Since March 1, 2025, new rules for state registration of medical devices have been in effect in Russia (Government Decree No. 1684).
Registration certificates issued earlier under national rules remain valid indefinitely. However, the deadline for making changes to such certificates is strictly limited — the last day for submitting documents is December 31, 2026. After this date, it will no longer be possible to amend "old" certificates.
What changes can be made?
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Change of the manufacturer's name or address;
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Update of applicant or authorised representative details;
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Adjustment of product labelling or packaging;
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Revision of technical documentation.
Depending on the nature of the changes, the procedure may take from 30 to 90 working days.
Important! The applicant is required to initiate the amendment procedure within 90 calendar days from the date of the relevant change. Delay may lead to serious consequences, including suspension of the device's circulation.
Elibrium is ready to help you with amendments to your registration certificate
We offer a full range of services:
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analysis of your current registration dossier and identification of required changes;
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preparation of a complete set of documents for submission to Roszdravnadzor;
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submission of the application via the Roszdravnadzor personal account;
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support throughout the entire procedure, including interaction with expert bodies;
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obtaining the updated registration certificate.
Why choose us?
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Many years of experience in medical device registration;
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A team of qualified specialists;
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Individual approach to each client;
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Full turnkey support of the process.
Do not delay! Deadlines are tight, and the procedure requires time and professional expertise.
Contact us right now to discuss your task and get a cost estimate for our services. We will help you through all the stages without risks or delays!
