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2026 China NMPA Bluebook is here:
The NMPA released the Draft Guideline for Inspection under the Medical Device Good Manufacturing Practices on June 9, 2026. Feedbacks need to be submitted by June 24, 2026. This draft
NMPA published four draft registration guidelines on June 3, 2026. Feedbacks need to be submitted by Jun 22, 2026. They are aimed at facilitating manufacturers with clarity in technical documentation,
On June 1, 2026, the NMPA released two documents that strengthen its dynamic medical device classification system. The first is the “Classification Adjustment Announcement.” The second is the “Working Procedure
The NMPA released two documents to enhance the dynamic management of medical device classification on June 1, 2026. Issued as “Classification Adjustment Announcement” and the “Working Procedure for Dynamic Adjustment
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
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in June 2026. These updates are presented by China Med Device, LLC, your partner in
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
The NMPA granted innovation approval to B.Braun Avitum’s CRRT hemofilter and issued a review report. The published review reports like this one serve as important references for you to understand
NMPA published the “Clinical Evaluation Exempt Draft Catalog for Medical Devices” and “Clinical Evaluation Exempt Draft Catalog for In Vitro Diagnostics” on April 30, 2026. Feedbacks need to be submitted
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
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