Back to On-demand Webcast: China Regulations on Medical Devices: Adverse Event Monitoring and Re-evaluation
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On-demand Webcast: China Regulations on Medical Devices: Adverse Event Monitoring and Re-evaluation

An on-demand recording of the RAPS Webcast, China Regulations on Medical Devices: Adverse Event Monitoring and Re-evaluation, originally recorded on February 2016.


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When the Medical Device Regulation in China was updated in June 2014 it included the regulatory requirements for the monitoring of adverse event and recall of medical device. In addition, CFDA also updated the provisions for the handling of medical device adverse event.

The regulatory requirements...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design