South Africa’s draft device regulations have been “significantly revised” following last year’s public consultation and could be approved this year, a Department of Health (DOH) official tells IMDRM.

Medical devicemakers who advertise their products in Australia’s mainstream and specified media would be required to get their advertisements preapproved, under a Therapeutic Goods Administration (TGA) proposal to extend a…

Implementing a new labeling requirement by the EU’s Central Management Committee (CMC) on Medical Devices will raise devicemakers’ costs without any benefit to patient safety, industry association Eucomed says.

The Association of the Heads of the European Radiological protection Competent Authorities (HERCA) and the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) have signed…

Makers of x-ray imaging devices would need to take special steps to ensure their products perform safely and effectively when used on children, under a U.S. Food and Drug Administration…

Manufacturers hoping the U.S. Food and Drug Administration (FDA) might adopt a more European-style approach to device approval got a strongly negative signal in a May agency report. Includes the…

While judging the Medicines and Healthcare products Regulatory Agency’s (MHRA) response to the PIP silicone breast implant scandal basically sound, a new review by the UK Department of Health (DOH)…