February 24, 2025

Navigating the regulatory landscape for medical devices in South Korea can be complex, particularly for foreign manufacturers. The Ministry of Food and Drug Safety (MFDS), previously known as the Korean FDA, oversees the registration and approval process for medical devices. This blog outlines the essential steps and guidelines for successfully registering medical devices in South Korea.

Understanding the Role of the MFDS

The MFDS is responsible for ensuring that all medical devices, including in vitro diagnostics (IVDs), meet stringent safety and efficacy standards before they can be marketed. The agency categorizes devices into different classes based on their risk levels, which determines the registration pathway required.

Classification of Medical Devices

Medical devices in South Korea are classified into four categories:

Class I: Low-risk devices, often exempt from extensive review processes.

Class II: Medium-risk devices requiring more detailed documentation and evaluation.

Class III: High-risk devices needing comprehensive safety and efficacy data.

Class IV: Very high-risk devices that undergo rigorous scrutiny.

Registration Process Overview

Step 1: Determine Device Classification

The first step in the registration process is to determine your device's classification according to MFDS guidelines. This classification will dictate the necessary documentation and evaluation procedures.

Step 2: Appoint a Korea License Holder (KLH)

Foreign manufacturers without a local office in South Korea must appoint a Korea License Holder (KLH). The KLH is responsible for managing your device registration with the MFDS and facilitating communication with regulatory authorities.

Step 3: Prepare Documentation

The documentation requirements vary by device class:

Class I Devices:

  Submit a Pre-Market Notification containing basic device information. All documents must be translated into Korean.

  Generally, do not require technical reviews or Korean Good Manufacturing Practice (KGMP) certification, except for sterile and measuring devices.

Class II Devices:

Prepare a General Technical File or a Safety and Effectiveness Review (SER).

Conduct type testing at a certified laboratory or submit equivalent foreign test reports.

Obtain KGMP certification through an on-site audit of your manufacturing facility.

Class III and IV Devices:

Submit comprehensive technical documentation, including clinical data, as part of the SER.

Follow similar type testing and KGMP certification processes as Class II devices.

Step 4: Submit Application

Once your documentation is prepared, submit your application to the MFDS. Ensure that all documents comply with Korean regulations. The MFDS may request additional information during their review process.

Step 5: Pay Applicable Fees

Be prepared to pay applicable fees based on device classification and complexity. These fees vary depending on the risk level of the device.

Step 6: Approval and Marketing Authorization

Upon successful review, the MFDS will issue marketing authorization for your device. This approval allows you to legally market your product in South Korea. The registration details will also be published on the MFDS website.

Key Documentation Requirements

Across all device classes, certain documentation is typically required:

Manufacturer Information: Company name, address, and proof of legal operation.

Declaration of Conformity: A signed document confirming compliance with applicable regulations.

 Instructions for Use (IFU): Clear user guidelines translated into Korean.

Labelling and Packaging Details: Must meet Korean standards, including Korean-language labels.

Additional Considerations

  KGMP Certification Timelines: The KGMP certification process may take several months and is a prerequisite for Class II-IV device approvals.

 Expedited Registration Pathways: Some devices may qualify for abridged review if they have prior approvals from the US FDA, EU MDR, or Japan PMDA.

 Renewal & Post-Market Surveillance: Registration is not permanent; manufacturers must comply with renewals and post-market surveillance obligations, especially for high-risk devices.

  Conclusion

Successfully registering a medical device with the MFDS requires careful planning and adherence to regulatory guidelines. Staying informed about MFDS updates and engaging local experts can streamline the process. Maven offers expert regulatory consulting services, including KLH support, technical documentation preparation, and KGMP certification assistance, helping manufacturers achieve smooth market entry in South Korea.