關於中國的輸入醫療機器登錄申請・承認的導引書 是由出版商Access China Management Consulting在2012年01月所出版的。
這份英文市場調查報告書包含154 Pages 價格從美金750起跳。
中國醫療機器市場預計在今後數年內會超越日本、成為僅次於美國的世界第2大市場。
本報告書提供中國的輸入醫療機器之登錄申請・認證相關的法律・法規的詳細導引書，包含法規當局的國家食品藥品監督管理局(SFDA)概要、義務以及組織構造、輸入醫療機器相關的法律・法規的最新框架、登錄申請・認證的一般性規範、醫療機器分類、登錄用的臨床實驗指導，概述如下。
第1章 總綱
第2章 中國國內醫療機器法規當局概要：國家食品藥品監督管理局(SFDA)
第3章 中國國內輸入醫療機器登錄的法律・法規
第4章 輸入醫療機器登錄申請・認證的一般性法規
- 定義
- 醫療機器法規當局
- 醫療機器登錄・管理分類
- 醫療機器登錄証明書與其有效期限
- 輸入醫療機器的登錄申請・認證
第5章 輸入醫療機器的登錄申請・認證的所有程序
- 等級Ⅱ或者等級Ⅲ的輸入醫療機器最初的登錄申請・認證程序
- 等級Ⅰ輸入醫療機器的最初登錄申請・認證程序
- 等級Ⅱ或者等級Ⅲ輸入醫療機器的登錄申請・認證程序
- 等級Ⅰ的輸入醫療機器的登錄申請・認證程序
第6章 醫療機器分類
第7章 醫療機器的臨床實驗
- 輸入醫療機器的登錄用臨床實験要件
- 權利的保証以及被驗者的關心
- 臨床實験協定
- 臨床實験的實施
- 醫療機關以及臨床實験要員
- 臨床實験報告書
- 醫療機器用臨床實験協定的格式
- 醫療機器用臨床實験報告書的格式
第8章 輸入醫療機器的登錄申請・認證用文書
- 醫療機器登錄記錄表格
- 輸入醫療機器的最初登錄用申請文件相關要件
- 輸入醫療機器的再登錄用申請文件相關要件
- 在外國沒有販售許可的等級Ⅰ輸入醫療機器的最初登錄用申請文件相關的要件
- 在外國沒有販售許可的等級Ⅱ或者等級Ⅲ的輸入醫療機器的最初登錄用申請文件相關要件
- 醫療機器登錄許可申請文件的改善相關要件
- 醫療機器登錄許可再保証的申請文件相關要件
- 醫療機器登錄用的臨床實験文件明細書相關規定
第9章 結論
第10章 附錄
Abstract
In 2009, the Chinese government vigorously launched “China's Health-Care
Reform”, developed an ambitious blueprint, in which health care system
will cover about 1.2 billion people by 2011. Medical devices have been widely
used in the process of disease prevention, diagnosis, therapy, care and
rehabilitation. It is estimated that within the next few years, Chinese
medical device market is likely to be more than 600 billion RMB, and will
surpass Japan to become the second largest medical device market following the
United States. The Chinese medical devices market will attract more and more
medical devices produced by overseas manufacturers and producers to penetrate
such market.
To enter Chinese lucrative medical device market, the first obstacle faced by
overseas medical devices manufacturers and producers is how to file the
application for their imported medical device registration with Chinese
regulatory authorities for medical devices.
In China, the process of application and approval for imported medical device
registration is very complex, because the Chinese regulatory authorities for
medical devices administer and control this process by exorbitant
administrative measures and regulations, moreover, these exorbitant
administrative regulations are variable and lack of transparency. Lack of
knowledge of the Chinese laws and administrative regulations, and the cultural
difference between China and Western countries as well as the language
barriers will increase the challenge faced by overseas medical devices
manufacturers and producers. Therefore, a detailed guidance of practical
operation for application and approval of imported medical device registration
and a comprehensive and thorough knowledge of the latest Chinese laws and
regulations for imported medical device registration have been become an
essential prerequisite for overseas medical devices manufacturers and
producers to achieve a successful application for their products entry into
the Chinese medical device market.
China's Guidebook for Application and Approval of Imported Medical Device
Registration is an essential resource for overseas medical devices
manufacturers and producers to achieve a successful application for their
products entry into the Chinese medical device market, which provides not only
a detailed guidance of practical operation for application and approval of
imported medical device registration but also comprehensive and thorough
knowledge of the latest Chinese laws and regulations for imported medical
device registration to guide overseas medical devices manufacturers and
producers step by step to pass through the entirely legal procedures of
application and approval for imported medical device registration smoothly.
Report Highlights
- An overview of the main responsibilities and organization structure of the
SFDA (The State Food and Drug Administration) that is current Chinese
regulatory authority being responsible for application and approval for
imported medical device registration.
- A framework of latest applicable Chinese laws and regulations for imported
medical device registration to provide a comprehensive and thorough knowledge
of the latest Chinese laws and regulations for imported medical device
registration.
- The general regulations for application and approval of imported medical
device registration to provide a guidance of practical operation for
application and approval of imported medical device registration.
- An overview of entire process of application and approval for imported
medical device registration, including the procedures of the initial
application and approval for imported medical device registration, the
application and approval for imported medical devices re-registration.
- The Chinese medical devices classification, including the guidelines and
principles, and the criteria for medical devices classification.
