GMP( 韩国)
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1.“质量管理体系”指对组织机构、职责、程序、工艺、资源等进行有效控制的管理系统，便于对产品的质量控制。
2. “Quality Manager” means a person who is responsible for establishing,performing, and maintaining the quality control and quality management system of medical devices.
9.“质量审核员”是根据质量管理体系认证审查员注册标准，《工业产品质量管理与安全管理法案》第7条与《工业标准化法案实施法规》第15条中规定医疗器械领域的评审员，是KFDA专员指定的医疗器械质量管理审查机构的一员，负责医疗器械方面的质量管理审查工作（以下简称“审核员”）。
Article 3 (Scope)①These Standards shall apply to the following parties:
Standards for Manufacture and Quality Management of Medical Device
医疗器械生产与质量管理标准
Standards for Manufacture and Quality Management of Med书面准许使用或发行的特定产品，该产品具备某些不合规的特征，但不会直接影响安全性与有效性，符合法律的要求。
8. “Advisory Notice” means a letter issued by the manufacturer to recommend additional information or actions in relation to use, change, return, or scrap of the medical device after it was distributed.
第1条（目的）这些标准旨在详细规定制造临床实验设备，制造或进口医疗器械过程中须遵守的制造与质量管理要求，以及医疗器械质量管理审查机构指定程序与管理方法，详细内容见《医疗器械法案》第10条第7款、第13条第1款、第15条第6款和第28条，以及本法案《实施法规》第13条第1款第10目、第15条第1款第6目、第20条第1款第4-2目、第29-5条之规定。
8.“建议性通知”指医疗器械分销后制造商发布的器械使用、变更、退货、报废等方面的附加信息或措施。
9. A “Quality Auditor” means a reviewer in the field of medical devices asprovided in the Criteria for Registration of a Quality ManagementSystem Certification Auditor under Article 7 of the「Act on QualityManagement and Safety Management of Industrial Products」andArticle 15 of the「Enforcement Regulations of the IndustrialStandardization Act」, who belongs to a medical device qualitymanagement review agency designated by the KFDA Commissionerand performs quality management review in respect of medicaldevices(hereafter referred to as "Auditor").
3.“无菌医疗器械”是指在制造过程中经过灭菌消毒，在容器或包装上注明“无菌”字样、灭菌方法、灭菌日期等信息的无菌产品。
4. “Traceability” means check and management of raw materials and components of the product, and the quality control history, distributor, the location, etc. thereof.
第2条（定义）文中所用的术语定义如下。但本文未定义的术语应符合《工业标准化法案》之韩国工业标准质量管理体系——基础和术语（KS Q ISO 9000）要求。
1. “Quality Management System” means the management system for efficient control of organization, responsibility, procedure, process, resources, etc. to facilitate quality control of the product.
Article 2 (Definition)Definitions of the terms used herein are as mentionedbelow. However, terms not defined herein shall be as provided in theQuality Management System of the Korean Industrial Standards – Basicsand Terms(KS Q ISO 9000) under the「Industrial Standardization Act」.
4.“可追溯性”即检查并管理产品原材料与部件、质量控制历史记录、经销商、位置等信息。
5. “Manufacturing” means all services for producing Medical Devices, including packing and labeling.
5.“制造”指生产医疗器械的所有服务项目，包括包装与贴标。
3.将通过《医疗器械良好生产规范》合规性评估的医疗器械制造商或者进口商（以下简称“合规性评估”）
4. A party who is to perform quality control review of medical device
4.将负责医疗器械质量控制审查的相关方
5. A quality control review agency(hereafter referred to as "Quality Control Review Agency") designated by the KFDA Commissioner(hereafter referred toas "KFDA Commissioner")
2.“质量经理”是指负责确立、执行、维系医疗器械质量控制与质量管理体系的人员。
3. A “Sterile Medical device” means a medical device that goes through sterilization in the manufacturing process, on the container or packageof which it indicates the word “STERILE”, sterilizing method, date of sterilization, etc. to show that it is a sterilized product.
