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2026 China NMPA Bluebook is here:
The NMPA published the “Announcement on Standardizing the Classification of Medical Devices” on May 11, 2024. It revises the classification processes for devices, combination products
The last time the NMPA In Vitro Diagnostic Reagents Classification Catalog was announced was in 2013 with two supplemental updates in 2017 and 2020 respectively.
The NMPA granted innovation approvals to Medtronic’s renal denervation device and issued a review report. This is the sixth report published this year for imported
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
Responsibilities of the Marketing Authorization Holder (OEM) Under the MAH system, OEMs can register “new” medical devices in two categories: the first type is innovative
China has been re-opening to the world after COVID isolation since 2023. Volume based purchasing and Made-in-China (MIC) policy are becoming more important in the
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