South Korea MFDS Medical Device Approval: KLH, KGMP and Class I to IV Routes

South Korea is a sophisticated, fast-moving medical device market with a regulator that is strict about documentation and quality systems. The Ministry of Food and Drug Safety (MFDS) regulates devices under the Medical Device Act, and its review work is carried out largely by the National Institute of Food and Drug Safety Evaluation (NIDS). Foreign manufacturers face three recurring tasks: appoint a local license holder, pass a Korean GMP (KGMP) assessment for most classes, and prepare Korean-language documents. This guide explains the route from classification to approval and what to plan first.

Classification and review routes

Class	Risk	Typical route
I	Low	Notification
II	Low to moderate	Certification when the device is substantially equivalent to an existing one; otherwise approval
III	Moderate to high	Approval (technical documentation review)
IV	High	Approval, with documentation in a STED-style format and, where needed, clinical data

MFDS maintains a database that assigns a class and a product code to many device types, so search it first. Where your device has no equivalent, expect a full approval route and, if the safety and effectiveness case is not complete, a clinical data review. Our guide to device classification explains how to compare classes across markets.

The Korea License Holder

The KLH is a Korean company that holds the license, deals with MFDS and is responsible for importing, distributing, post-market reporting and recalls. It must have a registered office and a qualified quality manager in Korea. Many foreign manufacturers use a specialist KLH rather than building a subsidiary. Contract carefully: document access, change notification, complaint handling, and what happens if you change KLH later.

KGMP: the Korean quality system certificate

Manufacturers of Class II to IV devices must hold a KGMP certificate, which is valid for a limited period and renewed through a document or on-site assessment. KGMP is based on ISO 13485 but adds Korean requirements, for example on post-market surveillance, reporting and the responsibilities of the KLH, so an ISO 13485 certificate alone is not enough. A first assessment is usually on site and takes the longest, so start it in parallel with the dossier. For the overall quality system picture see ISO 13485 and MDSAP audit readiness.

Step-by-step for a foreign manufacturer

1. Confirm the class, the product code and the route.
2. Appoint the KLH and agree the contract.
3. Start KGMP for each manufacturing site, if Class II or higher.
4. Check test reports. Compare your IEC 60601, ISO 10993 and performance tests with Korean expectations, and plan re-testing at a Korean lab if a report is not accepted. See IEC 60601 safety and EMC and biocompatibility.
5. Prepare the Korean dossier. Include device description, intended use, risk management, performance and safety data, labelling and, for higher classes, clinical evidence.
6. File and respond. MFDS or the review body may raise supplementary requests with short deadlines.
7. Launch and maintain. Approvals need periodic renewal, and Korea has a phased UDI system, so check the current requirements for your class.

Common mistakes

• Treating ISO 13485 or MDSAP as a substitute for KGMP.
• Choosing a KLH without checking its quality manager and reporting capacity.
• Assuming that foreign test reports will be accepted as they are.
• Translating the dossier at the last minute, with inconsistent technical terms.
• Making product changes during review without telling the KLH.

Frequently asked questions

Do I need a company in Korea?

You need a KLH, a licensed Korean entity. It does not have to be your own subsidiary.

Is a CE mark or FDA clearance accepted?

They are useful supporting evidence, especially for showing equivalence and safety history, but they do not replace MFDS review.

How long does approval take?

It depends on the route, the completeness of the dossier and how fast KGMP is completed. Certification routes are much quicker than approval routes with clinical review. Ask your KLH for current service times.

Which languages are required?

Korean for the submission and for labelling. Keep your English source documents controlled so the translations stay consistent.

MFDS rules, review times and fees change, and some guidance is published only in Korean. Confirm the current position with MFDS, your KLH and your regulatory advisers before you act on this guide.

Related reading

• Global market access beyond the US and EU: compare Korea with other markets.
• Japan PMDA approval: another Asian market with a local license holder.
• China NMPA registration: a long-lead Asian market.
• UDI in the EU and US: the structure behind Korean UDI.
• RAC (Devices) study material: covers MFDS and other global systems.

Talk to the AptSkill team

Planning a Korean filing or building global regulatory skills? Send us your device type, target markets and goal.