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2026 China NMPA Bluebook is here:
NMPA published 12 medical devices guidelines on August 12, 2024. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device Guidelines
Thirty-six newly established or revised industry standards were released by NMPA on July 10, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and
NMPA issued the “List of Mandatory Standards Applicable to Medical Devices” on June 13, 2024, directing manufacturers for type testing and regulatory submission. Over 400
The NMPA granted Class II approvals to Roche’s Vitamin K Antagonist Self-Test, the combination of CoaguChek INRange and CoaguChek XS PT Test PST, and issued
NMPA published 48 medical devices guidelines on May 27, 2024. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device Guidelines
NMPA approved Medtronic’s Symplicity Spyral Renal Denervation System, the disposable multipolar renal artery radiofrequency ablation catheter and renal artery radiofrequency ablation device, according to a
NMPA published the “2024 Medical Device Guidelines Revisions Plan” today on April 11, 2024, in which 49 guidelines for Class III and 60 for Class
NMPA published the “Medical Devices Usability Engineering Guideline” on March 19, 2024. Below is the “Interpretation on Device Usability Engineering Guideline” issued on March 27,
NMPA published the “Medical Devices Usability Engineering Guideline” on March 19, 2024. NMPA believes that, in improving the usability and the design of devices to
NMPA issued the draft version of “2024 Medical Device Industry Standards Revisions Plan” on March 22, 2024, with the deadline for feedback on March 29.
From April 1, 2024, some cosmetic devices shall not be produced, imported, or sold without obtaining a medical device registration certificate, which include radiofrequency (RF)
NMPA issued the “Clinical Evaluation Guideline with Predicate Comparison of Radiofrequency Ablation (RFA) and Microwave Ablation (MWA) Equipment (Draft)” for feedback on February 18, 2024.