Product Groups in Korean Medical Device Registration: Delineation and Fees

1. Key takeaways

Korea does not certify individual models one by one; it certifies product groups. Within one product group, several models that are substantially identical in intended use, principle of action, raw materials, performance and test specifications may be filed together, sharing one technical dossier and one licence. The breadth of the product group directly determines the number of filings, the total official fees and the workload of subsequent changes.

Official fees are charged per filing: for Class 2, KRW 2,400,000 initially and KRW 1,800,000 for a change. Filing twelve models as one group, versus splitting them into three filings, produces a fee difference approaching 3 times. A group drawn too wide will be ordered split during review; a group drawn too narrow means more licences, more review fees and one more dataset to maintain.

The rules for drawing product groups and handling their changes are set out in MFDS Notification No. 2022-52 (effective 29 July 2022). GRZAN advises fixing the group before dossier preparation; starting to write while the group is still unsettled is the most common cause of rework in Korean projects.

2. Legal basis

The instruments governing product groups, filing fees and UDI data, together with the comparison elements for group membership, are set out below.

Comparison elements for product group delineation (supplementary table)

3. Expert insights

Insight 1: The product group is a fee variable, not a formal categorisation.

The Class 2 initial review fee of KRW 2,400,000 is charged per filing, one group being one application and one fee. What GRZAN has encountered in projects is a company that divided 12 models into 6 groups by internal SKU; after review it was told 4 of the groups could be merged, and the fees already paid could not be refunded. Running a comparison table before fixing the group saves more money than negotiating afterwards.

Insight 2: Merging too wide is riskier than merging too narrow.

The cost of merging too narrow is extra fees and extra data maintenance, a predictable cost. The cost of merging too wide is being ordered to split during review, with the completed technical dossier reorganised around the new groups and the timetable disrupted. GRZAN advises, where uncertain, to draw the group on the narrower basis and keep the predictable cost within a controllable range.

Insight 3: The product group determines the granularity of later UDI data maintenance.

UDI data must be submitted to the Integrated Medical Device Information System (IMDIS), with data items maintained at the item and model level. Once the relationship between group and model is fixed wrongly, every later addition, change and discontinuation of a model must be corrected on the data side as well. GRZAN advises drawing the three-layer structure of group, item and model at the same time the group is fixed, as the baseline for data maintenance.

Insight 4: Adding models within a group requires a change, not automatic coverage.

For a licensed product group, adding a model requires a change procedure; it cannot be handled on the assumption that the same group means automatic inclusion. The change review period for Class 2 is 15 business days, and companies often leave this period out of the launch plan, passively delaying the market entry of the new model.

4. Practical recommendations

• Draw the three-layer structure of group, item and model before preparing documents. GRZAN treats this diagram as the second baseline document of a Korean project, used alongside the technical dossier master.
• Score each model against the six comparison elements. Only when all six items of intended use, mechanism of action, raw materials, performance, test specifications and instructions for use agree do the models enter the same group; any single difference splits the group, and the reasoning is written into the explanation of the application form.
• Schedule the change period for new models into the launch plan. The statutory change review period for Class 2 is 15 business days; back-plan the document preparation time from it.
• Pass the group conclusion to the UDI data owner on the day it is fixed. Synchronising immediately avoids running the data and the licence on two different bases.
• Re-review the group delineation across years. After product iterations, run the comparison table again to judge whether new groups are needed or existing groups must be adjusted.

5. Verification checklist

• □ Comparison of models within the group: compare model by model against the six elements; all six agree.
• □ Documented reasons for separation: check the comparison table and explanation documents; each judgement carries a written reason.
• □ Fee basis: calculate official fees by the number of groups; amounts consistent with the appendix table of the Enforcement Rule.
• □ Coverage of the technical dossier: check that the technical dossier covers every model in the group; no model omitted.
• □ UDI data consistency: compare the IMDIS data with the group-item-model structure diagram; the three layers correspond one to one.
• □ Changes for added models: check the change application and the review period; submitted and scheduled on 15 business days.
• □ Annual review: check the review record; reviewed once within 12 months.

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