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- Create Date January 23, 2020
- Last Updated January 30, 2023
China NMPA Latest Regulatory Updates with PMS QMS Focus
Did you know China, the second-largest medical device and in vitro diagnostic (IVD) industry market globally, is the only market with a 20 percent annual growth rate year after year?
Are you up to speed on the hundreds of new regulations introduced by China’s National Medical Products Administration (NMPA) — formally known as the China Food and Drug Administration?
What are the strategic factors to consider during the reform before your submission?
During the webinar, you will:
- Determine how to leverage a legal agent in China to increase your compliance by understanding their roles and responsibilities
- Discover how to assess and determine the new piloted MAH system by understanding its MAH qualification requirements and responsibilities
- Familiarize yourself with how to leverage your overseas QMS for your China operations by understanding China GMP regulations and Chinese culture differences
- Find out how to comply with required adverse events (AE) and serious adverse events (SAE) reports, including how to differentiate between AE and SAE and when to report