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市場調查報告書

中國的醫療設備回收管理辦法的最新旅遊指南

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

出版商 Access China Management Consulting 商品編碼 295028
出版日期 內容資訊 英文 34 Pages
商品交期: 最快1-2個工作天內
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中國的醫療設備回收管理辦法的最新旅遊指南 Latest guidebook for Chinese Medical Device Recall Regulations (2014 Edition)
出版日期: 2014年02月03日 內容資訊: 英文 34 Pages
簡介

中國是具全球最大醫療市場的急速成長中的經濟國。隨著持續性的經濟發展與人口增加,中國的醫療市場從1990年代開始維持著16%以上的年平均成長率。從2000年代開始,醫療設備市場也顯示活躍成長,2013年總額達1,790億人民幣。預計中國的醫療設備市場至2015年將超越3,400億人民幣,超過日本成為次於美國的全球第二大市場。

本報告提供中國的醫療設備回收管理辦法調查分析,總括且貫徹的知識的詳細指導,為您概述為以下內容。

第1章 簡介

第2章 中國的法規當局對醫療設備回收的概要

第3章 醫療設備回收管理辦法

  • 定義
  • 回收的方法
  • 調查與評估
  • 分類

第4章 醫療設備的自主回收

  • 自主回收的法規
  • 自主回收的全過程

第5章 醫療設備的強制回收

  • 強制回收的法規
  • 強制回收的全部過程

第6章 法律責任

第7章 患者的治療方法

第8章 案例研究:Philips Medical Systems(美國)

第9章 附錄

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
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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