CFDA Announcement on Releasing Good Manufacturing Practice for Medical Devices ([2014] No. 64)

国家食品药品监督管理总局关于发布医疗器械生产质量管理规范的公告(2014年第64号)
CFDA Announcement on Releasing Good Manufacturing Practice for Medical Devices ([2014] No. 64)
2014年12月29日发布
Released on December 29, 2014

国家食品药品监督管理总局
China Food and Drug Administration
公 告
Announcement
2014年 第64号
[2014] No. 64

关于发布医疗器械生产质量管理规范的公告
Announcement on Releasing Good Manufacturing Practice for Medical Devices 

为加强医疗器械生产监督管理,规范医疗器械生产质量管理,根据《医疗器械监督管理条例》(国务院令第650号)、《医疗器械生产监督管理办法》(国家食品药品监督管理总局令第7号),国家食品药品监督管理总局组织修订了《医疗器械生产质量管理规范》,现予以发布。
In order to enhance the supervision and administration of, and standardize the quality management of, the medical devices manufacturing, and in accordance with the Regulations for the Supervision and Administration of Medical Devices ( State Council Order No. 650) and the Provision for Supervision of Medical Devices Manufacturing (CFDA Order No. 7), China Food and Drug Administration(“CFDA”) organized the revision of the Good Manufacturing Practice for Medical Devices, and which is hereby released.

特此公告。
It is hereby notified!

附件:医疗器械生产质量管理规范
Annex: Good Manufacturing Practice for Medical Devices

食品药品监管总局
China Food and Drug Administration

2014年12月29日
December 29, 2014

附件
Annex

医疗器械生产质量管理规范
Good Manufacturing Practice for Medical Devices

第一章     总 则
Chapter I General Provisions 

第一条 为保障医疗器械安全、有效,规范医疗器械生产质量管理,根据《医疗器械监督管理条例》(国务院令第650号)、《医疗器械生产监督管理办法》(国家食品药品监督管理总局令第7号),制定本规范。
Article 1 With a view to ensuring the safety and effectiveness of medical devices and standardizing the management on quality of medical devices manufacturing, the Good Manufacturing Practice for Medical Devices (“GMP”) is hereby formulated in accordance with Regulations for the Supervision and Administration of Medical Devices (State Council Order No.650) and the  Provision for Supervision of Medical Devices Manufacturing (CFDA Order No. 7).

第二条 医疗器械生产企业(以下简称企业)在医疗器械设计开发、生产、销售和售后服务等过程中应当遵守本规范的要求。
Article 2 Medical device manufacturers (hereinafter referred to as “manufacturers”) shall comply with the requirements set out in the GMP when designing and developing,manufacturing and selling medical devices, as well as providing after-sales service.

第三条 企业应当按照本规范的要求,结合产品特点,建立健全与所生产医疗器械相适应的质量管理体系,并保证其有效运行。
Article 3 Manufacturers shall establish and improve the quality management system adapted to the medical devices manufactured in combination with product features according to the requirements in the GMP and ensure its effective operation.

第四条 企业应当将风险管理贯穿于设计开发、生产、销售和售后服务等全过程,所采取的措施应当与产品存在的风险相适应。
Article 4 Manufacturers shall conduct risk management through the whole process of design and development,manufacture, sales and after-sales service and take the measures adapted to product risks.

第二章 机构与人员
Chapter II Institution and Personnel 

第五条 企业应当建立与医疗器械生产相适应的管理机构,并有组织机构图,明确各部门的职责和权限,明确质量管理职能。生产管理部门和质量管理部门负责人不得互相兼任。
Article 5 Manufacturers shall establish the regulatory agency adapted to medical device manufacture with the organizational chart which clarifying the responsibilities and authorities of all divisions as well as quality function &responsibilities. Neither the head of manufacture management department nor the head of quality management department shall hold a concurrent post with each other.

第六条 企业负责人是医疗器械产品质量的主要责任人,应当履行以下职责:
Article 6 The principal of manufacturers is the main responsible person of the quality of medical devices and shall fulfill the following responsibilities:

(一)组织制定企业的质量方针和质量目标;
(1) Organize the formulation of quality policy and quality objectives of manufacturers;

(二)确保质量管理体系有效运行所需的人力资源、基础设施和工作环境等;
(2) Ensure the human resources, infrastructures and working environment required for the effective operation of quality management system, etc.;

(三)组织实施管理评审,定期对质量管理体系运行情况进行评估,并持续改进;
(3) Organize the management review and carry out periodical evaluation on the operation of quality management system, and continuously improve it;

(四)按照法律、法规和规章的要求组织生产。
(4) Organize themanufacture in accordance with laws and regulations.

