FDA
The document highlights the key points related to the regulatory requirements for certain orthopedic devices based on the draft guidance issued by the authority. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulatory agency in the...
EU MDR/IVDR
Medical devices are an integral part of healthcare, and their safety and efficacy are critical to ensure patient well-being. In 2017, the European Parliament and Council adopted the new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) to...
Africa
The document highlights the key points related to the current classification rules for different types of medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), the country’s national regulator agency, has published a...
Saudi Arabia
The document highlights the aspects relate to the requirements for the entities providing testing services, as well as the services in the sphere of laboratory testing, and also the ones proving quality assurance and radiology measurement services. Table of Contents...
FDA
The new article highlights the aspects related to the special framework allowing face masks intended for a medical purpose to be placed on the market under a simplified procedure. Table of Contents Introduction The Food and Drug Administration (FDA or the Agency), the...
Asia
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...
