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

Category : Medical Devices  | Published Date : Feb-2014 | Pages : 34
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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.

The organizations of this guidebook are arranged as follows. Chapter 2 provides the organizational structure of Chinese regulatory authorities for medical device recall. Chapter 3provides the 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. Chapter 4 introduces the detailed 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. Chapter 5 elaborates the mandatory recall of medical device, which cover how would trigger a mandatory recall of medical device, what the content of recall order issued by the drug regulatory authorities will be contained, 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. Chapter 6 introduces the detailed legal liabilities for the medical device manufacturer, the marketing or distributing enterprises, the user facilities of medical device, and the food and drug regulatory departments and their staff for a medical device recall. Chapter 7 addresses the remedy for patient. Chapter 8 introduces a case of recall of imported medical device from a U.S. company to expose practical operation. Chapter 9 provides a full set of the English and Chinese bilingual forms.

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

  • 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
Table of Contents…………………………………………………………………………………….1
Chapter 1 Introduction………………………………………………………………………..……...1
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

...
Publisher Name : Access China Management Consulting Ltd

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