Decree 64 Good Manufacturing Practice For Medical Devices

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
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;