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...
Asia
The article provides an overview of the Singaporean regulatory requirements for advertising medical devices marketed in the country. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...
FDA
The article provides an overview of the regulatory provisions related to the definition of a medical device as set forth by the existing legislation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
