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2026 China NMPA Bluebook is here:
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
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
As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting on
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2023. These updates are presented by China
NMPA published 54 draft guidelines on October 25, 2023, for feedback. Feedback needs to be submitted by November 23, 2023. Significance of Device Guidelines The
NMPA granted innovation approval to Siemens’s X-ray computed tomography equipment on October 17, 2023. What’s the Device In the approval notice, NMPA says that “the
On May 16, 2023, the NMPA granted innovation approval to Conavi Medical Inc., from Canada, for its intravascular imaging system. It is the fourth imported
48 AI independent software have been approved so far, according to work summary of Artificial Intelligence Medical Device Innovation Cooperation Platform that NMPA CMDE established
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
The CMDE published a revision of the supplement phase on February 20, 2023, suggesting that it is ending Covid measures on medical device registration. The
The NMPA released ninety-four review reports in 2022. Three categories of approvals are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers including