ Class conclusion — cross-check against Article 3 of the Medical Device Act and Annex 1 of the Enforcement Rule; standard: the class can be traced to a numbered classification rule.
• □ Pathway mapping — map the class against notification, certification, and approval; standard: a one-to-one match between pathway and class with no unhandled exceptions.
• □ Class 2 split self-check — compare item by item against the four situations: clinical trial required, digital health related, nomenclature undefined, drug combination; standard: a definite written conclusion for each of the four.
• □ Receiving body — map the pathway against NIDS, the designated review organization, and MFDS; standard: consistent with the statutory review period table.
• □ Periods and fees — check the Enforcement Rule annex; standard: use the working-day basis, and take fees by class and by whether a clinical trial is needed.
• □ Item-group split — check item-group composition against MFDS Public Notice No. 2022-52; standard: model consolidation has a documented basis and no consolidation across groups.

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 MFDS approvals, certifications and notifications, prepares equivalence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com