China Medical Device Regulatory Update-China Medical Webcast CD

Pacific Bridge Medical
January 21, 2009
SKU: PACB2123098
License type:
Countries covered: China

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


More China Regulation Reports

China’s Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration by Access China Management Consulting Ltd.
China is one of the fastest growing global economies with a fourth population in the world, and is one of the largest healthcare markets round ...

China’s Guidebook for Application and Approval of Imported Medical Device Registration by Access China Management Consulting Ltd.
In 2009, the Chinese government vigorously launched “China’s Health-Care Reform”, developed an ambitious blueprint, in which health care system will cover about 1.2 billion people ...

Emerging Markets Clinical Development Series Asia (China, India, Other Emerging Asian Countries) by Cutting Edge Information
Asia offers clinical development teams unique benefits for running trials. Among emerging markets, Asian countries offer the highest number of available patients. The region also ...

Quality Assurance for Medical Devices in China by Pacific Bridge Medical
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, ...

The Medical Equipment Regulatory Scenario in BRIC Countries by GlobalData
The Medical Equipment Regulatory Scenario in BRIC Countries Summary GlobalData viewpoints are an essential source of high quality information on all key events in the medical equipment ...

See all reports like this >>

More China Reports

D&B Country RiskLine Report: China by Dun & Bradstreet Inc.
This D&B Country RiskLine Report will help you analyze the risks, opportunities and likely payment delays when doing business in this country. It includes ...

Country Report China February 2011 by Economist Intelligence Unit
Country Reports analyse political and economic trends in featured countries. They show you exactly how national, regional and global events will affect your business in ...

Country Report China January 2011 by Economist Intelligence Unit
Country Reports analyse political and economic trends in featured countries. They show you exactly how national, regional and global events will affect your business in ...

D&B Country Report: China by Dun & Bradstreet Inc.
D&B Country Report. Comprehensive information for evaluating risks and opportunities when trading or investing in this country. Providing critical information and analysis on ...

Wine - BRIC (Brazil, Russia, India, China) Industry Guide by MarketLine
Datamonitor's Wine - BRIC (Brazil, Russia, India, China) Industry Guide is an essential resource for top-level data and analysis covering the BRIC (Brazil, Russia, India, ...

See all reports like this >>