NIDS and Designated Review Bodies: Class 1 and Class 2 Review in Korea

1. Key takeaways

Korea splits the review execution of Class 1 and Class 2 in two directions: the National Institute of Medical Device Safety Information (NIDS) accepts item notifications for Class 1 devices, with a statutory review period of 5 business days and an official fee of KRW 85,000; the designated review bodies undertake item certification for Class 2 devices, including technical document review and KGMP conformity audits, with 25 business days initially and 15 business days for a change.

The designated review bodies are designated by MFDS under Article 6-4 of the Medical Device Act; in practice the four bodies undertaking Class 2 review are KTL, KTR, KCL and KTC. Class 3 and Class 4 are outside this arrangement and are reviewed directly by MFDS, with 55 business days without clinical trials and 70 business days with clinical trials.

The value of understanding this boundary lies in scheduling: the Class 1 and Class 2 products of the same company run through two processes and two intake windows, and their correction rhythms do not affect each other. Managing them as one project distorts the timeline forecast.

2. Legal basis

The designation of review bodies and the division of work among institutions rest on the following instruments.

Institutions, classes and division of work (supplementary table)

3. Expert insights

Insight 1: NIDS and the designated review bodies are parallel assignments, not superior and subordinate.

The boundary of their work is set by the class; neither party re-examines the conclusions of the other. What GRZAN has encountered in projects is a company that submitted a correction question on a Class 2 product to NIDS and was told that this type of work is not accepted there, wasting the correction window. Correction replies must go back to the originally accepting body.

Insight 2: Class 2 products can shift to MFDS review in certain cases.

Class 2 by default follows certification by the designated review bodies, but where clinical data are needed, or the product involves digital medical products, review must shift to MFDS, and the statutory period and fee switch accordingly. GRZAN advises judging before filing whether any shift case exists, to avoid scheduling on 25 business days and then executing on 55 business days or more.

Insight 3: The KGMP conformity audit and item certification are two parallel tracks.

The KGMP certificate for Class 2 and above (valid 3 years) and the item certification proceed separately, but in the certification sequence the KGMP must come first. GRZAN advises drawing both tracks on the same Gantt chart and using completion of the KGMP as the milestone preceding acceptance of the item certification.

Insight 4: Choice of body is a project variable (practical estimate).

The law only provides that review is undertaken by bodies designated by MFDS; it does not give companies a free choice. The room for selection in practice comes from the timing of the application and the intake arrangement. GRZAN offers three criteria: first, whether the body’s concurrent schedule matches the product’s launch window; second, the body’s review experience with the item type; third, the responsiveness of correction communication. All three are practical estimates and must be judged against the actual situation at the time.

4. Practical recommendations

• Fix the accepting body by class before back-planning the schedule. Schedule Class 1 on 5 business days, Class 2 on 25 business days and Classes 3 and 4 on 55 to 70 business days separately; do not manage a multi-class product line on one common cycle.
• Route all correction communication only to the originally accepting body. Confirm the body name and contact person on the correction notice and avoid cross-institution enquiries.
• Make the KGMP a precondition of item certification. Classes 2 to 4 must obtain a KGMP certificate valid 3 years, with periodic audits arranged before expiry.
• Judge whether a shift-to-MFDS case exists. Situations requiring clinical data or involving digital medical products may shift review to MFDS; complete the judgement before filing.
• Coordinate body scheduling for multiple filings in the same period. When several Class 2 items are filed in one year, confirm the intake arrangement with the licensed entity in advance and avoid cramming everything into the same window.

5. Verification checklist

• □ Accepting body determination: match NIDS, the designated review bodies or MFDS by class, consistent with the statutory division table.
• □ Screening for shift cases: check whether clinical data are needed or the product is a digital medical product; the screening conclusion is definite and documented.
• □ Statutory review period: verify against the Appendix Table of the Enforcement Rule; the business-day basis is used.
• □ KGMP sequence: check when the KGMP certificate was obtained; earlier than acceptance of the item certification.
• □ Correction routing: check the accepting body named on the correction notice; identical to the originally accepting body.
• □ Body scheduling coordination: check the intake arrangement for multiple items in the same period; not all crowded into one window.
• □ Certificate validity: check the validity period of the KGMP certificate; 3 years, with a periodic audit scheduled before expiry.

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