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市場調查報告書

中國進口醫療設備的申請·登記的申請資料準備指南

Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition)

出版商 Access China Management Consulting 商品編碼 318568
出版日期 內容資訊 英文 190 Pages
商品交期: 最快1-2個工作天內
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中國進口醫療設備的申請·登記的申請資料準備指南 Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition)
出版日期: 2014年11月15日 內容資訊: 英文 190 Pages
簡介

中國的醫療設備市場是蘊藏了最大成長潛力的市場之一,海外有愈來愈多醫療設備廠商計劃打入該市場。推算該國醫療設備市場到2015年為止將成長到3,400億人民幣(約570億美元)的規模,預測將超越日本成為僅次於美國的全球第二大醫療設備市場。

本報告提供中國進口醫療設備的申請·登記手續相關之總括性調查,為您彙整申請資料·申請文件的種類和各種要件,手續的階段與流程順序,中國國內臨床試驗的相關指南,最近的法令修改狀況等詳細內容。

第1章 摘要整理

第2章 大幅度修改的醫療設備相關法律:總括性比較分析

  • 大幅度修改的法律規章
  • 醫療設備登記上有重大變更的法律規章
  • 進口醫療設備申請·登記的申請資料的最新要件

第3章 適用醫療設備的申請·登記之最新法律規章

第4章 在準備進口醫療設備的申請·登記資料時應該預先知道的事

  • 定義
  • 醫療設備的申請·登記的事務
  • 中國出口的醫療設備
  • 進口醫療設備的申請·登記的申請·申報人相關法規
  • 產品的技術要件
  • 登記檢驗
  • 臨床評估

第5章 應該準備的進口醫療設備登記申請資料

第6章 進口醫療設備的登記申請資料所需的要件

  • I級醫療設備的登記格式
  • 申請·登記申請資料清單
    • 登記申請資料的內容相關要件
    • 登記格式·登記申請資料的正式審查要件
    • 登記申請資料正式審查的實際運用
    • 登記認證

第7章 進口醫療設備應該準備的登記申請資料

第8章 進口醫療設備的登記申請資料所需的要件

  • 進口醫療設備的登記用申請文件
  • 證明文件
  • 醫療設備產品的安全性·有效性相關的基礎要件清單
  • 資料摘要
    • 摘要
    • 產品概要
    • 模式·規格
    • 包裝的翻譯
    • 適應患者·禁忌症等
  • 調查資料
    • 產品性能
    • 生物適合性的評估資料
    • 生物學的安全性
    • 殺菌·消毒的流程
    • 有效期·包裝
    • 前臨床動物實驗
    • 軟體
    • 其他
  • 製造資訊
    • 被動式醫療設備的製造工程:概要
    • 主動式醫療設備的製造工程:概要
    • 製造網站概要
  • 臨床評估資料
  • 產品風險的分析資料
  • 產品的技術要件
  • 產品登記的試驗報告
  • 產品的手冊等
  • 適合性宣言

第9章 醫療設備產品的安全性·有效性相關基礎要件的清單

第10章 產品的技術要件歸結方法

第11章 登記檢驗的新做法

第12章 醫療設備的指示書·表示標籤彙整方法

第13章 進口醫療設備登記的臨床評估實踐方法

第14章 進口醫療設備登記的臨床試驗實施方法

  • 中國國內臨床試驗的實施和核準所需的醫療設備
  • 為了通過醫療設備臨床試驗認證的申請文件
  • 為了通過醫療設備臨床試驗認證的申請文件要件
  • 臨床試驗機關的選擇方法
  • 臨床試驗的各個締約方之責任定義
  • 醫療設備臨床試驗的通知
  • 臨床試驗的Protocol與格式
  • 申請文件的繳交
  • 醫療設備臨床試驗的認證文件
  • 臨床試驗報告與其格式

第15章 申請資料的繳交與認證流程

  • 登記申請資料的形式要件
  • 登記申請資料的正式審查的實際
  • 認證流程
  • 醫療設備登記認證證和有效期限

第16章 附錄

目錄

Executive Summary

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. 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.

