Introduction of changes to the documents contained in the registration dossier and copy of RC

Introduction of changes to the documents contained in the registration dossier

Changes to the documents contained in the registration dossier not requiring a quality, effectiveness and safety examination of a medical product include:

  1. a) change in information about an applicant, including the information:

on a legal entity reorganization;

on a change in the name of a legal entity (full and (if available) abbreviated, including company name), its location address;

on a change in the name, surname and (if available) patronymic, residence address of an individual entrepreneur and identity document details;

  1. b) change in information about a person in whose name a registration certificate for a medical product may be issued, including the information:

on a legal entity reorganization;

on a change in the name of a legal entity (full and (if available) abbreviated, including company name), its location address or the name, surname and (if available) patronymic, residence address of an individual entrepreneur;

  1. c) change in the address of the place of manufacturing (production) of a medical product;
  2. d) change in the name of a medical product in case the properties and characteristics affecting the quality, effectiveness and safety of a medical product have not changed, or its properties and characteristics are improved with the same functionality and (or) mode of function, providing for:

addition (exclusion) of medical product accessories or change in their name;

indication, modification and exclusion of a trademark and other means of individualization of a medical product;

a change in the number of units of a medical product or its component parts, components specified in an annex to the registration certificate;

indication or exclusion of versions (models) of a medical product;

change in labeling and (or) packaging of a medical product;

  1. e) a change in the documents validity contained in the registration dossier by the manufacturer (producer) of a medical product;
  2. f) a change in the information about the authorized representative of the manufacturer (producer) of a medical product.

Introduction of changes in the technical and operational documentation of the manufacturer (except the cases specified in sub-clause “d”) are made based on the results of a quality, effectiveness and safety examination of a medical product, carried out in a manner analogous to the procedure for a quality, effectiveness and safety examination of a medical product for the purpose of its state registration, in case the registration authority, based on the results of completeness and accuracy verification of the information contained in the submitted documents, founds that the introduction of the indicated changes involves changes in the properties and characteristics that affect the quality, efficiency and safety of a medical product, or improve its properties and characteristics at constant functionality and (or) mode of function of a medical product.

 

Copy of a registration certificate

In case a registration certificate is lost or damaged, Roszdravnadzor shall provide a copy of a registration certificate upon application.

In case a registration certificate is damaged, a damaged registration certificate shall accompany an application for a copy provision.

Please note that in order to receive a copy of a registration certificate, it is also necessary to provide information on the state fee in the amount of 1,500 rubles and a power of attorney certified by the manufacturer of a medical product in accordance with the established procedure, confirming the applicant authority to receive a copy of a registration certificate.

 

Do not hesitate to contact our specialists for advice on making changes and receiving a copy.