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REGISTRATION DOSSIER AMENDMENT

Changes of the deviee, its labeling, packaging, as well as changes to the documents of the submitted registration dossier should be approved by Roszdravnadzor

Preparation of complete set of documents for making changes to the registration dossier, full support of the process of making changes until obtaining of positive conclusion on changes incorporation.
Organization and support of tests required for incorporation of changes to the registration dossier
Assessment of changes incorporated to the registration dossier for a medical device
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