2.计划生产试验药品的相关方
3. A manufacturer or importer of medical device who is to get evaluationfor compliance for Medical Device GMP(hereafter referred to as"Evaluation for Compliance")
第3条（范围）①这些标准适应于以下各方：
1. A party who is to obtain manufacturing or import approval of a MedicalDevice or make a report
1.获批制造或进口医疗器械，或者进行汇报的相关方
2. A party who is to manufacture Investigational Drugs
6. A “Batch” or “Lot” means a unit of finished product, component, and raw material, which are manufactured under the same manufacturing condition sand have constant characteristics and quality.
KFDA Notification No. 2012-12
韩国食药厅公告号2012-12
(Amended on April 5, 2012)
（2012年4月5日修订）
Chapter1General Rules
第一章总则
Article 1 (Purpose)The purpose of these Standards is to specify thedetails about manufacturing and quality management required to beobserved in manufacturing Investigational Devices or manufacturing orimporting medical devices, as well as the requirements for designationprocedure and management method of a Medical device QualityManagement Review Agency, as provided in Paragraph 7 of Article 10,Paragraph 1 of Article 13, Paragraph 6 of Article 15, and Article 28 ofthe「Medical device Act」, and Item 10, Paragraph 1, Article 13, Item6 of Paragraph 1 of Article 15, Item 4-2 of Paragraph 1 of Article 20,and Article 29-5 of the Enforcement Regulations of the Act.
5.韩国食药厅专员（以下简称“KFDA专员”）指定的质量控制审查机构（以下简称“质量控制审查机构”）
②Despite the provisions from Items 1~3 of Paragraph 1, this Standardmay not apply to a party who is to manufacture and import a MedicalDevice manufactured only for export or a Grade 1 Medical Deviceexcept for items pertinent to Annex 1.
6.“批”或“批次”指使用相同的生产条件进行制造的、具备相同特征与质量的单位成品、部件和原材料。
7. “Concession” means written approval of use or release of a specific product which meets legal requirements but has certain non-conformingfeatures not directly related to safety and effectiveness.
2. “Quality Manager” means a person who is responsible for establishing,performing, and maintaining the quality control and quality management system of medical devices.
9.“质量审核员”是根据质量管理体系认证审查员注册标准，《工业产品质量管理与安全管理法案》第7条与《工业标准化法案实施法规》第15条中规定医疗器械领域的评审员，是KFDA专员指定的医疗器械质量管理审查机构的一员，负责医疗器械方面的质量管理审查工作（以下简称“审核员”）。
Article 3 (Scope)①These Standards shall apply to the following parties:
Standards for Manufacture and Quality Management of Medical Device
医疗器械生产与质量管理标准
Standards for Manufacture and Quality Management of Med书面准许使用或发行的特定产品，该产品具备某些不合规的特征，但不会直接影响安全性与有效性，符合法律的要求。
8. “Advisory Notice” means a letter issued by the manufacturer to recommend additional information or actions in relation to use, change, return, or scrap of the medical device after it was distributed.
第1条（目的）这些标准旨在详细规定制造临床实验设备，制造或进口医疗器械过程中须遵守的制造与质量管理要求，以及医疗器械质量管理审查机构指定程序与管理方法，详细内容见《医疗器械法案》第10条第7款、第13条第1款、第15条第6款和第28条，以及本法案《实施法规》第13条第1款第10目、第15条第1款第6目、第20条第1款第4-2目、第29-5条之规定。
8.“建议性通知”指医疗器械分销后制造商发布的器械使用、变更、退货、报废等方面的附加信息或措施。
9. A “Quality Auditor” means a reviewer in the field of medical devices asprovided in the Criteria for Registration of a Quality ManagementSystem Certification Auditor under Article 7 of the「Act on QualityManagement and Safety Management of Industrial Products」andArticle 15 of the「Enforcement Regulations of the IndustrialStandardization Act」, who belongs to a medical device qualitymanagement review agency designated by the KFDA Commissionerand performs quality management review in respect of medicaldevices(hereafter referred to as "Auditor").
