All manufacturers must test their device in Russia through an officially approved laboratory. Submit application to Roszdravnadzor and assist with post-submission activities. However, the registration process can be a challenge. Unlike most countries, Russia still relies on in-country testing and clinical data to approve medical devices, even if the device is already sold in other major markets. Navigating Russian bureaucracy and language without the assistance of an experienced local representative can be frustrating. Coordinate testing, application, and registration fees. Assist with supplemental clinical data requirements according to Roszdravnadzor's requirements. Roszdravnadzor reviews your regulatory submission in two stages.
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