Australia and Oceania
The new article describes in detail the approach to be applied concerning comparable devices including substantially equivalent devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
FDA
The new article describes the particular way the least burdensome provisions should be applied to facilitate and streamline the regulatory processes associated with placing medical devices on the US market. Table of Contents The Food and Drug Administration (FDA or...
EU MDR/IVDR
The new article provides an overview of the medical device classification rules adopted in the European Union and highlights the key points associated thereto. Table of Contents The Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device...
FDA
The present article describes in detail the aspects related to modifications to tests already approved for use in the US, as well as the ones related to the content of notification and reporting. Table of Contents The Food and Drug Administration (FDA or the Agency),...
Asia
The article highlights the key points related to internal audits and outsourcing activities. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the...
FDA
The new article describes in detail the means for reducing the burden of traditional clinical studies, and also the use of benefit-risk assessments. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
