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2026 China NMPA Bluebook is here:
The NMPA granted innovation and priority review status to eight manufacturers in April, by which they can begin the fast-track application process. The complete list
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
Juvederm Volbella, indicated for lip enhancement, was approved by the NMPA on April 25, 2021. The clinical evaluation, conducted in Hainan utilizing Real-World Data methods,
The NMPA is now seeking comments to the draft guidance “Artificial Intelligence Medical Software Classification ”, due by May 3, 2021. AI technologies have the
The article below provides comprehensive technical review on AI-aided Software Guideline, released in June 2019. It was written by Elisa Mark and published on BioWorld,
The NMPA officially published the first guideline specifically for CDx reagents, the “Guideline for Technical Review and IFU Update for Oncology CDx Based on the
Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. Policies Highest Decree
The new “Regulation for Medical Device Administration and Supervision”, Order 739 LDT was released on Mar 18, 2021. The effective date is June 1, 2021.
China NMPA moves fast to provide more details in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, to support
The NMPA published “Guidelines Revisions for 22 Class II Medical Devices” on March 17, 2021. Feedback needs to be submitted by April 17, 2021. It
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
NMPA issued Notice regarding Medical Device Master Files Register on March 12, 2021. The draft was published in January 2019. Medical device master file in