Amendments of registration certificates and registration dossiers under national regulations and EAEU regulations

AMENDMENT OF REGISTRATION CERTIFICATES AND REGISTRATION DOSSIERS; DUPLICATE REGISTRATION CERTIFICATES UNDER NATIONAL REGULATIONS

1. Amendments

1)  Change of the Applicant’s details, including information about:

-    Reorganization of a legal entity;

-    Change in the 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;

2)  Change in the details of the legal entity in whose name a Registration Certificate for the medical device 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;

3)  Change in the address (place of manufacture) of the medical device;

4)  Change in the name of the medical device, in case 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 or accessories of the medical device;

-    Specifying, changing and excluding a trademark and other identifications of the medical device;

-    Changing the number of units of the medical device or its component 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.

5)  Change in validity periods of documents in the registration dossier by the manufacturer of the medical device.

6)  Change in the details of the authorized representative of the manufacturer of the medical device.

State fees shall be paid in accordance with the laws of the Russian Federation on taxes and duties subject to the risk class of the medical device.

2. Duplicate registration certificate

In case of loss or damage of a registration certificate, the Applicant is eligible for a duplicate of the registration certificate by filing an application to Roszdravnadzor.

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 a duplicate registration certificate is RUB 2,500. 

AMENDMENT OF REGISTRATION CERTIFICATES AND REGISTRATION DOSSIERS UNDER THE EAEU REGULATIONS

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

1. Change in the applicant’s details, including information about 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;
2. Change in the name of the medical device, provided there is a reasoned rationale for the need to change the name of the medical device without affecting its functional properties and characteristics;
3. Change in the scope of accessories, components and/or consumables, provided this does not affect the functional characteristics of the medical device;
4. Change in indications, application, contraindications and side effects, provided that the safety of the medical device must be maintained and supported by research data on clinical safety and quality;
5. Change in the details of the manufacturer of the medical device, provided there is no change in the manufacturing process or specifications, including testing methods;
6. 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.