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Stakeholders lauded the FDA’s efforts in developing draft guidance on the use of investigational in vitro diagnostic devices in clinical trials but said the agency needs to provide more specific examples for the guidance to be useful. Read More
China’s Food and Drug Administration reported that International Medical Device Regulators Forum (IMDRF) members unanimously supported China’s proposal for a new work item on clinical evaluation of medical devices — presented during the March 20-22 IMDRF meeting in Shanghai. Read More
In a reshuffle of regulatory authorities in China, the FDA will split into separate units for medical products and foods, with medical devices handled by the State Drug Administration within the National Market Supervision Administration (NMSA). Read More
Sponsors should list the product’s intended uses, the user base and potential impact on the environment, as well as any skills, knowledge or training needed to properly use the device. Read More
Medical device disinfectants and sterilants that don’t meet the definition of an antimicrobial agent are now subject to Canada’s medical device regulations. Read More