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2026 China NMPA Bluebook is here:
NMPA published the “2026 Medical Device Guidelines Revisions Plan” on April 27, 2026, affecting 56 Class III and 219 Class II devices. The revisions are
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in May 2026. These updates are presented by China
The Health Commission of Guangdong Province, together with the provincial healthcare security and medical products authorities, has jointly announced the first batch of pilot hospitals
The NMPA issued an inspection result on March 31, 2026 for German manufacturer KARL STORZ’s High-frequency Surgery System. NMPA organized a remote inspection of KARL
NMPA published 5 medical devices final guidelines on April 9, 2026. They are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical
The NMPA issued an inspection result on March 31, 2026 for German manufacturer KARL STORZ’s High-frequency Surgery System. NMPA organized a remote inspection of KARL
NMPA announced the “2026 National Inspection Plan for Medical Devices” on April 8, 2026. The Plan asks provincial NMPA offices and testing centers to conduct
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in April 2026. These updates are presented by China Med
On March 24, 2026, NMPA published draft versions of registration review key points for 18 medical devices. Once finalized, the documents aim to provide manufacturers
On March 17, 2026, the NMPA released 26 medical device industry standards, including the revised YY/T 1406—2026: Guidance on the Application of GB/T 42062 to
The NMPA, together with National Health Commission and National Healthcare Security Administration, issued the “Advancing UDI Implementation for Subsequent Device Categories” and “UDI Implementation under
The NMPA Center for Medical Device Evaluation (CMDE) issued the “Pre-Review of Clinical Trial Protocols for Innovative Medical Devices” on March 13, 2026. This initiative