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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
The agency also detailed how to comply with the Postmarketing Safety Reporting Rule, noting the rule applies to both combination product applicants and constituent part applicants. Read More
India’s Central Drugs Standard Control Organization is requiring laboratories that test medical devices and in vitro diagnostics to register with the agency. Read More