市場調査レポート

中国における医療機器有害事象報告・モニタリング規制のガイドブック

Chinese guidebook for Medical Device Adverse Event Reporting and Monitoring Regulations (2014 Edition)

発行 Access China Management Consulting 商品コード 298122
出版日 ページ情報 英文 69 Pages
納期: 即日から翌営業日
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中国における医療機器有害事象報告・モニタリング規制のガイドブック Chinese guidebook for Medical Device Adverse Event Reporting and Monitoring Regulations (2014 Edition)
出版日: 2014年02月25日 ページ情報: 英文 69 Pages
概要

持続的な経済・人口の成長により、中国の医療市場は1990年代以降、年間平均16%以上の成長率を維持しています。2013年までに、中国の医療市場における医療機器総額は1,790億人民元に達しています。中国の医療機器市場は2015年までに3,400億人民元を上回る可能性が高く、日本を抜いて、米国に次ぐ世界第2位の医療機器市場になると予測されています。

当レポートでは、中国における医療機器有害事象報告・モニタリングについて調査し、一般的な規制、メーカー・流通業者・ユーザー施設に対する詳細な規制、中国における医療機器有害事象報告のモニタリングネットワークの概要、および治験における規制などの分析を提供しており、概略以下の構成でお届けします。

第1章 イントロダクション

第2章 医療機器有害事象報告・モニタリングの一般的な規制

  • 定義
  • 医療機器有害事象と品質事故または医療ミスの違い
  • 中国内外で販売されている製品の有害事象報告
  • 治験における医療機器の有害事象報告
  • 医療機器リコールに適用できる法律
  • 医療機器有害事象報告コンテンツの機能・満足度情報
  • 医療機器有害事象の報告者
  • 輸入医療機器の海外メーカー向け特殊規制

第3章 医療機器有害事象報告に対するメーカーの義務

  • 責任と義務
  • 専門機関の指定およびアウトフィッティング人事の要件
  • 主なモニタリングシステム
  • 主要オペレーション手順
  • 医療機器有害事象報告
  • 有害事象の管理
  • 有害事象モニタリングのアーカイブ

第4章 医療機器有害事象報告に対する流通業者の義務

  • 責任と義務
  • 専門機関の指定およびアウトフィッティング人事の要件
  • 主なモニタリングシステム
  • 主要オペレーション手順
  • 医療機器有害事象報告
  • 有害事象の管理
  • 有害事象モニタリングのアーカイブ

第5章 医療機器有害事象報告に対するユーザー施設の義務

  • 責任と義務
  • 専門機関の指定およびアウトフィッティング人事の要件
  • 主なモニタリングシステム
  • 主要オペレーション手順
  • 医療機器有害事象報告
  • 有害事象の管理
  • 有害事象モニタリングのアーカイブ

第6章 医療機器有害事象報告に対する市民、法人およびその他の社会的組織の権利

第7章 医療機器有害事象報告に対する中国のモニタリングネットワークの概要

  • 規制当局とその機能
  • 医療機器有害事象報告に対する中国のモニタリングネットワークの概要

第8章 治験における医療機器有害事象報告に対する規制

第9章 付録

目次

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, 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. 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 by 2015, and will surpass Japan to become the second largest medical device market following the United States. The Chinese medical device market will attract more and more overseas medical device manufacturers and producers to penetrate such market.

However, when searching on website of the Chinese regulatory authority of medical devices, China Food and Drug Administration, you may find there are many announcements of medical devices recall and adverse event reports for those that made by overseas and multinational medical device manufacturers. How to report adverse events to the Chinese regulatory authorities? Who should report adverse events to the Chinese regulatory authorities? How the Chinese regulatory authorities to monitor the medical device adverse event reporting? How to comply with Chinese regulations for medical device adverse events reporting and monitoring? A series of questions are facing overseas and multinational medical device manufacturers. The overseas and multinational medical device manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of the Chinese regulations for medical device adverse event reporting and monitoring. The regulations on medical device adverse event reporting and monitoring between China and US-EU are different. Moreover, 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.

Chinese Guidebook for Medical Device Adverse Event Reporting and Monitoring is an essential resource for overseas and multinational medical device manufacturers and producers to handle a medical device adverse event reporting smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese medical device adverse event reporting and monitoring regulations.

