Register for Upcoming Webinar on DEC. 8 @ 11AM
2025 China NMPA Bluebook is here:
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 15, 2025, for feedback. Feedback
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 three overseas companies. Companies Found
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 Objectives Key Activities Recommended Areas
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, 2021. The new registration measures
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