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【CODEX】Provisions for the Supervision of Medical Device Manufacturing
Date:2022-02-14
¥1293.45
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【CODEX】医疗器械生产监督管理办法-中英双语PDF


医疗器械生产监督管理办法

Provisions for the Supervision of Medical Device Manufacturing


第一章 总则

Chapter I General Provisions


第一条 为加强医疗器械生产监督管理,规范医疗器械生产行为,保证医疗器械安全、有效,根据《医疗器械监督管理条例》,制定本办法。

Article 1.        In order to strengthen the supervision and administration of medical device manufacturing, standardize the manufacturing of medical device and ensure the safety and effectiveness of medical device, according to Regulations for the Supervision and Administration of Medical Device, CFDA has formulated the Provisions.

 

第二条 在中华人民共和国境内从事医疗器械生产活动及其监督管理,应当遵守本办法。

Article 2.        Whoever engages in the manufacturing as well as the supervision and administration of medical device within the territory of the People's Republic of China shall abide by the Provisions.

 

第三条 国家食品药品监督管理总局负责全国医疗器械生产监督管理工作。县级以上食品药品监督管理部门负责本行政区域的医疗器械生产监督管理工作。

Article 3.        China Food and Drug Administration shall be responsible for the supervision and administration of the medical device manufacturing nationwide. The food and drug regulatory authorities at or above the county level shall be responsible for the supervision and administration of medical device manufacturing within their respective administrative regions.

 

上级食品药品监督管理部门负责指导和监督下级食品药品监督管理部门开展医疗器械生产监督管理工作。

The food and drug regulatory authorities at higher level shall be responsible for the guidance and supervision of the authority at lower level on the supervision and administration of medical device manufacturing.

 

第四条 国家食品药品监督管理总局制定医疗器械生产质量管理规范并监督实施。

Article 4.        CFDA formulates Good Manufacturing Practices of Medical Device and supervise the implementation of it.

 

第五条 食品药品监督管理部门依法及时公布医疗器械生产许可和备案相关信息。申请人可以查询审批进度和审批结果;公众可以查阅审批结果。

Article 5.        The food and drug regulatory authority timely releases information on licensing and filing of medical device manufacturing accordingly. The applicant can inquire about the progress and result of examination and approval. The public can inquire about the result of examination and approval.

 

第六条 医疗器械生产企业应当对生产的医疗器械质量负责。委托生产的,委托方对所委托生产的医疗器械质量负责。

Article 6.        The medical device manufacturer shall be responsible for the quality of manufactured medical device. For entrusted manufacturing, the entrusting party shall be responsible for the quality of manufactured medical device they entrust.

 



      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买
【CODEX】Provisions for the Supervision of Medical Device Manufacturing
Date:2022-02-14
¥1293.45
Download

【CODEX】医疗器械生产监督管理办法-中英双语PDF


医疗器械生产监督管理办法

Provisions for the Supervision of Medical Device Manufacturing


第一章 总则

Chapter I General Provisions


第一条 为加强医疗器械生产监督管理,规范医疗器械生产行为,保证医疗器械安全、有效,根据《医疗器械监督管理条例》,制定本办法。

Article 1.        In order to strengthen the supervision and administration of medical device manufacturing, standardize the manufacturing of medical device and ensure the safety and effectiveness of medical device, according to Regulations for the Supervision and Administration of Medical Device, CFDA has formulated the Provisions.

 

第二条 在中华人民共和国境内从事医疗器械生产活动及其监督管理,应当遵守本办法。

Article 2.        Whoever engages in the manufacturing as well as the supervision and administration of medical device within the territory of the People's Republic of China shall abide by the Provisions.

 

第三条 国家食品药品监督管理总局负责全国医疗器械生产监督管理工作。县级以上食品药品监督管理部门负责本行政区域的医疗器械生产监督管理工作。

Article 3.        China Food and Drug Administration shall be responsible for the supervision and administration of the medical device manufacturing nationwide. The food and drug regulatory authorities at or above the county level shall be responsible for the supervision and administration of medical device manufacturing within their respective administrative regions.

 

上级食品药品监督管理部门负责指导和监督下级食品药品监督管理部门开展医疗器械生产监督管理工作。

The food and drug regulatory authorities at higher level shall be responsible for the guidance and supervision of the authority at lower level on the supervision and administration of medical device manufacturing.

 

第四条 国家食品药品监督管理总局制定医疗器械生产质量管理规范并监督实施。

Article 4.        CFDA formulates Good Manufacturing Practices of Medical Device and supervise the implementation of it.

 

第五条 食品药品监督管理部门依法及时公布医疗器械生产许可和备案相关信息。申请人可以查询审批进度和审批结果;公众可以查阅审批结果。

Article 5.        The food and drug regulatory authority timely releases information on licensing and filing of medical device manufacturing accordingly. The applicant can inquire about the progress and result of examination and approval. The public can inquire about the result of examination and approval.

 

第六条 医疗器械生产企业应当对生产的医疗器械质量负责。委托生产的,委托方对所委托生产的医疗器械质量负责。

Article 6.        The medical device manufacturer shall be responsible for the quality of manufactured medical device. For entrusted manufacturing, the entrusting party shall be responsible for the quality of manufactured medical device they entrust.

 



      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买
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Sixteen years of translation experience in medical and intellectual property fields
Sixteen years of translation experience in medical and intellectual property fields
Since the establishment, CODEX has been deeply engaged in medical translation. Quality translation and services are the driving force for our sustainable development.
Professional and Elite Team
Professional and Elite Team
The translation team consists of graduates returned from abroad, post-graduate students from the most prestigious universities, professional native-speaking translators and consultants in the medical industry.
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Authoritative Quality Certification
We provide services for many world-renowned pharmaceutical companies with ISO9001:2015 and ISO17100:2015 Quality Management System Certification.
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Strict Control Process
Codex has established a perfect translation quality assurance system and systematic operation process, strictly adopts the working procedure of  “firstly translation, secondly modification, thirdly proofreading and fourthly review”.
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Excellent Staff Quality
Being strictly examined and selected, every one of us is characterized with a strong sense of responsibility and proficiency in medical translation , and we strictly follow the confidential system.
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As one of the few medical translation suppliers in China that have been certified by ISO17100: 2015, we have been providing life sciences translation services, localization services and intellectual property translation services since our founding 16 years ago.
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