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MEDTECH INSIGHT

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UDI Database Deadline Extended Again for Certain Combo Products
Executive Summary Following an extension for Unique Device Identifier requirements for low-risk devices earlier this summer, US FDA has pushed...

Risk of Sterilization Plant Shutdowns Across US Sends Shockwave Through Industry
Executive Summary While a number of US states are taking actions that could potentially ban or limit ethylene oxide (EtO) sterilization plants...

New Roadmap Shows Route to Regulatory System Adoption in South Africa
Executive Summary The efficient implementation of a dedicated medtech regulatory system is a top priority for South African manufacturers, whose...