The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro ...
The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are ...
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 ...
CDSCO releases final guidance document on Medical Device Software: Gireesh Babu, New Delhi The Central Drugs Standard ...
FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...
Digital health innovators who use artificial intelligence (AI) must navigate a range of regulatory risks under Australia's medical device regime. To help them do so, the TGA has recently published ...
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