The World Trade Organization 's Committee on Technical Barriers to Trade (TBT) has issued formal notifications of two draft legislation concerning the Brazilian medtech sector 1 ,2 . The notifications are dated 13 January and relate to proposed ...
From next May, the Brazilian in vitro diagnostics market will be subject to new regulations 1 ,2 . The most important changes will be to the product classification system and how product risk is determined. The reforms introduce a simpler and ...
The US Food and Drug Administration is planning to hold a public meeting on 13 October to discuss performance evaluation of highly multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and public health needs, and ...
The US Food and Drug Administration has published a final rule that confirms a new exception concerning in vitro diagnostics to the general requirements on informed consent but includes a measure to protect against this exception being misused 1 ,2 ...
The UK's National Institute for Health and Clinical Excellence is seeking comments on its draft manual of the processes and methods involved in its diagnostics assessment programme 1 . NICE expects the programme manual to help manufacturers ...
The US Food and Drug Administration has issued draft guidance to clarify how manufacturers should or should not market in vitro diagnostic products that are labelled as "for research use only" (RUO) or "for investigation use only" (IUO) 1,2 ...
