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Latest Standards and Certification Update
Health Canada, the regulator for human and veterinary drugs and...
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RAPS Launches Europe Conference as European Regulatory Environment for Medical Products Faces Sweeping Changes
The Regulatory Affairs Professionals Society (RAPS) will hold its inaugural RAPS Regulatory Conference – Europe 2019 at the Radisson Blu in Brussels, between 13 and 14 May.
Transvaginal surgical mesh banned by the FDA
The US Food and Drug Administration (FDA) has ordered manufacturers of transvaginal surgical mesh to halt sales and distribution in the country following safety concerns.
FDA warning against unregulated devices for concussion
Last week the FDA warned against using medical devices purported to assess head injuries, stating that only five companies are cleared to market such devices in the US and that...
Overhaul for medical devices in Australia
The Australian Therapeutic Goods Administration (TGA) has just announced plans to overhaul the regulatory system for medical devices in the country to improve patient safety.
The Global Medical Device Nomenclature is now free available for all manufacturers
The Global Medical Device Nomenclature (GMDN), the de facto global standard for identifying the world’s millions of medical devices, has been made freely available to all...
Man-mimicking machinery for the brain
A study by Harvard University have designed a probe that looks, acts and feels like a real neuron so that the brain does not identify it as a foreign object and try to attack it
Brain Tumour 'Pied Piper' Device Gains Breakthrough Status
A biomedical tool that tricks aggressive brain tumours into migrating to an external container rather than in the brain has been designated a “breakthrough device” by the FDA
US researchers develop new medical devices for children
Researchers from Stanford University and the University of California-San Francisco in the US have partnered to drive development of new medical devices for children
Call for better regulation of AI-based medical products
Products based on artificial intelligence should be regulated like drugs, and those that are deemed unsafe should be removed from the market, according to a new report from the Academy...
The consequences of a no-deal Brexit
Today MPs in the House of Commons vote on Theresa May’s deal, which could result in a no-deal scenario if it is not supported
Medical device manufacturers want more information from FDA about 3D printing
Medical device manufacturers want the US Food and Drug Administration (FDA) to provide more clarity on its guidance on 3D printing.
FDA proposes medical device rule to simplify classification process
The US Food and Drug Administration (FDA) is proposing to amend its regulations governing classification and reclassification of medical devices to conform to provisions in the FDA...
Applied Silicone offers comprehensive material compendia for long-term implantable silicone products
Applied Silicone Corporation, a global supplier of implantable silicone material for the critical healthcare and medical device markets, announces the availability of material...
Study calls for repeal of tax
Just a few months after the implementation of the US medical device tax, and hot on the heels of much criticism for it, a new study has concluded the policy should be repealed.
Europe split on approvals
In March the European Commission and Parliament were reported to be in a disagreement over the possible introduction of central agency to oversee the approval of medical devices.