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市場調查報告書

從中國醫療設備臨床評估·臨床實驗實施相關最新旅遊指南:法規到實行

Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition)

出版商 Access China Management Consulting 商品編碼 316345
出版日期 內容資訊 英文 199 Pages
商品交期: 最快1-2個工作天內
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從中國醫療設備臨床評估·臨床實驗實施相關最新旅遊指南:法規到實行 Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition)
出版日期: 2014年10月15日 內容資訊: 英文 199 Pages
簡介

中國的醫療市場自1990年代以後便一直維持16%的年平均成長率。到2013年中國的醫療市場上醫療器具總額達到了1,790億人民幣(約290億美金)。外國進口及跨國醫療器具廠商的醫療器具約構成中國醫療器具市場半數。中國醫療器具市場預測到2015年將達到約3,400億人民幣(約570億美金)以上,預測美國將超越日本成為僅次於中國的全球第二大醫療設備市場。

本報告提供中國的進口醫療設備臨床評估·臨床實驗實施相關法律·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·核準的一般性法規,醫療設備的分類,登記的臨床試驗指導等資料,為您概述為以下內容。

第1章 摘要整理

第2章 中國醫療設備登記臨床評估·臨床實驗的最新適用法規

第3章 中國醫療設備法規相關的急進性改革:全面性比較分析

  • 中國的進口醫療設備登記相關法規的急進性改革
  • 海外的醫療設備進口醫療設備登記的臨床評估或臨床實驗的實行所需步驟

第4章 中國的進口醫療設備登記臨床評估·臨床實驗法規當局概要

  • CDFA的主要責任
  • CDFA的主要結構

第5章 進口醫療設備登記臨床評估·臨床實驗之前的預備知識

  • 定義
  • 醫療設備的登記·記錄之管理分類
  • 中國進口的醫療設備
  • 進口醫療設備登記·記錄的申請者或申報者相關法規
  • 產品的技術要件
  • 登記實驗
  • 臨床評估

第6章 醫療設備的分類

  • 醫療設備分類的指南
  • 醫療設備分類的分類表

第7章 進口醫療設備臨床實驗的實驗對象權利及所有相關人員的責任

  • 實驗對象的權利·利益
  • 臨床實驗實施者的責任
  • 臨床實驗機關·人物的責任

第8章 進口醫療設備登記臨床評估·臨床實驗

第9章 進口醫療設備登記臨床實驗申請的實用性指導

  • 醫療設備臨床實驗核準的申請書
  • 醫療設備臨床實驗核準的申請文件要件
  • 產品的技術要件的編輯法
  • 醫療設備臨床實驗的通知
  • 臨床實驗協定及醫療設備臨床實驗協定的格式
  • 中國領土內臨床實驗實行·核准所需的醫療設備數
  • 申請文件的繳交
  • 醫療設備臨床實驗的認證文件

第10章 進口醫療設備登記臨床評估的實用性指導

  • 免臨床實驗醫療設備目錄所刊載的產品臨床評估要件
  • 具有同種類醫療設備臨床資料比較的臨床評估實施之一般要件
  • 透過臨床實驗的臨床評估要件
  • 進口醫療設備登記臨床評估實施的實用性指導

第11章 附錄

目錄
Product Code: ACMC20141009

China's regulatory framework for medical devices is undergoing radical changes. The country's new leaders have recognized that the regulations for supervision and administration of medical devices 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, which has come into force as of June 1, 2014. Before long, China Food and Drug Administration (hereafter called as CFDA) issued the latest "Measures for the Administration of Medical Device Registration", which has come into force as of October 1, 2014.The overseas medical devices exporting into China market are subject to administration of overall new regulations on medical device registration since October 1, 2014.