第七条 企业负责人应当确定一名管理者代表。管理者代表负责建立、实施并保持质量管理体系,报告质量管理体系的运行情况和改进需求,提高员工满足法规、规章和顾客要求的意识。
Article 7 The principal of the manufacturer shall appoint a management representative. Such management representative shall be responsible for establishing, implementing and maintaining the quality management system, report the working conditions and improvement needs of the quality management system, and enhance the employees’ awareness of complying with the regulations, rules and customer requirements.

第八条 技术、生产和质量管理部门的负责人应当熟悉医疗器械相关法律法规,具有质量管理的实践经验,有能力对生产管理和质量管理中的实际问题作出正确的判断和处理。
Article 8 The head of technical, manufacture and quality management department shall be familiar with laws and regulations related to medical devices, have practical experiences on quality management and be able to make correct judgment and handling for the practical problems in manufacture management and quality management.

第九条 企业应当配备与生产产品相适应的专业技术人员、管理人员和操作人员,具有相应的质量检验机构或者专职检验人员。
Article 9 Manufacturers shall be equipped with the professional and technical personnel, management and operating personnel adapted to the products manufactured and have corresponding quality testing institutions or full-time testing personnel.

第十条 从事影响产品质量工作的人员,应当经过与其岗位要求相适应的培训,具有相关理论知识和实际操作技能。
Article 10 The personnel engaged in the work affecting the product quality shall receive the training adapted to their job requirements and have relevant theoretical knowledge and practical operation skills.

第十一条 从事影响产品质量工作的人员,企业应当对其健康进行管理,并建立健康档案。
Article 11 Manufacturers shall manage the health of the personnel engaged in the work affecting the product quality and establish health records.
 
第三章 厂房与设施
Chapter III Buildings and Facilities

第十二条 厂房与设施应当符合生产要求,生产、行政和辅助区的总体布局应当合理,不得互相妨碍。
Article 12 Buildings and facilities shall conform to manufacturing requirements. The overall lay out of manufacture, administration and the auxiliary areas shall be rational without interference with each other.

第十三条 厂房与设施应当根据所生产产品的特性、工艺流程及相应的洁净级别要求合理设计、布局和使用。生产环境应当整洁、符合产品质量需要及相关技术标准的要求。产品有特殊要求的,应当确保厂房的外部环境不能对产品质量产生影响,必要时应当进行验证。
Article 13 Buildings and facilities shall be rationally designed, deployed and applied according to the features, technological process and corresponding air cleanness class of the products manufactured. The manufacturing environment shall be clean and tidy and comply with the need of product quality and requirements in relevant technical standards. Where products have special requirements, it shall be ensure that the external environment of the buildings has no effect on products, and carry out verification if necessary.

第十四条 厂房应当确保生产和贮存产品质量以及相关设备性能不会直接或者间接受到影响,厂房应当有适当的照明、温度、湿度和通风控制条件。
Article 14 It shall ensure the quality of the products manufactured and stored and properties of relevant equipment not directly or indirectly influenced in the buildings,which shall be equipped with appropriate illumination, temperature, humidity and ventilating control conditions.

第十五条 厂房与设施的设计和安装应当根据产品特性采取必要的措施,有效防止昆虫或者其他动物进入。对厂房与设施的维护和维修不得影响产品质量。
Article 15 For the design and installation of buildings and facilities, necessary measures shall be taken in accordance with the product features so as to effectively prevent the insects or other animals from entering. The maintenance and repair of buildings and facilities shall not affect the product quality.

第十六条 生产区应当有足够的空间,并与其产品生产规模、品种相适应。
Article 16 There shall be sufficient space in the production area, matching with the manufacturing scale and type of the products to be manufactured there.

第十七条 仓储区应当能够满足原材料、包装材料、中间品、产品等的贮存条件和要求,按照待验、合格、不合格、退货或者召回等情形进行分区存放,便于检查和监控。
Article 17 The warehousing area shall meet the storage conditions and requirements necessary for the raw materials, packaging materials, intermediate products and finished products, within which they shall be stored in different segments as per their following status, namely, products to be inspected, conforming, nonconforming,returned or recalled, so as to facilitate the inspection and monitoring.

第十八条 企业应当配备与产品生产规模、品种、检验要求相适应的检验场所和设施。
Article 18 Manufacturers shall be equipped with inspection place and facilities adapted to the manufacturing scale, varieties and inspection requirements of products. 

