Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
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. These documents apply exclusively to
NMPA published the “2026 Medical Device Guidelines Revisions Plan” on April 27, 2026, affecting 56 Class III and 219 Class II devices. The revisions are aimed to facilitate manufacturers with
NMPA published 5 medical devices final guidelines on April 9, 2026. They are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical evaluation and regulatory submission. The
The NMPA recently released the industry standard YY/T 1987—2025, titled “Brain-Computer Interface Medical Equipment—Terminology”. This represents China’s first official standard dedicated to brain-computer interface (BCI) medical devices, providing a structured
NMPA published a draft document “Implementation Guideline for the Self-Testing Requirements of Medical Device Registration” on June 26, 2025 for feedback. Feedbacks need to be submitted by July 11, 2025.
NMPA published the “Implementation Rules for the Special Review of Innovative Medical Devices” on April 18, 2025. The document is based on the “Innovative Medical Devices Review Procedures” issued in
NMPA issued the “2025 Medical Device Industry Standards Revisions Plan” on February 24, 2025. Six mandatory and seventy-nine recommended standards will be revised or established. The Standards Revisions are aimed
The NMPA granted innovation approvals to MediBeacon Inc.’s transdermal GFR measurement system (TGFR) and issued a review report. The published review reports like this one serve as important references for
The NMPA released 49 national standards and 90 industry standards for medical devices and in vitro diagnostics (IVDs) in 2024. These standards were revised or newly established to assist manufacturers
The NMPA granted innovation approval to Roche’s Elecsys EBV VCA IgG and issued a review report on December 4, 2025. The published review reports like this one serve as important
Thirty-four newly established or revised industry standards were released by NMPA on October 8, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of Compliance
Thirty-four newly established or revised industry standards were released by NMPA on October 8, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of Compliance