KFDA (Medical Device)

General Description


In accordance with Chapter I, Article 2 of the Medical Device Act, the term “medical device” means any instrument, apparatus, appliance, material or similar product, whether used alone or in combination, to be used for human beings or animals and product that belongs to one of 1 to 4 below. However, it excludes pharmaceuticals and quasi drugs under the Pharmaceutical Affairs Act and, of rehabilitation aids, prosthetic limb/aid under the provisions of the Article 55 of the Welfare of Disabled Persons Act.
  1. Product used for the purpose of diagnosis, treatment, alleviation or prevention of disease
  2. Product used for the purpose of diagnosis, treatment, alleviation or compensation for an injury or handicap
  3. Product used for the purpose of investigation, replacement or modification of the anatomy or the physiology
  4. Product used for the purpose of the control of conception

Applicable Products

  • Most of medical devices and product with the following intention and purpose of use is included.
    • Instrument, apparatus, appliance, material or other article, whether used alone or in combination, including software, intended by the manufacturer to be used for human beings, and of which purpose for use is not on the human body by pharmacological, immunological or metabolic means, but which may be assisted its function by such means
  • Medical instrument
    • Operating and treatment table, bed for medical use, medical sterilizing apparatus, medical water sterilizer, respiratory apparatus, medical chamber, artificial internal organ apparatus, neonatal incubator, medical x-ray system, non-ionization diagnostic device, radiologic device, film developer for medical use
  • Medical Supplies
    • Knives for medical use, curettes, clamp, forceps, stethoscope, clinical thermometric system
  • Dental Materials
    • Orthodontic materials, dental boding and filling materials, dental metals, prosthodontic materials

Conformity Assessment Procedure


In accordance with the level of potential hazard on the human body, medical devices are classified into the following four classes by the medical device committee. If a given device can be classified into more than one class, then the highest possible class applies.
  • Class 1
  • Medical device that either does not directly touch the human body or touches but there is almost no potential danger, and has minimal effect on the human body by malfunction or disorder

  • Class 2
  • Medical device with low potential danger that, although there is a danger on the human body by malfunction or disorder during operation, there is little possibility of causing danger to life or encountering significant functional error

  • Class 3
  • Medical device that is used as implanted inside the human body for a period of time or poses potentially high danger

  • Class 4
  • Medical device that is permanently implanted inside the human body, directly touches the heart, central nervous system or central circulatory system, or uses tissues or derivatives of animal or raw material with insufficient information for the verification of its safety

    - Classification site: http://md.kfda.go.kr/technical/technical_4.jsp
Manufacturers and importers of medical devices should follow the below procedure for conformity assessment depending on the class of the product
  1. Manufacturer


  2. For Class 1,
    Declare product -> File for manufacture license and declare product -> KGMP approval for manufacture and quality management -> Sell after manufacture

    For Class 2, 3 or 4,
    File for product license -> Request for safety and effectiveness inspection -> Inspection -> Request for the review of technical report -> File for manufacturer license & declare product -> KGMP approval for manufacture and quality management -> Sell after manufacture
  3. Importer


  4. For Class 1,
    Declare product -> File for import license and declare importing product -> KGMP inspection for importation and quality management -> Customs clearance report -> Sell after customs clearance

    For Class 2, 3 or 4,
    Product license -> Request for safety and effectiveness inspection -> Test medical device confirmation -> Customs clearance report -> Import clearance -> Inspection -> Request for the review of technical document -> File for import license and declare importing product -> KGMP approval for import and quality management -> Customs clearance report -> Sell after clearance