Decree 650 Regulation On Supervision And Management Of Medical Devices (Expiry)

医疗器械监督管理条例
Regulations for the Supervision and Administration of Medical Devices
中华人民共和国国务院令
People’s Republic of China State Council Order
第 650 号
No.650
《医疗器械监督管理条例》已经 2014 年 2 月 12 日国务院第 39 次常务会议修订通过，
现将修订后的《医疗器械监督管理条例》公布，自 2014 年 6 月 1 日起施行。
Regulations for the Supervision and Administration of Medical Devices have been approved
by the 39th executive meeting of the State Council held on February 12th 2014. Now the amended
Regulations for the Supervision and Administration of Medical Devices are announced, and to be
executive since June 1st, 2014.
总理 李克强
Prime minister: Li Keqiang
2014 年 3 月 7 日
March 7th, 2013
医疗器械监督管理条例
Regulations for the Supervision and Administration of Medical Devices
（2000 年 1 月 4 日中华人民共和国国务院令第 276 号公布 2014 年 2 月 12 日国务院第 39
次常务会议修订通过）
(Announced under Order 276 of People’s Republic of China State Council Order on January 4th,
2000; amended on February 12th, 2014 on the 39th executive meeting of the State Council)
第一章 总 则
Chapter I General Provisions
第一条 为了保证医疗器械的安全、有效，保障人体健康和生命安全，制定本条例。
Article 1 These Regulations are hereby formulated with a view to strengthening the
supervision and administration of medical devices, ensuring their safety and effectiveness and
protecting human health and life safety.
第二条 在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督
管理，应当遵守本条例。
Article 2 All units or individuals engaged in the research and development, production,
distribution, use, supervision and administration of medical devices within the territory of the
Peoples Republic of China shall comply with the Regulation.
第三条 国务院食品药品监督管理部门负责全国医疗器械监督管理工作。国务院有关部
门在各自的职责范围内负责与医疗器械有关的监督管理工作。
Article 3 The drug regulatory authority under the State Council is responsible for supervision
and administration of medical devices nationwide. The relevant departments of the State
Council are responsible for the supervision and management of medical devices within their
scope of official duty.
县级以上地方人民政府食品药品监督管理部门负责本行政区域的医疗器械监督管理工
作。县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工
作。
The drug administration of the local government at county level and above is responsible for
supervision and administration of medical devices in each administrative region. The relevant
departments of the local government at county level and above are responsible for the
supervision and management of medical devices within their scope of official duty.
国务院食品药品监督管理部门应当配合国务院有关部门，贯彻实施国家医疗器械产业规
划和政策。
The drug regulatory authority under the State Council shall coordinate with other
departments under the State Council, responsible for comprehensive economic administration, in
the implementation of policies for the medical device industry.
第四条 国家对医疗器械按照风险程度实行分类管理。
Article 4 The State shall classify medical devices and administer them based on this
classification
第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。
Class I Medical Devices are those of low risk and those for which safety and effectiveness
can be ensured through routine administration;
第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。
Class II Medical Devices are those of middle level risk and those for which strict control
is required to ensure their safety and effectiveness
第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器
械。
Class III Medical Devices are those of high risk and those which must be specially strictly
controlled in respect to safety and effectiveness.
评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。
While evaluating the risk of medical devices, the intended use, structural feature, usage and
other factors of medical devices shall be taken into consideration.
国务院食品药品监督管理部门负责制定医疗器械的分类规则和分类目录，并根据医疗器
械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对分类目录进行调
整。制定、调整分类目录，应当充分听取医疗器械生产经营企业以及使用单位、行业组织的
意见，并参考国际医疗器械分类实践。医疗器械分类目录应当向社会公布。
China Food &Drug Administration is responsible for making classification rule and
classification catalog of medical devices and it takes medical device ion, operation and usage into
consideration while analyzing and evaluating the risk changes of medical devices, as well as
adjusting classification catalog. When drafting and making adjustment of classification catalog, it
shall fully listen to the advice of medical device manufacturing enterprises, users and industrial
organizations. It shall also refer to international medical devices classification practices. The
classification catalog of medical devices shall be to the public.
第五条 医疗器械的研制应当遵循安全、有效和节约的原则。国家鼓励医疗器械的研究
与创新，发挥市场机制的作用，促进医疗器械新技术的推广和应用，推动医疗器械产业的发
展。
Article 5 The development of medical device shall follow the principle of being safe,
effective and economical. The state encourages the research and innovation of medical devices,
to play the role of market mechanism, to promote the popularization and application of new
technologies for medical devices, and to promote the development of medical device industry.
