Register for Upcoming Webinar on DEC. 8 @ 11AM
2025 China NMPA Bluebook is here:
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,
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 “Key Points and Principles for Medical Device Clinical Trial Inspections (Draft) on November 28, 2023. Feedback needs to be submitted by December 31, 2023. It proposed to
China’s Ministry of Science and Technology published the “Details for the Implementation of the Human Genetic Resources Regulations” on June 1, 2023. Based on “Human Genetic Resources Management Regulations” effective
On March 2, 2022, Human Genetic Resources Administration of China (HGRAC) released the “Frequently Asked Questions on Human Genetic Resources Management”. On March 22, 2022, the Ministry of Science and
We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on an iliac vein stent system. Both technical and clinical requirements are outlined below. In
The NMPA and China Health Commission released the “Quality Management Practice Specification for Clinical Trials of Medical Devices”, implemented from May 1, 2022. The “China GCP” covers the whole process
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, Zhuhai,
If devices are not on the clinical evaluation exempt catalog but have an NMPA-approved predicate device to show substantial equivalence, per the “Guidance for Clinical Evaluation of Medical Devices” published
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