Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
The NMPA issued “2024 National Medical Device Clinical Evaluation Standards Project Proposals” on March 8, 2023, asking proposals by June 30, 2023. Those received thereafter
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in March 2023. These updates are presented by China
The NMPA published the “2023 Medical Device Guidelines Revisions Plan” on April 4, 2023, in which 247 guidelines are affected. The revisions are aimed to
The NMPA announced the “2023 National Inspection Plan for Medical Devices” today (March 31, 2023). The Plan asks provincial NMPA offices and testing centers to
Hainan government released the “Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone
The National Health Insurance Administration issued the “Reply to Recommendation No. 3298 of National People’s Congress” on March 4, in which the Administration agrees to
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