第六条 医疗器械产品应当符合医疗器械强制性国家标准；尚无强制性国家标准的，应
当符合医疗器械强制性行业标准。
Article 6 Medical devices shall comply with the mandatory national standards for medical
devices; If there are no mandatory national standards yet, it shall comply with mandatory
industrial standards of medical devices.
一次性使用的医疗器械目录由国务院食品药品监督管理部门会同国务院卫生计生主管
部门制定、调整并公布。重复使用可以保证安全、有效的医疗器械，不列入一次性使用的医
疗器械目录。对因设计、生产工艺、消毒灭菌技术等改进后重复使用可以保证安全、有效的
医疗器械，应当调整出一次性使用的医疗器械目录。
Catalog of disposable medical devices is formulated, adjusted and published by China Food
&Drug Administration and Health and Family Planning Authorities under the State Council. For
reusable medical devices that can assure safety and effectiveness, they are not listed in
disposable medical device catalog. For medical devices that can assure safety and effectiveness
for repeated usage after improving design, manufacturing technique, sterilization technique and
so on, they should be taken out from the disposable medical device catalog.
第七条 医疗器械行业组织应当加强行业自律，推进诚信体系建设，督促企业依法开展
生产经营活动，引导企业诚实守信。
Article 7 Medical devices industry organization shall strengthen self-discipline, promote
the construction of credit system, supervise and urge enterprises to conduct production and
operating activities legally, as well as guide the companies to be honest and trustworthy.
第二章 医疗器械产品注册与备案
Chapter II Registration and Recording of medical device
第八条 第一类医疗器械实行产品备案管理，第二类、第三类医疗器械实行产品注册管
理。
Article 8 Class I medical devices implement record management, class II and class III
medical device implement product registration management.
第九条 第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册，应当提交
下列资料：
Article 9 The recording of Class I medical devices and the registration of class II and class
III medical devices shall submit the following documents:
（一）产品风险分析资料；
（二）产品技术要求；
（三）产品检验报告；
（四）临床评价资料；
（五）产品说明书及标签样稿；
（六）与产品研制、生产有关的质量管理体系文件；
（七）证明产品安全、有效所需的其他资料。
(A) analysis data of product risk;
(B) technical requirements for products;
(C) inspection report;
(D) clinical evaluation materials;
(E) product specification/user manual and label sample;
(F) quality management system documentation related to product development and
production;
(G) other documents required to prove the safety and effectiveness of products
医疗器械注册申请人、备案人应当对所提交资料的真实性负责。
Registration applicant and filer of medical device is responsible for the authenticity of the
materials submitted.
第十条 第一类医疗器械产品备案，由备案人向所在地设区的市级人民政府食品药品监
督管理部门提交备案资料。其中，产品检验报告可以是备案人的自检报告；临床评价资料不
包括临床试验报告，可以是通过文献、同类产品临床使用获得的数据证明该医疗器械安全、
有效的资料。
Article 10 For recording the Class I medical device, the filler shall submit documents to the
Municipal Food &Drug Administration. For the submitted documents, the product inspection
report can be the self-inspection report of filer; Clinical evaluation material does not include
clinical trial report, it can be materials gained through references and similar product clinical data
that prove the safety and effectiveness of such medical device.
向我国境内出口第一类医疗器械的境外生产企业，由其在我国境内设立的代表机构或者
指定我国境内的企业法人作为代理人，向国务院食品药品监督管理部门提交备案资料和备案
人所在国（地区）主管部门准许该医疗器械上市销售的证明文件。
As for foreign manufacturers that export Class I medical devices to our country, they shall
ask their representative offices that are established in our country or business entity in our
country as their agents, to submit recording materials as well as local market approval of such
medical devices to China Food &Drug Administration under the State Council.
备案资料载明的事项发生变化的，应当向原备案部门变更备案。
If items in recording materials change, it shall be reported to the original recording
department for renewing recording.
第十一条 申请第二类医疗器械产品注册，注册申请人应当向所在地省、自治区、直辖
市人民政府食品药品监督管理部门提交注册申请资料。申请第三类医疗器械产品注册，注册
申请人应当向国务院食品药品监督管理部门提交注册申请资料。
Article 11 While applying for the registration of Class II medical device, the applicant shall
submit registration documents to the Food &Drug Administration of local provinces, autonomous
regions and municipal people’s government. While applying for the registration of Class III
medical device, the applicant shall submit registration documents to China Food &Drug
Administration under the State Council.
