Ten Common Misconceptions about Korean Medical Device Registration

1. Key takeaways

In Korean projects GRZAN repeatedly meets the same set of misjudgements, and the three with the highest frequency are: mapping an NMPA registration certificate directly onto the Korean route, taking the distributor for the licensed entity, and taking ISO 13485 for the KGMP. What these misjudgements share is the substitution of Chinese or European experience for Korean legal sources. The consequences do not show at the filing stage; they erupt in concentrated form at the correction, change of licence holder and post-market compliance stages.

This article lists 10 common misconceptions and gives, item by item, the legal source and the corrected conclusion. The judging standard is one: every conclusion must be traceable to the regulation name, number, publication date and provision number, and any judgement resting on experience is marked as a practical estimate.

2. Legal basis

The misconceptions below are corrected against the following instruments.

Misconceptions and legal sources (supplementary table)

3. Expert insights

Misconception 1: An NMPA registration certificate can be mapped directly onto the Korean route.

Source: Article 3 of the Medical Device Act and Appendix Table 1 of the Enforcement Rule. Correction: the Korean grade is determined independently under the domestic classification rules; a Chinese registration certificate is not a basis for a grade or a route.

Misconception 2: The distributor is the licensed entity.

Source: Article 15 of the Medical Device Act. Correction: the licensed entity must obtain an import business licence, maintain a business premises, storage and quality inspection facilities and appoint a full-time quality manager; binding it to the distributor subjects the import rights to commercial leverage.

Misconception 3: ISO 13485 equals the KGMP.

Source: KGMP, MFDS Notification No. 2023-79. Correction: Classes 2 to 4 must obtain a KGMP certificate valid 3 years; an ISO 13485 certificate cannot substitute.

Misconception 4: Class 1 devices have no post-market obligations.

Source: Article 54-2 of the Enforcement Rule and Article 31-2 of the Medical Device Act. Correction: Class 1 has been subject to UDI since 1 July 2022 and to distribution record reporting since 1 July 2023.

Misconception 5: Licences are valid indefinitely.

Source: Article 49 of the Medical Device Act (Act No. 17248, promulgated 7 April 2020, effective 8 October 2020). Correction: manufacturing and import licences, certifications and notifications must all be renewed every 5 years.

Misconception 6: Class 2 is always reviewed by a designated review body.

Source: MFDS Notification No. 2022-52. Correction: where clinical data are needed, or the product involves digital medical products, review shifts to MFDS, and the period and fee switch accordingly.

Misconception 7: Every change requires a prior licence.

Source: amendment draft of the Enforcement Rule (pre-noticed for legislation on 3 March 2026, not yet formally promulgated as of 29 October 2026). Correction: the plan is to move to a negative-list system in which only changes significantly affecting safety and effectiveness retain the prior licence; companies must submit a change self-assessment and management procedure with the initial licence application. Until then, the existing two procedures of change licence and change notification still apply, with a processing period of within 20 days under Article 17 Paragraph 2 of the Enforcement Rule.

Misconception 8: Software and AI devices are still filed under the Medical Device Act.

Source: the Digital Medical Products Act (enacted and promulgated 23 January 2024). Correction: digital medical devices have been subject to the special act since 24 January 2025, and digital medical and health support devices since 24 January 2026.

Misconception 9: In vitro diagnostic devices and ordinary devices follow the same act.

Source: the In Vitro Diagnostic Medical Devices Act (Act No. 16433, enacted and promulgated 30 April 2019, effective 1 May 2020; current version Act No. 21525, amended by another act on 7 April 2026, effective 8 October 2026). Correction: IVDs are managed independently across Classes 1 to 4, with separate routes and separate analytical and clinical performance trial requirements.

Misconception 10: Liability compensation insurance only concerns implantable devices and can be arranged later.

Source: the Medical Device Act (Act No. 18319, promulgated 20 July 2021, effective 21 July 2022); Articles 12-5 and 12-6 of the Enforcement Decree. Correction: the parties covered and the insured amounts are determined by the Enforcement Decree; the obligation applies from 21 July 2022, and the insurance judgement must be completed before commencing the relevant business.

4. Practical recommendations

• Build a legal-source index for every conclusion. GRZAN requires every external conclusion to state the regulation name, number, publication date and provision number, and any judgement that cannot be grounded in a legal source to be marked as a practical estimate.
• Run one misconception screening at project start. Check item by item against the 10 items of this article, list the failures as project risks and assign owners.
• Separate the licensed entity from the distributor. Merging the two subjects the import rights to commercial leverage; GRZAN advises preferring an independent licensed entity arrangement.
• Schedule separately by class and product type. Class 1 takes 5 business days, Class 2 takes 25 business days initially, and Classes 3 and 4 take 55 to 70 business days; do not manage a multi-class product line on one common cycle.
• Include regulatory developments in the annual review. The second stage of the Digital Medical Products Act (24 January 2026) and the Enforcement Rule amendment draft (pre-noticed 3 March 2026, not yet formally promulgated as of 29 October 2026) both affect existing routes and must be assessed item by item.

5. Verification checklist

• □ Independent grade determination: check against Article 3 of the Medical Device Act and Appendix Table 1 of the Enforcement Rule; no direct application of foreign certificates.
• □ Eligibility of the licensed entity: verify the import business licence, premises and facilities, and the quality manager; conditions of Article 15 met.
• □ KGMP status: check the certificate and its validity period; held for Classes 2 to 4, valid 3 years.
• □ Coverage of post-market obligations: check the UDI and distribution record reporting start dates by class; the obligation list matches the class.
• □ Renewal cycle: check the date of the last item renewal; renewed within the 5-year cycle.
• □ Route and body: check the accepting body by class and product type; consistent with the statutory division.
• □ Applicability of special acts: determine whether the product is an IVD or a digital medical product; a single attribution with a clear governing act.
• □ Insurance obligation: check against Articles 12-5 and 12-6 of the Enforcement Decree; the insurance judgement completed and documented.
• □ Change management: check against the current rules and the 2026 amendment developments; the self-assessment procedure prepared.
• □ Traceability of legal sources: sample the four elements of external conclusions; name, number, date and provision number all present.

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