Amendment of master files and registration certificates

1. Change of the applicant's details, including information about:
   1. Reorganization of a legal entity;
   2. Change in its name (full and abbreviated (if any), including business name) or address (place of business);
   3. Change in the surname, first name or patronymic (if any), residential address or identity document details of an individual entrepreneur;
2. Change in the address (place of manufacture) of the medical device;
3. Change in the name of the medical device (provided the properties and characteristics affecting its quality, performance and safety remain unchanged);
4. Change in the details of the legal entity in whose name a registration certificate may be issued, including information about:
   1. Reorganization of a legal entity;
   2. Change in its name (full and abbreviated (if any), including trade name) or address (place of business);
5. Indication of the type of medical device in accordance with the Nomenclature Classification of Medical Devices (if not previously included).

The state fee for amendment of the registration certificate is 1,500 rubles.

Registration documentation is subject to amendment where it is necessary to amend the documents listed in sub-paragraph "a", paragraph 54 of the Government Decree No. 1416 dated December 27, 2012.

The state fee for amendment of registration documentation is currently not provided in the Tax Code of the Russian Federation.

(in accordance with the Government Decrees No. 1416 dated December 27, 2012, and No. 160 dated February 10, 2017)

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

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

The state fee for amendment of registration documentation is currently not provided in the Tax Code of the Russian Federation.

(in accordance with paragraph 52 of the Government Decree No. 1416 dated December 27, 2012)

1. In case of loss or damage of a registration certificate, the applicant is entitled to file with Roszdravnadzor an application for a duplicate of the registration certificate (hereinafter referred to as the "application for a duplicate").

2. In case of damage of a registration certificate, the damaged registration certificate must be attached to the application for a duplicate.

The state fee for amendment of the registration certificate is 1,500 rubles.