In 2009, the Chinese government vigorously launched "China's Health-Care Reform", developed an ambitious blueprint, in which health care system covered about 1.2 billion people by 2011. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2013, total value of medical devices on Chinese healthcare market has reached 179 billion RMB (about 29 billion US dollars). Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. On the Chinese medical device market, imported medical devices made by overseas and multinational medical device manufacturers account for about a half, in which the high-tech and high-valued medical devices, such as magnetic resonance imaging, CT are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB about 57 billion US dollars) by 2015, and will surpass Japan to become the second largest medical device market behind the United States. The Chinese medical device market is one of segment market of the most growth potentiality, which is attracting more and more overseas medical device manufacturers and producers to penetrate such market.

China's radical change of regulatory framework for medical devices brings overseas and multinational medical device manufacturers the maximum challenges and opportunities. Those overseas 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 have been intercepted outside the door of Chinese clinical trial market not only, and be blocked outside the door of Chinese medical device market also. Nonetheless, Chinese authorities relaxed the admittance license of overseas medical devices. The overseas medical device manufacturer exporting Class I medical devices into China only need to file the archives and the certificate of marketing authorization of the government authorities of the country or region of origin to the CFDA for recordation. The overseas medical device manufacturer exporting Class II and Class III medical devices into China should be subject to be examined and approved by the CFDA. The Chinese authorities will strengthen the supervision and administration for medical devices, including their registration, production, distribution and use. How do you in compliance with the latest Chinese regulations on medical devices How do you operate business smoothly in China How do you conduct the clinical evaluation and clinical trial for your products exporting into the Chinese market

The Chinese concept of clinical evaluation and clinical trial for medical device registration is unique, which is distinct from the clinical trial in U.S. and EU countries.

In China, the process of application and approval for clinical evaluation and clinical trial of imported medical device registration is very complex, because the Chinese medical device authorities administer and control this process by exorbitant administrative measures and regulations, even the guidances. Moreover, these exorbitant administrative measures and regulations, and the guidances are variable and lack of transparency. In addition, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas and multinational medical device manufacturers and producers.

To enter such a lucrative medical device market, overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device clinical evaluation and clinical trial. Otherwise, the restrictive legal requirements and approval delays eat up your development time and budget.

Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical evaluation and clinical trial for imported medical device registration but also introduced the practical operation how to comply with the Chinese GCP to guide you use the Chinese trial venues to keep medical device development lean and 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 introduces the framework of the latest Chinese applicable regulations for clinical evaluation and clinical trial of medical device registration to provide a comprehensive and thorough knowledge of the latest Chinese regulations for clinical evaluation and clinical trial of medical device registration. Chapter 3 provides a comprehensive comparative analysis to tell overseas medical device manufacturer what Chinese regulations on medical device registration are undergoing radical changes, from what Chinese regulations on imported medical device registration are undergoing radical changes to what overseas medical devices need to conduct the clinical evaluation or clinical trial for imported 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 clinical evaluation and clinical trial of imported medical device registration to give the direction of gateway for application for approval of clinical trial of imported overseas medical device registration. Chapter 5 elaborates the knowledge preparation before consucting the clinical evaluation and clinical trial for imported 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 unique Chinese regulations for clinical evaluation and clinical trial of imported medical device registration to help overseas medical device manufacturers to remove their confusion. Chapter 9 provides the practical guidance for applying for clinical trials of imported overseas medical device registration, from what imported overseas medical devices need to conduct clinical trial and approval within chinese territory, how to apply for clinical trial of imported overseas medical device registration, how to compile the product technical requirements, how to compile application documents to how to acquire the approval document for clinical trial of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step. Chapter 10 provides the practical guidance for conducting clinical evaluation of imported overseas medical device registration, also from what imported overseas medical devices need to conduct clinical evaluation of imported overseas medical device registration, what requirements are for conducting clinical evaluation of imported overseas medical device registration, how to conduct the clinical evaluation of imported overseas medical device registration to how to compile application documents to smoothly navigate complex regulatory requirements step by step. Chapter 11 Appendices provide a complete set of full text in English of the latest Chinese applicable regulations for medical device clinical evaluation and clinical trial of imported overseas medical device registration, which include "Regulations for the Supervision and Administration of Medical Devices (2014 Edition)", "Measures for the Administration of Medical Device Registration (2014 Edition)", "Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)", "Rules for Medical Device Classification (2014 Edition)" , "Provisions for Clinical Trials of Medical Devices" and "Technical Guidance Principles for Clinical Evaluation of Medical Devices".