However, China's regulatory framework for medical devices is undergoing radical changes. China'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, and it has come into force as of June 1, 2014. China Food and Drug Administration issued the latest “Measures for the Administration of Medical Device Registration”, and it has come into force as of October 1, 2014. The overseas medical devices exporting into China market should be subject to administration of overall new regulations since October 1, 2014.

The Chinese administration system for medical device registration undergone significant changes. Chinese authorities have begun to strengthen the supervision and administration of its medical device market. To strictly examine and approve the application dossiers for oversea medical device registration in China has become as the key threshold of oversea medical device exporting into China. The Chinese approach to administer medical device registration is unique. The application and approval process, clinical evaluation and clinical trial, the requirements for application dossiers are distinct from in U.S. and EU countries.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 preparation of application dossiers compliance with overall new regulations becomes as the key for oversea medical device entry into 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.

Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition) not only provided a comprehensive and thorough knowledge of the overall new requirements of application dossiers for medical device registration or recordation in China but also provided the guidance of practical operation for how to 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 a comprehensively comparative analysis to introduce what the Chinese regulations on medical device are undergoing radical changes. Chapter 3 introduces the framework of the latest applicable Chinese regulations for medical device registration and recordation to provide a comprehensive and thorough knowledge of the latest Chinese regulations for medical device registration and recordation. Chapter 4 elaborates the knowledge preparation before application of imported overseas medical device registration or recordation to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration or recordation and lay the knowledge foundation for the practical operation. Chapter 5 introduces how many application dossiers for imported oversea medical device recordation should be prepared. Chapter 6 introduces the comprehensive and detailed requirements for application dossiers of imported oversea medical device recordation. Chapter 7 introduces how many application dossiers for imported oversea medical device registration should be prepared. Chapter 8 introduces the comprehensive and detailed requirements for application dossiers of imported oversea medical device registration. Chapter 9 provides a list of basic requirements for safety and effectiveness of medical device product, which is overall new requirements for imported overseas medical device registration in China. Chapter 10 elaborates the compilation of product technical requirements, which are also overall new requirements for imported overseas medical device registration in China. Chapter 11 introduces how to apply for registration test of imported overseas medical device. Chapter 12 elaborates the compilation of the instructions and labels of medical device. Chapter 13 provides the practical guidance for conducting the unique clinical evaluation for imported overseas medical device registration in China to help overseas medical device manufacturers to remove their confusion. Chapter 14 provides the practical guidance for conducting the clinical trials for imported overseas medical device registration in china, from what imported overseas medical devices need to conduct clinical trial and approval within Chinese territory, how to apply for clinical trial of imported medical device registration, how to compile application documents, how to select the clinical trial institutions and define every party's responsibilities in clinical trials to how to acquire the approval document for clinical trial of imported medical device registration to smoothly navigate complex regulatory requirements step by step. Chapter 15 introduces the approval process for imported overseas medical device registration to guide overseas and multinational medical device manufacturers how to submit the application dossiers, ultimately achieve a successful approval for products entry into the Chinese medical device market. Chapter 16 Appendices provide a complete set of full text in English of the latest Chinese regulations on medical devices, which over “Measures for the Administration of Medical Device Registration (2014Edition)”, “Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)” “Rules for Medical Device Classification (2014Edition)”, “Compiling Guidelines of Product Technical Requirements for 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 apply for registration or recordation of their medical device products in China, how to comply with the overall new Chinese regulations for medical device registration or recordation.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the overall new Chinese regulations on imported medical device registration and recordation but also the practical operation how to comply with the overall new requirements of application dossiers for overseas medical device registration and recordation in China. 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 - What Chinese Regulations on Medical Device are Undergoing Radical Changes ---- A Comprehensively Comparative Analysis

