SAHPRA Guidelines on Establishment Licensing: Application Submission Process
The new article highlights the aspects related to the process of applying for a medical device establishment license required to conduct operations with medical devices.
The new article highlights the aspects related to the process of applying for a medical device establishment license required to conduct operations with medical devices.
The new article covers the matters related to antigen diagnostic tests and explains the approach to be applied by the test developers in order to ensure the continued effectiveness of their devices. Table Of Contents: The Food and Drug Administration (FDA or the...
The new article highlights the key points related to molecular diagnostic tests and describes the recommendations provided by the authority in this respect. Table Of Contents The Food and Drug Administration (FDA or the Agency), the UA regulating authority in the...
The new article highlights the aspects related to the way the impact of viral mutations can be addressed when developing tests. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
The new article highlights the key points related to regulatory requirements for modifications to medical devices allowed for marketing and use. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...