South Korea Medical Device Registration

Regulatory Authority

The Ministry of Food and Drug Safety (MFDS)

The Korea Medical Devices Industry Association (KMDIA), the largest association of over 900 medical devices companies, aims to improve public health and boost industry growth by partnering with its members to lead technological advances in the 21st century.

Link for Regulatory Authority

https://www.mfds.go.kr/eng/index.do

Local Regulation

Medical Device Act (MDA)

Classification of Medical Devices

• Medical Devices: Class I, II, III and IV
• IVDs: Class I, II, III and IV

Overview of Notification, Certification and Approval Process in Medical Devices

The Ministry of Food and Drug Safety (MFDS) requires the submission of Technical Documentation for the certification and approval of medical devices.

In principle:

• Class I devices are subject to notification (self-declaration) to MFDS.
• Class II devices are subject to certification, which is reviewed by designated conformity assessment bodies such as Korea Testing & Research Institute (KTL) or National Institute of Medical Device Safety Information.
• Class III & IV devices require approval directly from MFDS.
  
  

  However, certain Class II devices must be approved by MFDS instead of certification, including those:

  • Requiring clinical trial data
  • Related to digital healthcare technologies (e.g., telemedicine systems, AI-based software)
  • Without established classification or nomenclature
  • Combined with pharmaceutical products or other regulated components

Listing or Registration Requirements

• Classify the medical device
• Appoint an Authorized Korean License holder
• Apply for KGMP Certification 4. Submit Certification/ Approval
• MFDS requires those who intend to produce a medical device in Korea, or who intend to import a medical device from overseas to obtain a manufacturing business license and an import business license, respectively.

Documents Required for South Korea Medical Device Registration

1. Technical Documents

Technical documentation must demonstrate the safety, quality, and performance of the medical device. It typically includes:

• Intended Use
• Mechanism of Action (MoA)
• Functional/Operational Structure
• Raw Materials
• Instructions for Use (IFU)
• Test Specifications and Performance Data

2. Technical Document Classification

The technical documents consist of ‘Application Form’ and ‘Supplementary Evidence.’ The presence of mandatory submission of ‘clinical trial reports’ (as a part of ‘Supplementary Evidence’) determines application procedure to be followed.

• General Technical Document Review

If the device is substantially equivalent to an already approved/registered device, clinical data may not be required.

• Safety and Efficacy Review (SER)

• Intended Use
• Mechanism of Action (MoA)
• Raw Materials

3. Premarket Approval

• Class I (Notification)
• Class II (Certification, Approval)
• Class III, IV (Approval)

Premarket Approval Process:

• MDITAC

Class I Approval Process: Notification

• Notification submission to MFDS
• No prior technical document review required
  
• Basic QMS compliance

Class II Approval Process: Certification

• Application submitted to MFDS-designated conformity assessment bodies (e.g., Korea Testing & Research Institute (KTL), National Institute of Medical Device Safety Information)
• Technical document review
• KGMP (QMS) requirements

Class II, III and IV Approval Process: Approval

• Application submitted directly to MFDS
• Technical documentation review
• Timeline:
  • Technical Document: 55 days
  • Clinical trial: ~70–75 working days

Certification of Class II Medical Devices

• Substantial Equivalent (SE) Device:
  A device equivalent to an existing approved/certified/notified device in:

  • Intended Use
  • Mechanism of Action (MoA)
  • Raw Materials
  • Performance
  • Test Specifications*
  • Instructions for Use*

  ( Not applicable to IVDs)

• Modified Device:
  A device equivalent in:

  • Intended Use
  • Mechanism of Action (MoA)

  But different in one or more of:

  • Raw Materials
  • Performance
  • Test Specifications*
  • Instructions for Use*

  ( Not applicable to IVDs)

Approval of Class II, III and IV Medical Devices

NIFDS (affiliated agency of MFDS) approves ‘New devices (Class II)’ and ‘Class III and IV Devices’

Class II, III and IV devices must submit:

• Technical File
• S&EP Data
• Clinical Trial Reports
• Test Reports
• IFUs, Labelling

Registration Timeline

• Class I (NIDS) – 1 Month
• Class II(NIDS)- 3-5 months
• Class III- 9 months
• Class IV – 9-12 months

• ( Timelines may vary based on device complexity and data requirements)

License Validity and Renewal

Medical device registration licenses do not expire, but the KGMP Certificate must be renewed every three years.

Special Labelling Requirements

Label and instructions for use must be provided in Korean

Additional Comments

All application files must be available in Korean language

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the Process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation:  sales@omcmedical.com

Frequently Asked Questions

1. What are the key steps in the South Korea medical device registration process?

The process involves product classification, MFDS approval, obtaining KGMP certification, and assigning a local authorized representative.

2. What is KGMP certification, and why is it necessary for medical devices?

KGMP (Korean Good Manufacturing Practice) ensures that the manufacturing process meets South Korea’s quality standards for medical devices.

3. How are medical devices classified under MFDS regulations in South Korea?

Devices are classified into four risk-based categories: Class I (low risk) to Class IV (high risk), with stricter requirements for higher classes.

4. Is it mandatory to have a local representative for medical device registration in South Korea?

Yes, foreign manufacturers must appoint a local authorized representative to manage regulatory submissions and compliance.

5. How long does it take to register a medical device in South Korea?

The timeline varies based on device classification and regulatory requirements, typically ranging from 6 months to over a year for higher-risk devices.