Quality Assurance for Medical Devices in China Presentation

More and more medical device companies are sourcing and manufacturing their products in China. However, given recent problems with heparin, di-ethylene glycol and melamine poisoning, quality issues have become paramount. What do you need to know about QA in China to be successful and avoid pitfalls? This presentation will go over the latest regulations for medical device QA, GMP, adverse event reporting, and additional plans for quality control. A Chinese case audit will help emphasize key issues.


To view these presentation slides, please click onĀ Quality Assurance for Medical Devices in China Presentation


Table of Contents:

  • Overview of China
    • Demographics
    • Regulatory Authorities
  • Sourcing from China
    • Trends
    • Key Factors
    • Things to check for
  • Quality Assurance/GMP
    • GMP Development
    • Draft GMP Regulations
    • Required Documents
    • GMP Inspection Process
    • SFDA Inspection Focus
  • Regulations for Quality Control
    • Plans for Quality Control
  • Adverse Event Reporting
    • New Regulations
  • Case Study
    • Background
    • Due Diligence/Acquisition
    • Quality Systems
    • Quality from a China Perspective
    • Quality from an International Perspective
  • Other Quality Issues Seen at Chinese Factories
  • Upgrading Your China Facility
  • Quality Control in China
  • Coordination with HQ and China Office
  • Regulatory Personnel in China Office
  • Other Updates on Regulations
  • IPR
  • Cross-Cultural Issues