• Regulatory NewsRegulatory News

    WHO Advances International Harmonized Nomenclature for Medical Devices

    The World Health Organization (WHO) reported Monday on recent progress toward the development of its international nomenclature for medical devices, known as the International Classification of Medical Devices (ICMD). WHO discussed work in progress at the 4th Global Forum on Medical Devices, which took place last December. “Having a nomenclature system in place for medical devices facilitates their management and regulation by standardizing terms that enable communic...
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    New Medical Device Classifier Complicating Russian Registrations

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. A new medical device nomenclature system launched and enforced by Russian regulators is causing challenges for registrants due to incomplete and missing codes, as well as more stringent requirements for grouping products together in the same registration. Roszdravnadzor’s  Nomenclature Classification of Medical Devices by Type  (link in R...
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    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...
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    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...