Category: Monthly Newsletter

NMPA News Roundup December 2020

January 27, 2021

Here’s the latest NMPA regulatory and clinical affairs news for medical device and IVDs pros in December 2020. These updates are presented by China Med

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NMPA (CFDA) Updates

Inspection Points for IVD Reagents: Centering on Control of Contamination, Traceability and Contract Manufacturing

Inspection Points for AI Medical Devices: Centering on Lifecycle Traceability and Risk Control of Data and Algorithms

NMPA Inspection Guideline for Independent Software under the New GMP: Summary, Key Points, and Comparison with the 2020 Version

Latest Resources

China’s New GMP 2025 – What Every Global Manufacturer Must Prepare Before Nov 1, 2026

Key Takeaways and Best Practices of China Human Factor/Usability

202505 NMPA News Roundup

Contact CMD

Email: info@chinameddevice.com

Phone: 978-390-4453

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Cambridge, MA 02142

CHINA Office:
Suite 1702C, Beijing Hailongshiyou Building, Chaoyang District, Beijing

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