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  • Regulatory NewsRegulatory News

    Russian Regulators Publish New Medical Device Nomenclature System

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Roszdravnadzor, Russia’s medical device market regulator, has published a new system for nomenclature classification according to 19 different device types. The  categories  (link in Russian) appear to be based on Global Medical Device Nomenclature (GMDN), which could suggest that Roszdravnadzor will realign its market registration requir...
  • Regulatory NewsRegulatory News

    FDA Unveils Final Details about Medical Device Tracking System

    Regulators with the US Food and Drug Administration (FDA) have released a second, substantially more complete guidance document indicating how its Global Unique Device Identification Database (GUDID), an integral part of the agency's pending oversight of the Unique Device Identification (UDI) system, works. Background Under FDA's UDI regulation, medical device manufacturers will soon have to start affixing device identifiers and production identifiers to most devi...