The Global Harmonization Task Force’s (GHTF) Study Group 1 has modified its definition of a medical device and provided an explicit definition for the term in vitro diagnostic (IVD) medical device, according to a final document released May 16.
Category Archives: International Medical Device Regulatory Monitor
Devicemakers doing business in Malaysia must register their products, beginning in November, a Medical Devices Control Division (MDCD) official confirmed to IMDRM.
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 system currently limited to nonprescription drugs.
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 a memorandum of understanding (MOU) to promote radiation protection initiatives.
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their products perform safely and effectively when used on children, under a U.S. Food and Drug Administration (FDA) draft guidance issued May 10.
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 full text of U.S. FDA Report on Devices Approved in the EU but Not in the U.S.
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) finds the agency needs better access to information on devices to preclude similar safety scares in the future.