第四章 设 备
Chapter IV Equipment 

第十九条 企业应当配备与所生产产品和规模相匹配的生产设备、工艺装备等,并确保有效运行。
Article 19 Manufacturers shall be equipped with manufacturing equipment and technological equipment matched with the products manufactured and manufacturing scale, and ensure their effective operation.

第二十条 生产设备的设计、选型、安装、维修和维护必须符合预定用途,便于操作、清洁和维护。生产设备应当有明显的状态标识,防止非预期使用。
Article 20 Manufacturing equipment shall conform to intended use in terms of design, model selection, installation, repair and maintenance to facilitate the operation,cleaning and maintenance. Manufacturing equipment shall have obvious status identification to prevent non-intended use.

企业应当建立生产设备使用、清洁、维护和维修的操作规程,并保存相应的操作记录。
Manufacturers shall establish the operating procedures for the use, cleaning,maintenance and repair of manufacturing equipment and maintain corresponding operating records.

第二十一条 企业应当配备与产品检验要求相适应的检验仪器和设备,主要检验仪器和设备应当具有明确的操作规程。
Article 21 Manufacturers shall be equipped with related inspection instruments and equipment according to the product inspection requirements. There shall be clear operating procedures for main inspection instruments and equipment.

第二十二条 企业应当建立检验仪器和设备的使用记录,记录内容包括使用、校准、维护和维修等情况。
Article 22 Manufacturers shall establish usage records of inspection instruments and equipment, including the usage, calibration, maintenance and repair, etc.

第二十三条 企业应当配备适当的计量器具。计量器具的量程和精度应当满足使用要求,标明其校准有效期,并保存相应记录。
Article 23 Manufacturers shall be equipped with appropriate measuring instruments, of which the measuring range and precision shall meet operating requirements, the expiration date of calibration indicated, and the corresponding records maintained.

第五章 文件管理
Chapter V Document Management

第二十四条 企业应当建立健全质量管理体系文件,包括质量方针和质量目标、质量手册、程序文件、技术文件和记录,以及法规要求的其他文件。
Article 24 The manufacturer shall establish and perfect the quality management system documents, including the quality policies and quality objectives, the quality manual, the procedure files, the technical documents and records, and other documents required by regulations.

质量手册应当对质量管理体系作出规定。
Quality manual shall include the requirements for quality management system.

程序文件应当根据产品生产和质量管理过程中需要建立的各种工作程序而制定,包含本规范所规定的各项程序。
Procedure files shall be formulated according to all working procedures to be established in product manufacturing and quality management, and shall contain all procedures specified in the GMP.

技术文件应当包括产品技术要求及相关标准、生产工艺规程、作业指导书、检验和试验操作规程、安装和服务操作规程等相关文件。
Technical documents shall include relevant documents such as product technical specification and relevant standards, manufacturing process procedures, operation instruction,operating procedures for inspection and testing, and operating procedures for installation and service, etc.

第二十五条 企业应当建立文件控制程序,系统地设计、制定、审核、批准和发放质量管理体系文件,至少应当符合以下要求:
Article 25 Manufacturers shall establish the document control procedure, systematically design, develop, review, approve and issue the documents of quality management system, which shall at least conform to the following requirements:

(一)文件的起草、修订、审核、批准、替换或者撤销、复制、保管和销毁等应当按照控制程序管理,并有相应的文件分发、替换或者撤销、复制和销毁记录;
(1) The draft,revision, review, approval, replacement or withdrawal, duplication, storage and destruction of documents shall be managed according to control procedures with corresponding records of document distribution, replacement or withdrawal,duplication and destruction;

(二)文件更新或者修订时,应当按规定评审和批准,能够识别文件的更改和修订状态;
(2) The update or revision of documents shall be reviewed and approved according to regulations.The modification and revision status of the documents shall be able to be identified;

(三)分发和使用的文件应当为适宜的文本,已撤销或者作废的文件应当进行标识,防止误用。
(3) The documents to be distributed and used shall be the appropriate documents, and those withdrawn or abolished shall be indicated to prevent misuse.

第二十六条 企业应当确定作废的技术文件等必要的质量管理体系文件的保存期限,以满足产品维修和产品质量责任追溯等需要。
Article 26 Manufacturers shall validate the storage life of abolished technical documents and other necessary quality management system documents so as to meet the need for product maintenance and traceability of product quality responsibilities.
 
