Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
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
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
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.