Decree 102 Good Manufacturing Practice For Implantable Medical Devices

CFDA’s Announcement on Issuing Appendix of Implantable Medical Devices
to Good Manufacturing Practice for Medical Devices ([2015] No.102)
2015 年 07 月 10 日 发布
Issued on July 10, 2015
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 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起草了《医疗器械生产质量管理规范附录植入性医疗器械》，现
予以发布。
With the view to strengthening supervision and management of medical devices manufacturing, and
standardizing quality management of medical devices manufacturing, China Food and Drug
Administration organized the drafting of Appendix of Implantable Medical Devices to Good
Manufacturing Practice for Medical Devices in accordance with Regulations for the Supervision and
Administration of Medical Devices (State Council Order No.650) and Provisions for the Supervision of
Medical Device Manufacturing (CFDA Order No.7), which is hereby released.
本附录是植入性医疗器械生产质量管理规范的特殊要求。植入性医疗器械生产质量管理体系
应当符合《医疗器械生产质量管理规范》及本附录的要求。
特此公告。
This Appendix is the special requirements of Good Manufacturing Practice for Implantable Medical
Devices. The manufacturing quality management system of implantable medical devices shall meet the
requirements of Good Manufacturing Practice for Medical Devices and this Appendix.
附件：医疗器械生产质量管理规范附录无菌医疗器械
Annex: Appendix of Implantable Medical Devices of Good Manufacturing Practice for Medical Devices
食品药品监管总局
China Food and Drug Administration
2015 年 7 月 10 日
July 10, 2015
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医疗器械生产质量管理规范附录
植入性医疗器械
Appendix of Implantable Medical Device to Good Manufacturing Practice for Medical Devices
第一部分 范围和原则
Part 1 Scope and Principles
1.1 本附录适用于植入性的有源医疗器械和无源医疗器械，但不适用于组织工程植入物中生物技
术组成部分和除齿科种植体外的其他齿科植入物。
1.1 This Appendix is applicable to implantable active and passive medical devices, and inapplicable to
the biotechnological compositions of tissue engineering implant or dental implantation materials other
than dental implants.
1.2 本附录是对植入性医疗器械生产质量管理规范的特殊要求。
1.2 This Appendix set forth special requirements for the good manufacturing practice for implantable
medical devices.
1.3 植入性的无菌医疗器械，生产中应当最大限度地降低污染，以保证医疗器械不受污染或能有
效排除污染。植入性的非无菌医疗器械，其生产环境的设置应当满足产品质量的要求。
1.3 During the production of sterile implantable medical devices, pollution shall be minimized in order
to protect the medical devices from pollution or to effectively eliminate pollution. The production
environment of non-sterile implantable medical devices shall meet the requirements for product
quality.
第二部分 特殊要求
Part 2 Special Requirements
2.1 人员
2.1 Personnel
2.1.1 植入性的动物源医疗器械和同种异体医疗器械的生产、技术和质量管理人员应当具有相应
的生物学、生物化学、微生物学、医学、免疫学等专业知识，并具有相应的实践经验，以确保具
备在生产、质量管理中履行职责的能力。
2.1.1 Manufacturing, technical and quality management personnel of implantable animal-derived
medical devices and allogeneic medical devices shall have professional knowledge in biology,
biochemistry, microbiology, medicine, immunology, etc., and corresponding practical experience, which
enable them to fulfill their responsibilities in manufacture and quality management.
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2.1.2 凡在洁净室（区）工作的人员应当定期进行卫生和微生物学基础知识、洁净作业等方面培
训。临时进入洁净室（区）的人员，应当对其进行指导和监督。
2.1.2 Personnel working in the clean room (zone) shall be provided with basic knowledge of hygiene
and microbiology, clean operation and other trainings. And guidance or supervision shall be given to
any person who enters clean room (zone) temporarily.
2.1.3 从事植入性的动物源医疗器械和同种异体医疗器械生产的全体人员，包括清洁、维修等人
员均应当根据其产品和所从事的生产操作进行专业和安全防护培训。
2.1.3 All personnel engaged in the manufacture of implantable animal-derived medical devices and
allogeneic medical devices, including cleaning and maintenance personnel, shall receive professional
and safety protection training based on the product and production operation that they are engaged in
2.1.4 应当建立对人员的清洁要求，制定洁净室（区）工作人员卫生守则。人员进入洁净室（区）
应当按照程序进行净化，并穿戴工作帽、口罩、洁净工作服、工作鞋。裸手接触产品的操作人员
每隔一定时间应当对手再次进行消毒。裸手消毒剂的种类应当定期更换。
2.1.4 Cleaning requirements for personnel shall be set up and hygiene code shall be formulated for
workers in clean room (zone).Any person who enters clean room (zone) shall wear work cap, respirator,
clean working garment and work shoes, as well as receive purification in accordance with applicable
procedures. Operators who contact products with bare hands shall disinfect their hands at regular
intervals. In addition, type of disinfector shall be changed regularly.