- The guidance of clinical trials for imported medical device registration.
- The requirements for documents of application and approval for imported
medical device registration to guide you prepare complex documents for
application and approval for imported medical device registration.
- The significant suggestions for overseas medical devices manufacturers and
producers looking to achieve a successful application for their medical device
registration in China.
- The English versions of full latest Chinese administrative regulations and
departmental regulations and provisions for medical device registration to
facilitate overseas medical devices manufacturers and producers to acquire a
comprehensive knowledge of latest applicable Chinese regulations for imported
medical device registration, including the Regulations for the Supervision and
Administration of Medical Devices, the Measures for the Administration of
Medical Device Registration, the Regulations on the Administration of the
Manuals, Labels and Packing Marks of Medical Devices, the Provisions for
Clinical Trials of Medical Devices, and the Provisions for Medical Device
Classification.
Who should buy this report?
- Senior executive officers engaging in regulatory and registration affairs
for medical device registration in China.
- Non-Chinese Companies wishing to enter a lucrative medical device market
in China.
- Non-Chinese Companies interested in understanding the latest Chinese
regulations on application and approval for imported medical device
registration.
- Non-Chinese medical devices manufacturers and producers.
About Access China
Access China is a professional provider of managements and consulting services
specifically designed to provide overseas clients a virtual gateway to enter
the lucrative market of China.
Table of Contents
Preface
Table of Contents
Chapter 1 - Executive Summary
Chapter 2 - An Overview of Chinese Regulatory Authorities for Medical Devices -- State Food and Drug Administration (SFDA)
- 2.1. SFDA's Main Responsibilities
- 2.2. SFDA's Organization Structure
- Figure 2.2. SFDA's Organization Structure
- Table 2.2. SFDA's Affiliated Organizations
Chapter 3 - Chinese Laws and Regulations for Imported Medical Device Registration
- 3.1. Chinese Legislation
- 3.2. Latest Applicable Administrative Regulations, and Departmental
Regulations, Provisions, Measures, and Guidance
Chapter 4 - General Regulations for Application and Approval of Imported Medical Device Registration
- 4.1. Definitions
- 4.2. Regulatory Authorities for Medical Devices
- 4.3. Classified Registration and Administration of Medical Devices
- 4.4. Medical Device Registration Certificate and its Valid Time Limitation
- 4.5.Application and Approval for Imported Medical Device Registration
- 4.5.1. Application and Approval for Initial Registration
- 4.5.2. Application and Approval for Re-registration
- 4.5.3. Modification and Re-issuance of Medical Device Registration
Certificate
Chapter 5 - Entire Process of Application and Approval for Imported Medical Device Registration
- 5.1. Process of Initial Application and Approval for Class II or III
Imported Medical Device Registration
- Figure 5.1. Process of Initial Application and Approval for Class II or
III Imported Medical Device Registration
- 5.2. Process of initial Application and Approval for Class I Imported
Medical Device Registration
- Figure 5.2. Process of initial Application and Approval for Class I
Imported Medical Device Registration
- 5.3. Process of Application and Approval for Class II or III Imported
Medical Device Re-registration
- Figure 5.3. Process of Application and Approval for Class II or III
Imported Medical Device Re-registration
- 5.4. Process of Application and Approval for Class I Imported Medical
Device Re-registration
- Figure 5.4. Process of Application and Approval for Class I Imported
Medical Device Re-registration
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. Criteria for Medical Device Classification
- Table 6.2 Criteria for Medical Device Classification
Chapter 7 - Clinical Trials of Medical Devices
- 7.1. Clinical Trial Requirements for Imported Medical Device Registration
- 7.2. Assurance of Rights and Interests of Human Subjects
- 7.3. Clinical Trials Protocol
- 7.4. Implementation of Clinical Trials
- 7.5. Medical Institutions and Personnel of Clinical Trials
- 7.6. Clinical Trials Report
- 7.7. Format of Clinical Trials Protocol for Medical Devices
- 7.8. Format of Clinical Trials Report for Medical Devices
Chapter 8 - Documents for Application and Approval of Imported Medical Device Registration
- 8.1. Form of Medical Device Registration Record
- 8.2. Requirements on Application Documents for the Initial Registration of
Imported Medical Devices.
- 8.3. Requirements on Application Documents for the Re-registration of
Imported Medical Devices
- 8.4. Requirements on Application Documents for the Initial Registration of
Class I Imported Medical Devices without Foreign Sales License for Medical
Devices
- 8.5. Requirements on Application Documents for the Initial Registration of
Class II and III Imported Medical Devices without Foreign Sales License for
Medical Devices
- 8.6. Requirements on Application Documents for the Modification of Medical
Device Registration Certificate
- 8.7. Requirements on Application Documents for the Re-issuance of Medical
Device Registration Certificate
- 8.8. Provisions on Itemization of Clinical Trial Documents for Medical
Device Registration
- Table 8.8. Provisions on Itemization of Clinical Trial Documents for
Medical Device Registration
Chapter 9 - Conclusion
Chapter 10 - Appendices
Appendix 1. Regulations for the Supervision and Administration of
Medical Devices
Appendix 2. Measures for the Administration of Medical Device
Registration
Appendix 3. Regulations on the Administration of the Manuals, Labels
and Packing Marks of Medical Devices
Appendix 4. Provisions for Clinical Trials of Medical Devices
Appendix 5. Provisions for Medical Device Classification
