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Labelling Standards Notification

The MFDS Labelling Standards Notification (์˜๋ฃŒ๊ธฐ๊ธฐ ๊ธฐ์žฌ ์‚ฌํ•ญ ๊ธฐ์ค€ ๊ณ ์‹œ) specifies mandatory content and format for medical device labels and IFU in Korea.

What it coversโ€‹

  • Mandatory label elements (product name, ํ’ˆ๋ชฉํ—ˆ๊ฐ€ number, manufacturer/importer, lot, date, etc.)
  • IFU minimum content requirements
  • Bilingual labelling rules (Korean mandatory)
  • Special labelling for sterile, single-use, implantable devices
  • Symbol requirements (ISO 15223 symbols generally accepted)

Add under 'Bilingual labelling rules': "Korean-language IFU must be legible and presented at the same prominence level as other language versions. Professional translation certified by a qualified translator is recommended. Abbreviations and acronyms must be explained in Korean. Product names registered in ํ’ˆ๋ชฉํ—ˆ๊ฐ€ must appear on all labels exactly as approved by MFDS."