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

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.

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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.

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.

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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.

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