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.

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.

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Table Of Contents:

1.Introduction

2.General Regulations for Medical Device Adverse Event Reporting and Monitoring

3.Manufacturer’s Duty for Medical Device Adverse Event Reporting

4.Distributor’s Duty for Medical Device Adverse Event Reporting

5.User Facility’s Duty for Medical Device Adverse Event Reporting

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

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

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