Labelling Standards Notification
The MFDS Labelling Standards Notification (의료기기 기재 사항 기준 고시) specifies mandatory content and format for medical device labels and IFU in Korea.
What it covers
- Mandatory label elements (product name, 품목허가 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)