韩国医疗器械质量体系审核 Korean Medical Device Quality System Audit

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• 文件语言：所有提交给MFDS的文件必须为韩语。企业内部文件可用英文，但现场审核时需能提供韩语翻译件。
• ISO 13485 vs KGMP：虽然ISO 13485是基础，但不能直接替代KGMP。企业必须确保其体系完全满足KGMP的特定要求。
• 风险管理：必须依据ISO 14971标准建立全面的风险管理体系，并贯穿产品全生命周期。
• 临床评价：高风险产品（III/IV类）通常需要在韩国境内进行临床试验。
• 标签与说明书：必须使用韩语标注，并符合MFDS的格式和内容要求。
• 上市后监管（PMS）：必须建立完善的不良事件监测、报告和产品召回系统。
• MDSAP审核结果：韩国是MDSAP（医疗器械单一审核程序）的成员。在某些情况下，有效的MDSAP审核报告可以用于申请KGMP的桌面审核，但这通常仅适用于初始审核、变更审核或附加审核，而证书的延续审核通常仍需进行现场审核。
  

File language: All files submitted to MFDS must be in Korean. Internal documents of the enterprise can be in English, but Korean translations must be provided during on-site audits.
ISO 13485 vs KGMP: Although ISO 13485 is the foundation, it cannot directly replace KGMP. Enterprises must ensure that their systems fully meet the specific requirements of KGMP.
Risk management: A comprehensive risk management system must be established in accordance with the ISO 14971 standard and run through the entire product lifecycle.
Clinical evaluation: High risk products (Class III/IV) typically require clinical trials within South Korea.
Labels and instructions: must be labeled in Korean and comply with the format and content requirements of MFDS.
Post Market Regulation (PMS): A comprehensive adverse event monitoring, reporting, and product recall system must be established.
MDSAP audit result: South Korea is a member of MDSAP (Medical Device Single Audit Program). In some cases, a valid MDSAP audit report can be used to apply for desktop audits of KGMP, but this usually only applies to initial audits, change audits, or additional audits, while certificate continuation audits typically still require on-site audits.

gaowenhua

如何准备审核？（Checklist要点）
✅ 确保质量体系文件符合KGMP和ISO 13485要求。
✅ 所有文件准备韩语版本。
✅ 完成内部审核和管理评审。
✅ 整理好所有记录（生产、检验、校准、培训、投诉、不良事件）。
✅ 确保生产现场整洁有序，标识清晰。
✅ 关键人员熟悉审核流程和自身职责。
✅ 与KRP和审核机构保持密切沟通。




How to prepare for the audit? (Checklist Key Points)
✅  Ensure that quality system documents comply with KGMP and ISO 13485 requirements.
✅  Prepare Korean versions of all documents.
✅  Complete internal audits and management reviews.
✅  Organize all records (production, inspection, calibration, training, complaints, adverse events).
✅  Ensure that the production site is clean and orderly, with clear labeling.
✅  Key personnel are familiar with the audit process and their own responsibilities.
✅  Maintain close communication with KRP and audit agencies.

gaowenhua

韩国医疗器械质量体系审核（KGMP）是一项严谨、规范的强制性程序。企业应提前规划，充分准备，重点关注文件合规性、现场一致性、风险管理与上市后监管，以确保顺利通过审核，成功进入韩国市场



The Korean Medical Device Quality System Audit (KGMP) is a rigorous and standardized mandatory procedure. Enterprises should plan ahead, prepare adequately, and focus on document compliance, on-site consistency, risk management, and post listing supervision to ensure smooth approval and successful entry into the Korean market

whping

感谢楼主的分享

廖斌

感谢分享，学习了！