China’s medical device and IVD market has grown to over $20 billion, the third largest in the world. Within the next five years, China’s device market is expected to surpass Japan’s device market to become the world’s second largest medical device market. The number of foreign medical device manufacturers registering their products in China has grown exponentially.
In the past year, China medical device regulations have seen many changes regarding medical device registration, production, labeling, and distribution. This webcast will give an overview of the main regulatory updates such as changes in Class I product registration and new clinical trial requirements for Class II and Class III devices. The new time frame, process, and documents required for product classification, registration, and approval will also be discussed.
To be successful in this fast growing market, view our webcast to learn about China medical device regulations and ways to expedite registration in China.
To view the webcast presentation slides in PDF format, please click on China Medical Regulatory Updates 2015 Webcast Slides.
Ames Gross, President and Founder of Pacific Bridge Medical.
- Overview of China’s Medical Device Market
- New Medical Device Regulations
- Product Classification
- New Product Registration Process and Timelines
- New Product Registration Requirements
- New Class 1 Device Notification Procedure and Required Documents
- New product standards
- New Clinical Trial Requirements for Class 2 and 3 Devices
- New Class 2 and 3 devices exempt from new clinical trial requirements
- Re-registration Regulations
- New Fast Track Approval
- Good clinical practice (GCP) in China
- New Labeling Requirements 2014
- Device Reimbursement Issues
- GMP Requirements
- IVD Product Registration
- IVD Registration Process
- New IVD Required Documents
- New IVD Clinical Trials Requirements
- New IVD Regulations
- Stem Cell Update
- Advertisement monitoring update
- Manufacturing Site Transfer Regulations
- Adverse Event Updates
- Recall Regulations
- New Good Supplier Practice (GSP) Regulations
- Case Studies: Transferring Manufacturing Locations
Pacific Bridge Medical can assist you with regulatory strategy and medical device registration in China, so you can obtain approval for your product in a timely and cost-effective manner. We can also act as your Chinese in-country representative. For updated China medical market information and a full list of our services in the Chinese medical market, please click here, or contact us for more information.