Back to On-demand Webcast: Medical Device Regulation: Labeling and Instructions for Use in China
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On-demand Webcast: Medical Device Regulation: Labeling and Instructions for Use in China

An on-demand recording of the RAPS Webcast, Medical Device Regulation: Labeling and Instructions for Use in China, originally recorded on February 2015.


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CFDA promulgated Provisions on the Administration of Instruction for Use and Labels of Medical Devices (NO. 6 Order of CFDA) on 30 July 2014. The provisions were adopted at the 27 June 2014 CFDA meeting, and took effect 1 October 2014.

To help management representatives and regulatory professionals...

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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