Agency
"Medical Systems"
Help in registration of medical devices in Russia according to the national procedure and according to the rules of the Eurasian Economic Union
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About company
Agency "Medical Systems" is a team of specialists with more than 10 years of experience in the field of registration of medical devices, both Russian and foreign, with knowledge of English. We will help you bring your products to the market of the Russian Federation and the EAEU in the shortest possible time, answer all questions, select the optimal registration scheme and help you optimize your costs.
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Our Services
We carry out a wide range of tasks related to the registration of medical devices and their circulation on the market of the Russian Federation and the EAEU
Help in registration of medical devices according to national rules and according to the EAEU
Help in registration of medical devices according to national rules and according to the EAEU
We help to register medical devices of any complexity, all risk classes, including medical devices for in vitro diagnostics, software, medical equipment and equipment, instruments and consumables in the Russian Federation in accordance with national rules and the rules of the EAEU. We register medical devices under an accelerated and simplified procedure.
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Dossier preparation for amendments to the registration documentation
Dossier preparation for amendments to the registration documentation for medical devices that are already on the market. If you need to change the address of the manufacturer, add a production site, add new sizes and options, change labeling and packaging, including in connection with MDR and other tasks, we will help you cope with them.
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Additional services
- obtaining a duplicate;
- organizing and conducting consultations with Roszdravnadzor* ;
- assistance with responding to requests and notifications from Roszdravnadzor related to state control;
- consultation on the circulation of medical devices on the market;
- correction of technical errors in the registration certificate, change of OKPD2 code**, nomenclature code;
- preparation and submission of letters and requests to Roszdravnadzor.
*MoH division which is responsible for MD registration
**Medical devices with certain OKPD 2 codes have 0% VAT
- organizing and conducting consultations with Roszdravnadzor* ;
- assistance with responding to requests and notifications from Roszdravnadzor related to state control;
- consultation on the circulation of medical devices on the market;
- correction of technical errors in the registration certificate, change of OKPD2 code**, nomenclature code;
- preparation and submission of letters and requests to Roszdravnadzor.
*MoH division which is responsible for MD registration
**Medical devices with certain OKPD 2 codes have 0% VAT
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Feedback from our clients
We work with both foreign and domestic companies - manufacturers of medical devices
Please write to us by e-mail info@regmedsystems.ru or call +7(980)169-20-83 and we will provide you with feedback from our customers and received Registration Certificates
Our partners
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OBTAINED REGISTRATION CERTIFICATES
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