Regulatory Blog

As the UK strengthens its regulatory framework for medical devices, the Medicines and Healthcare products Regulatory Agency (MHRA) outlines a clear system for sponsors intending to conduct clinical investigations. These investigations are essential for generating evidence on device performance and safety before market approval. The MHRA guidance, “ Clinical investigations for medical devices " : that provides a structured route that sponsors must follow before initiating any

Conducting clinical investigations for medical devices in the UK requires strict adherence to MHRA’s updated regulatory framework, designed to support patient safety, device innovation, and compliance with evolving UK (and EU for Northern Ireland) requirements. The guidance  “ Notify MHRA about a clinical investigation for a medical device ” provides a clear roadmap for manufacturers, sponsors, and investigators who plan to conduct clinical investigations of medical devices i

The Central Drugs Standard Control Organization (CDSCO)  under India’s Ministry of Health & Family Welfare has released a detailed...

The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...

The U.S. Food and Drug Administration (USFDA) has issued comprehensive Q&A guidance titled " Electronic Systems, Electronic Records, and...

A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...