Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in October 2026. These updates are presented by China Med Device, LLC, your partner in
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in August 2026. These updates are presented by China Med Device, LLC, your partner
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 guidance provides regulatory clarity for
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 substantial update to China’s device
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 Device Vigilance Quality Management Standards
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 guidance documents are directed at
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 STORZ. It was found that
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 Specific Circumstances” on March 13,
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 allows applicants for innovative devices
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 equipment consists of a main
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 Med Device, LLC, your partner
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 keep up with the international