Roszdravnadzor Order No. 11020 dated November 25, 2021

In accordance with Part 3.1 of Article 96 of Federal Law No. 323 dated November 21, 2011 "On the Basics of Public Health Protection in the Russian Federation" (Collection of Legislation of the Russian Federation, 2011, No. 48, Art. 6724; Official Internet Portal of Legal Information http://pravo.gov.ru, 04/30/2021), I hereby declare:

1. To approve the attached Procedure for Submitting Information by a Legal Manufacturer of a Medical Device (its Authorized Representative) or a Person Importing Medical Devices into the Territory of the Russian Federation, to the Authorized Federal Executive Body Exercising Functions of Control and Supervision in the Field of Healthcare.

2. This order comes into force on March 1, 2022 and is valid until March 1, 2028.

Head

A.V.SAMOYLOVA

 

Attachment

to the Order of the Federal Service

for Surveillance in Healthcare

dated November 25, 2021 No. 11020

 

PROCEDURE

FOR SUBMITTING INFORMATION BY A LEGAL MANUFACTURER OF A MEDICAL DEVICE (ITS AUTHORIZED REPRESENTATIVE) OR A PERSON

A PERSON IMPORTING MEDICAL DEVICES INTO THE TERRITORY OF THE RUSSIAN FEDERATION, INFORMATION TO THE AUTHORIZED FEDERAL EXECUTIVE BODY EXERCISING FUNCTIONS OF CONTROL AND SUPERVISION IN THE FIELD OF HEALTHCARE

 

1. Organizations or individual entrepreneurs engaged in the production (manufacture) of medical devices in the Russian Federation (their authorized representatives) (hereinafter referred to as the manufacturer) or persons importing medical devices into the territory of the Russian Federation (hereinafter referred to as the person importing), shall submit to the Federal Service for Surveillance in Healthcare, for analysis as part of monitoring the safety of medical devices, information about each serial (batch) number, factory (identification) number (hereinafter referred to as information) of the medical device manufactured in the Russian Federation or imported into the territory of the Russian Federation (hereinafter referred to as the medical device).

2. The Federal Service for Surveillance in Healthcare provides authorized access using the "Unified Identification and Authentication System in the infrastructure that ensures information and technological interaction of information systems used for the provision of state and municipal services in electronic form" <1> by providing a personal account in the automated system (hereinafter referred to as the personal account, AIS Roszdravnadzor) to manufacturers and persons importing, for submitting the information specified in paragraphs 4 and 5 of this procedure.

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<1> Decree of the Government of the Russian Federation No. 977 of November 28, 2011 "On the Federal State Information System "Unified Identification and Authentication System in the infrastructure that ensures information and technological interaction of information systems used for the provision of state and municipal services in electronic form" (Collection of Legislation of the Russian Federation, 2011, No. 49, Art. 7284; 2021, No. 27, Art. 5371).

 

3. A link to the AIS Roszdravnadzor is posted on the official website of the Federal Service for Surveillance in Healthcare in the "Services" section (roszdravnadzor.gov.ru/services) in the information and telecommunication network "Internet".

4. The manufacturer, within a period not exceeding 15 working days from the date of placing the medical device into circulation, shall submit the following information to the personal account:

• name of the medical device;

• registration certificate number for the medical device;

• date of issue of the registration certificate for the medical device;

• version or model of the medical device (if any);

• composition, package and list of accessories of the medical device (if necessary);

• serial (batch) number or factory (identification) number of the medical device (if available);

• number of medical devices in the series (batch) or number of factory numbers of the medical device (in pieces);

• date of manufacture (production) of the medical device (in the format "dd.mm.yyyy" or "mm.yyyy");

• shelf life (service life) of the medical device (in the format "dd.mm.yyyy" or "mm.yyyy" or "time period" or "unlimited");

• number and date of the universal transfer document.

5. The person importing, within a period not exceeding 15 working days from the date of placing the medical device into circulation, shall submit the following information to the personal account:

• name of the medical device;

• registration certificate number for the medical device;

• date of issue of the registration certificate for the medical device;

• version or model of the medical device (if any);

• composition, package and list of accessories of the medical device (if necessary);

• serial (batch) number or factory (identification) number of the medical device (if available);

• number of medical devices in the series (batch) or number of factory numbers of the medical device (in pieces);

• date of manufacture (production) of the medical device (in the format "dd.mm.yyyy" or "mm.yyyy");

• shelf life (service life) of the medical device (in the format "dd.mm.yyyy" or "mm.yyyy" or "time period" or "unlimited");

• registration number of the customs declaration for goods and the date of its registration.

6. If an official of Roszdravnadzor, when reviewing the information submitted in accordance with paragraphs 4 and 5 of this procedure, identifies incomplete or unreliable information, the manufacturer or the person importing is sent a notification by any available means within five working days from the date of identification of such information, about the need to correct it and resubmit it within five working days in the manner established by paragraphs 4 and 5 of this procedure. 

7. In the event that the manufacturer or the person importing identifies incomplete or unreliable information submitted in accordance with paragraphs 4 and 5 of this procedure, the manufacturer or the person importing shall correct it and resubmit it within five working days from the date of identification of such information, in the manner established by paragraphs 4 and 5 of this procedure.