Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU@s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe@s ...

This event focuses on two key areas in MedTech: the distinction between wellness and regulated health technologies, and the integration of artificial intelligence throughout the product lifecycle.

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, ...

The World Health Organization (WHO) issued an alert on Monday identifying oral cough syrups manufactured in India that contain diethylene glycol (DEG), a substance typically used as an industrial ...

Regulatory professionals must navigate change and uncertainty amid an evolving global regulatory landscape, new technologies such as artificial intelligence (AI), and the rapid pace of scientific ...

The US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health (CDRH) is seeking input on methods for assessing and evaluating AI-enabled medical devices in a newly released ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The European Medicines Agency (EMA) has begun accepting the Food and Drug Administration@s (FDA) findings from inspections of facilities outside the US.

The US Food and Drug Administration (FDA) recently issued warning letters to three domestic companies for multiple violations of good manufacturing practices (GMPs) in their production of ...

Over the past decade, the global landscape of medical device quality management has undergone a significant transformation. While ISO 13485:2016 provides a common foundation, regional adaptations ...

Global regulatory harmonization in the medical device sector is essential for ensuring timely patient access to safe and effective technologies while reducing redundant regulatory burdens. This ...

The Health Sciences Authority (HSA) has partnered with a trade group to provide early regulatory consultations and other support to Singapore@s medtech industry.