第二十七条 企业应当建立记录控制程序,包括记录的标识、保管、检索、保存期限和处置要求等,并满足以下要求:
Article 27 Manufacturers shall establish the record control procedure, including the identification,storage, searching, storage life and disposal requirements, etc. of the records, which shall meet the following requirements:

(一)记录应当保证产品生产、质量控制等活动的可追溯性;
(1) The records shall ensure the traceability of the activities such as product manufacturing and quality control;

(二)记录应当清晰、完整,易于识别和检索,防止破损和丢失;
(2) The records shall be clear, complete, easy to be identified and searched, and prevented from damage and loss;

(三)记录不得随意涂改或者销毁,更改记录应当签注姓名和日期,并使原有信息仍清晰可辨,必要时,应当说明更改的理由;
(3) The records shall not be arbitrarily altered or destroyed. It shall endorse one’s name and date for altering the records with original information that shall still be clear,and the reason for the alteration shall be illustrated when necessary;

(四)记录的保存期限应当至少相当于企业所规定的医疗器械的寿命期,但从放行产品的日期起不少于2年,或者符合相关法规要求,并可追溯。
(4) The storage life of records shall at least be equivalent to the shelf life of medical devices specified by manufacturers, but shall not be less than two years upon releasing date of products or incompliance with relevant laws and regulations, and shall be traceable. 

第六章 设计开发
Chapter VI Design and Development 

第二十八条 企业应当建立设计控制程序并形成文件,对医疗器械的设计和开发过程实施策划和控制。
Article 28 The manufacturer shall establish the design control procedures and formulate corresponding documents, and the medical device design and development process may be planned and controlled.

第二十九条 在进行设计和开发策划时,应当确定设计和开发的阶段及对各阶段的评审、验证、确认和设计转换等活动,应当识别和确定各个部门设计和开发的活动和接口,明确职责和分工。
Article 29 When planning the medical device design and development, the manufacturer shall validate the design and development stages, as well as the review,verification, validation and design conversion in each stage, and identify and validate the design and development activities attributable to each department and the interfaces so as to define their respective duties and functions.

第三十条 设计和开发输入应当包括预期用途规定的功能、性能和安全要求、法规要求、风险管理控制措施和其他要求。对设计和开发输入应当进行评审并得到批准,保持相关记录。
Article 30 The design and development input shall include the function, the performance and the safety requirements, regulatory requirements, risk control measures and other requirements set out in the intended use. The design and development input shall be reviewed and obtain approval, and relevant records shall be maintained.

第三十一条 设计和开发输出应当满足输入要求,包括采购、生产和服务所需的相关信息、产品技术要求等。设计和开发输出应当得到批准,保持相关记录。
Article 31 The design and development output shall meet the input requirements, including the information and product technical specification necessary for the product procuring, manufacturing and service. The design and development output shall be approved, and relevant records shall be maintained.

第三十二条 企业应当在设计和开发过程中开展设计和开发到生产的转换活动,以使设计和开发的输出在成为最终产品规范前得以验证,确保设计和开发输出适用于生产。
Article 32 In the process of design and development, the manufacturer shall perform the manufacturing conversion activities relating to design and development, so as to ensure the design and development output to be verified prior to final product specifications and ensure that the design and development output applicable to the manufacturing.

第三十三条 企业应当在设计和开发的适宜阶段安排评审,保持评审结果及任何必要措施的记录。
Article 33 The manufacturer shall schedule review in suitable design and development stage and maintain the records related to the review results and any necessary measures.

第三十四条 企业应当对设计和开发进行验证,以确保设计和开发输出满足输入的要求,并保持验证结果和任何必要措施的记录。
Article 34 The manufacturer shall verify the design and development to ensure that the output meets the input requirements and maintain the records related to the verification results and any necessary measures.
 
第三十五条 企业应当对设计和开发进行确认,以确保产品满足规定的使用要求或者预期用途的要求,并保持确认结果和任何必要措施的记录。
Article 35 The manufacturer shall validate the design and development to ensure that the products meet the required application requirements or the requirements for intended use and maintain the records related to the validation results and any necessary measures.

第三十六条 确认可采用临床评价或者性能评价。进行临床试验时应当符合医疗器械临床试验法规的要求。
Article 36 The manufacturer shall validate whether clinical evaluation or performance evaluation may be applied. Any clinical trial shall be conducted in accordance with the regulations for medical device clinical trials. 

第三十七条 企业应当对设计和开发的更改进行识别并保持记录。必要时,应当对设计和开发更改进行评审、验证和确认,并在实施前得到批准。
Article 37 The manufacturer shall identify any changes to the design and development and maintain relevant records. When necessary, the manufacturer shall review, verify and validate such changes, and may not implement them until the same is approved.