向我国境内出口第二类、第三类医疗器械的境外生产企业，应当由其在我国境内设立的
代表机构或者指定我国境内的企业法人作为代理人，向国务院食品药品监督管理部门提交注
册申请资料和注册申请人所在国（地区）主管部门准许该医疗器械上市销售的证明文件。
As for foreign manufacturers that export Class II and Class III medical devices to our
country, they shall ask their representative offices or business entity in our country as agent, to
submit registration documents as well as local market approval for such medical device to China
Food &Drug Administration under the State Council.
第二类、第三类医疗器械产品注册申请资料中的产品检验报告应当是医疗器械检验机构
出具的检验报告；临床评价资料应当包括临床试验报告，但依照本条例第十七条的规定免于
进行临床试验的医疗器械除外。
The product inspection report of Class II and class III medical devices is the inspection
report issued by medical devicetest institutions; clinical evaluation materials shall include clinical
trial report, but exclude medical devices that are free from clinical trials in accordance with the
provision of Article 17 of this regulation.
第十二条 受理注册申请的食品药品监督管理部门应当自受理之日起 3 个工作日内将
注册申请资料转交技术审评机构。技术审评机构应当在完成技术审评后向食品药品监督管理
部门提交审评意见。
Article 12 The Food &Drug Administration that is in charge of registration shall forward
registration documents to technical evaluation organization within 3 workdays from the data of
acceptance. The technical evaluation organization shall submit review opinions to Food &Drug
Administration after finishing their technical evaluation.
第十三条 受理注册申请的食品药品监督管理部门应当自收到审评意见之日起 20 个工
作日内作出决定。对符合安全、有效要求的，准予注册并发给医疗器械注册证；对不符合要
求的，不予注册并书面说明理由。
Article 13 The Food &Drug Administration that accepts the registration application shall
make decision within 20 workdays after receiving technical evaluation opinions. Where the
medical device is safe and effective, the application is approved and medical device registration
certificate is issued; where safety and effectiveness cannot be assured, the application is rejected
for registration and a written reason is provided.
国务院食品药品监督管理部门在组织对进口医疗器械的技术审评时认为有必要对质量
管理体系进行核查的，应当组织质量管理体系检查技术机构开展质量管理体系核查。
While organizing technical evaluation for foreign medical devices, if the Food &Drug
Administration under the State Council thinks it is necessary to check the manufacturer’s quality
management system, it shall ask the technicaltest institution of quality management system to
conduct quality management system inspection.
第十四条 已注册的第二类、第三类医疗器械产品，其设计、原材料、生产工艺、适用
范围、使用方法等发生实质性变化，有可能影响该医疗器械安全、有效的，注册人应当向原
注册部门申请办理变更注册手续；发生非实质性变化，不影响该医疗器械安全、有效的，应
当将变化情况向原注册部门备案。
Article 14 As for Class II and Class III medical devices that have been registered, if the design,
raw materials, manufacturing techniques, range of application, usage etc. have substantial
changes that may influence the safety and effectiveness of medical devices, the registrant shall
apply for change registration from the original registration department; As for non-substantial
changes that don’t influence the safety and effectiveness of medical devices, the changes shall be
put on record to original registration organization.
第十五条 医疗器械注册证有效期为 5 年。有效期届满需要延续注册的，应当在有效期
届满 6 个月前向原注册部门提出延续注册的申请。
Article 15 The expiry date of medical device registration certificate is 5 years. If the
registration certificate needs to be renewed at the expiration of valid date, the application shall
submit documents for continuation from the original registration organization 6 months before
the valid date.
除有本条第三款规定情形外，接到延续注册申请的食品药品监督管理部门应当在医疗器
械注册证有效期届满前作出准予延续的决定。逾期未作决定的，视为准予延续。
Except for situations specified in clause 3 of this Article, the Food &Drug Administration
that has accepted the continuation application shall make decision of approving before the expiry
date of medical device registration certificate. If it fails to make a decision after the valid date, it
is regarded as continuation is allowed.
有下列情形之一的，不予延续注册：
Any of the following circumstances, the continuation registration is not approved:
（一）注册人未在规定期限内提出延续注册申请的；
（二）医疗器械强制性标准已经修订，申请延续注册的医疗器械不能达到新要求的；
（三）对用于治疗罕见疾病以及应对突发公共卫生事件急需的医疗器械，未在规定期限
内完成医疗器械注册证载明事项的。
(A) the registrant fails to apply for continuation registration within the specified period;
(B) medical device mandatory standard has been amended, the medical device that applies
for continuation registration can’t meet new requirements;
(C) For medical device to cure rare diseases and devices that are for emergent treatment of
public health, it fails to finish the stated matters about medical device registration within
stipulated period.
