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The NITI Aayog on Indian Medical Device Regulations
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...
Recent FDA Guidance on Export Certificates
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:...
IMDRF Clinical Guidelines
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...
EC Extends Application Period for Expert Panels
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...