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South Korea Medical Device Registration

Ministry of Food and Drug Safety (MFDS) approval timelines and requirements

1-2 weeks

Typical Timeline

Device Classes

Yes

MDSAP Accepted

Required

Korea License Holder

South Korea Medical Device Registration Overview

South Korea medical device registration through MFDS typically takes 1-2 weeks for Class I devices. The official MFDS target is 1-2 weeks, but realistic timelines include preparation, documentation review, and potential questions from regulators.South Korea uses a 4-class (I, II, III, IV) risk-based classification system. Foreign manufacturers must appoint a Korea License Holder to register devices in South Korea. MFDS accepts MDSAP certification, which can waive on-site k-gmp audit. Registration is valid for 5 years.

Registration Timeline by Device Class

South Korea uses a 4-class (I, II, III, IV) risk-based classification system.

Class I

Self-declaration

Low Risk

Official

1-2 weeks

Realistic

1-2 weeks

• Fastest pathway

• No MFDS review

Class II

MFDS Review

Medium Risk

Official

2-4 months

Realistic

3-6 months

With Prior Approval

2-4 months

Accelerated with: MDSAP for K-GMP

• K-GMP certification required

• MDSAP can waive on-site audit

Local Testing RequiredGMP/QMS Required

Class III

MFDS Review with clinical data

High Risk

Official

4-8 months

Realistic

6-12 months

• Clinical data required

• K-GMP mandatory

Clinical Trial RequiredLocal Testing RequiredGMP/QMS Required

Class IV

MFDS Review with extensive clinical

Highest Risk

Official

8-12 months

Realistic

10-15 months

• Extensive clinical data

• On-site K-GMP audit

Clinical Trial RequiredLocal Testing RequiredGMP/QMS Required

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your South Korea registration.

FDA 510(k)

No direct recognition

None

EU CE Mark

No direct recognition

None

MDSAP

Can waive on-site K-GMP audit

2-3 months

Key Requirements

Korea License Holder (for foreign manufacturers)
K-GMP certification (Class II-IV)
Korean labeling
Local testing from accredited labs

Registration Validity:

5 years

MDSAP Benefit:

Can waive on-site K-GMP audit

Registration Process Flowchart

South Korea Medical Device Registration Process

Step-by-step MFDS registration process. Total estimated timeline: 1-2 weeks.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MFDS. Appoint a Korea License Holder.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MFDS including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MFDS reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-2 weeks

In-depth technical assessment of device safety and performance. MFDS may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MFDS issues South Korea market authorization certificate.

Summary: The South Korea medical device registration process through Ministry of Food and Drug Safety (MFDS) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.