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MFDS Application

Application to MFDS (renamed from KFDA)

MFDS is an acronym of Ministry of Food & Drug Safety.

MFDS is in charge of establishing regulations on personal health and safety related to

food, drugs, medical devices, cosmetics, etc., and also provides the public services of

guidance and restriction on product distribution in Korea including product

licensing & approval and quality management.

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Medical Device Approval Process via MFDS

  1. The details about manufacturing, importing or selling the medical devices are defined in the

    medical device law, which is to efficiently manage the medical devices, and to improve the national health.

  2. Definition of Medical Device

    A medical device means tools, machine, or materials, which can be applied to human or animals independently or in combination. It also can be defined as follows

    1. A product used to diagnose, cure, relieve, treat or prevent a disease

    2. A product used to diagnose, cure, relieve, or realign injuries or disabilities

    3. A product used to replace or transform a specific structure or function

    4. A product to control birth

  3. Licensing or Approving Medical Devices

    Medical devices should be licensed or approved in advance.

  4. Medical Device Classifications

    Class Definition
    1 Rarely exposed to patients, butthe risk to patients in the event of malfunction or exposure is regarded as almost negligible.
    2 The risk to patients in the event of malfunction including the probability of life threatening or critical disabilities is relatively low.
    3 The risk to patients in the event of malfunction is regarded as relatively high as it can be inserted to a human body for a specific period.
    4 The device is highly invasive with potentially fatal risk to patients as it is permanently implanted in a human body, in direct touch with a heart, raw materials of which information to guarantee its safety is insufficient is used, or a device is invented for a new purpose
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