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2026 China NMPA Bluebook is here:
There have been 92 recalls from overseas manufacturers reported to the NMPA in 2022, as of December 21. Many big names are on the list.
69 high-risk class III devices were included in the Unique Device Identification (UDI) application of First Group of Devices, which started from January 1, 2021.
The NMPA issued the “Guideline on Inspection of Quality Management System for Medical Device Registration” on October 10, 2022, implementing from the day of release.
Unique Device Identification (UDI) will be implemented with all Class III devices and IVDs, effective from June 1, 2022. It was announced by NMPA at
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,
NMPA published the “Evaluation of the Safety and Effectiveness of Medical Devices Containing Nanomaterials Part I: Framework” on August 30, 2021, directing manufacturers on key
Unique Device Identification (UDI) will be implemented with all Class III devices, announced by NMPA at the “Notice on Applying Unique Device Identification System for
Unique Device Identification (UDI) will be implemented with all Class III devices, announced by NMPA at the “Notice on Applying Unique Device Identification System for
The NMPA published Checkpoints for Medical Device Registrants and Fillers Conducting Adverse Event Monitoring on April 9, directing the manufacturers for quality management system inspection
NMPA issued 2020 Adverse Events Report on March 22, 2021, summarizing over 530,000 reports, 35.25% rise from the year before. “Medical device manufacturers should take
On January 25, 2021 the China National Health Commission issued the Technical Guideline for COVID-19 Prevention and Control on Manufacturers and Suppliers of Imported Products.
NMPA “Rules for Unique Device Identification (UDI) System” Issued on August 27, 2019 mandates that the China UDI system for the first group of devices