Register for Upcoming Webinar on DEC. 8 @ 11AM
2025 China NMPA Bluebook is here:
NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents” on June 24, 2025, which exempts 445 IVDs from clinical trials, including 27 Class III IVDs. The draft
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices” on May 13, 2025, which newly-includes 27 medical devices, including 7 Class III and 20 Class II devices. Implementing risk-based
NMPA Center for Food and Drug Inspection released the “Key Points for the Inspection of Real-World Studies on Medical Devices (Draft)” for feedback on December 27, 2024. Feedback needs to
NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents (Draft)” on November 5, 2024, which newly-includes 387 IVDs. Feedback needs to be submitted by December 3, 2024.
The NMPA CMDE (Center of Medical Device Evaluation) published the “Clinical Trial Design Types Recommendations for Non-active Implantable Devices, Neurological and Cardiovascular Surgical Devices, Dental Instruments, Radiotherapy Devices, Diagnostic Devices,
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen,
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices (Draft)” on July 31, 2024, which newly-includes 23 medical devices. Feedback needs to be submitted by August 30, 2024. Implementing
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen,
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen,
NMPA published the “Inspection Checkpoints and Judging Principles for Clinical Trial” for feedback. Feedback needs to be submitted by June 30, 2024. NMPA announced the “Measures for Supervision and Inspection
NMPA issued the clinical trial audit result for an IVD manufacturer on April 16, 2024. The audited firm is Guangdong Hexin. Its Respiratory Syncytial Virus, Influenza A Virus, Influenza B
“Quality Management Practice Specification for Clinical Trials of Medical Devices (so called China GCP)”, implemented from March 2022, specifies that “Clinical trial sites must be on the NMPA filed institutions
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