市場調査レポート

中国における医療機器リコール管理弁法のための最新ガイドブック

Latest guidebook for Chinese Medical Device Recall Regulations (2014 Edition)

発行 Access China Management Consulting 商品コード 295028
出版日 ページ情報 英文 34 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=102.06円で換算しております。
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中国における医療機器リコール管理弁法のための最新ガイドブック Latest guidebook for Chinese Medical Device Recall Regulations (2014 Edition)
出版日: 2014年02月03日 ページ情報: 英文 34 Pages
概要

中国は、世界でも最大の医療市場を有する急成長中の経済国です。持続的な経済成長と人口増加に伴い、中国の医療市場は、1990年代から16%以上の年平均成長率を維持しています。2000年代からは、医療機器市場でも活発な成長を示し、2013年には総額で1,790億人民元に達しました。中国の医療機器市場は、2015年までに3,400億人民元を超え、日本を抜いて、米国に次ぐ世界第2位の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リコール管理弁法について調査分析し、包括的かつ徹底した知識による詳細なガイダンスを提供して、概略以下の構成でお届けいたします。

第1章 イントロダクション

第2章 医療機器リコールに対する中国の規制当局の概要

第3章 医療機器リコール管理弁法

  • 定義
  • リコールの方法
  • 調査と評価
  • 分類

第4章 医療機器の自主リコール

  • 自主リコールの規制
  • 自主リコールの全過程

第5章 医療機器の強制リコール

  • 強制リコールの規制
  • 強制リコールの全過程

第6章 法的責任

第7章 患者の治療法

第8章 ケーススタディ:Philips Medical Systems(米国)

第9章 付録

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: ACMC20140204

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. 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.

If you search 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 for those that made by overseas and multinational medical device manufacturers, because the imported medical devices account for about a half of Chinese medical device market, in which the high-tech and high-value medical devices, such as magnetic resonance imaging, CT are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies. How to handle a medical device recall smoothly in China? When is recall reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? How to comply with Chinese medical device recall regulations? 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 recall. Otherwise the overseas and multinational medical device manufacturers and their imported medical devices will lose a lucrative medical device market. The regulations on medical device recall 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.

Latest Guidebook for Chinese Medical Device Recall Regulations is an essential resource for overseas and multinational medical device manufacturers and producers to handle a medical device recall smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese medical device recall regulations.

Report Highlights

  • An overview of organizational structure of Chinese Regulatory Authorities for Medical Device Recall.
  • Chinese general regulations for medical device recall, which cover the definitions relating to medical device recall, the answers of who, where and how to submit medical device recall report, the investigation and evaluation of medical device defects, as well as the classification for medical device recall.
  • Detailed Chinese regulations for voluntary recall of medical devices, from the time limits of notifying, the indispensable content of the recall notification and the investigation and evaluation report, the recall plan, the periodically reporting and summary report to termination of recall.
  • An entire process of voluntary recall of medical devices to guide you to successfully navigate complex regulatory requirements step by step.
  • Detailed Chinese regulations for mandatory recall of medical device, tell you how would trigger a mandatory recall of medical device, how the medical device manufacturer copes with a mandatory recall of medical device, and how to handle a mandatory recall of medical device smoothly in China.
  • An entire process of mandatory recall of medical device to guide you to smoothly navigate complex regulatory requirements step by step.
  • A case study of recall of imported medical device from a U.S. company to expose practical operation.
  • A full set of the English and Chinese bilingual forms relating to medical device recall.

After have skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese Medical Device Recall Regulations.

Latest Guidebook for Chinese Medical Device Recall Regulations is an essential resource for overseas and multinational medical device manufacturers and producers to handle a medical device recall smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese medical device recall regulations.

  • An overview of organizational structure of Chinese Regulatory Authorities for Medical Device Recall.
  • Chinese general regulations for medical device recall, which cover the definitions relating to medical device recall, the answers of who, where and how to submit medical device recall report, the investigation and evaluation of medical device defects, as well as the classification for medical device recall.
  • Detailed Chinese regulations for voluntary recall of medical devices, from the time limits of notifying, the indispensable content of the recall notification and the investigation and evaluation report, the recall plan, the periodically reporting and summary report to termination of recall.
  • An entire process of voluntary recall of medical devices to guide you to successfully navigate complex regulatory requirements step by step.
  • Detailed Chinese regulations for mandatory recall of medical device, tell you how would trigger a mandatory recall of medical device, how the medical device manufacturer copes with a mandatory recall of medical device, and how to handle a mandatory recall of medical device smoothly in China.
  • An entire process of mandatory recall of medical device to guide you to smoothly navigate complex regulatory requirements step by step.
  • A case study of recall of imported medical device from a U.S. company to expose practical operation.
  • A full set of the English and Chinese bilingual forms relating to medical device recall.

Table of Contents

Chapter 1 Introduction.2

Chapter 2 an Overview of Chinese Regulatory Authorities for Medical Device Recall. 4

  • Figure 2.1. Organizational Structure of Chinese Regulatory Authorities for Medical Device Recall.6

Chapter 3 General Regulations for Medical Device Recall.7

  • 3.1. Definitions.7
  • 3.2. Who, Where and How to Submit Medical Device Recall Report?.7
  • 3.3. Investigation and Evaluation of Medical Device Defects.8
  • 3.4. Classification for Medical Device Recall .9

Chapter 4 Voluntary Recall of Medical Devices.10

  • 4.1. Regulations for Voluntary Recall of Medical Devices.10
  • 4.2. Entire Process of Voluntary Recall of Medical Devices. 13
    • Figure 4.2. Entire Process of Voluntary Recall of Medical Devices.13

Chapter 5 Mandatory Recall of Medical Devices.15

  • 5.1. Regulations for Mandatory Recall of Medical Devices.15
  • 5.2. Entire Process of Mandatory Recall of Medical Devices.17
    • Figure 5.2. Entire Process of Mandatory Recall of Medical Devices.17

Chapter 6 Legal Liabilities.20

Chapter 7 Remedy for Patient.22

Chapter 8 Case Study ---- U.S. Philips Medical Systems (Cleveland), Inc. Recall Single Photon Emission Computed Tomography System 23

Chapter 9 Appendix. 27

  • 9.1. Medical Device Recall Event Report Form.27
  • 9.2. Recall Program Implementation Report. 29
  • 9.1. Medical Device Recall Event Report Form.27
  • 9.2. Recall Program Implementation Report. 29
    • Figure 2.1. Organizational Structure of Chinese Regulatory Authorities for Medical Device Recall.6
    • Figure 4.2. Entire Process of Voluntary Recall of Medical Devices.13
    • Figure 5.2. Entire Process of Mandatory Recall of Medical Devices.17
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