Latest / Medical Device Global Market Access
From MDR to NMPA: A Strategic Guide to China Market Entry
This episode details the strategic process for transitioning a medical device with a European CE mark under MDR to achieve Class II or III registration with China's NMPA. We break down the unique requirements, from local representation to in-country testing and clinical evaluation pathways, providing a clear roadmap for manufacturers looking to enter the complex but lucrative Chinese market. Key Questions: • Is a CE mark sufficient for selling a medical device in China? • What is a Product Technical Requirement (PTR) and why is it essential for NMPA registration? • Can we use our existing EU…
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