FDA
The article describes the approach to be applied with respect to viral mutations and their potential impact on the performance of tests intended to identify the virus. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority...
Saudi Arabia
The new article provides an overview of the regulatory requirements for the clinical evaluation of medical devices based on novel technologies. In particular, the document describes the three main components of clinical evaluation and highlights the most important...
Asia
The article provides an overview of the new draft guidance and highlights the key points to be considered. Table Of Contents: The National Health Regulatory Authority (NHRA), a Bahrain’s agency responsible for healthcare products regulations, has published a guidance...
Saudi Arabia
The article provides an overview of the applicable regulatory requirements and highlights the key points associated thereto. Table Of Contents: The Saudi Food and Drug Administration (SDFA), a country’s regulating authority in the sphere of healthcare products, has...
COVID-19
The new article highlights the aspects related to the use of tests developed by certified laboratories, as well as the ones being reviewed by the authority. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
Malaysia
The new article highlights the aspects related to the scope of information and documentation the authority expects to be included in requests from interested parties. Table Of Contents: The Medical Device Authority (MDA), a Malaysian regulating authority, has...
