MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE

ORDER
of 25 November 2021 No. 11020

ON APPROVAL OF THE PROCEDURE
FOR SUBMISSION OF INFORMATION BY THE MANUFACTURER
(PRODUCER) OF A MEDICAL DEVICE (OR ITS AUTHORISED
REPRESENTATIVE) OR BY THE PERSON IMPORTING MEDICAL DEVICES
INTO THE TERRITORY OF THE RUSSIAN FEDERATION
TO THE AUTHORISED FEDERAL EXECUTIVE AUTHORITY EXERCISING
FUNCTIONS OF CONTROL AND SUPERVISION IN THE FIELD
OF HEALTHCARE

In accordance with Part 3.1 of Article 96 of Federal Law No. 323-FZ of 21 November 2011 "On the Fundamentals of Health Protection of Citizens 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, 30.04.2021), I hereby order:

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

2. This Order shall enter into force on 1 March 2022 and shall remain in effect until 1 March 2028.

Head
A.V. SAMOYLOVA

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Annex
to Order of the Federal Service
for Surveillance in Healthcare
of 25.11.2021 No. 11020

PROCEDURE
FOR SUBMISSION OF INFORMATION BY THE MANUFACTURER
(PRODUCER) OF A MEDICAL DEVICE (OR ITS AUTHORISED
REPRESENTATIVE) OR BY THE PERSON IMPORTING MEDICAL DEVICES
INTO THE TERRITORY OF THE RUSSIAN FEDERATION
TO THE AUTHORISED FEDERAL EXECUTIVE AUTHORITY EXERCISING
FUNCTIONS OF CONTROL AND SUPERVISION IN THE FIELD
OF HEALTHCARE

1. Organisations or individual entrepreneurs engaged in the manufacture (production) of medical devices in the Russian Federation (or their authorised representatives) (hereinafter — the manufacturer), or persons importing medical devices into the territory of the Russian Federation (hereinafter — the importer), shall submit to the Federal Service for Surveillance in Healthcare, for analysis within the framework of medical device safety monitoring, information on each batch (lot) number and factory (identification) number (hereinafter — the information) of a medical device manufactured in the Russian Federation or imported into the territory of the Russian Federation (hereinafter — the medical device).

2. The Federal Service for Surveillance in Healthcare shall provide authorised access using the Unified System of Identification and Authentication in the infrastructure ensuring information technology interaction of information systems used to provide state and municipal services in electronic form <1> by granting access to a personal account in the automated information system (hereinafter — the personal account, AIS Roszdravnadzor) to manufacturers and importers for the submission of the information specified in paragraphs 4 and 5 of this Procedure.

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<1> Resolution of the Government of the Russian Federation of 28.11.2011 No. 977 "On the Federal State Information System 'Unified System of Identification and Authentication in the Infrastructure Ensuring Information Technology Interaction of Information Systems Used to Provide 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. The link to AIS Roszdravnadzor shall be published on the official website of the Federal Service for Surveillance in Healthcare in the "Services" section (roszdravnadzor.gov.ru/services) on the Internet.

4. The manufacturer shall, within no more than 15 working days from the date of placing the medical device into circulation, 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;

variant or model of the medical device (if applicable);

composition, configuration and list of accessories of the medical device (where required);

batch (lot) number or factory (identification) number of the medical device (if applicable);

number of medical devices in the batch (lot) or number of factory numbers of the medical device (in units);

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 importer shall, within no more than 15 working days from the date of placing the medical device into circulation, 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;

variant or model of the medical device (if applicable);

composition, configuration and list of accessories of the medical device (where required);

batch (lot) number or factory (identification) number of the medical device (if applicable);

number of medical devices in the batch (lot) or number of factory numbers of the medical device (in units);

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");

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

6. Where an official of Roszdravnadzor identifies incomplete or inaccurate information in the course of reviewing the information submitted in accordance with paragraphs 4 and 5 of this Procedure, the manufacturer or importer shall be notified by any available means within five working days of the date of identification of such information of the need to correct and resubmit it within five working days in the manner established by paragraphs 4 and 5 of this Procedure.

7. Where the manufacturer or importer identifies incomplete or inaccurate information submitted in accordance with paragraphs 4 and 5 of this Procedure, the manufacturer or importer shall, within five working days of the date of identification of such information, correct and resubmit it in the manner established by paragraphs 4 and 5 of this Procedure.