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2026 China NMPA Bluebook is here:
China has implemented stricter requirements over medical device manufacturing and quality systems. Analyzing China’s 2024 inspection data for overseas manufacturers reveals three key developments: heightened
NMPA published the “Inspection Checkpoints and Judging Principles for Clinical Trial” on March 12, 2025. The trial version was released in June 2024. For overseas
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in March 2025. These updates are presented by China Med
Devices and Equipment for Cataract Treatment The success of cataract surgeries hinges on the use of advanced surgical equipment. The main technology driving cataract surgeries
Introduction China’s healthcare market, one of the largest and most rapidly growing in the world, presents numerous opportunities for foreign manufacturers, particularly in specialized fields
NMPA issued the “2025 Medical Device Industry Standards Revisions Plan” on February 24, 2025. Six mandatory and seventy-nine recommended standards will be revised or established.
The NMPA granted innovation approvals to MediBeacon Inc.’s transdermal GFR measurement system (TGFR) and issued a review report. The published review reports like this one
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in February 2025. These updates are presented by China Med
The NMPA released 49 national standards and 90 industry standards for medical devices and in vitro diagnostics (IVDs) in 2024. These standards were revised or
The last time the China GMP were completely overhauled was in 2014. NMPA published the new draft “Medical Device Manufacturing Quality Management Standards” on January
The NMPA granted innovation approval to Roche’s Elecsys EBV VCA IgG and issued a review report on December 4, 2025. The published review reports like
The last time the China GMP were completely overhauled was in 2014. NMPA published the new draft “Medical Device Manufacturing Quality Management Standards” on January