  • 2.1. What Chinese Regulations on Medical Device are Undergoing Radical Changes
  • 2.2. What are Chinese Regulations on Medical Device Registration Significant Changes
  • 2.3. What are the Latest Requirements of Application Dossiers for Imported Overseas Medical Device Registration or Recordation in China

Chapter 3 - Latest Chinese Applicable Regulations for Medical Device Registration and Recordation

Chapter 4 - Knowledge Preparation of Preparing Application Dossiers for Imported Oversea Medical Device Registration or Recordation

  • 4.1. Definitions
  • 4.2. Classified Administration for Registration and Recordation of Medical Devices
  • 4.3. What Medical devices may be exported into China
  • 4.4. Regulations on Applicant or Filer for Imported Medical Device Registration or Recordation
  • 4.5. Product Technical Requirements
  • 4.6. Registration Tests
  • 4.7. Clinical Evaluation

Chapter 5 - How Many Application Dossiers for Imported Oversea Medical Device Recordation should be Prepared

  • Table 5: Titles of Application Dossiers for Imported Oversea Medical Device Recordation in China

Chapter 6 - Requirements for Application Dossiers of Imported Oversea Medical Device Recordation

  • 6.1.Recordation Form of Class I Medical Device
    • Table 6.1: Recordation Form of Class I Medical Device
  • 6.2. List of Application Dossiers for Recordation and Requirements for Application Dossiers for Recordation
    • 6.2.1. Requirements of Content for Application Dossiers for Recordation
    • 6.2.2. Requirements for Formal Examination of Recordation From and Application Dossiers for Recordation
    • 6.2.3. Operation Practices for Formal Examination of Application Dossiers for Recordation
    • 6.2.4. Recordation Certificate
      • Table 6.2.4: Recordation Certificate

Chapter 7 - How Many Application Dossiers for Imported Oversea Medical Device Registration should be Prepared

  • Table 7: Titles of Application Dossiers for Imported Oversea Medical Device Registration in China

Chapter 8 - Requirements for Application Dossiers of Imported Oversea Medical Device Registration

  • 8.1.Application Form for Registration of Imported Medical Device.43
    • Table 8.1: Application Form for Registration of Imported Medical Device
  • 8.2. Certificate Documents
  • 8.3. List of basic requirements for safety and effectiveness of medical device Product
  • 8.4. Summary of Data
    • 8.4.1. Summary
    • 8.4.2. Product Description
    • 8.4.3. Model and Specification
    • 8.4.4. Interpretation of Package
    • 8.4.5. Applicable People Group and Contraindications
    • 8.4.6. Situation of Reference Similar Products or Previous Generation Product (if any)
    • 8.4.7. Other content should be noted
  • 8.5. Research Data
    • 8.5.1. Research Data for Product Performance
    • 8.5.2. Evaluation Data of Biocompatibility
    • 8.5.3. Research Data for Biological Safety
    • 8.5.4. Research Data of Production Technical Process for Sterilization and Disinfection
    • 8.5.5. Research Data for Valid Period and Packaging
    • 8.5.6. Research Data for Preclinical Animals
    • 8.5.7. Research Data for Software
    • 8.5.8. Other Data
  • 8.6. Manufacturing Information
    • 8.6.1. An overview of the production process for passive medical device
    • 8.6.2. An overview of the production process for active medical device
    • 8.6.3. Description of Production Site
  • 8.7. Clinical Evaluation Data
  • 8.8. Analysis Data for Product Risk
  • 8.9. Product Technical Requirements.54
  • 8.10. Test Report for Product Registration
  • 8.11. Instruction (manual) of Product and Design sample drafts of label for minimum sale unit
  • 8.12. Declaration of Conformity

Chapter 9 - List of Basic Requirements for Safety and Effectiveness of Medical Device Product

  • Table 9: List of Basic Requirements for Safety and Effectiveness of Medical Device Product

