SaMD Registration in South Korea

Ensure Success in the South Korean Market with Freyr!

To navigate Software as Medical Device (SaMD) registration in South Korea, you must understand the guidelines set by the Ministry of Food and Drug Safety (MFDS). Freyr offers comprehensive Regulatory strategies tailored for SaMD in South Korea, thereby ensuring compliance with the country's regulations.

SaMD Registration in South Korea Overview

The South Korean Ministry of Food and Drug Safety (MFDS) recognizes the importance of Artificial Intelligence (AI), big data, and machine learning software in advancing the country's healthcare sector. To provide clarity on the registration process for Software as Medical Devices (SaMDs) and software utilizing AI and big data, the MFDS has issued several guidance documents. Freyr's expertise and comprehensive range of Regulatory services can streamline the medical device software registration process in South Korea, ensuring timely market entry while maintaining compliance with Regulatory requirements.

Freyr Competencies

    Comprehensive Regulatory strategy for registration of SaMDs in South Korea.
    Regulatory and market intelligence support.
    Product classification and registration services for SaMDs.
    Regulatory support for SaMDs product development documents.
    Consultation services on SaMDs clinical evaluation studies.
    Post-approval change management.
    Korean License Holder (KLH) services.

Frequently Asked Questions (FAQs)

The following software are considered medical devices according to the MFDS-

  • Software that diagnoses, predicts, or monitors the possibility of diseases, including the existence of disease and condition, or treats diseases using clinical information.
  • Software that provides clinical information for diagnosis and treatment by analyzing the medical image, signal from In-Vitro Diagnostic (IVD) device, as well as a pattern or signal from the signal acquisition system.

The following software are not considered as medical devices according to the MFDS-

  • Software that supports administrative work of a medical institution.
  • Software intended for exercise, leisure activities, and general health care.
  • Software for education/research purposes.
  • Software intended for managing medical records which are not related to treatment and diagnosis of diseases.
  • Software that provides a tool to organize and trace health or treatment information.

The safety classification of medical device software can be categorized as follows-

GradeDefinition of Safety Grade for Medical Device Software
ANo possibility of injury or physical harm.
BPossibility of minor injuries (e.g., superficial wounds).
CPossibility of serious injuries or fatalities.

The time it takes to get a SaMD approved in South Korea can vary significantly based on several factors. The key determinants include the device's classification, complexity, conformity assessment route, and the efficiency of the Regulatory submission process.

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Why Freyr?

  • Successful submissions for various classes of SaMDs.
  • Dedicated and expert personnel to provide Regulatory support.
  • On-time submission of deliverables.
  • Local affiliate access to meet the challenges of the authority and language-specific requirements.
  • In-country or legal representative support with a cost-effective model.
  • Regulatory resource management/Staff augmentation services.