Medical Device Registration in South Korea – Overview
Medical Device Registration in South Korea: South Korea is one of the most advanced and rapidly growing healthcare markets in the Asia‑Pacific region. Medical device regulation is overseen by the Ministry of Food and Drug Safety (MFDS) formerly the Korea Food and Drug Administration (KFDA). Medical devices and in‑vitro diagnostics are regulated under the Medical Device Act (MDA) and the Act on In‑Vitro Diagnostic Medical Devices.
To commercialize a medical device in South Korea, manufacturers must obtain approval from the MFDS and the National Institute of Medical Device Safety Information (NIDS). International manufacturers must also appoint a Korea License Holder (KLH), who acts as the authorized in‑country representative responsible for regulatory submissions and communication.
South Korea Regulatory Snapshot
Regulatory Authority:
- Ministry of Food and Drug Safety (MFDS)
Applicable Regulations:
- Medical Device Act (MDA)
- Act on In‑Vitro Diagnostic Medical Devices
Authorized Representative Requirement:
- Korea License Holder (KLH) mandatory for foreign manufacturers
QMS Requirement:
- Korea Good Manufacturing Practice (KGMP), aligned with ISO 13485:2016
Technical Review Bodies:
- MFDS
- Third‑party certifying organizations
Labeling Requirements:
- Medical Device Act, Articles 20–24 and Regulations 42–44
Submission Format:
- Online electronic submission
Language:
- Korean
South Korea Medical Device Classification
According to MFDS Notification No. 2021‑24, medical devices are categorized based on risk:| Class | Risk Level | Review Requirements |
| Class I | Low Risk | Notification by NIDS |
| Class II | Medium Risk | Certification + MFDS approval for new devices |
| Class III | High Risk | MFDS approval |
| Class IV | Highest Risk | MFDS approval |
- Class I and some Class II devices undergo certification via NIDS.
- New Class II, Class III, and Class IV devices require MFDS approval.
Korea License Holder (KLH)
Foreign manufacturers must designate a Korea License Holder, who must:- Have a registered business office in South Korea
- Employ a full‑time quality manager
- Submit regulatory filings on behalf of the manufacturer
- Manage communication with MFDS & NIDS
South Korea Medical Device Registration Pathway
- KGMP Certification (Mandatory Before Registration) Manufacturers must comply with KGMP, which includes:
- On‑site inspections for foreign manufacturers
- QMS evaluation aligned with ISO 13485
- Certification valid for 3 years
- Registration Process by Device Class Class I Devices – Notification Route
- Exempt from technical review and KGMP
- Basic device details submitted through MFDS portal
- Reviewed and finalized by NIDS
- No clinical data required if predicate device exists
- Applicable when the device is sufficiently comparable to approved products
- Required when no predicate exists or when new technology is involved
- Clinical studies may be required
Post‑Approval Services (Lifecycle Management)
We support manufacturers with complete lifecycle compliance, including:- Managing changes to approved devices (variants, accessories, new indications)
- License maintenance through timely renewals and fee management
- End‑to‑end communication with MFDS & NIDS
- Importation and customs compliance
- Post‑market surveillance and reporting
Registration Summary
| Class | Registration Pathway |
| Class I | Notification by NIDS |
| Class II | Certification by NIDS + MFDS approval |
| Class III | MFDS Approval |
| Class IV | MFDS Approval |
Masuu Global Solutions – South Korea Regulatory Expertise
We provide complete regulatory support for medical device and IVD manufacturers entering South Korea:- Regulatory due diligence for MFDS compliance
- Device notification, certification & approval pathways
- In‑country testing support (clinical & non‑clinical)
- KGMP readiness and certification assistance
- Mock inspections and audit preparation
- KLH / Legal Representative services
- Labeling & translation support
- Submission management and liaison with MFDS & NIDS
- Distributor identification and qualification
- Post‑market surveillance and reporting
- Approval renewals and license transfers
- UDI and KC certification support
Frequently Asked Questions
Medical device registration in South Korea depends on the device classification and applicable MFDS pathway. Foreign manufacturers must appoint a Korea License Holder (KLH), address KGMP requirements where applicable, prepare Korean-language documentation, and complete the appropriate notification, certification, or approval process through the relevant regulatory authorities.
Foreign manufacturers entering South Korea must comply with the Medical Device Act and applicable MFDS requirements. Depending on the device, requirements can include classification, KGMP compliance, technical documentation, testing, clinical evidence, Korean labeling, regulatory submissions, and appointment of a Korea License Holder to manage local regulatory communication.
Yes. Foreign medical device manufacturers must designate a Korea License Holder (KLH) for South Korean market access. The KLH must have a registered business office in South Korea and employ a full-time quality manager. It acts as the local regulatory liaison for submissions, MFDS and NIDS communication, renewals, and post-market requirements.
South Korea classifies medical devices into Class I, Class II, Class III, and Class IV according to risk. Class I represents lower-risk devices, while Class IV represents the highest-risk category. Classification affects whether a device follows notification, certification, or MFDS approval and determines the level of technical and regulatory review required.
KGMP refers to Korea’s Good Manufacturing Practice requirements for medical device manufacturers and is aligned with ISO 13485:2016. According to the provided page, KGMP certification is a prerequisite for Class II, III, and IV device registration, while Class I devices follow a notification route that is exempt from KGMP requirements.
Class II, III, and IV devices generally follow an approval pathway in South Korea. Depending on the device and available predicate, manufacturers may undergo a general technical file review or a technical safety and efficacy review. New technologies or devices without suitable predicates may require additional evidence, including clinical studies.
Yes. Class I devices can follow a notification route rather than the full technical approval process. Basic device information is submitted through the applicable MFDS electronic system and reviewed through NIDS. According to the provided information, Class I devices are also exempt from technical review and KGMP requirements.
Clinical evidence requirements depend on the device, technology, classification, and availability of an appropriate predicate. A general technical file review may not require clinical data when a sufficiently comparable approved device exists. When no suitable predicate exists or a device uses new technology, a technical safety and efficacy review may require clinical studies.
According to the provided page, pre-market approval for applicable Class II, III, and IV devices is valid for five years and requires renewal afterward. KGMP certification is stated to be valid for three years. Manufacturers must track these validity periods and complete required renewal activities to maintain market authorization.
Post-approval compliance can include maintaining device licenses, managing approved changes such as variants or new indications, completing renewals, communicating with MFDS and NIDS, and addressing importation and customs requirements. Manufacturers must also maintain post-market surveillance and reporting activities throughout the device lifecycle to support continued regulatory compliance.