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2026 China NMPA Bluebook is here:
NMPA issued the “Good Manufacturing Practice for Medical Devices: Inspection Guidelines for In Vitro Diagnostic Reagents (Draft)” on September 29, 2026. The document combines the China new GMP with its
In August 2026, the NMPA issued four announcements suspending the import, distribution, and use of specific medical devices from Coloplast A/S (Denmark), Avinger, Inc. (USA), Eurocor Tech GmbH (Germany), and
The NMPA issued two inspection results on July 27 and August 3, 2026 respectively to Japanese manufacturer HOYA Technosurgical and German manufacturer Eurocor Tech. NMPA organized a remote inspection of
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
NMPA Center for Food and Drug Inspection issued the “Notice of Unannounced Inspections Results in 2nd batch of 2025” on August 15, 2025. The unannounced inspections, also called surprise inspections
The NMPA released the results of two overseas inspections on October 8, 2024, which revealed noncompliance in two South Korean manufacturers. This marked the resumption of overseas on-site inspections of
The NMPA issued an inspection result on July 19, 2023, identifying the size error in product technical requirement (PTR). NMPA organized a remote inspection of SAMO S.p.A, an Italian orthopedic
NMPA announced the “2024 National Inspection Plan for Medical Devices” today on March 19, 2024. The Plan asks provincial NMPA offices and testing centers to conduct quality inspections based on
NMPA conducted quality inspection on eleven types of medical devices and released the result on November 14, 2023. Twenty manufacturers are found incompliance, including three overseas companies making soft contact
The NMPA issued an inspection result on October 25, 2023, for the inconsistence of manufacturing addresses. NMPA organized a remote inspection of XVIVO Perfusion AB, a Swedish medical technology company.
The NMPA conducted a “fly inspection”, also known as an unannounced inspection, on Chenfang Sichuang Technology Co., Ltd. According to the notice published on April 17, 2023, the inspection found