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

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韩国医疗器械质量体系审核是进入韩国市场的关键环节，由韩国食品药品安全部（MFDS, Ministry of Food and Drug Safety）主导，核心是 KGMP（Korean Good Manufacturing Practice）认证。该审核确保制造商的质量管理体系（QMS）能够持续生产出安全、有效的医疗器械。



The quality system audit of Korean medical devices is a key step in entering the Korean market, led by the Ministry of Food and Drug Safety (MFDS), with the core being KGMP (Korean Good Manufacturing Practice) certification. This audit ensures that the manufacturer's quality management system (QMS) can continuously produce safe and effective medical devices.

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KGMP认证

• 定义：KGMP是《医疗器械法》要求的强制性生产质量管理规范，其要求与国际标准 ISO 13485 高度协调，但包含韩国特有的法规和执行细节。
• 目标：验证制造商的质量体系是否覆盖产品全生命周期（设计、生产、销售、售后服务），并能持续保证产品质量。
  

KGMP certification
Definition: KGMP is a mandatory production quality management specification required by the Medical Device Act, which is highly coordinated with the international standard ISO 13485 but includes Korean specific regulations and implementation details.
Objective: To verify whether the manufacturer's quality system covers the entire product lifecycle (design, production, sales, after-sales service) and can continuously ensure product quality.

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谁需要接受审核？医疗器械类别是否需要KGMP审核说明
I类（低风险，如医用纱布、检查手套）否通常豁免现场审核。
II类（中风险，如血糖仪、超声设备）是需要进行KGMP审核。
III类（高风险，如心脏支架、人工关节）是需要进行更严格的KGMP审核。
IV类（极高风险，如心脏起搏器）是需要进行最严格的KGMP审核。

注意：所有II类、III类、IV类医疗器械的制造商（包括外国制造商）都必须获得KGMP证书。

Who needs to undergo review?Does the category of medical devices require KGMP audit instructionsClass I (low-risk, such as medical gauze and examination gloves) is usually exempt from on-site audits.Class II (medium risk, such as blood glucose meters and ultrasound equipment) requires KGMP review.Class III (high-risk, such as heart stents and artificial joints) requires stricter KGMP review.Class IV (extremely high-risk, such as pacemakers) requires the strictest KGMP review.Attention: All manufacturers of Class II, III, and IV medical devices (including foreign manufacturers) must obtain a KGMP certificate.

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• 指定韩国许可持有人（KRP）

  
  
  • 外国制造商必须指定一名韩国本地的授权代表（Korea Responsible Person, KRP）。
  • KRP负责向MFDS提交注册申请、沟通协调、处理审核事宜。
    

Designated Korean License Holder (KRP)
Foreign manufacturers must designate a Korean Responsible Person (KRP) who is a local authorized representative in Korea.
KRP is responsible for submitting registration applications to MFDS, communicating and coordinating, and handling review matters.

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• 申请KGMP认证

  
  
  • 由KRP向MFDS或其授权的第三方审核机构提交KGMP认证申请。
  • 提交材料包括：质量体系文件（需韩语）、产品技术文件摘要、工厂信息等。
    

Apply for KGMP certification
Submit KGMP certification application to MFDS or its authorized third-party auditing agency by KRP.
The submitted materials include: quality system documents (in Korean), product technical document summaries, factory information, etc.

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审核机构与类型

• II类器械：
  • 通常由第三方审核机构（如KSA, KTR, KTL等MFDS认可的机构）进行现场审核。
    
• III类与IV类器械：
  
  • 必须接受联合审查：由第三方审核机构与MFDS官方检查员共同进行现场审核。
  • 这是审核最严格、要求最高的类型.
    

Audit institution and type
Class II devices:
Usually, on-site audits are conducted by third-party auditing agencies (such as KSA, KTR, KTL, and other MFDS accredited organizations).
Class III and IV devices:
Must undergo joint review: on-site audit conducted jointly by third-party auditing agencies and MFDS official inspectors.
This is the most rigorous and demanding type of review

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• 现场审核（On-site Audit）

  
  
  • 提前通知：MFDS或审核机构通常会提前1-2个月通知审核时间。
  • 审核内容：审核团队（通常分质量管理、生产、检测等小组）将深入检查：
    • 质量管理体系文件：质量手册、程序文件、风险管理报告（ISO 14971）、设计开发记录、变更控制、内部审核、管理评审等。
    • 生产设施与环境：洁净车间（如适用）、设备维护与校准记录、生产过程控制、工艺验证（如灭菌、注塑）。
    • 产品一致性：抽样检查在产产品或库存品，确认其与注册技术文件一致。
    • 人员资质与培训：关键岗位人员（如QA、QC、生产主管）的培训记录和能力评估。
    • 供应商管理：原材料供应商的评估、审计和质量协议。
    • 上市后监管：不良事件报告流程、产品追溯系统、客户投诉处理记录。
      
  • 语言：现场审核时，文件需提供韩语版本，或配备合格的翻译人员。
    

On site Audit
Advance notice: MFDS or auditing agencies usually notify the auditing time 1-2 months in advance.
Audit content: The audit team (usually divided into quality management, production, testing, and other teams) will conduct in-depth inspections on:
Quality Management System Documents: Quality Manual, Procedure Documents, Risk Management Report (ISO 14971), Design and Development Records, Change Control, Internal Audit, Management Review, etc.
Production facilities and environment: cleanroom (if applicable), equipment maintenance and calibration records, production process control, process validation (such as sterilization, injection molding).
Product consistency: Sampling inspection of in production or inventory products to confirm their consistency with registered technical documents.
Personnel qualifications and training: Training records and competency assessments for key personnel in positions such as QA, QC, and production supervisors.
Supplier management: evaluation, audit, and quality agreement of raw material suppliers.
Post listing supervision: adverse event reporting process, product traceability system, customer complaint handling records.
Language: During on-site audits, documents must be provided in Korean or accompanied by qualified translators.

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• 审核报告与结果

  
  
  • 审核结束后，审核机构向MFDS提交审查报告。
  • 报告会列出符合项和不符合项（Non-conformities）。
  • 结果：
    
    • 通过：无严重不符合项，或轻微不符合项已整改。
    • 有条件通过：存在不符合项，需在规定期限内（如30-60天）提交整改计划（CAPA）和证据。
    • 不通过：存在严重不符合项，需重新申请审核。
      

Audit report and results
After the audit is completed, the auditing agency submits the audit report to MFDS.
The report will list both compliant and non compliant items.
Result:
Passed: No serious non conformities, or minor non conformities have been rectified.
Conditional approval: If there are non conformities, a corrective action plan (CAPA) and evidence must be submitted within the specified period (such as 30-60 days).
Not approved: There are serious non conformities and a new application for review is required.

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• 证书颁发

  
  
  • 审核通过后，由MFDS或授权机构颁发KGMP认证证书。
  • 证书有效期为 3年。
    

Certificate issuance
After approval, the KGMP certification certificate will be issued by MFDS or authorized institutions.
The certificate is valid for 3 years.

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• 后续监督

  
  
  • 定期审核：在3年有效期内，会进行监督审核（Surveillance Audit），通常每年一次。
  • 飞行检查（Unannounced Inspection）：MFDS有权在任何时间进行突击检查。
  • 证书更新：需在到期前90天内提交更新申请，并可能再次接受现场审核。
    

Subsequent supervision
Regular Audit: During the 3-year validity period, a Surveillance Audit will be conducted, usually once a year.
Unannounced Inspection: MFDS has the right to conduct surprise inspections at any time.
Certificate update: An update request must be submitted within 90 days before expiration and may undergo on-site review again.