China’s medical device market has grown to $13 billion, the second largest in Asia after Japan. The number of foreign medical device manufacturers registering their products in China has grown exponentially. View our webcast to learn about the new regulations in China. This webcast will also review ways to expedite registration in China.
To view the webcast presentation slides in PDF format, please click on China Medical Device Regulatory Updates 2014 Webcast Slides.
Presenter
Ames Gross, President and Founder of Pacific Bridge Medical.
Overview
- Overview of China’s Medical Device Market
- CFDA – Recent Reorganization
- Product Classification
- Product Registration Process
- Product Registration Requirements
- New product standards
- Document requirements
- Testing – best ways to do it
- New supplementary review update
- New CCC regulations
- Country of origin
- Raw materials update
- Product Registration Tips
- New Re-registration Regulations
- New Fast Track Approval
- Conducting Device Clinical Trials in China
- Good clinical practice (GCP) in China
- New clinical trial updates
- New clinical trials requests for products not yet registered in China
- New expansion of Class II products exempt from local clinical trials
- New local clinical trial requirement for certain high risk devices
- Device Reimbursement Issues
- High Value Device Purchasing
- GMP/QA Requirements
- New inspection standards
- Case Studies – Manufacturing
- New Labeling Requirements 2013
- Advertisement monitoring update
- New Manufacturing Site Transfer Regulations
- Adverse Event Updates
- New recall regulations
- New Good Supplier Practice (GSP) Regulations
- New Penalties for Violation
- New Future Expected Regulatory Changes