2.1.5 应当制定人员健康要求，设立人员健康档案。直接接触物料和产品的操作人员每年至少体
检一次。患有传染性和感染性疾病的人员不得从事直接接触产品的工作。
2.1.5 Health requirements for personnel shall be established, and health record shall be formulated.
Personnel who directly contact materials and products shall receive physical examination at least once
every year. Nevertheless, any person suffering infectious or contagious disease shall not engage in work
in which direct contact with products is required.
2.1.6 应当明确人员服装要求，制定洁净和无菌工作服的管理规定。工作服及其质量应当与生产
操作的要求及操作区的洁净度级别相适应，其式样和穿着方式应当能够满足保护产品和人员的要
求。洁净工作服和无菌工作服不得脱落纤维和颗粒性物质，无菌工作服应当能够包盖全部头发、
胡须及脚部，并能阻留人体脱落物。
2.1.6 Clothing requirements for personnel shall be defined, i.e. regulations on clean and sterile working
garment shall be formulated. Working garment and its quality shall match requirement of production
operation and cleanliness level of the operation area; furthermore, its style or wearing mode shall be
suitable for protecting products and personnel. Any fiber or particulate matter shall not fall off from
both clean working garment and sterile working garment; besides, sterile working garment shall be able
to cover hair, beard and feet completely, as well as hold substance falling off from human body.
2.2 厂房与设施
2.2 Workshops and Facilities
2.2.1 应当有整洁的生产环境。厂区的地面、路面周围环境及运输等不应对植入性的无菌医疗器
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械的生产造成污染。行政区、生活区和辅助区的总体布局应当合理，不得对生产区有不良影响。
厂区应当远离有污染的空气和水等污染源的区域。
2.2.1 Tidy production environment shall be maintained. The ground, surrounding of road surface,
transportation, etc. within the factory shall not cause pollution to the manufacture of implantable
sterile medical devices. The overall layout of administrative zone, living zone, and auxiliary zone shall be
rational and shall not bring in any adverse influence on the manufacturing zone. Furthermore, the
factory shall be far away from areas with contaminated air, water and other source of pollution.
2.2.2 应当根据所生产的植入性无菌医疗器械的质量要求，确定在相应级别洁净室（区）内进行
生产的过程，避免生产中的污染。空气洁净级别不同的洁净室（区）之间的静压差应大于 5 帕，
洁净室（区）与室外大气的静压差应大于 10 帕，并应有指示压差的装置。必要时，相同洁净级别
的不同功能区域（操作间）之间也应当保持适当的压差梯度。
2.2.2 The process of manufacturing in the clean room (zone) with corresponding cleanliness level shall
be confirmed as per the quality requirements of sterile implantable medical devices, so as to avoid
pollution in production. Static pressure difference between clean room (zone) with different cleanliness
levels shall be higher than 5 Pa while that between a clean room (zone) and outdoor atmosphere shall
be higher than 10 Pa. In addition, a device indicating pressure difference shall be equipped therein.
Appropriate pressure difference grades shall be maintained between different functional areas
(operating rooms) with same cleanliness level.
2.2.3 主要与骨接触的植入性无菌医疗器械或单包装出厂的配件，其末道清洁处理、组装、初包
装、封口的生产区域和不经清洁处理零部件的加工生产区域应当不低于 100,000 级洁净度级别。
2.2.3 As for the implantable sterile medical devices substantially in contact with bones or accessories
packaged item by item, the cleanliness level of the production area for their final cleaning, assembly,
primary package and sealing, and the production and processing area of parts not undergoing cleaning
shall not be lower than level 100,000.
2.2.4 主要与组织和组织液接触的植入性无菌医疗器械或单包装出厂的配件，其末道清洁处理、
组装、初包装、封口的生产区域和不经清洁处理零部件的加工生产区域应当不低于 100,000 级洁
净度级别。
2.2.4 As for the sterile implantable medical devices substantially in contact with tissue and tissue fluid
or accessories packaged item by item, the cleanliness level of the production area for their final
cleaning, assembly, primary package and sealing, and the production and processing area of parts not
undergoing cleaning shall not be lower than level 100,000.
