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Medical Device Regulations South Korea

We guide medical device and IVD manufacturers through South Korea’s MFDS regulatory requirements, ensuring compliant and efficient market access.

MFDS Authority

Medical Device Regulations South Korea

In South Korea, the regulatory submission process for medical devices is overseen by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA). The MFDS ensures medical devices' safety, efficacy, and quality in the South Korean market.  
 
The primary regulations governing medical devices in South Korea include the Medical Devices Act (MDA) and its associated regulations, such as the Enforcement Decree of the Medical Devices Act and the Enforcement Regulation of the Medical Devices Act. Qserve is helping manufacturers worldwide with market access and supports the requirements of the Medical Device Regulations in South Korea.

 

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Services

Qserve services for South Korea

More information
Global Regulatory Strategy

A tailored roadmap for regulatory compliance, aligning South Korea’s MFDS requirements with your global market goals.

Registration Support in South Korea

Step-by-step guidance through the MFDS registration process, from document preparation to final submission.

MFDS Certification

Support in obtaining MFDS clearance or pre-market approval, depending on your device classification and regulatory pathway.

QMS Compliance Support (KGMP & Gap Analysis)

Evaluation and alignment of your Quality Management System to meet Korean Good Manufacturing Practice (KGMP) audit expectations.

Translation of Labels and IFUs

Accurate translation and formatting of product labels and Instructions for Use in line with Korean language and regulatory standards.

Conformity Assessment Route Support

Expert advice on choosing the correct regulatory pathway, certification or pre-market approval, based on risk class and device type.

Medical Device Classification in South Korea

Risk-based classification

In South Korea, medical devices are regulated under a risk-based classification system with four categories: Class 1, Class 2, Class 3, and Class 4, where the requirements for product registration increase with the level of risk. The classification ensures that the regulatory scrutiny is proportionate to the device's potential impact on patient safety.

Classification Overview

Class 1: Low-Risk Devices
Examples: Bandages and surgical instruments without measuring functions.
Requirements: Pre-market notification to the National Institute of Medical Device Safety Information (NIDS).
Exemptions: No technical file review or Quality Management System (QMS) certification is required.

Class 2: Low to Medium-Risk Devices
Examples: Thermometers and infusion pumps.
Requirements: Pre-market approval, including technical documentation review and a valid QMS certification.

Class 3: Medium to High-Risk Devices
Examples: Orthopedic implants and diagnostic imaging equipment.
Requirements: Pre-market approval with detailed technical documentation and QMS compliance.

Class 4: High-Risk Devices
Examples: Pacemakers and heart valves.
Requirements: The approval process must be stringent, involving in-depth technical documentation and strict QMS conformity.

QMS Requirements and KGMP Certification
South Korea mandates Korean Good Manufacturing Practices (KGMP) certification for Class 2, 3, and 4 device manufacturers. Unlike other regulatory systems, an ISO 13485 certificate alone cannot meet the QMS requirements. KGMP certification involves auditing the manufacturing process to ensure compliance with South Korea's specific standards.

The Ministry of Food and Drug Safety (MFDS) oversees this certification, and manufacturers must maintain compliance to market their products successfully in South Korea.

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Registration Routes South Korea

Medical Device Regulations South Korea

South Korea offers two distinct registration pathways for Class II medical devices: certification or pre-market approval. The route choice depends on whether a substantially equivalent device already exists in the Korean market.

Certification Route
This pathway applies to devices with a substantially equivalent counterpart already available in South Korea.

  1. Submission Requirements: Manufacturers must prepare a submission with comparative data demonstrating equivalence to the existing device.
  2. Review Process:
    1. Certification is conducted by the National Institute of Medical Device Safety Information (NIDS).
    2. After certification, final approval is granted by the Ministry of Food and Drug Safety (MFDS).
  3. Advantages: This route is generally faster, relying on the equivalence assessment with a previously approved device.


Pre-Market Approval Route
Devices without a substantially equivalent counterpart in the Korean market must undergo this more detailed process.

  1. Submission Requirements: A complete technical file must be submitted, including extensive data on performance, safety, and efficacy.
  2. Review Process: The MFDS conducts an in-depth documentation review, ensuring the device meets all regulatory requirements.
  3. Challenges: This route typically takes longer due to the comprehensive evaluation process.
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Timelines and fees

Regulatory timelines and fees 

All documentation that needs to be submitted to the authorities must be in Korean. Once a registration is completed, it remains valid indefinitely if no changes are made to the device or its intended use.   

Approval timelines will vary depending on the risk class of the device. 

Class I devices

Class I devices in Korea require electronic notification to the Medical Device Information & Technology Assistance Center (MDITAC), which is accredited by the MFDS for low-risk applications. Unlike the US FDA’s Class I listing system, manufacturers must provide detailed information about their device and technology but do not need to submit test reports or a KGMP certificate. 

Class II devices 

The MFDS may announce Class II devices in Korea approved and certified more than three times as 'Recognized Substantial Equivalent (SE) devices.' 

Class III and IV 

Class III and IV devices require MFDS approval, and Class IV manufacturers must submit a technical file in Summary Technical Documentation (STED) format. The STED must be in Korean, though appendices like test reports and risk management files might not need translation. STED requirements are stricter than those for lower-risk devices.

All Class II-IV

All Class II-IV applications must include a comparison table to a substantially equivalent device registered with the MFDS. Devices without a South Korean market predicate need clinical data and will undergo Clinical Data Review (CDR) 

Expected registration fees also depend on device risk classification and whether or not a registered predicate device or substantial equivalent (SE) device already exists in South Korea. 

Representation for foreign manufacturers 

Korea License Holder (KLH) 

Foreign manufacturers must appoint a local authorized representative, also known as a Korea License Holder (KLH), who interacts with the regulatory authorities on the manufacturer’s behalf.  
KLHs (Korea License Holders) must comply with some requirements, including established officially in the territory of South Korea, 

the employment of a certified Quality Manager, 
possession of an Import Business License, 
being an ICC - ICC-in-country caretaker 
responsibility for each importation and quality control “check,” etc.  

Get in touch for more information about South Korea Market Access
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strategy
Go-to-market strategy

South Korea’s regulatory system shares similarities with the FDA’s framework, offering a streamlined path for low-risk devices, a substantial equivalence pathway for moderate-risk devices, and a comprehensive pre-market approval process for higher-risk devices. Our team at Qserve can help you assess your existing documentation to determine its suitability for the South Korean regulatory framework. We specialize in identifying gaps and preparing efficient solutions to ensure a smooth path to compliance.

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Medical devices and IVD registration

Navigating the South Korean regulatory landscape requires a clear understanding of the technical documentation and regulatory pathways. Qserve offers tailored support to guide you through:Performing a gap analysis of your current compliance to identify missing elements.Preparing complete and compliant technical documentation.Supporting your KGMP certification process, including on-site audit preparation.

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