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中国における輸入医療機器の登録申請・承認のためのガイドブック

Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition)

発行 Access China Management Consulting 商品コード 228279
出版日 ページ情報 英文 194 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=115.18円で換算しております。
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中国における輸入医療機器の登録申請・承認のためのガイドブック Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition)
出版日: 2014年08月25日 ページ情報: 英文 194 Pages
概要

中国における医療機器管理関連の規制は、過去30年間にわたる急速な経済の成長・人口の増加という変化に伴って、急激に変化しています。

当レポートは、中国における輸入医療機器の登録申請・承認に関する法律・規制の詳細なガイドラインを提供しており、規制当局である国家食品薬品監督管理局(CFDA)の概要、義務および組織構造、輸入医療機器に関する法律・規制の最新のフレームワーク、登録申請・承認の一般的な規制、医療機器分類、登録のための臨床試験ガイダンスなどについて体系的な情報を提供しています。

第1章 エグゼクティブサマリー

第2章 中国における医療機器規制の急激な変化に関する分析・調査

  • 中国におけるどの医療機器規制が驚くほど変化しているか?
  • 中国における医療機器規制の急進的変化を促進している理由は?

第3章 中国における医療機器登録関連の規制

第4章 中国における輸入医療機器登録規制当局の概要

  • CFDA(中国(国家食品薬品監督管理局)の主な責任
  • CDFAの組織構造
  • 輸入医療機器登録の申請・認可のロードマップ

第5章 輸入医療機器登録申請前に備える知識

  • 定義
  • 医療機器の登録・記録のための分類管理
  • どのような医療機器が中国に輸出されているか
  • 申請者または輸入医療機器登録or記録提出者に関する規制
  • 製品の技術要件
  • 登録試験
  • 臨床評価

第6章 医療機器の分類

  • 医療機器分類のガイドライン・指針
  • 医療機器分類の分別表

第7章 輸入医療機器の治験における被験者の権利および全関係者の責任

  • 被験者の権利・利益
  • 治験実行の責任
  • 医療機関・治験職員の責任

第8章 輸入医療機器記録の申請

第9章 輸入医療機器登録の申請・認可

  • 輸入医療機器登録の申請・認可
  • 医療機器登録事項
  • 管理の再検討
  • 医療機器登録証明書とその有効期限

第10章 輸入医療機器の修正登録申請・認可

第11章 輸入医療機器の更新登録申請・認可

第12章 輸入医療機器登録申請・認可の管理・手順

第13章 輸入医療機器記録申請の実用的ガイダンス

  • 輸入医療機器記録の申請
  • 輸入医療機器の修正記録申請

第14章 輸入医療機器登録申請・承認の実用的ガイダンス

  • 輸入医療機器登録の申請フォーム
  • 登録書類および登録書類要件のリスト
  • 製品技術要件の編集方法
  • 医療機器用治験の実施方法
  • 申請書類の提出

第15章 輸入医療機器の修正登録・更新登録の実用的ガイダンス

  • 輸入医療機器修正登録の実用的ガイダンス
  • 輸入医療機器更新登録の実用的ガイダンス

第16章 付録

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目次
Product Code: ACMC201408008

Now, Chinese regulations on medical devices are undergoing earthshaking changes. China's new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid economic and population growth over the pasted three decades. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” to try to completely change such imperfect status. China Food and Drug Administration issued the latest “Measures for the Administration of Medical Device Registration”, “Regulations on the Administration of the Instructions and Labels of Medical Devices”, “Measures for the Supervision and Administration of Medical Device Production”, “Measures for the Supervision and Administration of Medical Device Distribution” and “Measures for the Administration of IVD registration” on July 30, 2014 respectively, and they will come into force as October 1, 2014. The radical change of regulations on medical devices, especially for the latest “Measures for the Administration of Medical Device Registration” will bring overseas and multinational medical device manufacturers the maximum challenges and opportunities.

