Medical Device Registration in South Korea – Overview

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
The KLH acts as the official regulatory liaison for all device approvals, renewals, and post‑market requirements.

South Korea Medical Device Registration Pathway

  1. KGMP Certification (Mandatory Before Registration)
    2. Manufacturers must comply with KGMP, which includes:
    • On‑site inspections for foreign manufacturers
    • QMS evaluation aligned with ISO 13485
    • Certification valid for 3 years
    KGMP certification is a prerequisite for Class II–IV device registration.
  1. Registration Process by Device Class
    2. Class I Devices – Notification Route
    • Exempt from technical review and KGMP
    • Basic device details submitted through MFDS portal
    • Reviewed and finalized by NIDS
    Class II, III, and IV Devices – Approval Route
    Manufacturers must undergo pre‑market approval, valid for 5 years, with renewal thereafter.
    Two review options:
    General Technical File Review
    • No clinical data required if predicate device exists
    • Applicable when the device is sufficiently comparable to approved products
    Technical Safety & Efficacy Review (SER)
    • Required when no predicate exists or when new technology is involved
    • Clinical studies may be required
    MFDS conducts the final assessment for approval.

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
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