How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the ...
not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system; intended for the purpose of ...
FDA has finalized guidance on medical device classification product codes that are used to assist in accurate identification and tracking of current medical devices, and for easy reference to ...
Medical device startups, are you struggling to understand FDA regulations? Join our webinar with not-for-profit organization MITRE for help. Medical device startups, are you struggling to understand ...
Connected medical devices can improve patient care and operational efficiency. However, they also introduce new privacy and security risks. Healthcare providers should rethink their privacy and ...
Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...
Regulatory oversight has instead been exercised by the NAFDAC pursuant to its general mandate under the NAFDAC Act (Cap N1, ...
DALLAS, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster ...
South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...
A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...
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