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2026 China NMPA Bluebook is here:
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
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
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
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”
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,
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
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
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
On July 23, 2026, the National Center for ADR Monitoring (NCDR) of China released its annual report on medical device adverse event monitoring for 2025,
In August 2026, the NMPA issued four announcements suspending the import, distribution, and use of specific medical devices from Coloplast A/S (Denmark), Avinger, Inc. (USA),
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. It does NOT require local
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