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2015-10-5 · that this device passed all trials, and can be manufactured, imported, sold and used on in the territory of Russia. All medical devices that are manufactured in Russia or abroad should be registered. The registration certificate will contain the name of the title holder, who can be a manufacturer, distributor, or legal representative.
Get PriceRegistration of medical devices in Russia. In accordance with the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 No. 46 medical devices are allowed for use in the member state of the Eurasian Economic Union (Russia, Belarus, …
Get Price2020-10-29 · Medical Device Regulations and Classification in Russia. REGULATORY AUTHORITY: Federal Service for Surveillance in Healthcare (Rosdravnadzor or RZN). CLASSIFICATION SYSTEM: Medical devices are classified according to the EU risk-based model into Classes 1, 2a, 2b and 3. TIMEFRAME: New Registration: 10-16 months (including time to respond to RZN ...
Get Price2021-8-10 · Medical device product registration in Russia is controlled by the of Ministry of Health (Roszdravnadzor, or RZN). Medical device definition (including non-critical IVD, stand-alone software and aesthetics devices) and risk classification are closely aligned with IMDRF guidelines, but with Class I measuring and sterile considered Class II in Russia; consistent with a general trend to up ...
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Get Price2021-8-14 · The TGA post-market review of face masks. The TGA is undertaking a post-market review of face masks to validate the performance of face masks included in the ARTG, to ensure the safety of face mask users. Face masks found not to be medical devices or non-compliant with the safety, quality, and performance requirements will be cancelled from the ARTG.
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