The “MedTech Mitra” Revolution: A New Playbook for India’s Medical Innovators
CDSCO, 05,DEC — India’s healthcare sector is witnessing an exciting transformation, particularly in the field of In-Vitro Diagnostic (IVD) devices. With increasing demand for accurate, affordable, and accessible medical technologies, innovators are under pressure to ensure their products not only meet regulatory standards but also make an impactful contribution to global healthcare. A new publication, […]
FDA’s Updated eCopy Guidance: What It Means for Medical Device Manufacturers
US, December 10, 2025, The FDA has officially issued updated guidance for the eCopy Program, setting new ground rules for how medical device manufacturers must submit digital data. If you are preparing a 510(k), PMA, or IDE, this document is your new rulebook. eCopy Program Guidance Update (Issued Dec 3, 2025). Ready to submit your […]