第十六条 对新研制的尚未列入分类目录的医疗器械，申请人可以依照本条例有关第三
类医疗器械产品注册的规定直接申请产品注册，也可以依据分类规则判断产品类别并向国务
院食品药品监督管理部门申请类别确认后依照本条例的规定申请注册或者进行产品备案。
Article 16 As for newly developed medical device that has not been included into
classification catalog, the applicant can directly apply for product registration in accordance with
regulations about Class III medical device which is specified in this article, he can also judge the
product category and classification according to classification rule, then applies for classification
confirmation to Food &Drug Administration under the State Council. After getting confirmed, he
can apply for registration or carry out product recording in accordance with this regulation.
直接申请第三类医疗器械产品注册的，国务院食品药品监督管理部门应当按照风险程度
确定类别，对准予注册的医疗器械及时纳入分类目录。申请类别确认的，国务院食品药品监
督管理部门应当自受理申请之日起 20 个工作日内对该医疗器械的类别进行判定并告知申请
人。
Where apply for registration of Class III medical device directly, the Food &Drug
Administration under the State Council shall confirm classification according to risk degree, and
timely include medical device that is approved for registration is into classification catalog. As for
medical device that applies for classification confirmation, the Food &Drug Administration under
the State Council shall judge the classification of medical device and inform the applicant within
20 workdays since first day of acceptance.
第十七条 第一类医疗器械产品备案，不需要进行临床试验。申请第二类、第三类医疗
器械产品注册，应当进行临床试验；但是，有下列情形之一的，可以免于进行临床试验：
Article 17 the recording of Class I medical device doesn’t require clinical trial. The
application of registration of Class II and Class III medical device shall take clinical trial; However,
as for any of the following circumstances, clinical trials can be avoided:
（一）工作机理明确、设计定型，生产工艺成熟，已上市的同品种医疗器械临床应用多
年且无严重不良事件记录，不改变常规用途的；
（二）通过非临床评价能够证明该医疗器械安全、有效的；
（三）通过对同品种医疗器械临床试验或者临床使用获得的数据进行分析评价，能够证
明该医疗器械安全、有效的。
(A) has clear working mechanism, design, and mature manufacturing technique. The marketed
device of the same type has years of use experience without serious adverse event record, and
general intended use unchanged;
(B) non-clinical assessment can demonstrate the safety and effectiveness of the medical device;
(C)clinical trial about same type medical device and analysis about clinical data can prove the
effectiveness and safety of such medical device.
免于进行临床试验的医疗器械目录由国务院食品药品监督管理部门制定、调整并公布。
The catalog of medical device that is free from clinical trial is formulated, adjusted and
published by the Food &Drug Administration under the State Council.
第十八条 开展医疗器械临床试验，应当按照医疗器械临床试验质量管理规范的要求，
在有资质的临床试验机构进行，并向临床试验提出者所在地省、自治区、直辖市人民政府食
品药品监督管理部门备案。接受临床试验备案的食品药品监督管理部门应当将备案情况通报
临床试验机构所在地的同级食品药品监督管理部门和卫生计生主管部门。
Article 18 Clinical trial of medical devices shall be taken in accordance with the quality
management requirement of medical device and shall be performed in a qualified clinical trial
organization. It shall also be recorded at the Food &Drug Administration of province, autonomous
region and multiplicity where the applicant locates. The Food &Drug Administration that accepts
the clinical trial recording shall inform the Food &Drug Administration and health and family
planning authorities of the same level where the clinical trial organization locates.
医疗器械临床试验机构资质认定条件和临床试验质量管理规范，由国务院食品药品监督
管理部门会同国务院卫生计生主管部门制定并公布；医疗器械临床试验机构由国务院食品药
品监督管理部门会同国务院卫生计生主管部门认定并公布。
The Food &Drug Administration and health and family planning authorities under the State
Council shall formulate and publish the qualification conditions of medical device clinical trial
organization as well as management specifications of the quality of clinical trial. The medical
device clinical trial organization is identified and announced by the Food &Drug Administration
and health and family planning authorities under the State Council.
