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2026 China NMPA Bluebook is here:
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 Med Device, LLC, your partner
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 for international medical services. A
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 STORZ. It was found that
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 evaluation and regulatory submission. The
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 STORZ. It was found that
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 quality inspections based on Mandatory
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 Device, LLC, your partner in
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 with clearer guidance on testing,
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 Medical Device Software, effective March
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 Specific Circumstances” on March 13,
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 allows applicants for innovative devices
The NMPA approved Shanghai Lixiao’s thermal vapor therapy equipment and the single-use prostate thermal vapor therapy device on February 28, 2026. The thermal vapor therapy equipment consists of a main