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 regulation program has evolved rapidly over the past two decades. This two-hour overview covers the changes and key aspects of the regulations as they pertain to both domestic and overseas manufacturers.
- Recognize trends in China’s medical device market
- Identify key dates and changes to China’s medical device regulation
- 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 & 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
By completing/passing this course, you will attain the certificate Medical Device Certificate
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