2.2.5 主要与血液接触的植入性无菌医疗器械或单包装出厂的配件，其末道清洁处理、组装、初
包装、封口的生产区域和不经清洁处理零部件的加工生产区域应当不低于 10,000 级洁净度级别。
2.2.5 As for the implantable sterile medical devices substantially in contact with blood or accessories
packaged item by item, the cleanliness level of the production area for their final cleaning, assembly,
primary package and sealing, and the production and processing area of parts not undergoing cleaning
shall not be lower than level 10,000.
2.2.6 与人体损伤表面和粘膜接触的植入性无菌医疗器械或单包装出厂的零部件，其末道清洁处
理、组装、初包装、封口的生产区域和不经清洁处理零部件的加工生产区域应当不低于 300,000
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级洁净度级别。
2.2.6 As for the sterile implantable medical devices substantially in contact with the surface of
human-body injuries and mucosa, or accessories packaged item by item, the cleanliness level of the
production area for their final cleaning, assembly, primary package and sealing, and the production and
processing area of parts not undergoing cleaning shall not be lower than level 300,000.
2.2.7 与植入性的无菌医疗器械的使用表面直接接触、不需清洁处理即使用的初包装材料，其生
产环境洁净度级别的设置应当遵循与产品生产环境的洁净度级别相同的原则，使初包装材料的质
量满足所包装无菌医疗器械的要求；若初包装材料不与植入性无菌医疗器械使用表面直接接触，
应当在不低于 300,000 洁净室（区）内生产。
2.2.7 As for the primary packing materials directly in contact with the surface of sterile implantable
medical devices and not requiring cleaning, the cleanliness level of its production environment shall be
consistent with the cleanliness level of production environment of products to be packed, so that the
quality of primary packing materials will meet quality requirements of the sterile implantable medical
devices to be packed; primary packing materials not directly in contact with the surface of sterile
implantable medical devices shall be produced in such clean room (zone) with a cleanliness level of not
lower than 300,000.
2.2.8 对于有要求或采用无菌操作技术加工的植入性无菌医疗器械（包括医用材料），应当在
10,000 级下的局部 100 级洁净室（区）内进行生产。
2.2.8 As for sterile implantable medical devices (including medical materials) required to be or actually
processed with sterile operating technologies, they shall be produced in such clean room (zone) with a
cleanliness level of 10,000 (level 100 in partial areas).
2.2.9 洁净工作服清洗干燥间、洁具间、专用工位器具的末道清洁处理与消毒的区域的空气洁净
度级别可低于生产区一个级别，但不得低于 300,000 级。无菌工作服的整理、灭菌后的贮存应当
在 10,000 级洁净室（区）内。
2.2.9 The air cleanliness level of the cleaning and drying room for working garment, apparatus cleaning
room and the cleaning and sterilizing area of special working position apparatus may be one level lower
than that of the production area, but may not be lower than level 300,000. The sterile working garment
shall be sterilized and kept in the clean room (zone) with a cleanliness level of 10,000.
2.2.10 洁净室（区）应当按照植入性的无菌医疗器械的生产工艺流程及所要求的空气洁净度级别
进行合理布局，人流、物流走向应当合理。同一洁净室（区）内或相邻洁净室（区）间的生产操
作不得互相交叉污染。
2.2.10 Clean room (zone) shall be rationally arranged according to the technological process of
manufacturing of sterile implantable medical devices and the required air cleanliness level, and the
stream of people and direction of logistics shall be appropriate. The manufacturing operation in the
same clean room (zone) or between adjacent clean room (zone) shall not cause in-cross contamination
to each other.
2.2.11 洁净室（区）空气洁净度级别指标应当符合医疗器械相关行业标准的要求。
2.2.11 The indicators of air cleanliness level of clean room (zone) shall be in compliance with applicable
requirements of industrial standards of medical devices.
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2.2.12 洁净室（区）的温度和相对湿度应当与产品生产工艺要求相适应。无特殊要求时，温度应
当控制在 18～28℃，相对湿度控制在 45%～65%。
2.2.12 Both the temperature and the relative humidity in clean room (zone) shall be suitable for the
manufacturing process of the products. When there are no special requirements, the temperature shall
be controlled between 18℃~28℃ and the relative humidity shall be controlled between 45%~65%.