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2024 China NMPA Bluebook is here:
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
The NMPA granted innovation approvals to CryoLife, Inc’s BioGlue Surgical Adhesive and issued a review report. The published review reports like this one serve as important references for you to
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 The guidelines are prepared by
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 regulatory submissions. Significance of Compliance
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 mandatory national and industry standards
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 two review reports. The published
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 The guidelines are prepared by
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 notice released on April 30,
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 II devices are affected. The
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, 2024. For the first batch
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 minimize potential use errors and
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