Changes to the documents of the registration dossier

The following changes can be made to the registration dossier:

Change applicant details:
– on the reorganization of a legal entity;
– about changing the name of a legal entity,
– address of its location;
– about changing the last name, first name and patronymic, the address of the place of residence of an individual entrepreneur and the details of the document proving his identity.
Change information about the person in whose name a registration certificate for a medical device can be issued:
– on the reorganization of a legal entity;
– about changing the name of the company;
– about changing the address of the location of the organization;
– about changing the last name, first name and patronymic, place of residence of an individual entrepreneur.
Change the address of the place of manufacture (manufacture) of a medical device.
Change the name of the medical device.
Add or remove medical device accessories.
Change the name of the medical device accessories.
Indicate, change, exclude a trademark.
Change the number of units of a medical device or its component parts, components.
Indicate or exclude versions (models) of a medical device.
Change the labeling and / or packaging of the medical device.
Change the validity period of the documents of the registration dossier.
Change the information about the authorized representative of the manufacturer (manufacturer) of the medical device.

For medical devices that have perpetual national registration certificates, changes can be made until December 31, 2026.

You can get more information on the information on making changes, as well as get advice in the corresponding section of our website.