RegDesk Regulatory Roundup

Oct 12, 2023

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...

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. ...

Oman Guidance on Medical Devices Bundling / Grouping Criteria

Oct 29, 2021

Asia

Oman Guidance on Medical Devices Bundling / Grouping Criteria

Oman’s Directorate of the General Pharmaceutical affair and Drug Control (DGP&DC) has published draft guidance dedicated to medical devices bundling/grouping criteria. The document provides an overview of existing legislation and clarifications regarding the...

Saudi Arabia SFDA Guidance on UDI Requirements

Sep 17, 2020

COVID-19

Saudi Arabia SFDA Guidance on UDI Requirements

The Saudi Food & Drug Authority (SFDA), the regulating authority in the sphere of medical devices in Saudi Arabia, has published a guidance document dedicated to the requirements for unique device identification (UDI) for medical devices. The present document...

South Korea Enforces New IVD Regulation

The Medical Device Policy Division of the Ministry of Food and Drug Safety (MFDS), the South Korean authority responsible for medical devices` regulation, announced the enforcement of the new regulation on in vitro diagnostic (IVD) medical devices. The law No. 163433...