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.
Portland, OR -- (ReleaseWire) -- 06/04/2014 --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.
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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.
Table Of Contents:
2 General Regulations for Medical Device Adverse Event Reporting and Monitoring
2.1.1.Medical Device Adverse Event
2.1.2.Medical Device Adverse Event Monitoring
2.2.The differentiation between the medical device adverse events and the quality accidents or medical malpractice
2.3.The adverse event reporting for products are on sale within the territory of China and outside of the territory of China
2.4.The adverse event reporting for medical device in clinical trials
2.5.The applicable regulations for medical device recall
3 Manufacturer’s Duty for Medical Device Adverse Event Reporting
3.1.Responsibilities and obligations
3.2.Designation of Specialized Agency and Requirements of Outfitting Personnel
3.3.Main Monitoring Systems
3.4.Main Operation Procedures
4 Distributor’s Duty for Medical Device Adverse Event Reporting
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
4.5.Medical Device Adverse Event Reporting.22
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
6 Citizens, Legal Persons and other Social Organizations’ Right for Medical Device Adverse Event Reporting.35
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
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