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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, also referred to as the “Specification for Medical Device Production.”
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
The last time the China GMP were completely overhauled was in 2014. NMPA published the new draft “Medical Device Manufacturing Quality Management Standards” on January
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
NMPA Center for Medical Device Standardization Administration Issued the draft national standard “Post-Market Surveillance for Medical Device Manufacturers” on July 19, 2024, for feedback. Feedback
NMPA published the final document of “Guideline for On-Site Inspection of Medical Device Operation Quality Management” on July 30, 2024. The draft was issued on
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
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