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Chinese Medical Device Market Adverse Event Reporting & Monitoring 2014

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.

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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.

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.

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Table of Contents

Chapter 1 Introduction4

Chapter 2 General Regulations for Medical Device Adverse Event Reporting and Monitoring 6
2.1 Definitions  6
2.1.1 Medical Device Adverse Event 6
2.1.2 Medical Device Adverse Event Monitoring 6
2.1.3 Serious Injuries 6
2.1.4 Medical and Health Institutions 7
2.2 The differentiation between the medical device adverse events and the quality accidents or medical malpractice  7
2.3 The adverse event reporting for products are on sale within the territory of China and outside of the territory of China 7
2.4 The adverse event reporting for medical device in clinical trials 8
2.5 The applicable regulations for medical device recall  8
2.6 The functions of medical device adverse event reporting content and statistical information 8
2.7 The reporters of medical device adverse events 8
2.8 The special regulations for overseas manufacturers of imported medical devices 8

Chapter 3 Manufacturer’s Duty for Medical Device Adverse Event Reporting  9
3.1 Responsibilities and obligations  9
3.2 Designation of Specialized Agency and Requirements of Outfitting Personnel 10
3.3 Main Monitoring Systems  11
3.4 Main Operation Procedures  11
3.4.1 Identification and Collection for Medical Device Adverse Events 12
3.4.2 Investigation and Evaluation of Medical Device Adverse Events 12
3.5 Medical Device Adverse Event Reporting   12
3.5.1 Individual Adverse Event Report (Suspected Medical Device Adverse Event Report) 13
3.5.2 Unexpected and Group Adverse Event Report  14
3.5.3 Annual Summary Report 15
3.5.4 An Entire Process of Medical Device Adverse Event Reporting for Manufacturer   15
Figure 3.5.4 An Entire Process of Medical Device Adverse Event Reporting for Manufacturer   16
3.6 Control of Adverse Events 17
3.7 Archives of Adverse Event Monitoring 18

Chapter 4 Distributor’s Duty for Medical Device Adverse Event Reporting 19
4.1 Responsibilities and obligations   19
4.2 Designation of Specialized Agency and Requirements of Outfitting Personnel 20
4.3 Main Monitoring Systems  21
4.4 Main Operation Procedures  22
4.4.1.Collection and Notification for Medical Device Adverse Events 22
4.5 Medical Device Adverse Event Reporting 22
4.5.1 Individual Adverse Event Report (Suspected Medical Device Adverse Event Report)  22
4.5.2 Unexpected and Group Adverse Event Report 23
4.5.3 Annual Summary Report 24
4.5.4 An Entire Process of Medical Device Adverse Event Reporting for Distributor 24
Figure 4.5.4 An Entire Process of Medical Device Adverse Event Reporting for Distributor   25
4.6 Control of Adverse Events    26
4.7 Archives of Adverse Event Monitoring  26

Chapter 5 User Facility’s Duty for Medical Device Adverse Event Reporting 27
5.1 Responsibilities and obligations 27
5.2 Designation of Specialized Agency and Requirements of Outfitting Personnel 28
5.3 Main Monitoring Systems 28
5.4 Main Operation Procedures  29
5.4.1 Identification and Collection for Medical Device Adverse Events 29
5.4.2 Analysis and Confirmation for Medical Device Adverse Events 30
5.5 Medical Device Adverse Event Reporting  30
5.5.1 Individual Adverse Event Report (Suspected Medical Device Adverse Event Report)  31
5.5.2 Unexpected and Group Adverse Event Report 31
5.5.3 Annual Summary Report 32
5.5.4 An Entire Process of Medical Device Adverse Event Reporting for User Facility   32
Figure 5.5.4 An Entire Process of Medical Device Adverse Event Reporting for User Facility   33
5.6 Control of Adverse Events   34
5.7 Archives of Adverse Event Monitoring   34

Chapter 6 Citizens, Legal Persons and other Social Organizations’ Right for Medical Device Adverse Event Reporting  35

Chapter 7 An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting 35
7.1 Regulatory Authorities and their Functions 36
7.1.1 Regulatory Authorities at the city and county level 36
7.1.2 Regulatory Authorities of Provinces, Autonomous regions and Municipalities directly under the Central Government 38
7.1.3 National Medical Device Adverse Event Monitoring technical institution (National Center for ADR Monitoring)    42
7.2 An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting 46
Figure 7.2 An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting 47

Chapter 8 Regulations for Adverse Event Reporting of Medical Device in Clinical Trials  48

Chapter 9 Appendix  49
9.1 Form of Suspected Medical Device Adverse Event Reporting  49
9.2 Supplementary Form of Medical Device Adverse Event Reporting 58
9.3 Annual Summary Form of Medical Device Adverse Event Reporting 63