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2025 China NMPA Bluebook is here:
NMPA released the revised Good Manufacturing Practice (GMP) for Medical Devices on November 4, 2025, also referred to as the “Specification for Medical Device Production.”
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
NMPA conducted on-site quality inspection on eleven types of medical devices and released the result on December 18, 2023. Eighteen manufacturers are found incompliance, including
Here is our summary of our successful study with China GMP’s support. Guide a US manufacturer with 5 global sites to comply with China GMP
The NMPA “Medical Device Registration and Filing Management Measures” and “In Vitro Diagnostic Reagents Registration and Filing Management Measures” have been effective since October 1,