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2026 China NMPA Bluebook is here:
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
NMPA released the revised Good Manufacturing Practice (GMP) for Medical Devices on November 4, 2025, taking effect on November 1, 2026. This marks the most
NMPA published seven guidelines on post-market surveillance for medical device manufacturers in April 2026. These documents establish a mandatory, risk‑based vigilance system under the Medical
NMPA published 5 medical devices final guidelines on April 30, 2026. They are aimed to facilitate manufacturers with clarity in clinical evaluation requirements. All five
The NMPA issued an inspection result on March 31, 2026 for German manufacturer KARL STORZ’s High-frequency Surgery System. NMPA organized a remote inspection of KARL
The NMPA, together with National Health Commission and National Healthcare Security Administration, issued the “Advancing UDI Implementation for Subsequent Device Categories” and “UDI Implementation under
The NMPA Center for Medical Device Evaluation (CMDE) issued the “Pre-Review of Clinical Trial Protocols for Innovative Medical Devices” on March 13, 2026. This initiative
The NMPA approved Shanghai Lixiao’s thermal vapor therapy equipment and the single-use prostate thermal vapor therapy device on February 28, 2026. The thermal vapor therapy
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in March 2026. These updates are presented by China
The NMPA issued the “Announcement on Adjustments to Certain Items in the Medical Device Classification Catalog” on January 4, 2026. The adjustments are aimed to
NMPA issued the “2026 Medical Device Industry Standards Revisions Plan” today on January 28, 2026. One mandatory and seventy-nine recommended standards will be revised or
In the review reports released in December 2025, eight out of ten pertained to IVD reagents, reflecting the continued advancement and regulatory scrutiny in fields