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2013 China Medical Device Regulatory Updates

  • ID: 2474839
  • March 2013
  • Region: China
  • 90 Minutes
  • Pacific Bridge Medical

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 registering their products in China has grown exponentially. To be successful in this fast growing market, attend our webcast and learn the most efficient way to register your products in China. 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
- - Standards
- - 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

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown


Our Clients

AB Sciex Eli Lilly and Company B. Braun Melsungen AG Astellas Pharma, Inc. Hologic Corporation Merck & Co., Inc.