GMP( 韩国).docxVIP

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 Medical Device医疗器械生产与质量管理标准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）Chapter 1 General 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.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。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」.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.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.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 sterili