Chinese guidebook for medical device adverse

How to comply with Chinese regulations for adverse drug reaction reporting and monitoring? The Chinese regulations for disclosure and feedback of information about adverse drug reactions and events. An overview of Chinese monitoring network for adverse drug reaction and event reporting, which covers the detailed regulatory authorities at various administrative levels and their functions, and the complete picture of Chinese monitoring network for adverse drug reaction and event reporting and monitoring to provide a direction of gateway for adverse drug reaction and event reporting.

All device manufacturers that distribute their devices in China should continue to monitor the progress of this rule, and its implementation. Chapter 9 addresses the legal liabilities for manufacturer, distributor and medical institution.

How the Chinese regulatory authorities to monitor the adverse drug reaction and event reporting? Chapter 2 provides the general regulations for adverse drug reaction reporting and monitoring, and the special regulations for overseas manufacturers of imported drugs. This License type allows the report to be Printed.

The organizations of this guidebook are arranged as follows. 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.

How the Chinese regulatory authorities to monitor the medical device adverse event reporting? The proposed Measures set forth five circumstances in which an adverse event would constitute an SAE: March 25, Content info: How to report an adverse drug reaction and event to the Chinese regulatory authorities?

After having skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese Adverse Drug Reaction Reporting and Monitoring Regulations. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational pharmaceutical manufacturers and producers to achieve a successful entry into the Chinese drug market, and smoothly operate their companies in China.

The Chinese regulations for adverse event reporting of medical device in clinical trials. Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations is an essential resource for overseas and multinational pharmaceutical manufacturers and producers to handle an adverse drug reaction reporting smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese adverse drug reaction reporting and monitoring regulations.

How the Chinese regulatory authorities to monitor the adverse drug reaction and event reporting? Report Highlights Chinese general regulations for adverse drug reaction and event reporting and monitoring, and the special regulations for adverse drug reaction and event reporting and monitoring of overseas manufacturers of imported drugs into the Chinese drug market.

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.

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.

The proposed Measures also state, however, that the content of adverse event reports and related risk analyses may not serve as the basis for disputes or litigation surrounding medical treatment or for resolving incidents related to medical device quality. It is estimated that total value of drugs on Chinese healthcare market will be likely to be more than billion RMB byand will surpass Japan to become the second largest drug market following the United States.

CFDA Restructures Medical Device Adverse Event 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.

Foreign manufacturers must make those reports within 15 days of the event or of knowledge of the event. Who should report adverse drug reaction and event to the Chinese regulatory authorities? The Chinese medical device market will attract more and more overseas medical device manufacturers and producers to penetrate such market.

Report will be emailed in PDF format and can be accessed by a specific user. The overseas and multinational pharmaceutical manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of the Chinese regulations for adverse drug reaction reporting and monitoring.

Chapter 8 introduces the disclosure and feedback of information about adverse drug reactions and events. The Chinese healthcare market will attract more and more overseas pharmaceutical manufacturers and producers to penetrate such market.

Chapter 9 provides 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.

Individuals may also report suspected adverse events.

Chapter 8 elaborates the regulations for adverse event reporting of medical device in clinical trials. The Chinese regulations for adverse event reporting of medical device in clinical trials.

Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. Chapter 8 introduces the disclosure and feedback of information about adverse drug reactions and events.

In addition, both Chinese domestic medical device manufacturers that distribute their devices outside of China and foreign device manufacturers must report SAEs that occur abroad. The manufacturer or healthcare institution must report the event within 15 days of its occurrence or of learning of its occurrence.

Chapter 2 provides the 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 series of questions are facing overseas and multinational pharmaceutical manufacturers. Among them, medical devices represented dynamical growth since s. This License type does not allow the report to be Printed.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 guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations () market research report available in US $ only at mi-centre.com - Buy Now or Ask an Expert To know More about this report.

Home > Device Regulation in China > CFDA Restructures Medical Device Adverse Event Regulations. CFDA Restructures Medical Device Adverse Event Regulations both Chinese domestic medical device manufacturers that distribute their devices outside of China and foreign device manufacturers must report SAEs that occur abroad.

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.

Access China Report Copy right © Access China Management Consulting Ltd. 1 Chinese guidebook for Medical Device Adverse Event Reporting and Monitoring Regulations.

The Chinese State Administration of Food and Drug (SFDA) recently issued a Tentative Guidance for the Monitoring of Adverse Device mi-centre.com document outlines how manufacturers, distributors, and suppliers of medical .

Download
Chinese guidebook for medical device adverse
Rated 3/5 based on 80 review