The Central Drugs Standard Control Organisation (CDSCO) has announced risk classification of 187 medical devices pertaining to interventional radiology under Medical Devices Software, under the ...
The Central Drugs Standard Control Organisation (CDSCO) has announced risk classification of 119 medical devices pertaining to radiotherapy under the Medical Devices Rules (MDR), 2017, as part of ...
“Classification isn’t an administrative detail; it’s the foundation of patient safety,” he says. “If a platform is being used to support clinical decision-making, issue alerts or guide escalation, ...
Australia’s TGA provided updates regarding up-classification of several device types, including a number of spinal implants, which will henceforth be regulated as high-risk, class III devices, rather ...
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...
On Oct 7, 2021, FDA issued a guidance on surgical staplers and staples for internal use, reclassifying them from Class I (general controls) to Class II (special controls) devices and requiring them to ...
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