2012 China Medical Device Regulatory Update Webcast
China's medical device market has grown to $8.8 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 current China medical device regulations and how they affect the market. 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 China medical device regulations to streamline the regulatory process
- Does Your Medical Device Need to be Registered
- Product Classification
- Medical devices
- Combination products
- Product Registration Process
- 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
- 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
- Device Insurance and Reimbursement Issues
- QA/GMP Audits
- What is the current state of QA at China medical device factories
- How to upgrade your China facilities or suppliers
- Labeling Updates
- Country of Origin
- Sub-contract Manufacturing in China and Regulatory Ramifications
- Site product in China as made in West
- Organizational Issues with HQ and Your Local China Office or Distributor
- Adverse Events and Updates
- Cultural Issues to Be Successful
Who should attend:
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 regulations.
Ames Gross, President and Founder of Pacific Bridge Medical.
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 fifteen minutes before the start of the webcast.
Thursday, September 27, 2012
- 11:00 a.m. to 12:30 p.m. U.S./Eastern Standard Time
- 10:00 a.m. to 11:30 a.m. U.S./Central Standard Time
- 9:00 a.m. to 10:30 a.m. U.S./Mountain Standard Time
- 8:00 a.m. to 9:30 a.m. U.S./Pacific Standard Time
- 4:00 p.m. to 5:30 p.m. GMT Standard Time
Fee and registration:
Each dial-in number is $400. If you have any questions, please contact us at firstname.lastname@example.org or (301) 469-3400, ext. 8.
The registration fee is non-refundable. If you are unable to attend, we will be glad to send you a CD with the webcast recording.
Please see our website www.pacificbridgemedical.com for additional information and our upcoming schedule.