The time it takes for the US Food and Drug Administration to review 510(k) applications for clearing medical devices has increased because of industry's failure to file submissions of an adequate quality, an internal analysis by the FDA has revealed ...
The Tanzanian Food and Drugs Authority has issued two complementary draft guidelines to further the implementation of its new medtech regulatory framework 1 ,2 . The first draft document describes the agency's processes and procedures for issuing ...
The Tanzania Food and Drugs Authority has extended until 31 December the deadline by which importers of medical devices must submit information about their products to the agency 1 . Submitting this information to the TFDA is mandatory under the new ...
Australia's Therapeutic Goods Administration's "should move away from the conservative approach that has characterised its actions in the past and recognise that it has a duty to collaborate with stakeholders to create a culture in which the ...
The governments of New Zealand and Australia have agreed on a new trans-Tasman plan to implement a single patent application and examination process for both countries that would provide inventors with a faster, cheaper and more streamlined patent ...
Nanoparticle iron (NPI) products are used as diagnostic MRI contrast agents and as therapies for iron-deficiency anaemia. David Snodin argues that a European Medicines Agency working party should reconsider its position in its reflection paper that ...
The European standardisation committee, CEN , is on the point of ratifying pr EN ISO 23640, a standard relating to stability testing of in vitro diagnostics 1 . This standard, the only IVD standard on which CEN is currently working, has been drafted ...
The Global Harmonization Task Force has published a consolidated list of the definitions commonly used in its final guidance documents 1 . The list consolidates the various definitions published in guidance documents written by different study ...
The founding members of the Global Harmonization Task Force have agreed to terminate the body and are proposing replacing it with a regulators-only forum in the future 1 . The GHTF for the past 18 years or so has been working towards developing a ...
The promise of a system of device and in vitro diagnostics regulation is still very much alive in South Africa, even if the timelines remain sketchy. South Africa has a growing medtech market – 95% supplied by imports – but it has never had a ...
As the World Health Organization prepares for its first global medical devices forum, Michael Cheng calls on the WHO to bridge the gap – the role of the user – between its own guiding principles and the Global Harmonization Task Force's regulatory ...
The US Food and Drug Administration is giving stakeholders another chance to submit comments on factors affecting the reprocessing of reusable medical devices 1 . The FDA has reopened the opportunity to comment after stakeholders were unable to ...
