Amendment of master files and registration certificates • Медрелис

Amendment of master files and registration certificates

Amendment of registration certificates
Amendment of master files
Replacement of registration certificates
Duplicate registration certificate
Registration certificates are amended in the following cases:
  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.
Steps
Preparation of documents for amendment of the registration certificate
Submission of documents to Roszdravnadzor
No later than 30 business days after the relevant change
Processing of documents by Roszdravnadzor
5 business days
Amendment of the registration certificate
15 business days
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.
Steps
Preparation of documents for amendment of the master file
Submission of documents to Roszdravnadzor
Processing of documents by Roszdravnadzor
5 business days
Assessment of the quality, performance and safety of the medical device
20 business days
Amendment of the master file
2 business days
(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.
Steps
Preparation of documents for replacement of the registration certificate
Submission of documents to Roszdravnadzor
Processing of documents by Roszdravnadzor
Up to 30 days
Issue of a new registration certificate
Issue of a new registration certificate
(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.
Steps
Preparation of documents for obtaining a duplicate of the registration certificate
Submission of documents to Roszdravnadzor
Processing of documents by Roszdravnadzor
7 business days
Issue of a duplicate of the registration certificate
Issue of a duplicate of the registration certificate
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Customer testimonials

Thank you for your help in obtaining a Registration Certificate from Roszdravnadzor for laryngeal mask airways (LMA). High professionalism and competence of your staff invariably cause respect in our hearts. We consider the combination of timing and pricing offered by you one of the best in this market.
Vladislav Y. Chernyshev
General Director, REAN LLC https://reanmed.ru
We would like to thank your management and employees for their competence and ability to solve complex, integrated tasks with testing laboratories, the Federal Service for Surveillance in Healthcare and clinical sites. We hope for further mutually beneficial cooperation.
Alexey V. Mazanov
General Director, PTK Belva LLC http://www.belva.ru
Thank you for your high quality work in registration and amendment of registration certificates for products of Lojer Oy, Finland. We have been successfully working with MEDRELIC LLC and its staff for many years and undoubtedly recommend them as a trusted and proven partner.
Viktor Y. Samsonov
General Director, Lojer Medical LLC http://www.lojer-medical.ru
The services to support our registration projects have been provided with high quality and professionally. We would like to particularly mention the willingness and ability of your staff to resolve challenging situations with testing laboratories and clinical sites, as well as transparency and timeliness of communications.
Vitaly Khaindrava
Registration Manager for Russia http://dentsplycis.com

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Contacts
+7 (495) 785-72-85
+7 (495) 785-72-84

info@medrelic.ru
Moscow, 109074
2/5/4 Slavyanskaya square, build. 3,
office 4057
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