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【CODEX】无源植入性医疗器械稳定性研究指导原则(2022年修订版)-英文版

发布日期:2022-10-31
¥1505.00
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【CODEX】无源植入性医疗器械稳定性研究指导原则

(2022年修订版)-英文版PDF


无源植入性医疗器械稳定性研究指导原则(2022年修订版)

Guideline for Stability Study of Passive Implantable Medical Devices (Revised in 2022)


This Guideline aims at guiding registration applicants to prepare and write registration application dossiers for stability study of passive implantable medical devices and also provide reference for CMDE (Center for Medical Device Evaluation) to review.

This Guideline is the general requirements for stability study of passive implantable medical devices. The applicant shall determine whether the specific contents herein are applicable according to the characteristics of specific products. If not applicable, the applicant shall explain the justification for such inapplicability and the corresponding scientific basis, and supplement and refine the registration application dossiers according to specific characteristics of the product.

This Guideline is a guiding document for the registration applicant and technical reviewer which excludes the administrative matters involved in the review and approval, and shall not be enforced as regulations. This Guideline shall be applied on the premise of complying with relevant regulations. Other methods in compliance with relevant regulatory requirements may also be adopted, but detailed research data and verification data shall be provided. If other regulations and guiding documents address specific requirements for stability studies of certain types of medical devices, it is recommended that the registration applicant use them in conjunction with this guideline. For the stability study of the drug part of drug-device combined medical devices, it is recommended to refer to the relevant guiding documents of the drug.


      


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.


【CODEX】无源植入性医疗器械稳定性研究指导原则

(2022年修订版)-英文版PDF


无源植入性医疗器械稳定性研究指导原则(2022年修订版)

Guideline for Stability Study of Passive Implantable Medical Devices (Revised in 2022)


This Guideline aims at guiding registration applicants to prepare and write registration application dossiers for stability study of passive implantable medical devices and also provide reference for CMDE (Center for Medical Device Evaluation) to review.

This Guideline is the general requirements for stability study of passive implantable medical devices. The applicant shall determine whether the specific contents herein are applicable according to the characteristics of specific products. If not applicable, the applicant shall explain the justification for such inapplicability and the corresponding scientific basis, and supplement and refine the registration application dossiers according to specific characteristics of the product.

This Guideline is a guiding document for the registration applicant and technical reviewer which excludes the administrative matters involved in the review and approval, and shall not be enforced as regulations. This Guideline shall be applied on the premise of complying with relevant regulations. Other methods in compliance with relevant regulatory requirements may also be adopted, but detailed research data and verification data shall be provided. If other regulations and guiding documents address specific requirements for stability studies of certain types of medical devices, it is recommended that the registration applicant use them in conjunction with this guideline. For the stability study of the drug part of drug-device combined medical devices, it is recommended to refer to the relevant guiding documents of the drug.


      


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.


发布日期:2022-10-31
¥1505.00
立即购买
我们的优势
16年医疗、知识产权领域翻译经验
16年医疗、知识产权领域翻译经验
自成立以来,CODEX 一直深耕医疗、知识产权领域翻译,高品质的翻译和服务,是CODEX得以持续发展的源动力。
专业的精英团队
专业的精英团队
CODEX的团队是由留学归国人员、重点高校毕业的研究生、专业的母语籍译员以及医学行业的专家顾问组成。
权威的质量认证体系
权威的质量认证体系
通过国际ISO17100:2015,ISO18587:2017, ISO9001:2015, ISO14001:2015, ISO 13485:2016等多项通过国际级别认证,服务多家国际著名的医药企业。
严格的管控流程
严格的管控流程
CODEX制定了完善的翻译质量保证体系和系统化的运作流程,严格采取一译、二改、三校、四审的工作程序。
绝佳的员工素质
绝佳的员工素质
我们中的每一位都经过严格的考核和挑选,精通医学翻译工作,形象佳责任心强,并严格遵循保密制度。
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16年来,CODEX是一直致力于提供生命科学翻译和本地化服务的公司,是国内为数不多的通过国家ISO17100:2015认证的医学翻译提供商。
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