Chinese guidebook for medical device adverse

March 25, Content info: Bytotal value of drugs on Chinese healthcare market has reached RMB billion. On the Chinese healthcare market, imported drugs made by overseas and multinational pharmaceutical manufacturers account for about one fourth. 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.

Chinese guidebook for medical device adverse

February 25, Content info: Among them, medical devices represented dynamical growth since s. Bytotal value of medical devices Chinese guidebook for medical device adverse Chinese healthcare market has reached 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 billion RMB byand 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.

However, when searching on website of the Chinese regulatory authority of medical devices, China Food and Drug Administration, you may find there are many announcements of medical devices recall and adverse event reports for those that made by overseas and multinational medical device manufacturers.

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.

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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.

The organizations of this guidebook are arranged as follows. 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.

Chapter 3 introduces the detailed 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 required by the Chinese regulatory authorities for medical device monitoring to an entire process of medical device adverse event reporting for manufacturer, which is important for agents within the territory of China designated by overseas and multinational medical device manufacturers, because they must be in compliance with these regulations.

Chapter 4 addresses 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, which is important for the distributors within the territory of China of overseas and multinational manufacturers of imported medical devices, because they must be in compliance with these regulations.

Chapter 5 elaborates the user facility's duty for medical device adverse event reporting. Chapter 6 provides a brief introduction of citizens, legal persons and other social organizations' right for medical device adverse event reporting.

Chapter 7 provides 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.

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

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.

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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 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.

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.

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.

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

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The Chinese regulations for adverse event reporting of medical device in clinical trials. 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.An air pollutant is a material in the air that can have adverse effects on humans and the ecosystem.

Chinese guidebook for medical device adverse

The substance can be solid particles, liquid droplets, or gases. Issuu is a digital publishing platform that makes it simple to publish magazines, catalogs, newspapers, books, and more online.

Easily share your publications and get them in . However, when searching on website of the Chinese regulatory authority of medical devices, China Food and Drug Administration, you may find there are many announcements of medical devices recall and adverse event reports for those that made by overseas and multinational medical device manufacturers.

Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations () is an essential resource for overseas and multinational pharmaceutical . 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.

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. Foreign manufacturers must make those reports within 15 days of the event or of knowledge of the event.

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