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CDRH Implements Surveys on Medical Device Shortages
The Center for Devices and Radiological Health (CDRH), a division of the U.S. Food and Drug Administration (FDA) responsible for pre-marketing assessment and evaluation of medical devices and general supervision on...
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:...