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

Published :  Access China Management Consulting Ltd
Date :   Feb-2014
Page :   69
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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. 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. 1



Chapter 1 Introduction.4



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,



List of figures



Figure 3.5.4. An Entire Process of Medical Device Adverse Event Reporting for Manufacturer

Figure 4.5.4. An Entire Process of Medical Device Adverse Event Reporting for Distributor

Figure 5.5.4. An Entire Process of Medical Device Adverse Event Reporting for User Facility

Figure 7.2. An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting.



 







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