FDA The article provides an overview of the regulatory measures intended to encourage medical device manufacturers to participate in the improvement of medical devices intended to be marketed and used in the US. The document constitutes a draft guidance the authority has...
Asia The article provides an overview of the regulatory requirements and procedures related to the importation of medical devices. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other...
FDA The new article highlights specific aspects related to the clinical studies and the way they should be undertaken to ensure the accuracy and reliability of the results, including the patient demographics, safety endpoints, and analysis. The document constitutes a...
Ethiopia The new article provides additional details regarding the regulatory requirements to be applied concerning labeling for certain types of medical devices, including the in vitro diagnostic (IVD) and sterile products, as well as active and implantable medical devices. ...
FDA The article describes in detail the mechanisms to be used by the authority to provide its feedback regarding the device development. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
Asia The new article highlights additional aspects related to the change notification process, including the turn-around time and fees. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
