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Published Date: February 2014
Page Count: 69
Unit Price: US$ 750
Site License: US$3500
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Format: Electronic PDF copy



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

Summary Table of contents

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.

Chinese guidebook for Medical Device Adverse Event Reporting and Monitoring Regulations (2014 Edition) 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 audiences of this guidebook are overseas medical device companies wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand the latest Chinese Medical Device Adverse Event Reporting and Monitoring Regulations. After having skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese Medical Device Adverse Event Reporting and Monitoring Regulations. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, and smoothly operate their companies in China.

 

 

 

Report Highlights

 

l        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.

l        The detailed Chinese regulations for the 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 to an entire process of medical device adverse event reporting for manufacturer to guide agents within the territory of China designated by overseas and multinational medical device manufacturers to smoothly hande complex regulatory requirements step by step, because they must be in compliance with these regulations.

l        The detailed Chinese regulations for 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 to guide distributors within the territory of China of overseas and multinational manufacturers of imported medical devices to smoothly navigate complex regulatory requirements step by step, because they must be in compliance with these regulations.

l        The detailed Chinese regulations for the user facility¡¯s duty for medical device adverse event reporting.

l        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.

l        The Chinese regulations for adverse event reporting of medical device in clinical trials.

l        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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