Chapter 10 - How to Compile the Product Technical Requirements

  • 10.1. Basic Requirements
  • 10.2. Content Requirements
  • 10.3. Format Requirements
    • Table 10.3: Format Requirements for Product Technical Requirements of Medical Devices

Chapter 11 - How to Apply for Registration Test

Chapter 12 - How to Compile the Instructions and Labels of Medical Devices

  • 12.1. Definitions
  • 12.2. Requirements of Content.82

Chapter 13 - How to Conduct the Clinical Evaluation for Imported Overseas Medical Device Registration in China

  • 13.1. Practical Guidance for Clinical Evaluation of Contrasting Product Applying for Registration with Products listed into the Catalogue of Exempted Clinical Trial Medical Devices
    • Table 13.1: Contrast Table of Content between the product applying for registration and the product listed into the Catalogue of Exempted Clinical Trial Medical Devices
  • 13.2. Practical Guidance for Clinical Evaluation based on Clinical Data of Medical Devices with Same Varieties
    • Table 13.2.1:Contrast Items and Conclusion Requirements for the product applying for registration comparing with the products of same varieties
    • Table 13.2.2: Contrast Content between the product applying for registration and the products of same varieties
    • Figure 13.2.3: Path of Clinical Evaluation based on Clinical Data of Medical Devices with Same Varieties
    • Annex 13.2.4: Proposed Essential Factors for Retrieve and Screen of Literatures
    • Figure13.2.4: Proposed Screening Process of Literatures
    • Table 13.2.5: Scheme of Retrieve and Screen of Literatures
    • Table 13.2.6: Report of Retrieve and Screen of Literatures
    • Table 13.2.7: Content and Format of Clinical Evaluation Report based on Clinical Data of Medical Devices of Same Varieties

Chapter 14 - How to Conduct the Clinical Trials of Imported Medical Device Registration in China

  • 14.1. How Many Medical Devices need to Conduct Clinical Trial and Approval within Chinese Territory
    • Table 14.1: Catalogue of Class III Medical Devices Need to Clinical Trial Approval
  • 14.2. Application Form for Approval of Medical Device Clinical Trial
    • Table 14.2: Application Form for Approval of Medical Device Clinical Trial
  • 14.3. Requirements for Application Documents for Approval of Medical Device Clinical Trial
  • 14.4. How to Select the Clinical Trial Institutions
  • 14.5. How to Define Every Party's Responsibilities in Clinical Trials
    • 14.5.1.The Responsibilities for Sponsor of Clinical Trials
    • 14.5.2.The Responsibilities for Clinical Trial Institutions and Personnel of Clinical Trials
  • 14.6. Notice of Medical Device Clinical Trials
  • 14.7. Clinical Trials Protocol and Format of Clinical Trial Protocol for Medical Devices
    • Table 14.7: Format of Clinical Trial Protocol for Medical Devices
  • 14.8. Submission of Application Documents
  • 14.9. Approval Document for Medical Device Clinical Trial
    • Table 14.9: Approval Document for Medical Device Clinical Trial
  • 14.10. Clinical Trial Report and Format of Clinical Trial Report for Medical Devices
    • Table 14.10: Format of Clinical Trial Report for Medical Device

Chapter 15 - Submission of Application Dossiers and Approval Process

  • 15.1. Formal Requirements for Application Dossiers for Registration
  • 15.2. Operation Practices for Formal Examination of Application Dossiers for Registration
  • 15.3. Approval Process
  • 15.4. Medical Device Registration Certificate and its Valid Time Limitation

Chapter 16 - Appendices

  • Appendix 1: Measures for the Administration of Medical Device Registration (2014 Edition)
  • Appendix 2: Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)
  • Appendix 3: Rules for Medical Device Classification
  • Appendix 4: Compiling Guidelines of Product Technical Requirements for Medical Devices
  • Appendix 5: Technical Guidance Principles for Clinical Evaluation of Medical Devices
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