Health Canada has been asked to consider expanding the scope of medical devices currently covered under its transparency initiative, under which the regulator posts an online summary of the aspects...
The Asian Harmonization Working Party agreed six criteria for a medical device nomenclature system at its 14th meeting in Hong Kong on 4-7 November 2009 1 . The requirements ‒ which will help in the...
US medtech industry association AdvaMed is concerned about the US Food and Drug Administration ’s draft guidance on presenting risk information while promoting medical products because it is too...
A Swedish Medical Products Agency working group has issued recommendations for framing guidance on the classification of software-based healthcare information systems as a medical device 1 ,2 . The...
The European Commission has updated its guidance on borderline products, offering further clarity on cases where it is not clear from the outset whether a given product is a medical device, an in...
Steps are being taken to ensure that the Global Medical Device Nomenclature becomes the globally accepted and sustainable single device naming system that both medical device regulators and the...
The UK Medicines and Healthcare products Regulatory Agency has sent out questionnaires to clinicians who performed hip replacement revisions linked with primary metal-on-metal articulation in order...
