Navigating the regulatory landscape for medical devices in China can be complex. Our Linked series takes you step by step through the key processes, providing invaluable insights for manufacturers and stakeholders looking to enter or expand in this market. From product classification under the National Medical Products Administration (NMPA) to understanding the critical role of usability engineering, this series covers it all.
We explore the players, pathways, and requirements for medical devices in China, drawing comparisons to regulations you may already know from the FDA and European standards. You’ll also learn how cultural factors influence usability and user requirements in the Chinese healthcare environment.
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Stay tuned and discover how you can successfully navigate this regulatory landscape!