Modifications to the registration certificate for a medical product

Grounds for making modifications to registration certificate:

a) changes in information on the applicant, including information regarding:

  • corporate restructuring of legal entity;
  • changes in the name (full and, if applicable, short name, including brand name), or address (location);
  • changes in the surname, name and patronymic (if any), as well as in the place of residence of an individual entrepreneur, or in their ID details;

b) changes in the address (place of manufacturing) of the medical product;

c) changes made to the medical product name (provided these changes do not regard the features of the product having impact on its use, safety or efficiency);

d) changes in the information on the legal entity in whose name a registration certificate can be issued:

  • corporate restructuring of legal entity;
  • changes in the name (full and, if applicable, short name, including brand name), or address (location);

e) mention of the medical product types in accordance with nomenclature classification (if type was not mentioned).

To make modifications to the registration certificate, within 30 working days upon the introduction of respective changes, the applicant must forward a request to Roszdravnadzor to include the modifications in the registration certificate (hereinafter — request for modifications) drawn in accordance with paragraph 9 of the Rules, accompanied by the modifications made and supporting documents confirming that the changes made to the medical product have no impact on its use, safety or efficiency, and that they improve the medical product while maintaining its function and/or functioning principle.

Modifications to the registration certificate must be made within 15 working days.

If a decision is adopted to introduce modifications to the registration certificate, Roszdravnadzor should draw and issue a new registration certificate and marks the original registration certificate, which has been forwarded to it (by registered post with advice of delivery or in the form of electronic document signed with electronic signature) by the applicant upon receiving the new registration document, as invalid (with date mentioned

State duty for introducing modifications to the registration certificate for a medical product amounts to RUB 1,500.