RegDesk Regulatory Roundup

Dec 19, 2023

HSA Draft Guidance on Clinical Evaluation: Specific Aspects

The article highlights the aspects related to data evaluation, appraisal, and also to the reports to be prepared by the parties responsible for clinical evaluation.

HSA Draft Guidance on Clinical Evaluation: Data Sources

Nov 29, 2023

HSA

HSA Draft Guidance on Clinical Evaluation: Data Sources

The new article addresses the aspects related to the sources of data used in the context of clinical evaluation of medical devices.

HSA Draft Guidance on Clinical Evaluation: General Principles

Nov 22, 2023

HSA

HSA Draft Guidance on Clinical Evaluation: General Principles

The new article highlights the aspects related to the general principles of clinical evaluation.

HSA Draft Guidance on Clinical Evaluation: Overview

Nov 15, 2023

HSA

HSA Draft Guidance on Clinical Evaluation: Overview

The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.

Overview of Medical Device Regulations in 2023

Oct 12, 2023

Asia

Overview of Medical Device Regulations in 2023

This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...