RegDesk Regulatory Roundup

Oct 13, 2023

HSA Guidance on IVD Registration Submissions: Manufacturing Information

The new article highlights the aspects related to the information to be included in the submissions with respect to manufacturing processes and sites involved. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of...

HSA Guidance on IVD Registration Submissions: Device Labeling and Risk Analysis

Oct 3, 2023

HSA

HSA Guidance on IVD Registration Submissions: Device Labeling and Risk Analysis

The article addresses the aspects related to the labeling requirements in vitro diagnostic devices should comply with, as well as the approach to be applied with respect to risk analysis in order to ensure the proper health protection and safety of patients. ...

Aug 16, 2023

Asia

HSA on product registration submissions

The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...

HSA Guidance on Site Master File Preparation: Overview

Mar 30, 2023

Asia

HSA Guidance on Site Master File Preparation: Overview

The document describes in detail the aspects to be taken into account when preparing a site master file. Table of Contents Introduction The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance...

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...