Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, ...
A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). A suite of guidance ...
“The new Post-Market surveillance regulations will provide us with more safety information on medical devices in use in GB, ...
The import of refurbished medical devices was allowed in India after the Ministry of Environment, Forest, and Climate Change ...
GlobalData on MSN7d
The impact of regulation and AI on Europe’s medical device trial landscapeIn recent years, new regulation has been top-of-mind for medtech companies wishing to continue marketing their products in ...
The Centre is reclassifying 1,178 medical devices. This move is expected to enhance clarity and support the growth of India's ...
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...
Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.” ...
It specifies that by 2035, China expects to fully ensure the safety, efficacy and accessibility of drugs and medical devices, ...
New Delhi: In an attempt to bring regulatory uniformity in medical devices, the government plans to classify around 1,178 medical devices into four categories based on their risk approach under ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback