Amendment of registration documents under national rules and the EAEU regulations

AMENDMENT OF REGISTRATION CERTIFICATES AND REGISTRATION DOSSIER UNDER NATIONAL REGULATIONS

In pursuance of the amendments to the Agreement on Common Principles and Rules for Circulation of Medical Devices (Medical Products and Medical Equipment) Within the Eurasian Economic Union dated December 23, 2014, amendments can be made to the registration dossier of a medical device in accordance with national regulations until December 31, 2026.

AMENDMENT OF REGISTRATION CERTIFICATES (THAT DO NOT REQUIRE EXAMINATION OF QUALITY, EFFICACY AND SAFETY)

• Change of the data on the applicant, including information about:

  
  
  • Reorganization of a legal entity;
  • Change in legal entity’s name (full and abbreviated, if any, including business name) or address (place of business);
  • Change in the surname, first name or patronymic name, if any, residential address or identity document details of an individual entrepreneur.
  
  



• Change of the data on the person in whose name a registration certificate may be issued, including information about:

  
  
  • Reorganization of a legal entity;
  • Change in legal entity’s name (full and abbreviated, if any, including business name) or address (place of business) or the surname, first name or patronymic name, if any, and residential address of an individual entrepreneur.
  
  



• Change of the manufacture address of the medical device

  
  



• Change in the name of the medical device (where the properties and characteristics that affect its quality, efficacy and safety remain unchanged or its properties and characteristics improve while the functional use and/or principle of operation remain unchanged) that involves either of the following:

  
  
  • Adding/excluding or changing the name of the medical device accessories;
  • Specifying, changing and excluding a trademark and other identifications of the medical device;
  • Changing the number of units of the medical device, its parts or components specified in the Annex to the Registration Certificate;
  • Specifying or excluding versions/models of the medical device;
  • Changing the labeling and/or packaging of the medical device.
  
  

• Change in validity periods of documents in the registration dossier by the manufacturer.

  
  

• Change on the data on the authorized representative of the medical device manufacturer.

  
  

Amendment of the registration dossier

Registration dossier is subject to amendment where it is necessary to amend the technical and operational documentation (save as listed in sub-paragraph “d”, paragraph 37 of Government Decree No. 1416 dated December 27, 2012). Such amendments are based on results of the quality, efficacy and safety examination of a medical device executed in a manner similar to the procedure for the quality, efficacy and safety examination of a medical device for the state registration of such devices, if the registering authority, after having verified the completeness and accuracy of the data contained in the submission, finds that such amendments will result in a change in the properties and characteristics that affect the quality, efficacy and safety of the medical device, or will improve its properties and characteristics with the functional use and/or the principle of operation of the medical device remaining unchanged. State fees are payable following the laws of the Russian Federation on taxes and duties subject to the risk class of the medical device.

Replacement of registration certificates

• Registration certificates for medical devices and medical equipment with a fixed validity period issued before the effective date of this Decree shall be valid until the expiry date indicated therein;
• Registration certificates for medical devices and medical equipment with indefinite validity issued before the effective date of this Decree had to be replaced before January 1, 2021, with registration certificates in the form approved by the Federal Service for Surveillance of Healthcare (Decree of the Government of the Russian Federation No. 930 dated October 17, 2013).

Replacement of a registration certificate does not require undergoing state registration of the medical device and is based on an application submitted by the applicant to the Federal Service for Surveillance of Healthcare, indicating information provided in the Rules approved by this Decree.

Duplicate registration certificate

In case of loss or damage of a registration certificate, the applicant is eligible to file an application to the Federal Service for Surveillance of Healthcare for a duplicate of the registration certificate. In case a registration certificate is damaged, the damaged registration certificate must be attached to the application for a duplicate. The state fee for a duplicate registration certificate is RUB 1,500.

AMENDMENT OF REGISTRATION CERTIFICATES AND REGISTRATION DOSSIER UNDER THE EAEU REGULATIONS

Amendments to be made to registration dossier of medical devices that do not require new registration:

• Change of the data on the applicant, including information about the reorganization of a legal entity; change in the legal entity’s name or the surname, first name or residential address of an individual entrepreneur, provided the amendments to the registration certificate do not affect the efficacy and safety of the medical device;


• Change in the name of the medical device, provided there is a reasoned rationale for the name change of the medical device that does not affect its functional properties and characteristics;


• Change in the scope of accessories, components and/or consumables, provided this does not affect the functional characteristics of the medical device;


• Change in indications, application, contraindications and side effects, provided that the safety of the medical device is maintained and supported by research data on clinical safety and quality;


• Change of the data on the medical device manufacturer, provided there is no change in the manufacturing process or specifications, including testing methods;


• Change in the manufacturer’s specification or the Technical Specifications (if any) with which the medical device is compliant and/or operational documentation for the medical device, provided there is no change in the manufacturing process or specifications, including testing methods.

Forms of applications for making amendments to the registration dossier, cancellation of the registration certificate, or a duplicate of the registration certificate are given in the Annexes to Resolution 46 of the EEC Council.