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China’s medical device market has grown to $6 billion, the second largest in Asia after Japan. From 2004 to 2005, the number of device manufacturers grew by thousands. However, 2007 saw many 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. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.
This presentation has 61 slides and the speaker is Ames Gross.
Click here to see a sample page of our webcast presentation.
The following topics are covered in this webcast:
- Overview of China and Medical Device Market
- Product Registration Requirements
- Type testing
- Key documents for submission
- General timeframes
- SFDA – how it is organized, what changes have occurred
- Conducing Clinical Trials
- Advantages, disadvantages
- Picking the right CRO
- R+D in China
- Advantages, disadvantages
- New regulations in China, including New QA Regulations to Improve Product Quality
- Sourcing Opportunities
- Trends and benefits
- Protecting your IP
- Distributor search and agreements
- Types of distributors available
- Key issues in distributor agreements
- What Business Structure Should Your Company Utilize
- Recruiting regulatory people/QA people
- Case studies
- Examples of what foreign medical device companies are doing in China
- FAQs for entering China’s medical device market
- Chinese Business and Cultural Issues
Click here to purchase a CD which includes the audio and PowerPoint presentation.
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