Application and Exemptions of Korean Medical Device Standard Specifications

1. Key takeaways

Korea sets standard specifications for certain items, and conformity allows simplified technical materials; for items not covered, the test specifications fixed at licensing – the licensed test specifications – serve as the judgment basis. The two systems are 2 distinct judgment bases to manage simultaneously.

• The Enforcement Rule amendment bill was pre-announced on March 3, 2026, proposing to expand the recall standard from non-conformity with standard specifications to non-conformity with licensed test specifications. Via a historical-legislation search on the National Law Information Center of the Ministry of Government Legislation, as of October 29, 2026 it had not been formally promulgated and remains a draft. In the proposed direction the traceability basis would expand from 1 line to 2 lines; until formal promulgation, recall judgment still follows the current Enforcement Rule, and companies must not rely on the proposed basis for current compliance.
• The same bill also proposes shortening the condition fulfilment confirmation processing period from 20 days to 10 days for licences conditioned on satisfying KGMP within a set period, and adding an ex officio revocation procedure for sales and rental businesses. Under the current law, that period under Article 17, Paragraph 2 remains within 20 days.

2. Legal basis

The instruments below distinguish the two specification bases and record the bill status. Regulatory information verified as of October 29, 2026.

Comparison of the two specification bases. The table contrasts their sources, scope of application and judgment consequences.

3. Expert insights

Standard specifications exist only for some items; check existence before fixing the documentation strategy. Korea does not set standard specifications for all items: conformity with one allows simplified materials, while items not covered require self-set test specifications in the Technical Document with stated justification (practical estimate). GRZAN lists this as a mandatory check at project initiation: the answer determines how the testing specification chapter is written – direct citation where a standard specification exists, self-set with justification where not.

The licensed test specification is the company’s own commitment, not an industry-shared value. A standard specification is an externally given threshold applying uniformly across the industry; the licensed test specification is the set of concrete values the company fixes in the licence application and clears through review, and may differ for every company. The bill proposes to extend the recall standard to the latter; once in force, a batch result that misses the filed value falls into recall judgment even if still within the standard specification. As of October 29, 2026 the bill has not been formally promulgated, but every value and tolerance of the licensed test specification should already be managed against the filed values, not industry practice – then the ledger needs no rework when the basis changes.

The recall standard expansion, Article 31 side effect management and change management are three linked matters. The bill proposes expanding the judgment basis for specification deviation from 1 line to 2 lines (not formally promulgated as of October 29, 2026). In that direction, every specification adjustment in change management must update the licensed test specification in sync, or after entry into force a single change could trigger recall judgment at the same time. This is one reason raw materials are listed in Article 27: Change management – from item-by-item prior approval to a negative list system as an item retaining prior approval. Recall classification and reporting procedures are in Article 42: Medical device recall – initiation conditions and procedures.

The amendment bill is a package; do not watch only the recall clause. The bill pre-announced on March 3, 2026 also contains the 20-to-10-day shortening of the condition fulfilment confirmation processing period, the ex officio revocation procedure for sales and rental businesses, and the move of change management to a negative list system; it was not formally promulgated as of October 29, 2026. Companies must assess the package as a whole; watching only the recall clause misses the initial licensing requirements, whose timing arrives earlier. The proposed basis should not be written into current operating documents; scheduling still follows the within-20-days rule of Article 17, Paragraph 2.

4. Practical recommendations

• Build a specification ledger that separates the two sources. Mark item by item whether a standard specification exists, plus the values and approval dates of the licensed test specifications; keep the ledger aligned with the item group scope and register new models as added.
• Check specification impact before any change. Any adjustment to raw materials, processes or test methods should first be assessed against the licensed test specifications before deciding whether prior approval is required, see Article 27.
• Compare batch test results against the filed values monthly. Make comparing batch results against the licensed test specifications a routine; a deviation is better exposed at the licensing stage, handled by updating specifications, than at the recall stage, handled by recalling the product (practical estimate: comparison frequency may be set by output volume).
• Reserve the conditional licence confirmation window on the current within-20-days basis. Where a licence was granted on condition that KGMP be satisfied within a set period, the processing period under Article 17, Paragraph 2 is within 20 days; the bill proposes 10 days, but it was not formally promulgated as of October 29, 2026, so schedule on the current basis, leaving room to shorten after promulgation.
• Track whether the bill has been formally promulgated. The pre-announcement date is March 3, 2026, and it was not formally promulgated as of October 29, 2026; until promulgation, all references follow the legislative pre-announcement basis. See Article 49: Korean medical device regulatory updates 2026.

5. Verification checklist

• □ Existence of a standard specification: query whether the item has a Korean standard specification; conclusion clear and consistent with the Technical Document.
• □ Licensed test specification ledger: check the specification values and approval dates in the licence documents; all values traceable to the licence documents.
• □ Specification consistency: compare the Technical Document, test reports and licence documents; the specification values identical in all three.
• □ Batch result comparison: sample batch test records; conforming to the licensed test specifications, deviations handled.
• □ Change impact determination: judge from the change content whether specifications are touched; changes touching specifications went through prior approval.
• □ Recall judgment basis: compare the current rules with the proposed content; pre-assessed on both bases, while current judgment still follows the current Enforcement Rule.
• □ Conditional licence timing: check the KGMP fulfilment plan of the conditional licence; window reserved on the current within-20-days period.
• □ Promulgation status: search the National Law Information Center for whether the bill is promulgated; confirmed not formally promulgated as of October 29, 2026; citations labelled as pre-announcement basis.

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 prepares MFDS-compliant technical dossiers, coordinates KGMP documentation, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com