第十九条 第三类医疗器械进行临床试验对人体具有较高风险的，应当经国务院食品药
品监督管理部门批准。临床试验对人体具有较高风险的第三类医疗器械目录由国务院食品药
品监督管理部门制定、调整并公布。
Article 19 As for Class III medical device that has high risk for human body while carrying out
clinical trial, it shall get the approval of the Food &Drug Administration under the State Council.
The catalog of Class III medical device that has high risk for human body while carrying out
clinical trial is formulated, adjusted and published by the Food &Drug Administration under the
State Council.
国务院食品药品监督管理部门审批临床试验，应当对拟承担医疗器械临床试验的机构的
设备、专业人员等条件，该医疗器械的风险程度，临床试验实施方案，临床受益与风险对比
分析报告等进行综合分析。准予开展临床试验的，应当通报临床试验提出者以及临床试验机
构所在地省、自治区、直辖市人民政府食品药品监督管理部门和卫生计生主管部门。
While examining and approving clinical trial, the Food &Drug Administration under the State
Council shall comprehensively analyze the equipments, professional staff, the risk degree of the
medical device; clinical trial scheme, comparison report of clinical benefits and risk of the
organization that will undertake medical device clinical trial. If it is allowed to conduct clinical
trial, the clinical trial applicant and the province, autonomous region and multiplicity government
and health and family planning authorities where the clinical trial organization lie is located shall
be informed.
第三章 医疗器械生产
Chapter III Production of Medical Devices
第二十条 从事医疗器械生产活动，应当具备下列条件：
Article 28 Enterprises manufacturing medical devices shall meet the following conditions:
（一）有与生产的医疗器械相适应的生产场地、环境条件、生产设备以及专业技术人员；
（二）有对生产的医疗器械进行质量检验的机构或者专职检验人员以及检验设备；
（三）有保证医疗器械质量的管理制度；
（四）有与生产的医疗器械相适应的售后服务能力；
（五）产品研制、生产工艺文件规定的要求。
(A) Possess professional technical personnel, facility and environment, and equipment
required for the manufacture of its medical devices;
(B) Possess an establishment or personnel and equipment for quality testing required for the
manufacture of its medical devices.
(C) Possess management system that ensure the quality of medical device;
(D) Possess after-sale service capacity that can adapt to medical device
(E) requirements in documents about product development and manufacturing technique
第二十一条 从事第一类医疗器械生产的，由生产企业向所在地设区的市级人民政府食
品药品监督管理部门备案并提交其符合本条例第二十条规定条件的证明资料。
Article 21 Manufacturing enterprise that produces Class I medical device shall submit
documents that comply with conditions in Article 20 to the Food &Drug Administration of the
municipal People’s government.
第二十二条 从事第二类、第三类医疗器械生产的，生产企业应当向所在地省、自治区、
直辖市人民政府食品药品监督管理部门申请生产许可并提交其符合本条例第二十条规定条
件的证明资料以及所生产医疗器械的注册证。
Article 22 Manufacturing enterprise that produces Class II and Class III medical device shall
apply for manufacturing approval and submit documents that comply with conditions in Article
20 as well as registration certificate of the medical device that they manufactured to the Food
&Drug Administration of the government of the province, autonomous region and municipality.
受理生产许可申请的食品药品监督管理部门应当自受理之日起 30 个工作日内对申请资
料进行审核，按照国务院食品药品监督管理部门制定的医疗器械生产质量管理规范的要求进
行核查。对符合规定条件的，准予许可并发给医疗器械生产许可证；对不符合规定条件的，
不予许可并书面说明理由。
Food & Drug Administration that accepts the application of production license application
shall check submitted materials within 30 workdays since first day of the acceptance. The
inspection shall be carried out according to quality management specifications of medical device
ion formulated by the Food & Drug Administration under the State Council. With regard to
application that is in compliance with specified requirements, medical device production license
shall be issued; otherwise it is not permitted and a written document of reasons shall be given.
医疗器械生产许可证有效期为 5 年。有效期届满需要延续的，依照有关行政许可的法律
规定办理延续手续。
The valid date of medical device production license is 5 years. If needs to renew, the renewal
shall be processed in accordance with provisions in relevant administrative laws.
第二十三条 医疗器械生产质量管理规范应当对医疗器械的设计开发、生产设备条件、
原材料采购、生产过程控制、企业的机构设置和人员配备等影响医疗器械安全、有效的事项
作出明确规定。
Article 23 The good manufacturing practice of medical device shall have clear provision
about factors that may influence the safety and effectiveness of medical device, such as design
and development, the condition of production equipment, raw material purchase, production
process control, the institution setting and staffing.
