Navigating Korea’s Medical Device Registration Process: A Comprehensive Guide

korea medical market

Introduction

Korea’s medical device market is one of the fastest-growing in Asia, offering significant opportunities for international manufacturers. With a healthcare system that places a strong emphasis on cutting-edge medical technologies, entering the Korean market can be highly rewarding. However, to succeed, companies must navigate a complex regulatory landscape governed by the Ministry of Food and Drug Safety (MFDS). This guide provides an in-depth look at the medical device registration process in Korea, detailing classifications, procedural steps, key documentation, and recent regulatory updates that are shaping the future of digital healthcare.

The Role of the Ministry of Food and Drug Safety (MFDS)

The MFDS is the central authority overseeing the safety, efficacy, and market compliance of medical devices in Korea. Formerly known as the Korea Food and Drug Administration, the MFDS is divided into specialized bureaus, with the Medical Device Safety Bureau specifically handling medical device regulations. Its mandate includes pre-market evaluations, post-market surveillance, and fostering innovation within the medical device sector.

The MFDS’s dual focus on safety and innovation reflects Korea’s commitment to maintaining high standards while encouraging the adoption of new technologies, making it an attractive destination for foreign manufacturers.

Medical Device Classification in Korea

Medical devices in Korea are categorized into four risk-based classes as determined by the Ministry of Food and Drug Safety (MFDS). This classification system aligns closely with international standards, such as those established by the International Medical Device Regulators Forum (IMDRF). Each class is assigned based on the intended use of the device and its potential risks to patients and users. Understanding these classes is critical for determining the specific regulatory pathway and requirements that a product must meet.

Class I: Low-Risk Devices

Class I devices are those with minimal potential to harm patients or users. These are generally non-invasive products with straightforward functions, such as:

  • Surgical instruments (e.g., forceps and scalpels).
  • Medical thermometers.
  • Bandages and other wound dressings.

Since the risk associated with these devices is minimal, the regulatory process for Class I devices is the least stringent.

Class II: Medium-Risk Devices

Class II devices pose a moderate level of risk and typically include devices that are slightly more complex or invasive than Class I products.

Class III: Medium-High-Risk Devices

Class III devices are more advanced and pose a higher risk due to their invasive nature or critical function in patient care. Examples of Class III devices include Orthopedic implants, such as hip and knee replacements, etc.

Class IV: High-Risk Devices

Class IV devices represent the highest risk category and include products that are life-sustaining, life-supporting, or implanted in the body for long durations. Examples include pacemakers, artificial heart valves, etc.

Factors Influencing Classification

Device classification in Korea is influenced by several factors, including:

  1. Intended Use: The specific purpose of the device, as claimed by the manufacturer, plays a key role in classification. For example, a thermometer for general use may be Class I, while a thermometer intended for neonatal care might be classified higher.
  2. Mode of Operation: Devices with active components or those that interact with the human body, such as diagnostic imaging equipment, are typically classified as Class II or higher.
  3. Invasiveness: Devices that penetrate the body, even minimally, such as catheters or surgical implants, are generally classified as Class III or IV.
  4. Duration of Use: Devices used for longer periods, particularly those implanted in the body, are classified in higher-risk categories.

Registration Process Overview

Class I Devices: Streamlined Pathway

For Class I devices, the registration process is simpler and quicker compared to higher-risk devices. Key steps include:

  1. Pre-Market Notification: Submit basic device information to the MFDS, ensuring all documents are in Korean.
  2. Approval: The MFDS reviews the submission and issues an acceptance letter, which serves as the product license.
  3. Importation: The Korea License Holder (KLH) facilitates customs clearance using the Pre-Market Notification license.

Class I devices are generally exempt from technical review and Korean Good Manufacturing Practice (KGMP) certification, except for sterile and measuring devices, which follow Class II procedures.

