市場調査レポート

中国における輸入医療機器の登録・登記のための申請資料準備ガイド

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

発行 Access China Management Consulting 商品コード 318568
出版日 ページ情報 英文 190 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=102.85円で換算しております。
Back to Top
中国における輸入医療機器の登録・登記のための申請資料準備ガイド Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition)
出版日: 2014年11月15日 ページ情報: 英文 190 Pages
概要

中国の医療機器市場はもっとも成長の可能性を秘めた市場のひとつであり、海外のますます多くの医療機器メーカーが市場参入をはかっています。同国の医療機器市場は2015年までに3,400億人民元(約570億米ドル)を超える規模に成長すると推計されており、日本を抜いて米国に次ぐ世界第2位の医療機器市場となる見込みです。

当レポートでは、中国における輸入医療機器の登録・登記手続きについて包括的に調査し、申請資料・申請書類の種類や各種要件、手続きの段階と手順、中国国内での臨床試験に関連するガイダンス、最近の法改定の状況など、詳細にわたってまとめています。

第1章 エグゼクティブサマリー

第2章 大幅に改定されている医療機器関連法規制:包括的比較分析

  • 大幅な改定が実施されている法規制
  • 医療機器登録に大きな変更のある法規制
  • 輸入医療機器登録・登記の申請資料の最新要件

第3章 医療機器の登録・登記に適用される最新の法規制

第4章 輸入医療機器の登録・登記申請資料の準備にあたって知っておくべきこと

  • 定義
  • 医療機器の登録・登記の事務
  • 中国に輸出される医療機器
  • 輸入医療機器の登録・登記の申請・届出人に関する法規制
  • 製品の技術要件
  • 登録検査
  • 臨床評価

第5章 準備すべき輸入医療機器の登記申請資料

第6章 輸入医療機器の登記申請資料に求められる要件

  • クラスI医療機器の登記フォーム
  • 登記・登録申請資料のリスト
    • 登記申請資料の内容に関する要件
    • 登記フォーム・登記申請資料の正式審査における要件
    • 登記申請資料正式審査の実際の運用
    • 登記認定証

第7章 準備すべき輸入医療機器の登録申請資料

第8章 輸入医療機器の登録申請資料に求められる要件

  • 輸入医療機器の登録用申請用紙
  • 証明書類
  • 医療機器製品の安全性・有効性の関する基礎要件のリスト
  • データサマリー
    • サマリー
    • 製品概要
    • モデル・仕様
    • パッケージの翻訳
    • 適応患者・禁忌症、など
  • 調査データ
    • 製品性能
    • 生体適合性の評価データ
    • 生物学的安全性
    • 殺菌・消毒のプロセス
    • 有効期間・パッケージング
    • 前臨床動物実験
    • ソフトウェア
    • その他
  • 製造情報
    • パッシブ医療機器の製造工程:概要
    • アクティブ医療機器の製造工程:概要
    • 製造サイトの概要
  • 臨床評価データ
  • 製品リスクの解析データ
  • 製品の技術要件
  • 製品登録のテストレポート
  • 製品の手引書(マニュアル)など
  • 適合性宣言

第9章 医療機器製品の安全性・有効性に関する基礎要件のリスト

第10章 製品の技術要件のまとめ方

第11章 登録検査への新製法

第12章 医療機器の指示書・表示ラベルのまとめ方

第13章 輸入医療機器登録のための臨床評価の実践方法

第14章 輸入医療機器登録のための臨床試験の実施方法

  • 中国国内での臨床試験の実施と承認が必要な医療機器
  • 医療機器臨床試験の承認を得るための申請用紙
  • 医療機器臨床試験の承認を得るための申請書類の要件
  • 臨床試験機関の選定方法
  • 臨床試験における各パーティの責任の定義
  • 医療機器臨床試験の通知
  • 臨床試験のプロトコルとフォーマット
  • 申請書類の提出
  • 医療機器臨床試験の承認文書
  • 臨床試験レポートとそのフォーマット

第15章 申請資料の提出と認証プロセス

  • 登録申請資料の形式的要件
  • 登録申請資料の正式審査の実際
  • 認証プロセス
  • 医療機器登録認定証と有効期限

第16章 付録

目次

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
Back to Top