Jan 17, 2013

Neue Vorschriften zur elektronischen Kennzeichnung von Medizinprodukten in Europa treten im März 2013 in Kraft

Neue elektronische Kennzeichnungsvorschriften der Europäischen Kommission werden am 1. März 2013 in Kraft treten. Diese...
Apr 8, 2011

US Government Shutdown Would Hamper FDA Clearance and Approval Process

A potential shutdown of the US government due to Republican lawmakers’ stance on budget negotiations would significantly reduce the Food and Drug Administration’s ability to conduct inspections of foo
Apr 5, 2011

US Hospital Groups Wary of Medical Device Tax’s Impact

Hospital industry trade groups including the American Hospital Association, the Federation of American Hospitals and the Catholic Health Association of the United States are warning that their members
Mar 31, 2011

MITA Weighs in on Excise Tax Issues

The Medical Imaging & Technology Association (MITA), the trade group representing US medical imaging equipment manufacturers, has
Mar 30, 2011

AdvaMed, MDMA Pursue Different Approaches to Pending Medical Device Excise Tax

The medical device excise tax provision passed last year as part of the Patient Protection...
Mar 28, 2011

Health Canada Moving to Flat-Fee Structure April 1st

Citing rising costs of performing medical device and pharmaceutical regulatory activities in Canada, Health Canada has announced user fee increases—some of them substantial—for medical device license
Mar 25, 2011

CDRH Updates Import Entry Review Process for Medical Devices

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued recommendations to improve
Mar 23, 2011

Eucomed: Ease Regulatory Requirements for Smaller-tier Medical Device Makers

European medical device industry trade group Eucomed has issued four major recommendations to the European...
Jan 28, 2011

AdvaMed-sponsored Study: FDA Less Efficient than EU Regulators

A new study sponsored by the US medical device industry trade association Advanced Medical Technology...
Jan 6, 2011

Survey: Prosperous Year Ahead for Medical Device Industry

Prospects look healthy for the global medical device industry according to results of the 2011...