Brazil
The new article describes in detail the aspects related to various software products, including the ones intended for remote diagnostics or facilitating administrative procedures. Table of Contents The Brazilian regulating authority in the sphere of healthcare...
Australia and Oceania
The new article highlights the most important aspects related to the application of the least burdensome approach for deficiencies arising from the issues identified by the authority when reviewing the application for marketing approval. Table of Contents The Food...
Malaysia
The new article describes in detail the aspects related to establishment licenses, as well as the requirements related to the licenses for retailers and tendering agents. The Malaysian Medical Devices Authority (MDA), a country’s regulatory agency in the sphere of...
Australia and Oceania
The article provides an overview of the policy suggested for deficiencies in medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...
EU MDR/IVDR
The new article describes in detail the aspects related to the responsibilities of authorized representatives as set forth under the existing framework, as well as the liability they could be subject to, and situations when they are allowed to initiate termination of...
Australia and Oceania
The new article highlights the key points related to clinical outcome studies that are not using concurrent (or historical) controls. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
