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2026 China NMPA Bluebook is here:
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
China NMPA issued the “Notice on Implementation of GB 9706.1-2020 and Supporting Standards”, equivalent to IEC60601 on March 16, 2023, with effective date of May 1,
The last time the NMPA In Vitro Diagnostic Reagents Classification Catalog was announced was in 2013, with two supplemental updates in 2017 and 2020 respectively.
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in February 2023. These updates are presented by China Med
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
Sixty nine high-risk Class III devices were included in the Unique Device Identification (UDI) application of First Group of Devices, which started from January 1,
The NMPA issued a notice summarizing device approvals in January 2023. In total of 23 imported Class II and III were approved, among them are
Eight manufacturers became master file owners for their raw materials or key components so far in 2023, including two foreign producers: Covidien and Invibio. Full
NMPA published 18 voluntary recall notices submitted by foreign manufacturers in January 2023. Big names are on the list, some of which recalled overseas submitted
The NMPA issued the “List of Ventilator Products Approved by Drug Administration” on January 5, 2023. Ventilators are usually divided into invasive and non-invasive ventilators.
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros for January 2023. These updates are presented by China