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Government Legislation

  • Draft for partial revision of Guideline on marking and management of standard codes of medical devices
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2021-07-19
    • Opinion Submission Deadline : 2021-08-09

1. Reason for revision

When marking or attaching standard codes of medical devices using current data matrix, figure or letter type (legible characters) mark, etc. readable by human may be omitted but it is difficult to quickly recognize standard codes of medical devices when reporting details of supply; therefore, improvement is required.

 

2. Main content

It is intended to improve easy report of details of supply by the method to state legible characters when standard codes of medical devices in data matrix bar code type are marked or attached, too (Article 5 of draft).


Regulatory effect assessment
  • 의료기기 표준코드의 표시 및 관리요령(규제영향분석서)_20210715.hwp [download]
Legislative proposal (draft)
  • 의료기기 표준코드의 표시 및 관리요령 일부개정고시안.hwp [download]