Policies
Boston Scientific, Abbott and Medtronic Have Urgent Needed Devices Designated in GBA
Ten imported devices have been added to the sixth batch to pilot the Greater Bay Area’s Urgent Needs Devices Program, according to a notice published by Guangdong Health Commission on January 15, 2024.
Those devices, without NMPA approval, are currently used in Hong Kong and Macau public hospitals, and are imported to designated hospitals in Guangdong. Devices from Boston Scientific, Abbott and Medtronic are on the list. For our comprehensive review please click HERE
Guidelines & Standards
Study Design and Statistical Analysis Guideline Propels Hainan to be World Leader
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 September 28, 2023. The guideline will facilitate overseas manufacturers to further explore the Hainan Real-world Data pilot program.
The document explicates different study designs of two types research: Pragmatic Randomized Controlled Trials (pRCTs) and Observational Real-World Research. It also emphasizes the importance of Quality Control in terms of data quality, bias risks, bias assessment and ethical review. For more information on the guideline, please click HERE
IVD Core Raw Materials Guideline Issued by NMPA
NMPA published the “Guideline on Core Raw Materials of In Vitro Diagnostic Reagents” on January 3, 2024, along with eleven IVD related guidance. It comes as the File No.1 released by NMPA CMDE (Center for Medical Device Evaluation) in 2024.
The core raw materials document first discusses various materials essential for the core reaction system in biological assays and the broader biological detection process. In the review key points section, it emphasizes transparency in providing information about the selected raw materials, their sources, and the quality standards applied, ensuring a thorough understanding of the product’s composition and performance during the registration review process. For more information click HERE
Manufacturing & QMS
Medical Device GSP Announced
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.
By the end of November 2023, the number of medical device suppliers nationwide had nearly tripled compared to those in 2014. New policies, including centralized procurement of high-value medical consumables and the unique identification system, have been introduced. New trends such as internet sales, third-party logistics, and innovative medical consumables supply chain have emerged. The new GSP adjusts to these changes. For the main revisions please click HERE
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: https://chinameddevice.com/nmpa-regulatory-and-clinical-affairs-news/
