The system of national marketing authorization of medical devices in the Russian Federation uses the Nomenclature Classification of Medical Devices by Type (hereinafter referred to as “NCMD”). In the system of marketing authorization of Medical Devices in the EAEU, there is a very close equivalent in content: the European Medical Device Nomenclature (hereinafter referred to as “EMDN”). According to EAEU regulatoryRead more
Tag Archives: regulation
The standard registration procedure* for medical devices, in vitro diagnostic devices (IVD) and personal protective equipment includes a Conformity Assessment. Depending on the risk class of MD, IVD and the category of personal protective equipment, the manufacturer either registers its product independently through the EUDAMED system (for non-sterile MDs that are not measuring instruments, I risk class), or applies toRead more
Are Wearable Devices Considered Medical Devices? According to the definition of the Federal Service for Surveillance in Healthcare: Medical devices are any instruments, apparatuses, devices, equipment, materials and other items used for medical purposes individually or in conjunction, or together with other accessories necessary for the operation of the aforementioned items as per indications; this includes also specific software products;Read more
USA In the USA, medical device regulators consider wearable devices to be low-risk devices and therefore do not label them. For example, the U.S. Food and Drug Administration (FDA) considers such products to be “general wellness” products. The FDA believes that wearable devices pose low risks to user safety and therefore refrains from regulating them. Manufacturers either self-regulate the production andRead more
Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 1113n).
In the previous article devoted to the update regarding safety monitoring, we considered Order 980n “On Approval of the Procedure for Safety Monitoring of Medical Devices” . In this small review, we would like to refer to Order 1113n, which will replace the Order 12n on January 1, 2021 and will be valid until January 1, 2027. Before talking aboutRead more
Update of legislation in the field of safety monitoring of medical devices (Analysis of Order 980n).
With the new year 2021, all subjects of circulation of medical devices, especially the manufacturer and its authorized representative (AR), expect innovations related to safety monitoring of medical devices. From January 1, 2021, two legislative acts (Order No. 980n from 15th Sept 2020 (monitoring system) and Order No. 1113n) come into force, which significantly details the procedure for interaction betweenRead more