3.“无菌医疗器械”是指在制造过程中经过灭菌消毒，在容器或包装上注明“无菌”字样、灭菌方法、灭菌日期等信息的无菌产品。
4. “Traceability” means check and management of raw materials and components of the product, and the quality control history, distributor, the location, etc. thereof.
第2条（定义）文中所用的术语定义如下。但本文未定义的术语应符合《工业标准化法案》之韩国工业标准质量管理体系——基础和术语（KS Q ISO 9000）要求。
1. “Quality Management System” means the management system for efficient control of organization, responsibility, procedure, process, resources, etc. to facilitate quality control of the product.
Article 2 (Definition)Definitions of the terms used herein are as mentionedbelow. However, terms not defined herein shall be as provided in theQuality Management System of the Korean Industrial Standards – Basicsand Terms(KS Q ISO 9000) under the「Industrial Standardization Act」.
4.“可追溯性”即检查并管理产品原材料与部件、质量控制历史记录、经销商、位置等信息。
5. “Manufacturing” means all services for producing Medical Devices, including packing and labeling.
5.“制造”指生产医疗器械的所有服务项目，包括包装与贴标。
3.将通过《医疗器械良好生产规范》合规性评估的医疗器械制造商或者进口商（以下简称“合规性评估”）
4. A party who is to perform quality control review of medical device
4.将负责医疗器械质量控制审查的相关方
5. A quality control review agency(hereafter referred to as "Quality Control Review Agency") designated by the KFDA Commissioner(hereafter referred toas "KFDA Commissioner")
2.“质量经理”是指负责确立、执行、维系医疗器械质量控制与质量管理体系的人员。
3. A “Sterile Medical device” means a medical device that goes through sterilization in the manufacturing process, on the container or packageof which it indicates the word “STERILE”, sterilizing method, date of sterilization, etc. to show that it is a sterilized product.
2.计划生产试验药品的相关方
3. A manufacturer or importer of medical device who is to get evaluationfor compliance for Medical Device GMP(hereafter referred to as"Evaluation for Compliance")
第3条（范围）①这些标准适应于以下各方：
1. A party who is to obtain manufacturing or import approval of a MedicalDevice or make a report
1.获批制造或进口医疗器械，或者进行汇报的相关方
2. A party who is to manufacture Investigational Drugs
6. A “Batch” or “Lot” means a unit of finished product, component, and raw material, which are manufactured under the same manufacturing condition sand have constant characteristics and quality.
KFDA Notification No. 2012-12
韩国食药厅公告号2012-12
(Amended on April 5, 2012)
（2012年4月5日修订）
Chapter1General Rules
第一章总则
Article 1 (Purpose)The purpose of these Standards is to specify thedetails about manufacturing and quality management required to beobserved in manufacturing Investigational Devices or manufacturing orimporting medical devices, as well as the requirements for designationprocedure and management method of a Medical device QualityManagement Review Agency, as provided in Paragraph 7 of Article 10,Paragraph 1 of Article 13, Paragraph 6 of Article 15, and Article 28 ofthe「Medical device Act」, and Item 10, Paragraph 1, Article 13, Item6 of Paragraph 1 of Article 15, Item 4-2 of Paragraph 1 of Article 20,and Article 29-5 of the Enforcement Regulations of the Act.
5.韩国食药厅专员（以下简称“KFDA专员”）指定的质量控制审查机构（以下简称“质量控制审查机构”）
②Despite the provisions from Items 1~3 of Paragraph 1, this Standardmay not apply to a party who is to manufacture and import a MedicalDevice manufactured only for export or a Grade 1 Medical Deviceexcept for items pertinent to Annex 1.
6.“批”或“批次”指使用相同的生产条件进行制造的、具备相同特征与质量的单位成品、部件和原材料。
7. “Concession” means written approval of use or release of a specific product which meets legal requirements but has certain non-conformingfeatures not directly related to safety and effectiveness.