Brief information on working with the Roszdravnadzor Order No. 11020 dated November 25, 2021

On March 1, 2022, Roszdravnadzor Order No. 11020 of November 25, 2021 "On Approval of the Procedure for Submission by the Manufacturer (Producer) of a Medical Device (their Authorized Representative) or a Person Importing Medical Devices into the Territory of the Russian Federation of Information to the Authorized Federal Executive Body Exercising Functions for Control and Supervision in the Sphere of Healthcare" (hereinafter referred to as the Order) entered into force, valid until March 1, 2028. This Order obliges Roszdravnadzor to be informed about medical devices placed into circulation for the purpose of improving the safety monitoring carried out by Roszdravnadzor as part of state control over the circulation of medical devices.

Information in accordance with the Order is submitted within 15 working days from the date of entry into circulation of medical devices (for Russian manufacturers) or their import into Russia (submission is carried out either by an authorized representative of the manufacturer or by the person carrying out the import).

For Russian manufacturers, the sale of their product, i.e., the issuance of a universal transfer document (invoice), constitutes the entry into circulation. According to Order No. 11020, there is no requirement to immediately submit information on all manufactured products; this requirement applies only to medical devices actually sold or transferred. When importing medical devices into Russia, the requirement to submit information in accordance with this order begins from the moment the customs declaration is issued.

The list of information required varies slightly depending on the entry method: Russian manufacturers are required to submit information about the universal transfer document, while imported products require information about the goods declaration. Otherwise, the data set is identical:

1. Identification of a medical device: name of the product, number and date of the registration certificate ( author's note: this wording is partially outdated, since at the moment, registration certificates have been replaced by registry entries ), variant/model;

2. Information on composition and accessories (if necessary);

3. Identification of product items: series or batch numbers/serial number (if available), number of items, production dates and expiration dates;

If the provided data is incomplete or inaccurate, the Order provides for the possibility of submitting a correction within 5 days from the moment such information is discovered (either on your own initiative or upon receipt of notification from Roszdravnadzor).

Previously, applications were submitted through a personal account on the Roszdravnadzor website, but in June 2025, this service was moved to the GosTech platform. Authorization is required through the Federal State Information System "Unified Portal of State and Municipal Services (Functions), " also known as the "Gosuslugi Portal."

In August 2022, Roszdravnadzor announced support for batch data submission using XML documents of a specific structure. It is recommended that these documents be generated automatically in accordance with Roszdravnadzor's certificate.

For more detailed information on how to use the information submission form, please refer to the following documents from the Roszdravnadzor website: 

1. Service for providing information on the introduction of medical devices into civil circulation

2. Applicant's Guide

3. Answers to frequently asked questions about the introduction of medical devices into civil circulation

Based on publicly available practice, there is a risk that failure to submit reports under the Order may result in a fine in accordance with Article 19.7.8 of the Code of Administrative Offenses. Failure to submit information or knowingly submitting false information to the federal executive body exercising control and supervision functions in the field of healthcare for legal entities is punishable by a fine ranging from 30,000 to 70,000 rubles. However, the Order itself contains no information on penalties for failure to comply with the requirements, therefore