The organizations of this guidebook are arranged as follows. Chapter 2 provides the general regulations for medical device adverse event reporting and monitoring, which cover the definitions and reporters relating to medical device adverse event reporting and the special regulations for medical device adverse event reporting of overseas manufacturer for imported medical devices. Chapter 3 introduces the detailed manufacturer's duty for medical device adverse event reporting, from the responsibilities and obligations, main monitoring systems and operation procedures, medical device adverse event reporting, archives of adverse event monitoring required by the Chinese regulatory authorities for medical device monitoring to an entire process of medical device adverse event reporting for manufacturer, which is important for agents within the territory of China designated by overseas and multinational medical device manufacturers, because they must be in compliance with these regulations. Chapter 4 addresses the distributor's duty for medical device adverse event reporting, also from the responsibilities and obligations, main monitoring systems and operation procedures, medical device adverse event reporting, archives of adverse event monitoring to an entire process of medical device adverse event reporting for distributor, which is important for the distributors within the territory of China of overseas and multinational manufacturers of imported medical devices, because they must be in compliance with these regulations. Chapter 5 elaborates the user facility's duty for medical device adverse event reporting. Chapter 6 provides a brief introduction of citizens, legal persons and other social organizations' right for medical device adverse event reporting. Chapter 7 provides an overview of Chinese monitoring network for medical device adverse event reporting, which covers the detailed regulatory authorities at various administrative levels and their functions, and the complete picture of Chinese monitoring network for medical device adverse event reporting and monitoring. Chapter 8 elaborates the regulations for adverse event reporting of medical device in clinical trials. Chapter 9 provides a full set of the English and Chinese bilingual forms relating to medical device adverse event reporting to facilitate audiences to clearly understand submitted forms for medical device adverse event reporting.

The audiences of this guidebook are overseas medical device companies 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 the latest Chinese Medical Device Adverse Event Reporting and Monitoring Regulations. After having skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese Medical Device Adverse Event Reporting and Monitoring Regulations. 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 companies in China.

Report Highlights

  • Chinese general regulations for medical device adverse event reporting and monitoring, which cover the definitions and reporters relating to medical device adverse event reporting and the special regulations for medical device adverse event reporting of overseas manufacturer for imported medical devices.
  • The detailed Chinese regulations for the manufacturer's duty for medical device adverse event reporting, from the responsibilities and obligations, main monitoring systems and operation procedures, medical device adverse event reporting, archives of adverse event monitoring to an entire process of medical device adverse event reporting for manufacturer to guide agents within the territory of China designated by overseas and multinational medical device manufacturers to smoothly hande complex regulatory requirements step by step, because they must be in compliance with these regulations.
  • The detailed Chinese regulations for the distributor's duty for medical device adverse event reporting, also from the responsibilities and obligations, main monitoring systems and operation procedures, medical device adverse event reporting, archives of adverse event monitoring to an entire process of medical device adverse event reporting for distributor to guide distributors within the territory of China of overseas and multinational manufacturers of imported medical devices to smoothly navigate complex regulatory requirements step by step, because they must be in compliance with these regulations.
  • The detailed Chinese regulations for the user facility's duty for medical device adverse event reporting.
  • An overview of Chinese monitoring network for medical device adverse event reporting, which covers the detailed regulatory authorities at various administrative levels and their functions, and the complete picture of Chinese monitoring network for medical device adverse event reporting and monitoring to provide a direction of gateway for medical device adverse event reporting.
  • The Chinese regulations for adverse event reporting of medical device in clinical trials.
  • A full set of the English and Chinese bilingual forms relating to medical device adverse event reporting to facilitate audiences to clearly understand submitted forms for medical device adverse event reporting.

Table of Contents

Chapter 1 Introduction.

Chapter 2 General Regulations for Medical Device Adverse Event Reporting and Monitoring.

