Back to Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview
4.00 RAC

Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview

This course examines and introduces medical device regulations and registration requirements in China, South Korea, Japan and Singapore. You will learn how to obtain and maintain product approvals, and receive the most up-to-date information about pre-market and post-market regulations.


Credits:
4.00 RAC

  • List Price: $630.00
  • Member Price: $455.00

 
Want to save more?
to see if you qualify for a lower rate.
Members: save $175.00 or more
Item Details:

Navigating global regulatory markets in Asia can be a challenge, particularly when each country has unique regulations and requirements. Every country has its own body or system of legal requirements for placing medical devices in the market. Therefore, comprehending the various Asian laws and...

Back to Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview
View More

» View the Table of Contents

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