PrintChina’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, given recent problems with heparin, di-ethylene glycol and melamine poisoning, quality issues have become paramount. What do you need to know about China to be successful and avoid pitfalls? Attend this webcast to learn more about China's current medical device market and its newest regulations. Make sure you have the right regulatory strategy to enter and grow your China business. There will be a 60-minute presentation followed by a 30-minute Q&A session.
See a sample page of our webcast presentation.
- Overview of China
- Demographics
- Number of medical facilities
- Regulatory authorities
- Best ways to interact with regulatory authorities
- Medical device classification
- Medical device product registration
- Class I device timeframe and process
- Class II and III devices timeframe and process
- Product Standard
- Type Testing
- Clinical Trials
- Documents required
- Agents
- Regulatory updates
- Device clinical trials in China
- Updates on requirements
- R&D in China
- Which companies are doing it
- Sourcing medical devices or components from China
- How to be successful and avoid pitfalls
- Quality Assurance/GMP
- GMP Development
- Draft GMP Regulations
- Required Documents
- GMP Inspection Process
- SFDA Inspection Focus
- Adverse Event Reporting
- New Regulations
- How do you find the right distributor for your medical device
- What areas to focus on
- What are the medical distribution channels
- What's the best strategy to win tenders
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 Chinese regulatory issues.
This webcast CD includes the audio and PowerPoint presentation.