  • 2.1. Definitions.
    • 2.1.1. Medical Device Adverse Event.
    • 2.1.2. Medical Device Adverse Event Monitoring.
    • 2.1.3. Serious Injuries.
    • 2.1.4. Medical and Health Institutions.
  • 2.2. The differentiation between the medical device adverse events and the quality accidents or medical malpractice.
  • 2.3. The adverse event reporting for products are on sale within the territory of China and outside of the territory of China.
  • 2.4. The adverse event reporting for medical device in clinical trials.
  • 2.5. The applicable regulations for medical device recall.
  • 2.6. The functions of medical device adverse event reporting content and statistical information.
  • 2.7. The reporters of medical device adverse events.
  • 2.8. The special regulations for overseas manufacturers of imported medical devices.

Chapter 3 Manufacturer's Duty for Medical Device Adverse Event Reporting.

  • 3.1. Responsibilities and obligations.
  • 3.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.
  • 3.3. Main Monitoring Systems.
  • 3.4. Main Operation Procedures.
    • 3.4.1. Identification and Collection for Medical Device Adverse Events.
    • 3.4.2. Investigation and Evaluation of Medical Device Adverse Events.
  • 3.5. Medical Device Adverse Event Reporting.
    • 3.5.1. Individual Adverse Event Report (Suspected Medical Device Adverse Event Report).
    • 3.5.2. Unexpected and Group Adverse Event Report.
    • 3.5.3. Annual Summary Report.
    • 3.5.4. An Entire Process of Medical Device Adverse Event Reporting for Manufacturer.
  • Figure 3.5.4. An Entire Process of Medical Device Adverse Event Reporting for Manufacturer.
  • 3.6. Control of Adverse Events.
  • 3.7. Archives of Adverse Event Monitoring.

Chapter 4 Distributor's Duty for Medical Device Adverse Event Reporting.

  • 4.1. Responsibilities and obligations.
  • 4.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.
  • 4.3. Main Monitoring Systems.
  • 4.4. Main Operation Procedures.
    • 4.4.1.Collection and Notification for Medical Device Adverse Events.
  • 4.5. Medical Device Adverse Event Reporting.
    • 4.5.1. Individual Adverse Event Report (Suspected Medical Device Adverse Event Report).
    • 4.5.2. Unexpected and Group Adverse Event Report.
    • 4.5.3. Annual Summary Report.
    • 4.5.4. An Entire Process of Medical Device Adverse Event Reporting for Distributor.
    • Figure 4.5.4. An Entire Process of Medical Device Adverse Event Reporting for Distributor.
  • 4.6. Control of Adverse Events.
  • 4.7. Archives of Adverse Event Monitoring.

Chapter 5 User Facility's Duty for Medical Device Adverse Event Reporting.

  • 5.1. Responsibilities and obligations.
  • 5.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.
  • 5.3. Main Monitoring Systems .
  • 5.4. Main Operation Procedures.
    • 5.4.1. Identification and Collection for Medical Device Adverse Events.
    • 5.4.2. Analysis and Confirmation for Medical Device Adverse Events.
  • 5.5. Medical Device Adverse Event Reporting.
    • 5.5.1. Individual Adverse Event Report (Suspected Medical Device Adverse Event Report).
    • 5.5.2. Unexpected and Group Adverse Event Report.
    • 5.5.3. Annual Summary Report.
    • 5.5.4. An Entire Process of Medical Device Adverse Event Reporting for User Facility.
    • Figure 5.5.4. An Entire Process of Medical Device Adverse Event Reporting for User Facility.
  • 5.6. Control of Adverse Events.
  • 5.7. Archives of Adverse Event Monitoring.

Chapter 6 Citizens, Legal Persons and other Social Organizations' Right for Medical Device Adverse Event Reporting.

Chapter 7 An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting.

  • 7.1. Regulatory Authorities and their Functions.
    • 7.1.1. Regulatory Authorities at the city and county level.
    • 7.1.2. Regulatory Authorities of Provinces, Autonomous regions and Municipalities directly under the Central Government.
    • 7.1.3. National Medical Device Adverse Event Monitoring technical institution (National Center for ADR Monitoring).
  • 7.2. An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting.
    • Figure 7.2. An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting.

Chapter 8 Regulations for Adverse Event Reporting of Medical Device in Clinical Trials.

Chapter 9 Appendix.

  • 9.1. Form of Suspected Medical Device Adverse Event Reporting.
  • 9.2. Supplementary Form of Medical Device Adverse Event Reporting.
  • 9.3. Annual Summary Form of Medical Device Adverse Event Reporting.
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