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中国における輸入体外診断用試薬の登録申請・承認の最新ガイドブック:規制から実行まで

Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)

発行 Access China Management Consulting 商品コード 231402
出版日 ページ情報 英文 208 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=101.50円で換算しております。
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中国における輸入体外診断用試薬の登録申請・承認の最新ガイドブック:規制から実行まで Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)
出版日: 2014年09月28日 ページ情報: 英文 208 Pages
概要

中国は世界で最も急速に成長する経済国のひとつであり、世界最大規模の医療市場のひとつです。持続的な経済成長、人口増加、および人口高齢化により、中国の医療市場は1990年代以降、年間平均成長率16%を維持しています。体外診断試薬は2007年以降、力強い成長を示しています。2013年までに、中国の医療市場における体外診断試薬の総額は35億米ドルに達し、2012年の水準から22.9%の増加となりました。中国の体外診断試薬市場は最も成長潜在性を秘めた市場のひとつであり、2015年までに55億米ドルを上回る見込みです。

当レポートは、中国における輸入体外診断用試薬の登録申請・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総局(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、体外診断用試薬分類、登録のための臨床試験ガイダンスなどについて、お届けいたします。

第1章 エグゼクティブサマリー

第2章 中国の体外診断試薬関連規制の根本的変化についての分析・調査

第3章 中国における最新の体外診断試薬登録規制

第4章 中国における輸入体外診断試薬登録規制当局の概要

  • CFDA(国家食品薬品監督管理総局)の主な責任
  • CFDAの組織構造

第5章 輸入体外診断試薬登録の一般的な規制

  • 定義
  • 分類
  • 中国に輸出される予定の体外診断試薬
  • 輸入体外診断試薬登録もしくは記録の申込者または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 体外診断試薬の分類・命名指針

  • 分類
  • 命名指針

第7章 体外診断試薬の治験

  • 治験の基本原則
  • 治験設計の原則
  • 治験レポート
  • 治験プロトコル

第8章 体外診断試薬登録指示資料

第9章 輸入体外診断試薬記録の申請

第10章 輸入体外診断試薬登録の申請・承認

  • 輸入体外診断試薬登録の申請・承認
  • 輸入体外診断試薬登録事項
  • 管理上の検討事項
  • 医療装置登録認証とその有効期間制限

第11章 輸入体外診断試薬修正登録の申請・承認

第12章 輸入体外診断試薬更新登録の申請・承認

第13章 輸入体外診断試薬更新登録・記録の申請・承認の監督・管理

第14章 輸入体外診断試薬記録申請の実用的ガイダンス

  • 輸入体外診断試薬記録の申請
  • 輸入体外診断試薬記録の修正記録申請

第15章 輸入体外診断試薬登録の申請・承認の実用的ガイダンス

  • 輸入体外診断試薬登録の申請フォーム
  • 申請登録書類のリストおよび登録書類申請の要件
  • 製品の技術要件の編集法
  • 申請書類の提出
  • 医療機器登録認証

第16章 輸入体外診断試薬の修正・更新登録の実用的ガイダンス

  • 輸入体外診断試薬修正登録の実用的ガイダンス
  • 輸入体外診断試薬更新登録の実用的ガイダンス

付録

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目次
Product Code: ACMC201409028

China's regulatory framework for in-vitro diagnostic reagents is undergoing earthshaking changes. The country's new leaders have recognized that the regulations for supervision and administration of in-vitro diagnostic reagents are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” on February 12, 2014, and it has come into force as June 1, 2014. Before long, China Food and Drug Administration issued a series of the latest regulations on in-vitro diagnostic reagents on July 30, 2014 respectively, and they will come into force as October 1, 2014. The overseas in-vitro diagnostic reagents exporting into China market will be subject to administration of overall new regulations on in-vitro diagnostic reagent registration since October 1, 2014.

China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth as well as an ageing population, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, in-vitro diagnostic reagents represented dynamical growth since 2007. By 2013, total value of in-vitro diagnostic reagents on Chinese healthcare market has reached 3.5 billion US dollars, an increase of 22.9% over 2012 level. It is estimated that Chinese in-vitro diagnostic reagent market is likely to be more than 5.5 billion US dollars until 2015, and it is one of segment market of the most growth potentiality. The Chinese in-vitro diagnostic reagent market is attracting more and more in-vitro diagnostic reagents produced by overseas and multinational manufacturers to penetrate such market.

