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Government Legislation

  • Notice on Partial Amendment to the Designation of the Scope of Quasi-Drugs
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2020-03-23
    • Opinion Submission Deadline : 2020-03-25

(1) Reasons for Proposal

The Notice aims to secure national safety by designating masks that can be used to protect the respiratory system from infectious agents by blocking droplets of bodily fluids during daily life as a quasi-drug in addition to the existing “health masks” and “surgical masks.”

(2) Major Provisions

Designation of additional quasi-drugs (Subparagraph 1 Item (b) 3)

Newly designate masks for the purpose of protecting the respiratory system by blocking droplets of bodily fluids during daily life as a quasi-drug.



Regulatory effect assessment
  • 규제영향분석서 제출_의약외품 범위 지정.hwp [download]
Legislative proposal (draft)
  • 200320_의약외품 범위 지정_개정_심사_초안.hwp [download]