当选用的材料、零件或者产品功能的改变可能影响到医疗器械产品安全性、有效性时,应当评价因改动可能带来的风险,必要时采取措施将风险降低到可接受水平,同时应当符合相关法规的要求。
In the event that any change to the selected materials, parts or product functions may affect the safety and effectiveness of any medical device, the manufacturer shall evaluate the risks which may arise from such change, and if necessary,take measures to reduce the risks to an acceptable degree, meanwhile, pursuant to the requirements set out in relevant regulations.

第三十八条 企业应当在包括设计和开发在内的产品实现全过程中,制定风险管理的要求并形成文件,保持相关记录。
Article 38 In the whole process, including the product design and development, the manufacturer shall establish the risk control requirements and formulate corresponding documents,and maintain relevant records.

第七章 采 购
Chapter VII Procurement

第三十九条 企业应当建立采购控制程序,确保采购物品符合规定的要求,且不低于法律法规的相关规定和国家强制性标准的相关要求。
Article 39 Manufacturers shall establish procurement control procedure to ensure that the procured articles conform to the requirements specified, which shall at least meet the relevant provisions in laws and regulations and relevant coercive  national mandatory standards.

第四十条 企业应当根据采购物品对产品的影响,确定对采购物品实行控制的方式和程度。
Article 40Manufacturers shall validate the way and degree of control on procured articlesaccording to the procured articles’ effect on products.

第四十一条 企业应当建立供应商审核制度,并应当对供应商进行审核评价。必要时,应当进行现场审核。
Article 41 Manufacturers shall establish supplier review system and carry out review and evaluation on the suppliers in which carrying out on-spot review when necessary.

第四十二条 企业应当与主要原材料供应商签订质量协议,明确双方所承担的质量责任。
Article 42Manufacturers shall conclude and sign Quality Agreement with the suppliers ofmain raw materials clarifying the quality responsibilities of both sides.

第四十三条 采购时应当明确采购信息,清晰表述采购要求,包括采购物品类别、验收准则、规格型号、规程、图样等内容。应当建立采购记录,包括采购合同、原材料清单、供应商资质证明文件、质量标准、检验报告及验收标准等。采购记录应当满足可追溯要求。
Article 43 In case ofprocurement, manufacturers shall clarify procurement information and clearlydescribe procurement requirements, including the category of procured articles,acceptance criteria, models and specifications, procedures and drawings.Procurement records shall be established, including Procurement Contract, listof raw materials, supporting documents of supplier’s qualification, qualitystandards, testing report and acceptance criteria. Procurement records shall meetthe requirements for traceability.

第四十四条 企业应当对采购物品进行检验或者验证,确保满足生产要求。
Article 44 The manufacturer shall inspect or verify any articles procured thereby so as to ensure that they meet the manufacturing requirements. 

第八章 生产管理
Chapter VIII Manufacture Management

第四十五条 企业应当按照建立的质量管理体系进行生产,以保证产品符合强制性标准和经注册或者备案的产品技术要求。
Article 45 Manufacturers shall carry out manufacture according to established quality management system to ensure that the products conform to mandatory standards as well as product technical specification registered or filed.

第四十六条 企业应当编制生产工艺规程、作业指导书等,明确关键工序和特殊过程。
Article 46 Manufacturers shall compile manufacturing process procedures and operation instructions, and  clarify critical process and special process.

第四十七条 在生产过程中需要对原材料、中间品等进行清洁处理的,应当明确清洁方法和要求,并对清洁效果进行验证。
Article 47 Where raw materials, work-in-progress require to be cleaned during the manufacturing process, cleaning method and requirements shall be clarified, and cleaning effect shall be verified.

第四十八条 企业应当根据生产工艺特点对环境进行监测,并保存记录。
Article 48 Manufacturers shall carry out environment monitoring according to manufacturing process features and maintain the records.

第四十九条 企业应当对生产的特殊过程进行确认,并保存记录,包括确认方案、确认方法、操作人员、结果评价、再确认等内容。
Article 49 Manufacturers shall validate the special manufacturing process and maintain the records, including validation plan, validation method, operators, result evaluation and re-validation, etc.

生产过程中采用的计算机软件对产品质量有影响的,应当进行验证或者确认。
Where computer softwareused in the manufacturing process has effect on the product quality, theverification or validation shall be carried out.

