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The recent crackdown by the SFDA has meant new regulations and stricter enforcement for all aspects of the Chinese medical device market. Make sure you know of all the recent regulatory changes in China and the SFDA’s plan for the future. This webcast CD will cover dossier preparation and product registration processes in addition to recent new Chinese medical device regulations. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.
Click here to see a sample page of our webcast presentation.
The following topics are covered in this webcast:
- Overview of China’s medical device markets
- Dossier preparation and key documents for submissions
- Medical device classification system
- Type testing
- Product registration and timeline of review process
- Clinical trials and Good Clinical Practice (GCP)
- Good Manufacturing Practice (GMP)
- Post-marketing surveillance and quality control
- Reimbursement and pricing
- Current issues in China’s medical device market
- New pending medical device regulations on:
- IVDs
- Clinical trials and Adverse event reporting
- Medical device registration
- Inspection of imported medical devices
- And more
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.
Click here to purchase a CD which includes the audio and PowerPoint presentation.
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