PrintThis webcast CD provides an overview of the medical device regulations of the Chinese State Food and Drug Administration (SFDA) as well as discusses the most recent regulatory issues (including product registration). This China presentation has 62 PowerPoint slides. The speaker is PBM's partner in China.
See a sample page of our webcast presentation.
The following topics are covered in this webcast:
- Product registration and timeline of review process
- Reimbursement and pricing
- Approval procedures for conducting clinical trials in China
- Requirements for product inserts, labeling and packaging
- Dossier preparation and key documents for submissions
- Classification system of medical devices
- Good Manufacturing Practice (GMP)
- Good Clinical Practice (GCP) Good Labor Practice (GLP) ISO 13485
- Post-marketing surveillance and quality control
- Other new regulations
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 a number of new Chinese regulatory issues.
Our speaker is from China and has over twenty years of experience in Chinese regulatory affairs.