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2024 China NMPA Bluebook is here:
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
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 conduct quality inspections based on
The NMPA “Medical Device Registration and Filing Management Measures” and “In Vitro Diagnostic Reagents Registration and Filing Management Measures” have been effective since October 1, 2021. The new registration measures
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