第五十条 每批(台)产品均应当有生产记录,并满足可追溯的要求。
Article 50 There shall be manufacturing record for each batch (set) of products which can meet the requirements for traceability.

生产记录包括产品名称、规格型号、原材料批号、生产批号或者产品编号、生产日期、数量、主要设备、工艺参数、操作人员等内容。
Manufacturing records shall include the product name, model and specification,batch number of raw materials, manufacturing batch number or product ID,manufacturing date, quantity, main equipment, technological parameters and operators.

第五十一条 企业应当建立产品标识控制程序,用适宜的方法对产品进行标识,以便识别,防止混用和错用。
Article 51 Manufacturers shall establish product identification control procedure and identify the products with appropriate method to facilitate identification and prevent mixing and misuse.

第五十二条 企业应当在生产过程中标识产品的检验状态,防止不合格中间产品流向下道工序。
Article 52 Manufacturers shall indicate the inspection status of products during manufacturing process to prevent the nonconforming work-in-progress from flowing to next procedure.

第五十三条 企业应当建立产品的可追溯性程序,规定产品追溯范围、程度、标识和必要的记录。
Article 53 Manufacturers shall establish a procedure for the traceability of products and specify its scope, degree, identification and necessary records.

第五十四条 产品的说明书、标签应当符合相关法律法规及标准要求。
Article 54 The product instruction for use and labels shall conform to relevant laws and regulations as well as standards.

第五十五条 企业应当建立产品防护程序,规定产品及其组成部分的防护要求,包括污染防护、静电防护、粉尘防护、腐蚀防护、运输防护等要求。防护应当包括标识、搬运、包装、贮存和保护等。
Article 55 Manufacturers shall establish product protection procedure and specify the protection requirements for products and their components, including requirements for pollution protection, electrostatic protection, dust protection, corrosion prevention and transportation protection, etc. The protection shall include identification, transportation, packaging, storage and protection, etc.

第九章 质量控制
Chapter IX Quality Control

第五十六条 企业应当建立质量控制程序,规定产品检验部门、人员、操作等要求,并规定检验仪器和设备的使用、校准等要求,以及产品放行的程序。
Article 56 Manufacturers shall establish quality control procedure specifying requirements for product inspection department, personnel and operation, and requirements for the use and calibration of inspection instruments and equipment as well as product release procedure.

第五十七条 检验仪器和设备的管理使用应当符合以下要求:
Article 57 The management and use of inspection instruments and equipment shall conform to the following requirements:

(一)定期对检验仪器和设备进行校准或者检定,并予以标识;
(1) Carry out calibration or verification of inspection instruments and equipment periodically and identify them;

(二)规定检验仪器和设备在搬运、维护、贮存期间的防护要求,防止检验结果失准;
(2) Specify the protection requirements for the inspection instruments and equipment during their transportation, maintenance and storage to prevent the inaccuracy of inspection results;

(三)发现检验仪器和设备不符合要求时,应当对以往检验结果进行评价,并保存验证记录;
(3) Where inspection instruments and equipment failing to meet the requirements, evaluate the previous inspection results and maintain verification records;

(四)对用于检验的计算机软件,应当确认。
(4) Validate the computer software used for inspections.

第五十八条 企业应当根据强制性标准以及经注册或者备案的产品技术要求制定产品的检验规程,并出具相应的检验报告或者证书。
Article 58 Manufacturers shall develop inspection procedures of products according to mandatory standards as well as product technical specification registered or filed, and issue corresponding inspection report or certificate.

需要常规控制的进货检验、过程检验和成品检验项目原则上不得进行委托检验。对于检验条件和设备要求较高,确需委托检验的项目,可委托具有资质的机构进行检验,以证明产品符合强制性标准和经注册或者备案的产品技术要求。
The incoming inspection, process inspection and finished product inspection projects requiring routine control shall not be entrusted for inspection in principle. Where the projects have comparatively high requirements for inspection conditions and equipment needing entrusted inspection, a qualified institution may be entrusted to carry out inspections so as to prove that products conform to mandatory standards as well as product technical specification registered or filed.

第五十九条 每批(台)产品均应当有检验记录,并满足可追溯的要求。检验记录应当包括进货检验、过程检验和成品检验的检验记录、检验报告或者证书等。
Article 59 Each batch(set) of products shall be accompanied with such inspection records that can be traceable. Such incoming records shall include any inspection records, testing reports or certificates arising out of incoming inspection, process inspection and finished product inspection.