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 smoothly conduct clinical evaluation and clinical trial for their medical device product registration in China, and how to comply with the Chinese GCP.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of latest Chinese regulations on clinical evaluation and clinical trial for imported overseas medical device registration but also the practical operation how to comply with the Chinese GCP, how to conduct the clinical evaluation and clinical trial for imported overseas medical device registration. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate laws and 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 the clinical evaluation and the clinical trial for their products in China.

Report Highlights

  • An overview of the latest Chinese applicable regulations for clinical evaluation and clinical trial of medical device registration.
  • A comprehensive comparative analysis ---- what Chinese regulations on medical device registration are undergoing radical changes.
  • An overview of organizational structure of Chinese regulatory authorities for clinical evaluation and clinical trial of imported overseas medical devices registration to give the direction of gateway for application for approval of clinical trial for imported overseas medical device registration.
  • The knowledge preparation before consucting the clinical evaluation and clinical trial for 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.
  • The detailed Chinese classification for medical devices.
  • The rights of human subjects and every party's responsibilities in clinical trials for imported overseas medical device registration in China.
  • The unique Chinese regulations for clinical evaluation and clinical trial of imported overseas medical device registration to help overseas medical device manufacturers to remove their confusion.
  • The practical guidance for applying for clinical trials of imported overseas medical device registration, from what imported overseas medical devices need to conduct clinical trial and approval within Chinese territory, how to apply for clinical trial of imported overseas medical device registration, how to compile the product technical requirements, how to compile application documents to how to acquire the approval document for clinical trial of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step.
  • The practical guidance for conducting clinical evaluation of imported overseas medical device registration, also from what imported overseas medical devices need to conduct clinical evaluation of imported overseas medical device registration, what requirements are for conducting clinical evaluation of imported overseas medical device registration, how to conduct the clinical evaluation of imported overseas medical device registration to how to compile application documents to smoothly navigate complex regulatory requirements step by step.
  • A complete set of full text in English of the latest Chinese applicable regulations for medical device clinical evaluation and clinical trial of imported overseas medical device registration, which include "Regulations for the Supervision and Administration of Medical Devices (2014 Edition)", "Measures for the Administration of Medical Device Registration (2014 Edition)", "Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)", "Rules for Medical Device Classification (2014 Edition)" , "Provisions for Clinical Trials of Medical Devices" and "Technical Guidance Principles for Clinical Evaluation of Medical Devices".

Who should buy this report

  • Overseas medical device manufacturers wishing to enter into the Chinese medical device market.
  • Multinational medical device manufacturers have penetrated into the Chinese medical device market.
  • Companies interested in understanding the latest Chinese regulations for clinical evaluation and clinical trial of imported overseas medical device registration.
  • Senior executive officers engaging in regulatory affairs for clinical evaluation and clinical trial of exporting overseas medical device into Chinese lucrative medical device market.
  • Senior executive officers engaging in applying for approval of exporting overseas medical device registration in China.

