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【CODEX】Regulations for the Supervision and Administration of Medical Devices
Date:2022-03-16
¥5992.50
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【CODEX】医疗器械监督管理条例(第739号)-英文版PDF


医疗器械监督管理条例

 Regulations for the Supervision and Administration of Medical Devices


 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,促进医疗器械产业发展,制定本条例。

Article 1. The Regulations are hereby formulated with a view to ensuring safety and effectiveness of medical devices, protecting human health and life safety, and promoting the development of the medical device industry.

  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,适用本条例。

Article 2. The Regulations apply to all entities or individuals engaged in the research and development, manufacturing, distribution, use, supervision and administration of medical devices within the territory of the People’s Republic of China.

  第三条 国务院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 the supervision and administration of medical devices nationwide.

Relevant authorities under the State Council are responsible for the supervision and administration related to medical devices within the scope of their respective duties.

  第四条 县级以上地方人民政府应当加强对本行政区域的医疗器械监督管理工作的领导,组织协调本行政区域内的医疗器械监督管理工作以及突发事件应对工作,加强医疗器械监督管理能力建设,为医疗器械安全工作提供保障。

  县级以上地方人民政府负责药品监督管理的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。

Article 4. The local people’s government at or above the county level shall strengthen the leadership of the supervision and administration of medical devices in its administrative region, organize and coordinate the supervision and administration of medical devices and emergency response in its administrative region, and strengthen the capacity building of the supervision and administration of medical devices, so as to provide guarantee for the safety of medical devices.

The drug regulatory authority of the local people’s government at or above the county level is responsible for the supervision and administration of medical devices in its administrative region. Relevant authorities of the local people’s government at or above the county level are responsible for the supervision and administration related to medical devices within the scope of their respective duties.

  第五条 医疗器械监督管理遵循风险管理、全程管控、科学监管、社会共治的原则。

Article 5. The supervision and administration of medical devices shall follow the principles of risk management, whole-process control, scientific supervision, and social co-governance.

  第六条 国家对医疗器械按照风险程度实行分类管理。

  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。

  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。

  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。

  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。

  国务院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,对分类规则和分类目录进行调整。制定、调整分类规则和分类目录,应当充分听取医疗器械注册人、备案人、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。医疗器械分类规则和分类目录应当向社会公布。

  第七条 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。

  第八条 国家制定医疗器械产业规划和政策,将医疗器械创新纳入发展重点,对创新医疗器械予以优先审评审批,支持创新医疗器械临床推广和使用,推动医疗器械产业高质量发展。国务院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引导政策。

  第九条 国家完善医疗器械创新体系,支持医疗器械的基础研究和应用研究,促进医疗器械新技术的推广和应用,在科技立项、融资、信贷、招标采购、医疗保险等方面予以支持。支持企业设立或者联合组建研制机构,鼓励企业与高等学校、科研院所、医疗机构等合作开展医疗器械的研究与创新,加强医疗器械知识产权保护,提高医疗器械自主创新能力。

  第十条 国家加强医疗器械监督管理信息化建设,提高在线政务服务水平,为医疗器械行政许可、备案等提供便利。

  第十一条 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。

  第十二条 对在医疗器械的研究与创新方面做出突出贡献的单位和个人,按照国家有关规定给予表彰奖励。




      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】Regulations for the Supervision and Administration of Medical Devices
Date:2022-03-16
¥5992.50
Download

【CODEX】医疗器械监督管理条例(第739号)-英文版PDF


医疗器械监督管理条例

 Regulations for the Supervision and Administration of Medical Devices


 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,促进医疗器械产业发展,制定本条例。

Article 1. The Regulations are hereby formulated with a view to ensuring safety and effectiveness of medical devices, protecting human health and life safety, and promoting the development of the medical device industry.

  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,适用本条例。

Article 2. The Regulations apply to all entities or individuals engaged in the research and development, manufacturing, distribution, use, supervision and administration of medical devices within the territory of the People’s Republic of China.

  第三条 国务院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 the supervision and administration of medical devices nationwide.

Relevant authorities under the State Council are responsible for the supervision and administration related to medical devices within the scope of their respective duties.

  第四条 县级以上地方人民政府应当加强对本行政区域的医疗器械监督管理工作的领导,组织协调本行政区域内的医疗器械监督管理工作以及突发事件应对工作,加强医疗器械监督管理能力建设,为医疗器械安全工作提供保障。

  县级以上地方人民政府负责药品监督管理的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。

Article 4. The local people’s government at or above the county level shall strengthen the leadership of the supervision and administration of medical devices in its administrative region, organize and coordinate the supervision and administration of medical devices and emergency response in its administrative region, and strengthen the capacity building of the supervision and administration of medical devices, so as to provide guarantee for the safety of medical devices.

The drug regulatory authority of the local people’s government at or above the county level is responsible for the supervision and administration of medical devices in its administrative region. Relevant authorities of the local people’s government at or above the county level are responsible for the supervision and administration related to medical devices within the scope of their respective duties.

  第五条 医疗器械监督管理遵循风险管理、全程管控、科学监管、社会共治的原则。

Article 5. The supervision and administration of medical devices shall follow the principles of risk management, whole-process control, scientific supervision, and social co-governance.

  第六条 国家对医疗器械按照风险程度实行分类管理。

  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。

  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。

  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。

  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。

  国务院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,对分类规则和分类目录进行调整。制定、调整分类规则和分类目录,应当充分听取医疗器械注册人、备案人、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。医疗器械分类规则和分类目录应当向社会公布。

  第七条 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。

  第八条 国家制定医疗器械产业规划和政策,将医疗器械创新纳入发展重点,对创新医疗器械予以优先审评审批,支持创新医疗器械临床推广和使用,推动医疗器械产业高质量发展。国务院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引导政策。

  第九条 国家完善医疗器械创新体系,支持医疗器械的基础研究和应用研究,促进医疗器械新技术的推广和应用,在科技立项、融资、信贷、招标采购、医疗保险等方面予以支持。支持企业设立或者联合组建研制机构,鼓励企业与高等学校、科研院所、医疗机构等合作开展医疗器械的研究与创新,加强医疗器械知识产权保护,提高医疗器械自主创新能力。

  第十条 国家加强医疗器械监督管理信息化建设,提高在线政务服务水平,为医疗器械行政许可、备案等提供便利。

  第十一条 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。

  第十二条 对在医疗器械的研究与创新方面做出突出贡献的单位和个人,按照国家有关规定给予表彰奖励。




      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 Translation has been deeply engaged in medical translation. Quality translation and services are the driving force for our sustainable development.
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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 ISO17100:2015,ISO18587:2017, ISO9001:2015, ISO14001:2015, ISO 13485:2016 Quality Management System Certification.
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Strict Control Process
Codex Translation 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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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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