第六十条 企业应当规定产品放行程序、条件和放行批准要求。放行的产品应当附有合格证明。
Article 60 Manufacturers shall specify product release procedure, conditions and requirements for release approval. Certificate of Conformance shall be attached for the products released.

第六十一条 企业应当根据产品和工艺特点制定留样管理规定,按规定进行留样,并保持留样观察记录。
Article 61 Manufacturers shall formulate administrative provisions for sample retention according to product and process features, retain the samples according to relevant provisions and maintain the observation records of retention samples.

第十章 销售和售后服务
Chapter X Sales and After-sales Service

第六十二条 企业应当建立产品销售记录,并满足可追溯的要求。销售记录至少包括医疗器械的名称、规格、型号、数量;生产批号、有效期、销售日期、购货单位名称、地址、联系方式等内容。
Article 61 Manufacturers shall establish product sales records meeting the requirements for traceability which shall at least include: the name, specification, model and quantity of medical devices; batch number, expiry date, distribution date,the name, address and contact of procuring units, etc.

第六十三条 直接销售自产产品或者选择医疗器械经营企业,应当符合医疗器械相关法规和规范要求。发现医疗器械经营企业存在违法违规经营行为时,应当及时向当地食品药品监督管理部门报告。
Article 63 The manufacturer,which sells or retains a medical device distributing enterprise to sell any products manufactured by it, shall comply with the relevant medical devices regulations and rules. Upon their awareness of any distributing activities by such medical device distributing enterprise in violation of any laws or regulations, the manufacturer shall promptly report to the local food and drug regulatory authority.

第六十四条 企业应当具备与所生产产品相适应的售后服务能力,建立健全售后服务制度。应当规定售后服务的要求并建立售后服务记录,并满足可追溯的要求。
Article 64 Manufacturers shall be equipped with after-sales service ability adapted to the products manufactured, and establish and improve after-sales service system.They shall specify the requirements for after-sales service and establish after-sales service record, and meet the requirements for traceability.
 
第六十五条 需要由企业安装的医疗器械,应当确定安装要求和安装验证的接收标准,建立安装和验收记录。
Article 65 Where the medical devices need to be installed by manufacturers, manufacturers shall validate the installation requirements and acceptance criteria for installation and verification and establish installation and acceptance record.

由使用单位或者其他企业进行安装、维修的,应当提供安装要求、标准和维修零部件、资料、密码等,并进行指导。
Where the medical devices are installed and repaired by consumption units or other enterprises, manufacturers shall provide installation requirements,criteria, components and parts,material, password etc., and provide guidance.

第六十六条 企业应当建立顾客反馈处理程序,对顾客反馈信息进行跟踪分析。
Article 66 Manufacturers shall establish the customer feedback handling procedure, and carry out follow-up analysis on customer feedback information.

第十一章 不合格品控制
Chapter XI Control of Nonconforming Products

第六十七条 企业应当建立不合格品控制程序,规定不合格品控制的部门和人员的职责与权限。
Article 67 The manufacturer shall establish control procedures of non-conforming products and define the responsibilities and authorities of the departments and personnel controlling nonconforming products. 

第六十八条 企业应当对不合格品进行标识、记录、隔离、评审,根据评审结果,对不合格品采取相应的处置措施。
Article 68 The manufacturer shall mark, record, isolate and review any non-conforming products and take corresponding disposal measures against them based on the review results.

第六十九条 在产品销售后发现产品不合格时,企业应当及时采取相应措施,如召回、销毁等。
Article 69 Where manufacturers discover products nonconforming after sale, they shall promptly take corresponding measures, such as recall or destruction, etc.

第七十条 不合格品可以返工的,企业应当编制返工控制文件。返工控制文件包括作业指导书、重新检验和重新验证等内容。不能返工的,应当建立相关处置制度。
Article 70 Where nonconforming products may be reworked, manufacturers shall develop control document of rework including the contents of operation instruction,re-inspection and re-verification, etc. Where nonconforming products cannot be reworked, manufacturers shall establish relevant disposal systems.

 
第十二章 不良事件监测、分析和改进
Chapter XII Adverse Events Monitoring, Analysis and Improvement 

第七十一条 企业应当指定相关部门负责接收、调查、评价和处理顾客投诉,并保持相关记录。
Article 71 Manufacturers shall assign relevant department to receive, investigate,evaluate and handle customer complaints and maintain relevant records.

第七十二条 企业应当按照有关法规的要求建立医疗器械不良事件监测制度,开展不良事件监测和再评价工作,并保持相关记录。
Article 72 Manufacturers shall establish the medical device adverse event monitoring system in accordance with relevant laws and regulations, carry out monitoring and re-evaluation of adverse events and maintain the relevant records.

