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A registration certificate is a document that allows you to legally convert a medical device (hereinafter referred to as a medical device, MI) on the territory of the Russian Federation. A registration certificate is issued on the basis of an Order of the registering authority (Federal Service for Supervision in the Field of Healthcare/Roszdravnadzor) after passing all the mandatory stages of state registration, during which the registration dossier is formed
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The Certificate and Declaration of Conformity of the Customs Union is a document confirming compliance with the safety requirements of products subject to the technical regulations of the Customs Union, issued in circulation on the territory of Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan.
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