Korea Medical Device Classification: Grades, Review Bodies and Official Fees

1. Key takeaways

Korea divides medical devices into four grades from Class 1 to Class 4, based on Article 3 of the Medical Device Act and Appendix Table 1 of the Enforcement Rule (the standards and procedures for medical device classification and designation). The grade is not a label; it is the switch for three variables: the review body, the statutory review period and the official fee.

The mapping of grade to period is as follows: Class 1 is accepted by the National Institute of Medical Device Safety Information (NIDS) with a statutory review period of 5 business days and an official fee of KRW 85,000; Class 2 is certified by the designated review bodies with 25 business days initially and 15 business days for a change, at KRW 2,400,000 initially and KRW 1,800,000 for a change; Class 3 and Class 4 are reviewed directly by MFDS with 55 business days without clinical trials and 70 business days with clinical trials, at fees from KRW 561,000 to KRW 1,338,000. Moving one grade up or down changes the order of magnitude of both the timeline and the budget.

Items covered by the naming rules follow the existing grades. For products not covered by the naming rules, a grade designation application must first produce the grade conclusion before entering the corresponding route. GRZAN advises putting this step into the project plan rather than waiting for the accepting body to raise it during review.

2. Legal basis

The classification framework and the grade-to-fee mapping are grounded in the following instruments.

Grade, body, period and fee comparison (per the Appendix Table of the Enforcement Rule, supplementary table)

3. Expert insights

Insight 1: Grade determination looks at the combination of invasiveness, contact duration and energy or substance transfer, not a single attribute.

Appendix Table 1 of the Enforcement Rule sets the determination elements by potential risk. Devices implanted for more than 1 year, devices contacting the central circulatory system, and devices in short-term contact with the body surface can fall into different grades even with identical materials. GRZAN advises listing, one by one, the contact site, the contact duration, whether the device is implantable and whether energy is supplied in the determination sheet; omitting any one item easily triggers a correction request at intake.

Insight 2: The grade designation application is a separate pre-project step.

Innovative products, combination products and cross-boundary products not covered by the naming rules cannot have their grade read off a comparison table and must first apply for grade designation. What GRZAN has encountered in projects is a company that submitted the grade designation application together with the licence application; after acceptance the file was shelved because the grade was undetermined, which lengthened the overall timeline. The two applications should proceed in sequence, not in parallel.

Insight 3: The grade conclusion sets the KGMP applicability threshold.

Class 2 and above must obtain a KGMP certificate (MFDS Notification No. 2023-79, certificate valid 3 years); Class 1 has a separate arrangement. A deviation in grade determination drags the quality system investment with it: if an underestimated grade is raised in a later review, all the system work not prepared under KGMP has to be completed retroactively.

Insight 4: A grade change reaches the licence already obtained.

When a product upgrade or an extension of intended use raises the grade, the original licence no longer corresponds to the requirements of the new grade and the route must be performed again under the new grade. GRZAN advises assessing the grade impact in parallel with product iteration planning and putting registration changes and product changes on the same timetable.

4. Practical recommendations

• Fill in the determination element sheet before consulting the comparison table. Complete the five items of contact site, contact duration, implantation, energy supply and drug-device combination, then read the conclusion from Appendix Table 1 of the Enforcement Rule; this significantly reduces arbitrary determinations.
• Apply for grade designation early for products not covered by the naming rules. GRZAN advises scheduling the grade designation application as an independent milestone and starting technical dossier preparation only after the conclusion is obtained.
• Back-plan the KGMP schedule from the grade. Class 2 and above must complete the KGMP conformity audit before filing; the certificate is valid 3 years and periodic audits must be arranged before expiry.
• Write the grade conclusion on the first page of the technical dossier. When the review body compares the grade with the depth of the dossier, the grade and the cited provision number on the first page reduce back-and-forth communication.
• Re-check the grade at each product iteration. Any change in intended use, contact duration or implantation duration can move the grade; the cost of re-checking is far below re-running the route afterwards.

5. Verification checklist

• □ Completeness of determination elements: check the five items of contact site, duration, implantation and energy; all five completed with no blank fields.
• □ Basis of the grade conclusion: check against Appendix Table 1 of the Enforcement Rule; traceable to specific determination elements.
• □ Coverage by the naming rules: search the item naming rules; if covered, applied directly; if not covered, grade designation applied for.
• □ Corresponding review body: match NIDS, the designated review bodies or MFDS by grade, consistent with the statutory review period table.
• □ KGMP applicability: judge applicability and audit type by grade; Classes 2 to 4 hold a KGMP certificate valid 3 years.
• □ Fee basis: check whether official fees are charged by grade and by the presence of clinical trials; amounts consistent with the appendix table.
• □ Grade re-check after iteration: check the change assessment record; a conclusion exists and documents were updated in step.

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 premarket approvals and KGMP conformity, coordinates import requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com