Those medical devices have not been granted the certificate of marketing authorization of medical device issued by the government authorities of the country or region of origin will be intercepted outside the door of Chinese medical device market. How do you in compliance with the latest Chinese regulations on medical devices? How do you operate business smoothly in China? How to seize a bigger Chinese medical device market? The overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device registration. Otherwise, the restrictive legal requirements and approval delays eat up your time and energy to achieve a successful entry into such a lucrative medical device market, and cause trouble for your business smoothly in China.

Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations for imported medical device registration but also introduced the practical operation how to comply with the Chinese regulations to guide you achieve a successful approval for your products entry into the Chinese medical device market.

The organizations of this guidebook are arranged as follows. Chapter 2 provides the analysis and research for radical change of Chinese regulations on medical devices. Chapter 3 introduces the framework of the latest applicable Chinese regulations for medical device registration to provide a comprehensive and thorough knowledge of the latest Chinese regulations for medical device registration. Chapter 4 provides an overview of the Chinese regulatory authorities -- China Food and Drug Administration (CFDA) being responsible for application and approval for imported overseas medical device registration and recordation to give the direction of gateway for imported overseas medical devices registration and recordation. Chapter 5 elaborates the knowledge preparation before application of imported overseas medical device registration to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration and lay the knowledge foundation for the practical operation. Chapter 6 elaborates the medical device classification to let overseas medical device manufacturer understand the Chinese medical device classification, because the imported overseas medical device registration must be in compliance with such classification of medical devices. Chapter 7 introduces the rights of human subjects and every party's responsibilities in clinical trials for imported overseas medical devices in China. Chapter 8 introduces the regulations for application for imported medical device recordation, which is applicable to Class I imported overseas medical devices. Chapter 9 provides the regulations for application and approval for imported medical device registration, which is applicable to Class II and II imported overseas medical devices. Chapter 10 introduces the regulations for application and approval for alteration registration of imported overseas medical devices. Chapter 11 introduces the regulations for renewal registration of imported overseas medical devices. Chapter 12 introduces the regulations for supervision and administration for application and approval of imported overseas medical device registration. Chapter 13 provides the practical guidance for application of imported overseas medical device recordation, from how to compile recordation documents, how to apply for recordation to how to handle alteration recordation to smoothly navigate complex regulatory requirements step by step. Chapter 14 provides the practical guidance for application and approval of imported overseas medical device registration, from how to compile application documents, how to conduct clinical trials for imported overseas medical devices to the application for approval of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step. Chapter 15 provides the practical guidance for alteration registration and renewal registration of imported overseas medical devices, also from how to compile application documents to how to submit application documents step by step. Chapter 16 Appendices provide a complete set of full text in English of the latest Chinese regulations involving with the imported overseas medical device registration

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their medical device products in China, how to comply with the latest Chinese regulations for medical device registration.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the latest Chinese regulations on imported medical device registration but also the practical operation how to comply with the latest Chinese regulations. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, and smoothly operate their products in China.

Table of Contents

Chapter 1 - Executive Summary

Chapter 2 - Analysis and Research for Radical Change of Chinese Regulations on Medical Devices

  • 2.1. What Chinese Regulations on Medical Devices are Undergoing Earthshaking Changes?
  • 2.2. What is the Reason to Drive Chinese Regulations on Medical Devices Radical Change?

Chapter 3 - Chinese Applicable Regulations for Medical Device Registration

Chapter 4 - An Overview of Chinese Regulatory Authorities for Imported Medical Device Registration

  • 4.1. CFDA's Main Responsibilities
  • 4.2. CFDA's Organizational Structure
    • Figure 4.2.1. CFDA's Organizational Structure
    • Table 4.2.1. CFDA's affiliated organizations
  • 4.3. Roadmap of Application and Approval for Imported Medical Device Registration
    • Figure 4.3.1. Roadmap of Examination and Approval for Imported Overseas Medical Device Registration

Chapter 5 - Knowledge Preparation before Application of Imported Medical Device Registration

  • 5.1. Definitions
  • 5.2. Classified Administration for Registration and Recordation of Medical Devices
  • 5.3. What Medical devices may be exported into China
  • 5.4. Regulations on Applicant or Filer for Imported Medical Device Registration or Recordation
  • 5.5. Product Technical Requirements
  • 5.6. Registration Tests
  • 5.7. Clinical Evaluation

