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.

1. Chinese guidebook for Medical Device Adverse Event Reporting and
Monitoring Regulations (2014 Edition)
Report Pages: 135
Category: Medical Devices

2. Description
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.
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.

3. 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.
• 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 detailed Chinese regulations for the user facility’s duty for medical device adverse event
reporting.
• The Chinese regulations for adverse event reporting of medical device in clinical trials.
• 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.

4. 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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event-reporting-and-monitoring-regulations-market
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