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2026 China NMPA Bluebook is here:
NMPA issued the “Regulations on Self-test of Medical Device Registration (Draft)” on June 2, 2021, directing manufacturers on how to self-test and to submit the
NMPA issued the 2021 Medical Device Industry Standards Revisions Plan (draft) on May 26, in which 77 medical devices and IVDs are affected. The Standards
Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in May 2021. Policies Major
China NMPA released eight draft clinical guidelines for urgent feedback to support the new overarching State Order 739, the “Regulation for Medical Device Administration and
The NMPA issued eight draft guidelines to regulate the clinical pathways in May. Feedback needs to be submitted to the NMPA by May 30, 2021.
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The NMPA is now seeking comments to the draft guidance “Artificial Intelligence Medical Software Classification ”, due by May 3, 2021.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