However, China's radical change of regulatory framework for in-vitro diagnostic reagents will bring overseas and multinational in-vitro diagnostic reagent manufacturers the maximum challenges and opportunities. How do you in compliance with the latest Chinese regulations on in-vitro diagnostic reagents How do you operate business smoothly in China To enter such a lucrative in-vitro diagnostic reagent market, overseas and multinational in-vitro diagnostic reagent manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on in-vitro diagnostic reagent registration. Otherwise, the restrictive legal requirements and approval delays eat up your time and energy to achieve a successful entry into such a lucrative in-vitro diagnostic reagent market, and cause trouble for your business smoothly in China.

Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations for imported in-vitro diagnostic reagent 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 in-vitro diagnostic reagent market.

Report Highlights

  • An analysis and research for radical change of Chinese regulations on in-vitro diagnostic reagents.
  • An overview of the latest Chinese applicable regulations for for in-vitro diagnostic reagent registration.
  • An overview of organizational structure of Chinese regulatory authorities for imported overseas in-vitro diagnostic reagent registration and recordation to give the direction of gateway for imported overseas in-vitro diagnostic reagent registration.
  • The Chinese general regulations for imported overseas in-vitro diagnostic reagent registration to let overseas in-vitro diagnostic reagent manufacturer understand the unique Chinese approach for in-vitro diagnostic reagent registration and lay the knowledge foundation for the practical operation.
  • The detailed Chinese classification and naming principles for in-vitro diagnostic reagents.
  • The Chinese unique requirements for clinical trials of in-vitro diagnostic reagents, from the basic principles of clinical trials, the clinical trial design, scheme and methods, the sample size of clinical trial, to the clinical trial report and protocol.
  • The requirements for compilation of instruction of in--vitro diagnostic reagent registration in China.
  • The practical guidance for application of imported overseas in-vitro diagnostic reagent 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.
  • The practical guidance for application and approval of imported overseas in-vitro diagnostic reagent registration, also from how to compile application documents, how to compile the product technical requirements, how to apply for approval of imported overseas in-vitro diagnostic reagent registration to how to submit application documents to smoothly navigate complex regulatory requirements step by step.
  • The practical guidance for alteration registration and renewal registration of imported overseas in-vitro diagnostic reagents, also from how to compile application documents to how to submit application documents step by step.
  • A complete set of full text in English of the latest Chinese regulations for imported overseas in-vitro diagnostic reagent registration, which cover “Regulations for the Supervision and Administration of Medical Devices”, “Measures for the Administration of In Vitro Diagnostic Reagent Registration”, “Rules for Medical Device Classification”, “Technical Guidance Principles for Clinical Trials of In--vitro Diagnostic Reagents” and “Guidance Principles for Compilation of Instruction of In--vitro Diagnostic Reagents ”.

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

Table of Contents

Contents

Chapter 1 - Executive Summary

Chapter 2 - Analysis and Research for Radical Change of Chinese Regulations on In Vitro Diagnostic Reagents

  • 2.1. What the Chinese regulations on in-vitro diagnostic reagents are undergoing earthshaking changes
  • 2.2. What is the reason to drive Chinese regulations on in-vitro diagnostic reagents radical change

Chapter 3 - Latest Chinese Applicable Regulations for In-vitro Diagnostic Reagent Registration

Chapter 4 - An Overview of Chinese Regulatory Authorities for Imported In-vitro Diagnostic Reagent 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

Chapter 5 - General Regulations for Imported In-vitro Diagnostic Reagent Registration

  • 5.1. Definitions
  • 5.2. Classified Administration for Registration and Recordation of In-vitro Diagnostic Reagents
  • 5.3. What in-vitro diagnostic reagents may be exported into China
  • 5.4. Regulations on Applicant or Filer for Imported In-vitro Diagnostic Reagent Registration or Recordation
  • 5.5. Product Technical Requirements
  • 5.6. Registration Tests
  • 5.7. Clinical Evaluation

Chapter 6 - Classification and Naming Principles for In-vitro Diagnostic Reagents

  • 6.1. Classification for In-vitro Diagnostic Reagents
    • Table 6.1. Judgment Table for Medical Device Classification
  • 6.2. Naming Principles for In-vitro Diagnostic Reagents

Chapter 7 - Clinical Trials of In-vitro Diagnostic Reagents

  • 7.1. Basic Principles of Clinical Trials
    • 7.1.1. Basic Requirements
    • 7.1.2. Requirements for Clinical Trial Institutions and Personnel
  • 7.2. Principles of Clinical Trial Design
    • 7.2.1. Clinical Trial Scheme
    • 7.2.2. Clinical Trial Methods
      • 7.2.2.1. The Clinical Trial Methods for New Diagnostic Reagent Products
      • 7.2.2.2. The Clinical Trial Methods for Products that Same Species Approved to be sold on Market
      • 7.2.2.3. The Clinical Trial Methods for Products of Change Application and Approval for Registration
      • 7.2.2.4. The Clinical Trial Methods for Imported In-vitro Diagnostic Reagent Registration
    • 7.2.3. Sample Size of Clinical Trial
      • 7.2.3.1. General Requirements
      • 7.2.3.2. Special Requirements
    • 7.2.4. Requirements for Signature and Seal of Clinical Trial Scheme
  • 7.3. Clinical Trial Report
  • 7.4. Clinical Trial Protocol

