South Korea Medical Device Regulatory System: MFDS, NIDS and Review Bodies

1. Key takeaways

Regulatory authority over medical devices in the Republic of Korea is concentrated in the Ministry of Food and Drug Safety (MFDS), but review execution is distributed across three tiers of institutions according to risk class: item notifications for Class 1 devices are accepted by the National Institute of Medical Device Safety Information (NIDS); item certification for Class 2 devices is undertaken by MFDS-designated review bodies, which carry out technical document review and KGMP conformity audits; item licences for Class 3 and Class 4 devices are reviewed directly by MFDS.

The statutory review periods of the three bodies are not the same: Class 1 takes 5 business days; Class 2 takes 25 business days for an initial certification and 15 business days for a change; Class 3 and Class 4 take 55 business days without clinical trials and 70 business days with clinical trials. The spread reaches 14 times (5 business days versus 70 business days). If a project schedule runs on one common set of time assumptions, the errors will concentrate on Class 3 and Class 4 products.

A foreign manufacturer cannot hold a Korean import item licence in its own name and must submit applications through a licensed entity in Korea that maintains a business premises and a full-time quality manager. This condition determines the project structure: Korean registration is not “one dossier sent over” but “a local licensed entity plus a set of local responsibilities”.

2. Legal basis

The following instruments govern the Korean regulatory system and the distribution of review authority.

Statutory review periods and official fees (per the Appendix Table of the Enforcement Rule of the Medical Device Act)

3. Expert insights

Insight 1: The split reflects risk stratification, not institutional hierarchy.

There is no superior-subordinate approval relationship among NIDS, the designated review bodies and MFDS; the division of work rests on the classification of grades established by Article 3 of the Medical Device Act. Two products of the same company, one in Class 2 and one in Class 3, fall into two separate processes, two intake windows and two deficiency-correction rhythms. GRZAN has repeatedly seen companies schedule such projects on one rhythm, only to find the Class 3 deficiency notice arriving months apart from the Class 2 certificate notice.

Insight 2: Statutory review periods are counted in business days and exclude deficiency-correction time.

Converted to calendar time, 55 business days is roughly 11 weeks, and that is only the review period after acceptance. Once a review body issues a request for corrections, the period is usually recalculated or suspended because of the corrections (the treatment follows the deficiency notice). GRZAN advises treating the statutory period as a floor and the first-pass acceptance rate of the dossier as the real schedule-control variable. Dossier quality affects the actual certification date more than route selection does.

Insight 3: The list of designated review bodies is a project variable, not a fixed constant.

Technical document review and KGMP conformity audits for Class 2 devices are undertaken by review bodies designated by MFDS. Different bodies differ in concurrent scheduling, auditor-days and deficiency style. When a company files multiple Class 2 items in the same year, the choice of body directly affects the overall rhythm. This point is a practical estimate: the law only provides that the review is undertaken by a body designated by MFDS and does not grant companies a free choice; the room for selection in practice comes from the timing of the application and the intake arrangement.

Insight 4: In vitro diagnostic devices and digital medical products each have their own acts.

Since 1 May 2020, in vitro diagnostic devices have been governed separately by the In Vitro Diagnostic Medical Devices Act; since 24 January 2025, digital medical devices, and since 24 January 2026, digital medical and health support devices, have been governed by the Digital Medical Products Act. The architecture has moved from one act with subordinate rules to one Medical Device Act as the base plus two special acts with their own jurisdictions, so the applicability determination must come before classification.

4. Practical recommendations

• Run the applicability determination before the classification determination. Confirm whether the product is a medical device, an in vitro diagnostic device or a digital medical product, and only then enter grade classification. A wrong determination costs a full technical dossier rebuilt from scratch, not a supplementary explanation.
• Back-plan the dossier preparation schedule from the accepting body. For Class 3 and Class 4 products, reserve at least an equal amount of time for dossier preparation and corrections beyond the 55 to 70 business days review period, instead of treating the statutory period as the total project cycle.
• Make the quality manager arrangement of the licensed entity a condition for project start. The licensed entity must have a full-time quality manager formally registered with MFDS; GRZAN advises writing the quality manager’s presence-in-post into the contract terms.
• Build a unified technical dossier master for multi-grade product lines. Using different documentation granularity per grade for the same manufacturing site increases duplicate work in later changes and UDI data maintenance; a master built on the IMDRF STED structure and tailored by grade significantly lowers later maintenance costs.
• Set the first-pass acceptance rate of the dossier as a project KPI. In its Korean projects GRZAN uses the number of correction rounds rather than the review days as the primary schedule metric, because the former is controllable and the latter is not.

5. Verification checklist

• □ Applicability: check the product 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; clearly in one of the three categories with no unresolved overlaps.
• □ Grade determination: check against Article 3 of the Medical Device Act and Appendix Table 1 of the Enforcement Rule; the grade conclusion must be traceable to the number of the classification rule.
• □ Accepting body: match NIDS, the designated review bodies or MFDS by grade, consistent with the statutory review period table.
• □ Statutory review period: verify against the Appendix Table of the Enforcement Rule; use the business-day basis and never mix it with calendar days.
• □ Eligibility of the licensed entity: verify the business premises, storage facilities, quality inspection facilities and full-time quality manager against Article 6 and Article 15 of the Medical Device Act.
• □ Quality system requirement: judge KGMP applicability and audit type by grade; Classes 2 to 4 must hold a KGMP certificate valid for 3 years.
• □ Language and submission: confirm the submission language and the electronic submission system; Korean documents complete, online submission available.

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