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 ...
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 U.S. Food and Drug Administration has a proposed a rule that would allow reclassification of devices via an administrative order published in the Federal Register. The proposed rule would conform ...
DCGI releases classification of 77 medical devices related to oncology: Gireesh Babu, New Delhi Wednesday, January 7, 2026, 08:00 Hrs [IST] As part of its efforts to regulate the ...
The Global Harmonization Task Force issued a guidance that provides 17 rules for device classification, according to a MassDevice report. The guidance provides rules for classification of devices and ...
The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both ...
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