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2026 China NMPA Bluebook is here:
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
Twenty newly-established or revised industry standards were released by NMPA on February 19, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory
All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system, according to Decree 739 “Medical Device
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
NMPA published the “Draft Guideline on Clinical Trial of Peripheral Drug-Coated Balloon Catheters” on February 5, 2024 for feedback. Feedback needs to be submitted by
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC,
Covidien issued voluntary recall notice for Coated Braided Nylon Nonabsorbable Suture on January 4, 2024. It is a Class I recall, which indicates the most
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities
NMPA released “Quality Management Measures for Medical Device Operations”, on December 7, 2023, effective July 1, 2024. The previous version published in 2014 was obsoleted.
NMPA published the finalized document “Guideline on Medical Device Real-world Study Design and Statistical Analysis” on January 15, 2024. The draft version was released on
NMPA published the four IVD-related guidelines on January 18, 2024. They are aimed to facilitate manufacturers with more product-specific guidance and clarity in registration process.
NMPA Roundup December 2023 Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in December 2023. These updates