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2026 China NMPA Bluebook is here:
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in May 2024. These updates are presented by China Med
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
The NMPA granted innovation approval to Ivantis, Inc.’ hydrus microstent and issued a review report. This is the fifth report published for overseas manufacturers, after
The NMPA Medical Device Standardization Administration issued the “First Batch of Medical Device Classification Results for 2024” on April 4, 2024. The document identifies 57
NMPA issued the clinical trial audit result for an IVD manufacturer on April 16, 2024. The audited firm is Guangdong Hexin. Its Respiratory Syncytial Virus,
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
“Quality Management Practice Specification for Clinical Trials of Medical Devices (so called China GCP)”, implemented from March 2022, specifies that “Clinical trial sites must be
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,
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in April 2024. These updates are presented by China
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.
The NMPA granted innovation approvals to Intuitive Surgical’s bronchial navigation system and issued a review report. These published review reports serve as important references for