2019 Chinese Guidebook for Medical Device Adverse Events Reporting, Monitoring and Re-Evaluation - ResearchAndMarkets.com

January 24, 2019

DUBLIN--(BUSINESS WIRE)--Jan 24, 2019--The “Latest Chinese Guidebook for Medical Device Adverse Events Reporting, Monitoring and Re-Evaluation” report has been added to ResearchAndMarkets.com’s offering.

This report is an essential resource for overseas and multinational medical device manufacturers to handle the medical device adverse event reporting, monitoring and re-evaluation smoothly in China, which provided a detailed guidance of comprehensive and thorough knowledge of the Chinese medical device adverse event reporting, monitoring and re-evaluation regulations.

Statistical data showed that the scale of the Chinese healthcare market has reached RMB 6464.1 billion (about equivalent to US$973.5 billion) in 2017. Among them, the total value of medical device sales was RMB 663.2 billion (US$95.2 billion) with annual compound growth rate of 20.27% by 2017.

Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. However, large and medium-sized medical devices, high-end medical equipments and high-value medical materials are mainly relying on imported, such as the high-tech and high-valued imaging systems and navigation and positioning systems.

Facing a gigantic population and rapid population aging, the Chinese government, on one side, accelerated the priority approval of innovative medical devices and relaxed the market access for overseas medical devices, on other side, intensified the supervision and administration for medical devices at the post-marketed.

Companies Featured

AstraZeneca PLC (AZN) FibroGen (China) Medical Technology Development Co. Ltd.

Topics Covered

Chapter 1 Executive Summary

Chapter 2 China’s Healthcare Market Landscape and Rapidly Changing

Chapter 3 General Regulations for Medical Device Adverse Event Reporting, Monitoring and Re-evaluation

Chapter 4 Regulatory Authorities and their Functions

Chapter 5 MA Holders’ Duties and Obligations

Chapter 6 Medical Device Distributors’ and Medical Device User Facilities’ Duties and Obligations

Chapter 7 Medical Device Adverse Event Reporting and Evaluation

Chapter 8 Key Monitoring

Chapter 9 Control of Risk

Chapter 10 Re-Evaluation

Chapter 11 Supervision and Inspection

Chapter 12 An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting and Monitoring

For more information about this report visit https://www.researchandmarkets.com/research/v7wrzb/2019_chinese?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20190124005633/en/

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Related Topics:Medical Devices



SOURCE: Research and Markets

Copyright Business Wire 2019.

PUB: 01/24/2019 12:43 PM/DISC: 01/24/2019 12:43 PM


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