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2026 China NMPA Bluebook is here:
NMPA published 57 medical devices final guidelines on July 21, 2026. They are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical
The NMPA released the “Draft Guideline on Clinical Evaluation for Cardiac Radiofrequency Ablation Devices” on July 2, 2026 for feedback. Feedbacks need to be submitted
NMPA released the “Draft Guideline on Clinical Evaluation of AI-Assisted Diagnostic Medical Devices” on June 17, 2026. Feedbacks need to be submitted by July 10,
The NMPA issued the “Technical Review Points for Tumor Gene Variation Detection Reagents (Trial)” on June 15, 2026. This guidance covers NGS‑based IVD reagents for
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your
The NMPA issued “Guideline on Product Classification of Brain-Computer Interface (BCI) Medical Devices” and “Guideline on Nomenclature of BCI Medical Devices” on June 30, 2026.
The NMPA released the Draft Guideline for Inspection under the Medical Device Good Manufacturing Practices on June 9, 2026. Feedbacks need to be submitted by
NMPA published four draft registration guidelines on June 3, 2026. Feedbacks need to be submitted by Jun 22, 2026. They are aimed at facilitating manufacturers
On June 1, 2026, the NMPA released two documents that strengthen its dynamic medical device classification system. The first is the “Classification Adjustment Announcement.” The
The NMPA released two documents to enhance the dynamic management of medical device classification on June 1, 2026. Issued as “Classification Adjustment Announcement” and the
To support the implementation of the IVD Reagent Classification Catalog issued in May 2024, NMPA issued a detailed interpretive guideline specifically for staining solutions. This
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in June 2026. These updates are presented by China Med