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  • Regulatory NewsRegulatory News

    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...
  • 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...
  • Russia Unveils New Clinical Trial Requirements for Medical Devices

    Russia's Ministry of Health has issued an order establishing a requirement that medical organizations obtain approval before conducting clinical trials on medical devices and setting forth procedures for ensuring compliance. According to the order, before undertaking a clinical trial, a medical organization must submit an application to Russia's Federal Service on Surveillance in Healthcare, Roszdravnadzor, together with a host of required documents. Information to be ...
  • Russia Decides Pre-2013 Device Clinical Trials Can Support Marketing Approval

    • 06 September 2013
    Russia's Federal Service on Healthcare Surveillance (Roszdravnadzor) and the Ministry of Health have agreed that clinical trials conducted on medical devices prior to January 2013 can be used to support applications for the renewal of or new marketing registration for devices in the 2013-2014 timeframe.  This comes as part of the agency's ongoing initiative to simplify the device registration procedure following consultations with industry in which concern was ex...
  • Russia Developing New Guidance for IVDs

    Russia's Federal Service on Healthcare Surveillance (Roszdravnadzor) has launched a public consultation to develop new guidelines for the evaluation of the quality, effectiveness and safety of in-vitro diagnostics products.  According to the agency, the guidance will be prepared under the direction of the Ministry of Health's Head Specialist for Clinical Laboratory Diagnostics, Anatolia Kochetova, with the assistance of expert organizations and leading experts in...
  • Russian Device Reauthorization Deadline Extended

    • 17 July 2013
    Russian regulatory authority Roszdravnadzor and Russia's Ministry of Health have decided, after consulting with Russia's medical device industry as represented by the Union of Industrialists and Entrepreneurs (RSPP) and the Chamber of Commerce, to extend a deadline for reissuance of medical device registration certificates. An amendment to Government Decision 1416 of 27 December 2012 was introduced by Deputy Minister of Health Igor Kagramanyan and was approved by the M...
  • Top Russian Regulator: We Don't Have Authority to Stop Counterfeiters

    • 26 July 2012
    Russia's top regulator is claiming Russian regulators are handicapped in the fight against counterfeiting because no penalties exist under Russian law to prohibit the sale and production of counterfeit drugs. In an television interview, the Acting Head of Roszdravnadzor, Elena Telnov, said her agency is powerless to stop counterfeiters, and provided an exemple of a fake cancer drug in the Rostov region of Russia where counterfeiters were located but could not b...
  • Russia: New Clinical Trial Regulations In Effect

    New regulations governing the conduct of preclinical studies and clinical trials of drugs for medical use have entered into force in Russia, which require the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) to implement control measures and the analysis of study and trial results.  The regulations also establish appeal procedures for Roszdravnadzor decisions. The changes stem from an order of the  Ministry of Health issue...
  • Topic of Regulation Central to APEC Meeting

    Regulators from Asia-Pacific Economic Cooperation (APEC) member countries discussed the topic of regulation and its effect on member economies during a recent meeting in Russia, according to press releases from the meeting. The trade liberalization forum of 21 nations met in Moscow in February to discuss ways to increase market access to the Asia-Pacific region by 25% in the next four years. The organization particularly focuses on the movement of physical goods, which i...