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 and
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Labeling of accumulators as a part of medical devices is required – full information in our new technical regulation issue.
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Beawire team took part in workshop during MD&M west, main themes were: Biocompatibility ISO 10993 – group of standards, ISO 13485 – expected changes, Risk management based approach for medical device
Read moreRenewal process for old registration certificates is ended and formally by law manufacturers who didn’t change drafts of registration certificate couldn’t use them. Which registration certificates must be renewed: Issued before 2013 and without expiry date. Registration certificates after duplicate receiving process must be renew if main registration certificate falls under previously written condition, registration certificates after changing process made
Read moreRoszdravnadzor’s head Mikhail Murashko took part in the 2nd International Conference on Development of Palliative Care for Adults and Children held in Moscow from 29 November to 1 December 2016. In his report he noted that the situation in the country in general changed for the better: the number of medical organizations providing palliative care in the regions grew; doctors
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An individual entrepreneur was punished under criminal law in the Samara Region for wholesaling unregistered medical products.In the end of 2015, the officers of the Chief Administration of Internal Affairs in the Samara region detected the following medical products in circulation in the region: “Products for wrinkle filling Dermal Filler Platinum Bronze” produced by Renne BioMed Sarl, France, “Products for
Read moreWhich medical devices were registered during 2015 by product type? We prepared this information for you – updates of our term why sanctions don’t work.
Read moreOrder No. b2229-р, dated October 22, 2016. 160 types of medical products have been added to the List of medical products subject to implantation into the human body. Decisions have been adopted to facilitate medical aid within the framework of the program of state guarantees for free medical care of the Russian citizens and provision of social services package. Background.
Read moreThe Federal Service for Surveillance in Healthcare (Roszdravnadzor) holds a workshop titled “Monitoring of the Safety, Quality, and Effectiveness of Medical Devices. Regulation in the Russian Federation. Rules of the Eurasian Economic Union”. A workshop titled “Monitoring of the Safety, Quality, and Effectiveness of Medical Devices. Regulation in the Russian Federation. Rules of the Eurasian Economic Union” was held in Moscow
Read moreRoszdravnadzor analyzed the efficiency of operation of medical equipment in the context of territorial entity of the Russian Federation, as well as the calculation of the load on some types of medical equipment following the results of 2015.
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