FDA
The new article highlights the aspects related to the general approach to the changes related to software products and also describes the most important concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
North America
The article provides additional details regarding the approach to be applied with respect to certain types of medical devices in terms of regulatory flexibility. Table of Contents Introduction The Food and Drug Administration (FDA), a Philippines regulatory agency in...
Uncategorized
Periodic Safety Update Reports (PSURs) are critical documents for medical device and in vitro diagnostic product manufacturers. These reports are a key component of a manufacturer’s post-market surveillance and risk management program, providing ongoing...
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...
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...
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