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
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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.
Assessment of changes incorporated to the registration dossier for a medical device
Organization and support of tests required for incorporation of changes to the registration dossier
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Administrative liability is provided for violations in the sphere of circulation of medical devices in accordance with Articles 6.28 and 6.33 of the Code of Administrative Offences of the Russian Federation, and criminal liability is also established for the circulation of falsified, substandard and unregistered medical devices in accordance with Article 238.1 of the Criminal Code of the Russian Federation.
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INN: 7713477889, OGRN: 1207700364740
INN: 7713477889, OGRN: 1207700364740
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