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2026 China NMPA Bluebook is here:
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
China’s ophthalmology market is on the cusp of transformation, presenting lucrative opportunities for global device manufacturers. As one of the fastest-growing healthcare sectors in the
The NMPA issued the “Regulation on the Supervision and Administration of Medical Devices” on January 7, 2025, a revised version of the same-named regulation implemented
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your
The NMPA granted innovation approval to Mevion Medical System’s proton therapy system and issued a review report on December 4, 2025. The published review reports
The General Office of the State Council issued the “Opinions on Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of