Chapter 8 - Compilation of Instruction of In--vitro Diagnostic Reagent Registration

Chapter 9 - Application for Imported In--vitro Diagnostic Reagent Recordation

Chapter 10 - Application and Approval for Imported In--vitro Diagnostic Reagent Registration

  • 10.1. Application and Approval for Imported In--vitro Diagnostic Reagent Registration
  • 10.2. Matters of In-vitro Diagnostic Reagent Registration
  • 10.3. Administrative Reconsideration
  • 10.4. Medical Device Registration Certificate and its Valid Time Limitation

Chapter 11 - Application and Approval for Alteration Registration of Imported In-vitro Diagnostic Reagents

Chapter 12 - Application and Approval for Renewal Registration of Imported In-vitro Diagnostic Reagents

Chapter 13 - Supervision and Administration for Application and Approval of Imported In-vitro Diagnostic Reagent Registration and Recordation

Chapter 14 - Practical Guidance for Application of Imported In-vitro Diagnostic Reagent Recordation

  • 14.1. Application for Imported In-vitro Diagnostic Reagent Recordation
    • 14.1.1. Recordation Form of Class I Medical Device.81
      • Table 14.1.1. Recordation Form of Class I Medical Device
    • 14.1.2. List of Recordation Documents and Requirements for Recordation Documents
    • 14.1.3. Requirements for Formal Examination of Recordation Form and Documents
    • 14.1.4. Operation Practices for Formal Examination of Recordation Documents
    • 14.1.5. Recordation Certificate
      • Table 14.1.5 Recordation Certificate
  • 14.2. Application for Alteration Recordation of Imported In-vitro Diagnostic Reagent
    • 14.2.1. Form of Recordation Information
      • Table 14.2.1. Form of Recordation Information of Class I In-vitro Diagnostic Reagent
    • 14.2.2. List of Alteration Recordation Documents and Requirements for Alteration Recordation Documents..96
    • 14.2.3. Operation Practices for Formal Examination of Alteration Recordation Information

Chapter 15 - Practical Guidance for Application and Approval of Imported In-vitro Diagnostic Reagent Registration

  • 15.1. Application Form for Registration of Imported In-vitro Diagnostic Reagent
    • Table 15.1. Application Form for Registration of Imported In-vitro Diagnostic Reagent
  • 15.2. List of Application Registration Documents and Requirements for Application Registration Documents
    • Table 15.2. The application documents for the initial application of imported in-vitro diagnostic reagent registration
  • 15.3. How to Compile the Product Technical Requirements.114
    • Table 15.3. Format Requirements for Product Technical Requirements of Medical Devices
  • 15.4. Submission of Application Documents
  • 15.5. Medical Device Registration Certificate (for In-vitro Diagnostic Reagent )
    • Table 15.5. Medical Device Registration Certificate (for In-vitro Diagnostic Reagent)

Chapter 16 - Practical Guidance for Alteration Registration and Renewal Registration of Imported In vitro Diagnostic Reagent

  • 16.1. Practical Guidance for Alteration Registration of Imported In vitro Diagnostic Reagent
    • 16.1.1. List of Alteration Registration Documents and Requirements for Alteration Registration Documents for Alteration of Registration Matters
    • 16.1.2 List of Alteration Registration Documents and Requirements for Alteration Registration Documents for Alteration of License Matters
    • 16.1.3. Alteration Document of Medical Device Registration (for In-vitro Diagnostic Reagent)
      • Table 16.1.3. Alteration Document of Medical Device Registration (for In- vitro Diagnostic Reagent)
  • 16.2. Practical Guidance for Renewal Registration of Imported In -vitro Diagnostic Reagent

Chapter 17 - Appendices

  • Appendix 1 Regulations for the Supervision and Administration of Medical Devices (2014 Edition)
  • Appendix 2 Measures for the Administration of In Vitro Diagnostic Reagent Registration (2014 Edition)
  • Appendix 3 Rules for Medical Device Classification (2014)
  • Appendix 4 Technical Guidance Principles for Clinical Trials of In--vitro Diagnostic Reagents (2014 Edition)
  • Appendix 5 Guidance Principles for Compilation of Instruction of In--vitro Diagnostic Reagents (2014 Edition)
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