Table of Contents

Contents

Chapter 1 Executive Summary

Chapter 2 Latest Chinese Applicable Regulations for Clinical Evaluation and Clinical Trial of Medical Device Registration

Chapter 3 What Chinese Regulations on Medical Device Registration are Undergoing Radical Changes ---- A Comprehensive Comparative Analysis

  • 3.1. What Chinese Regulations on Imported Medical Device Registration are Undergoing Radical Changes
  • 3.2. What Overseas Medical Devices Need to Conduct the Clinical Evaluation or Clinical Trial for Imported Medical Device Registration 16

Chapter 4 An Overview of Chinese Regulatory Authorities for Clinical Evaluation and Clinical Trial of 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

Chapter 5 Knowledge Preparation before Conducting Clinical Evaluation and Clinical Trial for 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 Clinical Trial Institutions and Personnel of Clinical Trials

Chapter 8 Clinical Evaluation and Clinical Trial of Imported Medical Device Registration

Chapter 9 Practical Guidance for Applying for Clinical Trials of Imported Medical Device Registration

  • 9.1. Application Form for Approval of Medical Device Clinical Trial
    • Table 9.1. Application Form for Approval of Medical Device Clinical Trial
  • 9.2. Requirements for Application Documents for Approval of Medical Device Clinical Trial
  • 9.3. How to Compile the Product Technical Requirements
    • Table 9.3. Format of Product Technical Requirements of Medical Devices
  • 9.4. Notice of Medical Device Clinical Trials
  • 9.5. Clinical Trials Protocol and Format of Clinical Trial Protocol for Medical Devices
    • Table 9.5. Format of Clinical Trial Protocol for Medical Devices
  • 9.6. How Many of Medical Devices need to Conduct Clinical Trial and Approval within Chinese territory
    • Table 9.6. Catalogue of Class III Medical Devices Need to Clinical Trial Approval
  • 9.7. Submission of Application Documents
  • 9.8. Approval Document for Medical Device Clinical Trial
    • Table 9.8. Approval Document for Medical Device Clinical Trial

Chapter 10 Practical Guidance for Conducting Clinical Evaluation of Imported Medical Device Registration

  • 10.1. Requirements for Clinical Evaluation of Product listed into the Catalogue of Exempted Clinical Trial Medical Devices
  • 10.2. General Requirements for Conducting Clinical Evaluation by Comparation of Clinical Data of Medical Device with Same Varieties
    • 10.2.1. Basic Principles
    • 10.2.2. Comparison and Judgment of Clinical Data of Medical Device with Same Varieties
    • 10.2.3. Path of Evaluation
    • 10.2.4. Collection of Clinical Data for Medical Devices of Same Varieties
    • 10.2.5. Clinical Evaluation based on Clinical Data of Medical Devices of Same Varieties
  • 10.3. Requirements for Clinical Evaluation by Conducting Clinical Trials
  • 10.4. Practical Guidance for Conducting Clinical Evaluation of Imported Medical Device Registration
    • 10.4.1. Clinical Evaluation of Contrasting Product Applying for Registration with Products listed into the Catalogue of Exempted Clinical Trial Medical Devices 91
      • Table 10.4.1. Contrast Table of Content between the product applying for registration and the product listed into the Catalogue of Exempted Clinical Trial Medical Devices.92
    • 10.4.2. Clinical Evaluation based on Clinical Data of Medical Devices with Same Varieties
      • Table 10.4.2.1.Contrast Items and Conclusion Requirements for the product applying for registration comparing with the products of same varieties
      • Table 10.4.2.2. Contrast Content between the product applying for registration and the products of same varieties
      • Table 10.4.2.4. Path of Clinical Evaluation based on Clinical Data of Medical Devices with Same Varieties
      • Annex 10.4.2.5. Proposed Essential Factors for Retrieve and Screen of Literatures
      • Figure 10.4.2.5.Proposed Screening Process of Literatures
      • Table 10.4.2.6. Scheme of Retrieve and Screen of Literatures
      • Table 10.4.2.7. Report of Retrieve and Screen of Literatures
      • Table 10.4.2.8. Content and Format of Clinical Evaluation Report based on Clinical Data of Medical Devices of Same Varieties

Chapter 11 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 Rules for Medical Device Classification (2014 Edition)
  • Appendix 5 Provisions for Clinical Trials of Medical Devices
  • Appendix 6 Technical Guidance Principles for Clinical Evaluation of Medical Devices
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