第七十三条 企业应当建立数据分析程序,收集分析与产品质量、不良事件、顾客反馈和质量管理体系运行有关的数据,验证产品安全性和有效性,并保持相关记录。
Article 73 Manufacturers shall establish the data analysis procedure, collect and analyze the data related to the product quality, adverse event, customer feedback and operation of quality management system, verify the safety and effectiveness of products,and maintain relevant records.

第七十四条 企业应当建立纠正措施程序,确定产生问题的原因,采取有效措施,防止相关问题再次发生。
Article 74 The manufacturer shall establish corrective action and procedures to validate the cause of any problem and take efficient measures to prevent the re-occurrence of such problem.

应当建立预防措施程序,确定潜在问题的原因,采取有效措施,防止问题发生。
The manufacturer shall establish preventive measures and procedures to validate the cause of any potential problem and take efficient measures to prevent such problem from happening.

第七十五条 对于存在安全隐患的医疗器械,企业应当按照有关法规要求采取召回等措施,并按规定向有关部门报告。
Article 75 For the medical devices with potential safety hazards, manufacturers shall take measures such as recall, etc. in accordance with relevant laws and regulations,and report to relevant authorities in accordance with relevant provisions.

第七十六条 企业应当建立产品信息告知程序,及时将产品变动、使用等补充信息通知使用单位、相关企业或者消费者。
Article 76 Manufacturers shall establish the notification procedure of product information and promptly inform consumption unit, enterprises or consumers concerned of supplementary information such as product change and usage, etc.

第七十七条 企业应当建立质量管理体系内部审核程序,规定审核的准则、范围、频次、参加人员、方法、记录要求、纠正预防措施有效性的评定等内容,以确保质量管理体系符合本规范的要求。
Article 77 The manufacturer shall establish internal review procedures for the quality management system and specify the requirements for reviewing rules, scope, frequency,participants, method, records, as well as evaluation on the effectiveness of corrective and preventive action so as to ensure that the quality management system meets the requirements in the GMP.

第七十八条 企业应当定期开展管理评审,对质量管理体系进行评价和审核,以确保其持续的适宜性、充分性和有效性。
Article 78 The manufacturer shall perform regular management review, through which the quality management system may be evaluated and reviewed, to ensure its continuous suitability,sufficiency and effectiveness.

第十三章 附 则
Chapter XIII Supplementary Provisions

第七十九条 医疗器械注册申请人或备案人在进行产品研制时,也应当遵守本规范的相关要求。
Article 79 Where medical devices registration applicant or filing applicant conducting product development, they shall also comply with the relevant requirements in the GMP.

第八十条 国家食品药品监督管理总局针对不同类别医疗器械生产的特殊要求,制定细化的具体规定。
Article 80 CFDA shall formulate detailed provisions for different categories of medical devices according to their respective manufacturing requirements.

第八十一条 企业可根据所生产医疗器械的特点,确定不适用本规范的条款,并说明不适用的合理性。

Article 81 The manufacturer may identify those inapplicable provisions in the GMP according to the characteristics of the medical devices manufactured thereby and explain the reasons. 

第八十二条 本规范下列用语的含义是:
Article 82 Thefollowing terms in the GMP are defined as:

验证:通过提供客观证据对规定要求已得到满足的认定。
Verification: the affirmation that the requirements specified have been satisfied through providing objective evidence.

确认:通过提供客观证据对特定的预期用途或者应用要求已得到满足的认定。
Validation: the affirmation that specific intended use or application requirements have been satisfied through providing objective evidence.

关键工序:指对产品质量起决定性作用的工序。
Critical process: refers to the process that plays decisive role in product quality.

特殊过程:指通过检验和试验难以准确评定其质量的过程。
Special process: refers to the process the quality of which is hard to be correctly evaluated through inspections and tests.

第八十三条 本规范由国家食品药品监督管理总局负责解释。
Article 83 The GMP shall be explained by CFDA.

第八十四条 本规范自2015年3月1日起施行。原国家食品药品监督管理局于2009年12月16日发布的《医疗器械生产质量管理规范(试行)》(国食药监械〔2009〕833号)同时废止。
Article 84 The GMP shall come into force as of March 1, 2015, and the Good Manufacturing Practice for Medical Devices (Interim) (GSYJX[2009] No. 833) published by the former CFDA on December 16, 2009 shall be abolished simultaneously.
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