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Navigating Dual Regulations: Strategies for IVD Market Approval in China and the EU

In vitro diagnostic (IVD) manufacturers planning to penetrate both the Chinese and European markets face a complex regulatory environment. This white paper provides an insightful comparison between the Chinese National Medical Products Association (NMPA) and the EU In Vitro Diagnostic Regulation (IVDR), offering a comprehensive guide for simultaneous market entry. This is also beneficial for Chinese manufacturers entering the European market and vice versa, examining the intricacies of each region’s regulatory framework, language requirement, in-country representative, manufacturers’ obligation, clinical evidence, regulatory submission, conformity assessment timeframe and post-market considerations. Understanding these similarities and differences is not only essential for compliance, but pivotal for establishing effective market strategies.

Navigating multiple regulations can be challenging when launching medical devices in a global market. With recent changes and varying requirements in the EU and Chinese markets, what similarities and differences should Sponsors be aware of when preparing for submission?

Access NAMSA’s latest White Paper to learn more.