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2026 China NMPA Bluebook is here:
NMPA released the revised Good Manufacturing Practice (GMP) for Medical Devices on November 4, 2025, taking effect on November 1, 2026. This marks the most
NMPA published seven guidelines on post-market surveillance for medical device manufacturers in April 2026. These documents establish a mandatory, risk‑based vigilance system under the Medical
The NMPA granted innovation approval to B.Braun Avitum’s CRRT hemofilter and issued a review report. The published review reports like this one serve as important
NMPA published the “Clinical Evaluation Exempt Draft Catalog for Medical Devices” and “Clinical Evaluation Exempt Draft Catalog for In Vitro Diagnostics” on April 30, 2026.
NMPA published 5 medical devices final guidelines on April 30, 2026. They are aimed to facilitate manufacturers with clarity in clinical evaluation requirements. All five
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