RegDesk Regulatory Roundup

Apr 12, 2024

HSA Guidance on Product Registration Submission Preparation: Device Description and Summary

The new article outlines the scope of information to be included in the device description and executive summary sections of the submission.

Apr 1, 2024

MDCG Guidance on Content of Clinical Investigation Plan: Specific Aspects

The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent and how it should be obtained before commencing a study.

FDA: Basic Safety and Essential Performance of Medical Electrical Equipment

Oct 5, 2020

FDA

FDA: Basic Safety and Essential Performance of Medical Electrical Equipment

The Food and Drug Administration (FDA) has published a guidance document dedicated to the basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment. The document provides the standards-specific...