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2026 China NMPA Bluebook is here:
NMPA published the “Guideline for On-Site Inspection of Medical Device Supplier Quality Management (Draft)” on June 27, 2024. Feedback needs to be submitted by July
NMPA released “Quality Management Measures for Medical Device Operations” on December 7, 2023, effective July 1, 2024. The previous version published in 2014 was obsoleted.
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
All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system, according to Decree 739 “Medical Device
Covidien issued voluntary recall notice for Coated Braided Nylon Nonabsorbable Suture on January 4, 2024. It is a Class I recall, which indicates the most
NMPA conducted on-site quality inspection on eleven types of medical devices and released the result on December 18, 2023. Eighteen manufacturers are found incompliance, including
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
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 total of 23 imported devices issued voluntary recall notices from July to September 2023. Affected manufacturers include Medtronic, Siemens, Abbott, Covidien, Johnson & Johnson,
Here is our summary of our successful study with China GMP’s support. Guide a US manufacturer with 5 global sites to comply with China GMP
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
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