RegDesk Regulatory Roundup

Jan 27, 2023

SFDA Guidance on Clinical Trials: Overview

The article provides an overview of the regulatory requirements for clinical trials of medical devices. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulating authority in the sphere of healthcare products, has published...

FDA Guidance on Diagnostic Clinical Performance Studies: Key Points

Dec 2, 2022

FDA

FDA Guidance on Diagnostic Clinical Performance Studies: Key Points

The new article addresses the aspects related to the design considerations for diagnostic clinical performance studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...

HSA Guidance on Change Notification: Categories of Changes

Sep 28, 2022

Asia

HSA Guidance on Change Notification: Categories of Changes

The article describes in detail the way the changes to medical devices are divided into categories and also highlights the key points to be considered in this respect. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere...

HSA Guidance on SAR: Post-Market Obligations and Summary

Sep 11, 2022

Asia

HSA Guidance on SAR: Post-Market Obligations and Summary

The new article provides additional clarifications regarding the regulatory matters related to post-market obligations, and distribution records, and also summarizes the regulatory requirements associated thereto. Table of Contents The Health Sciences Authority (HSA),...

FDA Guidance on Medical Device Patient Labeling: Warnings and Precautions

Aug 31, 2022

FDA

FDA Guidance on Medical Device Patient Labeling: Warnings and Precautions

The new article addresses the aspects related to warnings and precautions to be included in medical device patient labeling. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...