Dec 5 - 4:17
Indian policy thinktank NITI Aayog has not denied proposals to classify medical devices under the Central Drugs Standard Control Organization (CSDCO), but pushes instead for the implementation of new laws to regulate...
Nov 25 - 6:55
The US medical device circulation regulating authority, the Food and Drugs Administration (FDA), has issued guidance describing the issues related to denial in handling an export certificate. The Scope of the Guidance:...
Nov 15 - 4:36
The International Medical Device Regulators Forum (IMDRF) has released guidelines on clinical evaluations, clinical investigations, and clinical evidence for medical devices. These documents replaced the previous...
Nov 13 - 2:35
The European Commission has announced the extension of the application period for medical device and in vitro diagnostic device expert panels. It is intended that experts will be able to provide technical and...
Nov 8 - 2:00
The Food and Drug Administration (FDA) has published a document amending the list of consensus standards utilized in the review of premarket submissions. Voluntary Consensus Standards Recognized by FDA The 1997 Food...
Nov 1 - 4:02
According to the information available, the implementation of Eudamed database could possibly be delayed for 2 years. Information on the delay was published for the first time after the medical device forum that took...