Class II, III, and IV Devices: Comprehensive Evaluation

For higher-risk devices, the registration process involves detailed evaluations to ensure safety and efficacy:

  1. Technical Documentation: Prepare a General Technical File or a Safety and Effectiveness Review (SER).
  2. Type Testing: Conduct independent testing at a certified lab, such as the Korea Testing Laboratory, or submit equivalent foreign test reports.
  3. KGMP Certification: Obtain KGMP certification through an on-site audit of the manufacturing facility, valid for three years.
  4. MFDS Review: Submit the technical documentation for thorough review.
  5. Approval: Upon approval, the MFDS issues a Pre-Market Approval license, which does not expire.
  6. Importation: The KLH manages customs clearance, ensuring compliance with all regulatory requirements.

The timeline for this process ranges from six months for Class II devices to over a year for Class IV devices, depending on the complexity of the device.

Documentation Requirements

The documentation required for registering medical devices in Korea varies based on the device’s classification and risk level. While higher-risk devices necessitate more extensive records, all classes require precise and well-prepared submissions to meet the Ministry of Food and Drug Safety (MFDS) standards.

General Requirements

Across all device classes, the following documentation is typically required:

  1. Manufacturer Information: Includes the company name, address, and proof of legal operation.
  2. Declaration of Conformity: A signed document confirming the device meets applicable Korean regulations.
  3. Instructions for Use (IFU): Clear user guidelines translated into Korean.
  4. Labeling and Packaging Details: Compliant with Korean standards, including Korean-language labels.

Class-Specific Requirements

Class I Devices

For low-risk devices, manufacturers need to submit a Pre-Market Notification containing basic device information, translated into Korean. Additional documents may be required for sterile or measuring devices, such as type testing results.

Class II Devices

Medium-risk devices require a General Technical File covering design, performance, and risk analysis. Type testing results and proof of compliance with KGMP standards, including a manufacturing audit, are mandatory.

Class III and IV Devices

High-risk devices demand comprehensive technical and clinical evidence, submitted through a Safety and Effectiveness Review (SER). For Class IV devices, a Summary Technical Documentation (STED) is required, following international standards. Clinical trial data and a post-market surveillance plan are often included for these classes.

Recent Developments in Digital Healthcare Regulations

Korea is at the forefront of integrating digital technologies into healthcare, with several regulatory changes designed to support innovation. One notable development is the acceptance of Real-World Evidence (RWE) as valid clinical data for digital medical devices. Since 2023, the Ministry of Food and Drug Safety (MFDS) has allowed manufacturers to use RWE in their submissions, significantly accelerating the approval process for AI-based products and other innovative technologies.

Another key advancement is international collaboration. In 2023, the MFDS entered into an agreement with the U.S. Food and Drug Administration (FDA) to harmonize regulations for AI medical devices. This partnership promotes global standardization, making it easier for manufacturers to navigate regulatory requirements across different markets.

Korea has also introduced greater regulatory flexibility to encourage innovation. Low-risk AI medical devices can now, in certain cases, bypass clinical trials, while higher-risk devices are permitted to use non-MFDS-approved trial sites. These reforms reduce the barriers to market entry for cutting-edge products without compromising safety.

These regulatory updates reflect Korea’s commitment to fostering technological advancement while maintaining robust safety standards, positioning the country as a leader in the digital healthcare sector.

Market Outlook and Future Trends

Korea’s medical device market is expected to grow at a compound annual growth rate (CAGR) of 6% over the next decade. Key drivers include:

  • Increased demand for innovative devices due to an aging population.
  • Expanding government support for digital healthcare initiatives.
  • Rising adoption of AI and data-driven medical technologies.

The MFDS’s efforts to harmonize international regulations and streamline approval pathways further enhance Korea’s appeal as a medical device market.

Successfully entering the Korean medical device market requires meticulous preparation and adherence to MFDS regulations. By understanding the classification system, following the detailed registration steps, and leveraging the latest regulatory updates, manufacturers can navigate this complex process with confidence. As digital healthcare continues to evolve, staying informed and adaptable will be critical for long-term success in this dynamic market.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)

Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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