Today, Senators Jim Banks (R-Ind.) and John Hickenlooper (D-Col.) introduced the Medical Device Electronic Labeling Act. This ...
Dublin, April 07, 2026 (GLOBE NEWSWIRE)-- The "Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers Training Course (June 8, 2026)" training has been added to ...
The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
The Advanced Medical Technology Association (AdvaMed) is at odds with a recent proposal by the US Food and Drug Administration (FDA) to create a public facing electronic database for home-use medical ...
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Why medical device makers are objecting to new govt draft rules on testing fees, sterilisation labelling
New Delhi: After the Union Ministry of Health notified the draft amendment to the Medical Devices Rules, 2017 on 10 April, India’s medical device industry has pushed back against two proposed ...
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