NMPA published twelve review reports in January 2024 for innovation devices. Among them are two imported devices.
These published review reports serve as important references...
The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it.
Table of...
The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party...
All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system, according to Decree 719 “Medical...
The NMPA granted innovation approvals to Israeli company CarboFix Orthopedics’ carbon fiber polyetheretherketone (PEEK) osteosynthesis plate system and issued a review report.
These published review...
SCD-PED (Pediatric) is the first FDA-approved product in the Company’s Quelimmune™ product family
DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq:...
Novel Nanoparticle Platform Shows Efficacy Against Antimicrobial Resistance; Potential to Disrupt the $29 Billion Catheter Market
SALT LAKE CITY, Feb. 22, 2024 /PRNewswire/ --...