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Navigating China's New Regulatory Policy: Order 739 0.00 KB 205 downloads

China’s regulations for medical technologies are undergoing a significant revision...
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2021 New Updates: China NMPA Medical Device Clinical Pathways 0.00 KB 85 downloads

Want to reduce your device’s clinical trial costs and accelerate its time to market...
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Learn to Comply With China's UDI Submissions Requirements 0.00 KB 64 downloads

To keep up with international standards and help device manufacturers prepare for...
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Fast-Track Your Initial Clinical Use with the Hainan RWD/S Pilot Program 0.00 KB 62 downloads

Learn how the Hainan Real-World Data/Study (RWD/Study) pilot program can shave months...
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China IVD Registration Pitfalls and COVID-19 Test Kit Updates 0.00 KB downloads

The China IVD market has seen record growth recently and will continue to be an important...
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China Mandatory Period Risk Evaluation Report and the latest PMS Requirements in NMPA and FDA 0.00 KB 66 downloads

Did you know China, the second-largest medical device and in vitro diagnostic (IVD)...
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Update on China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19 0.00 KB 2 downloads

As COVID-19 has become a pandemic, the time is critical for the support and reassurance...
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2019 NMPA (CFDA) Key Updates & Trends: Look Ahead to 2020 0.00 KB 3 downloads

Hundreds of new NMPA regulatory policies, guidelines, standards and announcements...
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China’s NMPA Latest Regulatory Updates with PMS QMS Focus 0.00 KB 3 downloads

Did you know China, the second-largest medical device and in vitro diagnostic (IVD)...
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Developments in Clinical Pathways for NMPA (CFDA) Submission 0.00 KB downloads

This webinar will cover different clinical pathways and how to decide which pathway...
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China Adverse Event and Post Market Surveillance 0.00 KB 18 downloads

This webinar covers China post market surveillance (PMS). NMPA (CFDA) has started...
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How to Navigate Type Testing in China 0.00 KB 13 downloads

China FDA (NMPA) requires local type testing for the market approval of Class II...