Register for Upcoming Webinar on DEC. 8 @ 11AM
2024 China NMPA Bluebook is here:
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
NMPA announced the “Measures for Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)” on March 12, 2024, for feedback, along with the inspection checkpoints and judging principles. Feedback
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” today on March 18, 2024. The document suggests manufacturers how to choose predicate device comparison or clinical trial
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