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China Medical Device Regulatory Update Webcast CD

China Medical Device Regulatory Update Webcast CD

China's medical device market has grown to $6 billion, the second largest in Asia after Japan. From 2004 to 2005, the number of foreign medical device manufacturers selling, sourcing, or manufacturing in China has grown exponentially. However, 2007 saw many quality control problems with recalls and scandals. To be successful in this fast growing market, buy this webcast CD to learn more about China's current medical device market and its newest regulations. Make sure you have the right business and regulatory strategy to enter and grow your China business.

What you will learn:

  • Overview of China and Medical Device Market
  • SFDA - how it is organized, what changes have occurred
    • New regulations to streamline the regulatory process
  • Product Classification
    • Medical devices
  • Product Registration Requirements
    • Type testing
    • Key documents for submission
    • General timeframes/costs
  • Product Registration Tips
    • Consistency in all documents, certificates
    • Necessary agents in China
    • Registration agent, after-sales service agent, local agent
  • Case Studies
    • Regulatory tips/suggestions
  • Conducting Device Clinical Trials in China
    • When are they needed
    • Advantages, disadvantages
    • Picking the right CRO
    • Clinical trials for products not yet registered in China
  • QA/GMP Audits
    • What is the current state of QA at China medical device factories
    • How to upgrade your China facilities or suppliers
    • Timeframes and costs
  • Organizational Issues with HQ and Your Local China Office or Distributor
    • Centralization of files
    • Communication strategies that work
  • Recruiting Regulatory Staff/Consultants
    • Who is available? What is their compensation?
    • How to retain the best people
  • Due Diligence/Acquisition
    • Appropriate due diligence strategies
    • Legal and business issues
  • Chinese Business and Cultural Issues
    • Guanxi, relationships
    • Meetings, negotiations

Due to the nature of this report, no table of contents is provided

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