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2026 China NMPA Bluebook is here:
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities
NMPA released “Quality Management Measures for Medical Device Operations”, on December 7, 2023, effective July 1, 2024. The previous version published in 2014 was obsoleted.
NMPA published the finalized document “Guideline on Medical Device Real-world Study Design and Statistical Analysis” on January 15, 2024. The draft version was released on
NMPA published the four IVD-related guidelines on January 18, 2024. They are aimed to facilitate manufacturers with more product-specific guidance and clarity in registration process.
NMPA Roundup December 2023 Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in December 2023. These updates
NMPA published the twelve guidelines (IVD Guidelines) for in vitro diagnostic reagents-related products on January 3, 2024. It comes as File No.1 released by NMPA
NMPA published the “Guideline on Core Raw Materials of In Vitro Diagnostic Reagents” on January 3, 2024, along with eleven IVD related guidance. It comes
AI Guidelines 2023 The NMPA (National Medical Products Administration) affiliated Artificial Intelligence Medical Device Innovation Cooperation Platform has provided a comprehensive summary of six pivotal
NMPA granted innovation approvals to seven devices in December 2023, for indications ranging from cardiovascular, orthopedic, immunology and urology. Among them are two imported devices.
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
In October 23, a total of 221 medical device products were approved by China National Medical Product Administration (NMPA). Among them, there are 176 domestic
NMPA issued four draft clinical guidelines on December 11, 2023. Feedback needs to be submitted by January 2, 2024. For an English copy of any