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2026 China NMPA Bluebook is here:
China’s revised Good Manufacturing Practice (GMP) for medical devices will take effect on November 1, 2026, marking the most substantial update to the country’s device manufacturing regulation since the original
NMPA released the final guideline “Clinical Trial Key Points on Implanted Brain-Computer Interface (BCI) Hand-Movement Compensation Systems” on October 22, 2026. The draft version was issued in July 2026 for
NMPA issued the “Good Manufacturing Practice for Medical Devices: Inspection Guidelines for In Vitro Diagnostic Reagents (Draft)” on September 29, 2026. The document combines the China new GMP with its
NMPA Center for Drug Inspection issued the “Inspection Points for Artificial Intelligence Medical Devices (Draft)” for feedback. Feedbacks need to be submitted by October 28, 2026. Based on the new
The NMPA issued “On-Site Inspection Guideline for Standalone Software of the Medical Device Production Quality Management Specification” on September 30, 2026. It is intended to strengthen production supervision and guide
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
NMPA published 130 medical devices draft guidelines on September 1, 2026 for feedback. Feedbacks need to be submitted by October 8, 2026. Among them are 16 IVDs, 55 non-active, and
The NMPA released the “Draft Guideline on Artificial Intelligence Medical Devices” and “Draft Guideline on Clinical Evaluation of Artificial Intelligence Multi-Disease Auxiliary Decision-Making Medical Device” on September 14 and 15
The NMPA issued the “Guideline for Inspection under the Medical Device Good Manufacturing Practices” on September 15, 2026, which will take effect on November 1, 2026. The final guideline follows
The revised China Medical Device Good Manufacturing Practices (GMP), released in November 2025, will take effect on October 1, 2026. Following the release, NMPA has issued comprehensive suite of GMP
Here’s the latest China 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 in
NMPA issued the “Technical Review Key Points for Implanted BCI Motor Function Compensation Device (Draft)” on August 18, 2026. This document is for premarket review of implanted brain‑computer interface (BCI)