Legalization of all documents from manufacturer side is usually required in case of state approval process — for Russian (and not only — electronic documents acceptance is rear) states this is a must.

How legalization process for product registration as a medical device looks like?

First manufacturer prepares document (kind of document depends on state body requirements according to list). After that manufacturer or company in country of origin (agent who provides such services) starts legalization process in country of origin. Process type depends on country —it could be apostille process or consul legalization (in embassy of Russian Federation).

So after that manufacturer has hard copy — original document with legalization — and he is ready to send this document to Russian company who supports approval process. When company in charge of state registration in Russia (“third party” below) receives this document – it still couldn’t be used just because there is no translation into Russian of legalization (consulate or apostille stamp even if all another part of document already translated during legalization process). Thus, third party needs to do translation to Russian with notarization of translation (official process for translated documents) – after this hard copy will look like original document with apostille (for example), with translation of full text (apostille text must be translated too) and stamped by Russian notary.

Only after this process document could be used as a part of registration dossier as well as notary copy of this hard document in case of manufacturer or third party doesn’t prefer to submit original (for example — if same document will be used for several registration cases).