第二十四条 医疗器械生产企业应当按照医疗器械生产质量管理规范的要求，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；严格按照经注册或者备案的产
品技术要求组织生产，保证出厂的医疗器械符合强制性标准以及经注册或者备案的产品技术
要求。
Article 24 Medical device manufacturing enterprise shall, in accordance with the good
manufacturing practice of medical device, establish and ensure the effective running of quality
management system that adapts to medical devices; It shall organize production strictly in
accordance with technical requirements which were registered or recorded, so as to make sure
the produced medical device complies with mandatory standard and technical requirements
which were registered or recorded.
医疗器械生产企业应当定期对质量管理体系的运行情况进行自查，并向所在地省、自治
区、直辖市人民政府食品药品监督管理部门提交自查报告。
Medical device manufacturing enterprise shall carry out self-examination regularly about
the condition of quality management system, and submit self-examination report to the Food &
Drug Administration of people’s government of local province, autonomous region and
municipalities.
第二十五条 医疗器械生产企业的生产条件发生变化，不再符合医疗器械质量管理体系
要求的，医疗器械生产企业应当立即采取整改措施；可能影响医疗器械安全、有效的，应当
立即停止生产活动，并向所在地县级人民政府食品药品监督管理部门报告。
Article 25 If the changed production condition of medical device manufacturing enterprise
no longer complies with requirements of quality management system of medical device, the
medical device manufacturing enterprise shall immediately take corrective measures; If the
changes may influence the safety and effectiveness of medical device, the manufacturing
enterprise shall immediately cease production activity, and report to the Food & Drug
Administration of local people’s government at the county level.
第二十六条 医疗器械应当使用通用名称。通用名称应当符合国务院食品药品监督管理
部门制定的医疗器械命名规则。
Article 26 Medical device shall use general name. The general name shall in accordance with
medical device naming rule which is formulated by the Food & Drug Administration under the
State Council.
第二十七条 医疗器械应当有说明书、标签。说明书、标签的内容应当与经注册或者备
案的相关内容一致。
Article 27Medical device shall have specification and label. The content of specification and
label shall be consistent with relative content of the registered or recorded content.
医疗器械的说明书、标签应当标明下列事项：
The following items shall be included in the specification and label of medical device:
（一）通用名称、型号、规格；
（二）生产企业的名称和住所、生产地址及联系方式；
（三）产品技术要求的编号；
（四）生产日期和使用期限或者失效日期；
（五）产品性能、主要结构、适用范围；
（六）禁忌症、注意事项以及其他需要警示或者提示的内容；
（七）安装和使用说明或者图示；
（八）维护和保养方法，特殊储存条件、方法；
（九）产品技术要求规定应当标明的其他内容。
(A) general name, type/model and specification;
(B) the name and address, production address and contact information of manufacturing
enterprise;
(C) the number of product technical requirement;
(D) production date, life time or expiry date;
(E) product performance, main structure and scope of application
(F) contraindications, precautions and other contents that need to be warned or prompted;
(G)illustration or diagram about installation and use ;
(H) maintenance and service methods, special storage conditions and methods;
(I)other contents that product technical requirement requires to be marked.
第二类、第三类医疗器械还应当标明医疗器械注册证编号和医疗器械注册人的名称、地
址及联系方式。
Class II and Class III medical device shall clearly indicate the medical device registration
certificate number as well as the name, address and contact information of registrant.
由消费者个人自行使用的医疗器械还应当具有安全使用的特别说明。
Medical devices used by the consumers themselves shall have special instruction about safe
use.
第二十八条 委托生产医疗器械，由委托方对所委托生产的医疗器械质量负责。受托方
应当是符合本条例规定、具备相应生产条件的医疗器械生产企业。委托方应当加强对受托方
生产行为的管理，保证其按照法定要求进行生产。
Article 28 As for sub-contract production, the consignor shall be responsible for the quality
of medical device that it produces. The consignee shall be medical device manufacturing
enterprises that comply with this regulation and have relative production conditions. The
consignor shall enhance the management of consignee’s production behavior, and ensure that it
carry out production in accordance with statutory requirements.
具有高风险的植入性医疗器械不得委托生产，具体目录由国务院食品药品监督管理部门
制定、调整并公布。
Implantable medical device of high risk shall not be manufactured by sub-contract
manufacturer; the detailed catalog shall be formulated, adjusted and published by Food & Drug
Administration of the State Council.