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市場調查報告書

中國的進口體外診斷用試劑之登記申請·核準的最新指南:法規到實行

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

出版商 Access China Management Consulting 商品編碼 231402
出版日期 內容資訊 英文 208 Pages
商品交期: 最快1-2個工作天內
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中國的進口體外診斷用試劑之登記申請·核準的最新指南:法規到實行 Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)
出版日期: 2014年09月28日 內容資訊: 英文 208 Pages
簡介

中國是全球最急速成長的經濟國之一,是全球最大規模的醫療市場之一。由於持續性的經濟發展、人口增加,以及人口高齡化,中國的醫療市場自1990年以後便維持16%的年平均成長率。體外診斷試劑在2007年以後展現出強力成長。在2013年中國的醫療市場上體外診斷劑的總額達到35億美元,和2012年水準相比成長了22.9%。中國體外診斷試劑市場是蘊藏最大成長潛力的市場之一,預測到2015年將超越55億美金。

本報告提供中國的進口體外診斷用試劑之登記申請·核准相關法律·規定的詳細指南,彙整法規當局的國家食品藥品監督管理總局(CFDA)概要,義務及組織結構,進口醫療設備相關法律·規定的最新組成架構,登記申請·核準的一般法規,體外診斷用試劑分類,登記所需之臨床試驗指導等相關資料,為您概述為以下內容。

第1章 摘要整理

第2章 中國的體外診斷劑相關法規的根本變化相關分析·調查

第3章 中國最新的體外診斷劑登記法規

第4章 中國進口體外診斷劑登記法規當局概要

  • CFDA(國家食品藥品監督管理整體局)的主要責任
  • CFDA的組織結構

第5章 進口體外診斷劑登記的一般法規

  • 定義
  • 分類
  • 中國出口的預定體外診斷劑
  • 進口體外診斷劑登記或記錄申請者以及提交者相關法規
  • 產品的技術必要條件
  • 登記實驗
  • 臨床評估

第6章 體外診斷劑的分類·命名指南

  • 分類
  • 命名指南

第7章 體外診斷劑臨床實驗

  • 臨床實驗的基本原則
  • 臨床實驗設計的原則
  • 臨床實驗報告
  • 臨床實驗通訊協定

第8章 體外診斷劑登記指示資料

第9章 進口體外診斷劑記錄的申請

第10章 進口體外診斷劑登記的申請·核准

  • 進口體外診斷劑登記的申請·核准
  • 進口體外診斷劑登記事項
  • 管理上檢討事項
  • 醫療設備登記認證和那個有效期限制

第11章 進口體外診斷劑修正登記的申請·核准

第12章 進口體外診斷劑更新登記的申請·核准

第13章 進口體外診斷劑更新登記·記錄的申請·核準的監督·管理

第14章 進口體外診斷劑記錄申請的實用的指導

  • 進口體外診斷劑記錄的申請
  • 進口體外診斷劑記錄的修訂記錄申請

第15章 進口體外診斷劑登記的申請·核準的實用的指導

  • 進口體外診斷劑登記的申請表格
  • 申請登記文件的清單及登記文件申請的必要條件
  • 產品的技術必要條件的編輯法
  • 申請文件的繳交
  • 醫療設備登記認證

第16章 進口體外診斷劑的修正·更新登記的實用的指導

  • 進口體外診斷劑修正登記的實用指南
  • 進口體外診斷劑更新登記的實用指南

附錄

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目錄
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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