医疗器械与体外诊断用品的良好生产技术规范
TECHNICAL REGULATION OF GOOD MANUFACTURING PRACTICES FOR MEDICAL DEVICES AND
PRODUCTS FOR IN VITRO DIAGNOSTIC USE
注：参考葡萄牙语-英语翻译版本
美国食品和药物管理局质量体系要求第21章第820节的基本术语。
Note: The translation from Portugue to English ud as reference
the basic terminology of the FDA QSR 21 Part 820.
巴西国家卫生监督局——联合董事会决议第16号RDC2013年3月28日
ANVISA - COLLEGIATE BOARD RESOLUTION RDC No.16 28 MAR 2013
友情的句子唯美批准医疗用品与体外诊断用品的良好生产技术规范及其他措施。
Approves the Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic U and other measures.
巴西国家卫生监督局在2013年3月7日召开的会议上，根据第1999年4月16日3029号法令批准的规范的第11条第4款规定，以及根据巴西国家卫生监督局的第354号法令附录一批准的附则的第54条第1款与第3款规定获得授权行使权力，公布于2006年8月21日的公报上。参考1976年9月23日生效的6360号法案及其规定，以及1977年1月5日的79094号法令；
The Board of the National Health Surveillance Agency, in exerci of the powers conferred upon him by ction IV of article. 11 of the Regulation approved by Decree No. 3029 of April 16, 1999, and in view of the provisions of ction II and in § 1 and § 3 of art. 54 of the Bylaws approved in accordance with Annex I of Ordinance No. 354 of ANVISA, of August 11, 2006, republished in the Official Gazette of August 21, 2006, at a meeting held March 7, 2013, considering the Law. 6360 of September 23, 1976 and its regulations, Decree No. 79094 of January 5, 1977;
参考了内在化决议南美共同市场/GMC/RES的需要。参考了内在化20/11号南美共同市场/G
MC/RES.决议，批准了“南北共同市场医疗用品与体外诊断用品的良好生产技术规范”（废除了第04/95、38/96、65/96与131/96号的GMC决议）；
considering the need to internalize the Resolution MERCOSUR / GMC / RES. No. 20/11, which approved the "MERCOSUR Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic U (repeal of
GMC Resolution No. 04/95, 38/96, 65/96 and 131/96) ";
考虑到医疗用品与体外诊断用品的生产规范规则应保证在巴西出售用品的质量、安全与功效。
considering that the rules of Good Manufacturing Practices relating to medical products and products for in vitro diagnostic u should ek to guarantee the quality, safety and efficacy of the products marketed in Brazil;
因此，医疗用品与体外诊断用品监管体制的优化推动工作至关重要；
Whereas it is esntial to promote the improvement of national systems aimed at the regulation and control of medical products and products for in vitro diagnostic u;
基于以下董事会决议，本人作为总裁，宣布发表：
adopts the following resolution of the Board and I, the Chairman, determine its publication:
第1条规定，批准“医疗用品与体外诊断用品的良好生产技术规范”。该规范作为附录，是本决议的组成部分。
Art 1st - Approve the "Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic U", which is included as Annex and part of this resolution.
单一段落。本规范含国家法律体制规范GMC MERCOSUR第20号2011年“南方共同市场医疗用品与体外医疗用品的良好生产技术规范（废除第04/95、38/96、65/96与131/96号GMC决议）”。
Single paragraph. This regulation incorporates the national legal system Resolution GMC MERCOSUR No. 20/2011 "MERCOSUR Technical Regulation of Good Manufacturing Practice for Medical Products and Products for Diagnostic U In Vitro (repeal of GMC Resolution No. 04/95, 38/96, 65/96 and 131/96) ".
鸡蛋一天吃几个最好第2条：替代1998年8月27日的第686号法令，2000年6月27日发布的第59号RDC决议，以及2004年我的兵哥哥7月2日发布的第167号RDC决议。
Article 2: - Repealing Ordinance No. 686, of August 27, 1998, the RDC Resolution No. 59, dated June 27, 2000, and Resolution RDC No. 167 of July 2, 2004.
第3条——适用时，医疗用品与体外诊断用品的经销商与存放/托管人应符合决议要求。
Article 3 - Distributors and storage/hosts of medical products and diagnostic products for u in vitro should meet the requirements of this Resolution, as applicable.
第4条——并入此法律文件后180日之内可采取必要的措施落实本技术规范。
Article 4 - It is granted within 180 days from the date of incorporation of the legislative instrument, to adopt the measures necessary for the implementation of the Technical Regulations.
海字第5条——该决议于公布之日生效。
Article 5 - This Resolution shall enter into force on the date of its publication.
DIRCEU BRÁS APARECIDO BARBANO
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附件
ANNEX
医疗用品与体外诊断用品的良好生产技术规范
TECHNICAL REGULATION OF GOOD MANUFACTURING PRACTICES FOR MEDICAL PRODUCTS AND
PRODUCTS FOR IN VITRO DIAGNOSTIC USE
CONTENT
清洁服务第1章——总则
时光会记得CHAPTER 1 - GENERAL PROVISIONS
第2章——一般质量体系要求 Part B
CHAPTER 2 - GENERAL REQUIREMENTS OF QUALITY SYSTEM
2.1. 总则
2.1. General provisions
2.2.管理职责
2.2. Managerial responsibility
2.3.雇员
2.3. Staff
2.4.风险管理
2.4. Risk Management
2.5.采购控制
2.5. Purchasing Control
第3铁观音产地章——文件和记录 Part D
CHAPTER 3 - DOCUMENTS AND RECORDS OF QUALITY
3.1. 一般要求
3.1. General requirements
3.2.器械历史记录
3.2. Device History Record (DHR)
3.3.检测和试验记录
3.3. Records of inspections and tests
第4章——设计开发文档 Part C
CHAPTER 4 - DESIGN CONTROL AND DEVICE MASTER RECORD (DMR)
4.1.设计控制
地形特征答题模板4.1. Design Control
4.2.器械主文档
4.2. Device Master Record (DMR)
第5章——产品过程控制 partG
CHAPTER 5 - PROCESS AND PRODUCTION CONTROLS
