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2026 China NMPA Bluebook is here:
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
The new “Regulation for Medical Device Administration and Supervision”, Order 739, effective since June 1, 2021, allows the implied permission for class III devices conducting
The NMPA granted innovation approval to Suzhou LinaTech for the electron linear accelerator, and CMDE (Center for Medical Device Evaluaiton) issued the Review Report for
NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostics” on December 3, 2021, finalizing the draft version issued in late November
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros for November 2021. These updates are presented by China Med
NMPA published the “Medical Device Clinical Trial Data Submission Guideline” and “In Vitro Diagnostic Reagent Clinical Trial Data Submission Guideline” on November 25, finalizing the
Hainan NMPA published “Guideline for Importation of Urgently Needed Drugs and Medical Devices in Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone”
The published the “Clinical Evaluation Guideline for In Vitro Diagnostic Reagents Listed in Catalog of Clinical Trial Exemption” and “Clinical Guideline for In Vitro Diagnostic
The NMPA published the “Guideline on Decision Making of Conducting Clinical Trial for Medical Devices” on September 28, 2021, directing manufacturers on how to decide
The NMPA released the “Catalog of Medical Devices and IVD Products Exempted from Clinical Trials” on September 18, 2021, which includes 1010 devices and 423
The Hainan Provincial NMPA, the Hainan Health Commission, and the Haikou Customs jointly issued the “Optimizing Regulatory Services to Support the High-Quality Development of Hainan
The last time the “Medical Device Registration Administrative Measures” were completely overhauled was in 2014. The newer regulations with significant changes have been introduced focusing