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    【CODEX翻譯】創新醫療器械特別審查程序-中英雙語
    發布日期:2022-02-15
    ¥683.25
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    【CODEX翻譯】創新醫療器械特別審查程序-中英雙語


    創新醫療器械特別審查程序

    Special Review Procedure for Innovative Medical Devices

     

    第一條 為了保障醫療器械的安全、有效,鼓勵醫療器械的研究與創新,促進醫療器械新技術的推廣和應用,推動醫療器械產業發展,根據《醫療器械監督管理條例》《醫療器械注冊管理辦法》《體外診斷試劑注冊管理辦法》等法規和規章,制定本程序。

    Article 1 This Procedure is formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices, the Provisions for Medical Device Registration and the Provisions for In-Vitro Diagnostic Reagent Registration in order to ensure the safety and effectiveness of medical devices, to encourage the research and innovation of medical devices, to accelerate the promotion and application of new technologies for medical devices and to promote the development of the medical device industry.

     

    第二條 符合下列情形的醫療器械審查,適用于本程序:

    Article 2 The medical device review in any of the following circumstances is applicable to this Procedure:

     

    (一)申請人通過其主導的技術創新活動,在中國依法擁有產品核心技術發明專利權,或者依法通過受讓取得在中國發明專利權或其使用權,創新醫療器械特別審查申請時間距專利授權公告日不超過5年;或者核心技術發明專利的申請已由國務院專利行政部門公開,并由國家知識產權局專利檢索咨詢中心出具檢索報告,報告載明產品核心技術方案具備新穎性和創造性。

    (i) If the applicant owns the invention patent of the core technology of the product in China through its leading technological innovation activities, or obtains his patent right or right of use in China by means of transfer in accordance with law, the application time for the special review of innovative medical devices shall be no more than five years from the date of patent authorization; Or, the application for the invention patent of core technology has been publicized by the patent administration department under the State Council, and a search report stating that the core technology protocol of the product is novel and creative is issued by the Patent Search and Consultation Center of SIPO.

     

    (二)申請人已完成產品的前期研究并具有基本定型產品,研究過程真實和受控,研究數據完整和可溯源。

    (ii) The applicant has completed the preliminary research of the product with the result of a nearly finalized product. The research process is authentic and controlled, and the research data is complete and traceable.

     

    (三)產品主要工作原理或者作用機理為國內首創,產品性能或者安全性與同類產品比較有根本性改進,技術上處于國際領先水平,且具有顯著的臨床應用價值。

    (iii) The main working principle or mechanism of action of the product is the first of its kind appeared in China. The product performance or safety is fundamentally improved compared with equivalent products and technologically, the product is at an international leading level and has a significant value in clinical application.


     




          CODEX北京科譯翻譯有限公司是一家專業提供生命科學翻譯和本地化服務的公司,作為中國專業的生命科學翻譯公司之一以及國內為數不多的通過國際ISO17100: 2015認證的醫學翻譯提供商,CODEX科譯擁有更多的醫學資深語言專家,能實現40多種語言對的互譯,接受更高難度的醫學領域的項目挑戰,并在最短時間內適應以給出最合理的解決方案。保證最高質量,100%按時交付,高效、完善的售后保障是CODEX科譯給客戶的用心承諾。

    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.


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    【CODEX翻譯】創新醫療器械特別審查程序-中英雙語


    創新醫療器械特別審查程序

    Special Review Procedure for Innovative Medical Devices

     

    第一條 為了保障醫療器械的安全、有效,鼓勵醫療器械的研究與創新,促進醫療器械新技術的推廣和應用,推動醫療器械產業發展,根據《醫療器械監督管理條例》《醫療器械注冊管理辦法》《體外診斷試劑注冊管理辦法》等法規和規章,制定本程序。

    Article 1 This Procedure is formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices, the Provisions for Medical Device Registration and the Provisions for In-Vitro Diagnostic Reagent Registration in order to ensure the safety and effectiveness of medical devices, to encourage the research and innovation of medical devices, to accelerate the promotion and application of new technologies for medical devices and to promote the development of the medical device industry.

     

    第二條 符合下列情形的醫療器械審查,適用于本程序:

    Article 2 The medical device review in any of the following circumstances is applicable to this Procedure:

     

    (一)申請人通過其主導的技術創新活動,在中國依法擁有產品核心技術發明專利權,或者依法通過受讓取得在中國發明專利權或其使用權,創新醫療器械特別審查申請時間距專利授權公告日不超過5年;或者核心技術發明專利的申請已由國務院專利行政部門公開,并由國家知識產權局專利檢索咨詢中心出具檢索報告,報告載明產品核心技術方案具備新穎性和創造性。

    (i) If the applicant owns the invention patent of the core technology of the product in China through its leading technological innovation activities, or obtains his patent right or right of use in China by means of transfer in accordance with law, the application time for the special review of innovative medical devices shall be no more than five years from the date of patent authorization; Or, the application for the invention patent of core technology has been publicized by the patent administration department under the State Council, and a search report stating that the core technology protocol of the product is novel and creative is issued by the Patent Search and Consultation Center of SIPO.

     

    (二)申請人已完成產品的前期研究并具有基本定型產品,研究過程真實和受控,研究數據完整和可溯源。

    (ii) The applicant has completed the preliminary research of the product with the result of a nearly finalized product. The research process is authentic and controlled, and the research data is complete and traceable.

     

    (三)產品主要工作原理或者作用機理為國內首創,產品性能或者安全性與同類產品比較有根本性改進,技術上處于國際領先水平,且具有顯著的臨床應用價值。

    (iii) The main working principle or mechanism of action of the product is the first of its kind appeared in China. The product performance or safety is fundamentally improved compared with equivalent products and technologically, the product is at an international leading level and has a significant value in clinical application.


     




          CODEX北京科譯翻譯有限公司是一家專業提供生命科學翻譯和本地化服務的公司,作為中國專業的生命科學翻譯公司之一以及國內為數不多的通過國際ISO17100: 2015認證的醫學翻譯提供商,CODEX科譯擁有更多的醫學資深語言專家,能實現40多種語言對的互譯,接受更高難度的醫學領域的項目挑戰,并在最短時間內適應以給出最合理的解決方案。保證最高質量,100%按時交付,高效、完善的售后保障是CODEX科譯給客戶的用心承諾。

    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.


          以上是免費內容,查看更多可立即購買
    發布日期:2022-02-15
    ¥683.25
    立即購買
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    自成立以來,CODEX 一直深耕醫療、知識產權領域翻譯,高品質的翻譯和服務,是CODEX得以持續發展的源動力。
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