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China's Medical Device Regulatory Update
Pacific Bridge Medical, Feb 2011, Minutes: 90
China’s medical device market has grown to $7.5 billion, the second largest in Asia after Japan. The number of foreign medical device manufacturers selling, sourcing, or manufacturing in China has grown exponentially. However, there are still quality control problems with recalls and scandals. To be successful in this fast growing market, attend this webcast 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. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.
What you will learn:
Overview of China's Medical Device Market
SFDA - how it is organized, what changes have occurred
- New regulations to streamline the regulatory process
Product Classification
- Medical devices
- Combination products
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
Conducing 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 People/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
Who should purchase:
This webcast is designed for medical device professionals in regulatory affairs, business development, international sales and marketing, and anyone who wants to be current on the Chinese medical device markets.
How a webcast works:
Webcasts allow participants in their office or conference room to access our presentation with their phone line and internet connection. The day before the webcast, you will receive an email which will include the dial-in number and web access information. Please dial in ten minutes before the start of the webcast.
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