Chapter 6 - Medical Device Classification

  • 6.1. Guidelines and Principles for Medical Device Classification
    • 6.1.1. Guidelines for Medical Device Classification
    • 6.1.2. Principles for Medical Device Classification
  • 6.2. Judgment Table for Medical Device Classification
    • Table 6.2. Judgment Table for Medical Device Classification

Chapter 7 - Rights of Human Subjects and Every Party's Responsibilities in Clinical Trials for Imported Medical Devices

  • 7.1. Rights and Interests of Human Subject
  • 7.2. The Responsibilities for Implementer of Clinical Trials
  • 7.3. The Responsibilities for Medical Institutions and Personnel of Clinical Trials

Chapter 8 - Application for Imported Medical Device Recordation

Chapter 9 - Application and Approval for Imported Medical Device Registration

  • 9.1. Application and Approval for Imported Medical Device Registration
  • 9.2. Matters of Medical Device Registration
  • 9.3. Administrative Reconsideration
  • 9.4. Medical Device Registration Certificate and its Valid Time Limitation

Chapter 10 - Application and Approval for Alteration Registration of Imported Medical Devices

Chapter 11 - Application and Approval for Renewal Registration of Imported Medical Devices

Chapter 12 - Supervision and Administration for Application and Approval of Imported Medical Device Registration

Chapter 13 - Practical Guidance for Application of Imported Medical Device Recordation

  • 13.1. Application for Imported Medical Device Recordation
    • 13.1.1. Recordation Form of Class I Medical Device
      • Table 13.1.1 . Recordation Form of Class I Medical Device
    • 13.1.2. List of Recordation Documents and Requirements for Recordation Documents
    • 13.1.3. Requirements for Formal Examination of Recordation From and Documents
    • 13.1.4. Operation Practices for Formal Examination of Recordation Documents
    • 13.1.5. Recordation Certificate
      • Table 13.1.5. Recordation Certificate
  • 13.2. Application for Alteration Recordation of Imported Medical Device
    • 13.2.1. Form of Recordation Information
      • Table 13.2.1. Form of Recordation Information of Class I Medical Device
    • 13.2.2. List of Alteration Recordation Documents and Requirements for Alteration Recordation Documents
    • 13.2.3. Operation Practices for Formal Examination of Alteration Recordation Information

Chapter 14 - Practical Guidance for Application and Approval of Imported Medical Device Registration

  • 14.1. Application Form for Registration of Imported Medical Device
    • Table 14.1. Application Form for Registration of Imported Medical Device
  • 14.2. List of Registration Documents and Requirements for Registration Documents
  • 14.3. How to Compile the Product Technical Requirements
    • Table 14.3. Format Requirements for Product Technical Requirements of Medical Devices
  • 14.4. How to Conduct the Clinical Trials for Medical Device
    • 14.4.1. Application Form for Medical Device Clinical Trial
      • Table 14.4.1. Application Form for Medical Device Clinical Trial
    • 14.4.2. Notice of Medical Device Clinical Trials
    • 14.4.3. Clinical Trials Protocol and Format of Clinical Trial Protocol for Medical Devices
      • Table 14.4.3. Format of Clinical Trial Protocol for Medical Devices
    • 14.4.4. Clinical Trial Report and Format of Clinical Trial Report for Medical Devices
      • Table 14.4.4. Format of Clinical Trial Report for Medical Device
  • 14.5. Submission of Application Documents

Chapter 15 - Practical Guidance for Alteration Registration and Renewal Registration of Imported Medical Devices

  • 15.1. Practical Guidance for Alteration Registration of Imported Medical Devices
  • 15.2. Practical Guidance for Renewal Registration of Imported Medical Devices

Chapter 16 - Appendices

  • Appendix 1: Regulations for the Supervision and Administration of Medical Devices (2014 Edition)
  • Appendix 2: Measures for the Administration of Medical Device Registration (2014 Edition)
  • Appendix 3: Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)
  • Appendix 4: Provisions for Clinical Trials of Medical Devices
  • Appendix 5: Rules for Medical Device Classification
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