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 ...

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 ...

FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...

“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, ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...