Global Medical Device Regulatory Requirements – China (2 hours)

This course provides a comprehensive overview of China's medical device regulatory framework, including both pre-market and post-market requirements. China’s medical device regulations have evolved rapidly over the past two decades. This two-hour course covers the changes and key aspects of the regulations relevant to manufacturers wanting to market and sell in China.

Key learning objectives:

By the end of this course you will be able to:

• Recognize trends in China’s medical device market
• Identify key dates and changes to China’s medical device regulations
• Recognize key differences in China’s medical device classification system
• Explain the pros and cons of the registration process in China for domestic and overseas manufacturers
• Explain the importance of the clinical evaluation report (CER) for approval of most Class II and III medical devices
• Recognize the increasing importance of post-market surveillance activities for medical devices
• Recognize the importance of complying with NMPA guidelines for labeling and IFUs

This course is vital for any medical device professional looking to bring products to market, or to manufacture or audit products in China. This course is particularly helpful for employees responsible for regulatory compliance, including developing pre-market submissions for entry into China.