Notification of Medical Device Release to the Russian Market or Import into Russia: Roszdravnadzor Order No. 11020 Reporting

If you manufacture medical devices in Russia or import registered medical devices into Russia, you are required to submit batch/lot (and serial/identification number) information to Roszdravnadzor (Russia’s federal healthcare regulator) under Order No. 11020. This is submitted electronically through Roszdravnadzor’s online account and is designed to support traceability, market monitoring, and safety oversight.

What is « Roszdravnadzor Order 11020 reporting» and why does it exist?

Roszdravnadzor Order No. 11020 is a Russian regulatory order that requires manufacturers (or their authorized representatives) and importers to submit information on imported medical devices and medical devices placed on the Russian market (typically at batch/lot level).

In business practice, companies often refer to this requirement using different names, for example:

• “Order 11020 report” (Roszdravnadzor Order No. 11020 report).
• “Notification of placing medical devices into civil circulation”.
• “Submission of information on import / release to the market (medical devices)”.

These all mean the same thing: you provide a defined set of data about registered medical devices to Roszdravnadzor under Order No. 11020.

Who Must Submit Import and Market Release Notifications for Medical Devices in Russia?

Obligation to submit import and market release notifications (Roszdravnadzor Order № 11020 reporting) applies to all registered medical devices and is not optional.

You must submit the information if you are:

• the manufacturer of the medical device (or the manufacturer’s authorized representative); or
• the importer bringing medical devices into the territory of the Russian Federation.

When Do You Need to Submit Import and Market Release Notifications for Medical Devices in Russia?

The reporting deadline to submit import and market release notifications for medical devices in Russia is no later than 15 business days, counted from different “trigger dates” depending on your role: manufacturer or importer.

Submission Deadlines for Import and Market Release Notifications (15 Business Days)

Scenario	15 business days counted from	What is typically used as the “event date”
Manufacturing in Russia	date of release to the market (placing into circulation)	date of the UTD/transfer document for the batch (or another supporting document confirming release)
Import into Russia	date of import / batch clearance for circulation	customs declaration registration date

Practical tip: Don’t wait until the last day. Data reconciliation (registration certificate details, batch/lot, quantity, shipment/import documents) often takes longer than expected – especially if several departments are involved.

Where and How to Submit Import and Market Release Notifications for Medical Devices in Russia?

In 2026, submission of import and market release notifications for medical devices in Russia (Roszdravnadzor Order № 11020 reporting) is performed only online via Roszdravnadzor’s electronic form in the personal account on the GosTech platform (a Russian government IT platform used to host and run official online services for businesses and citizens).

Key operational points:

• Login is typically via Gosuslugi (ESIA) – Russia’s government e-services portal (Gosuslugi) and the unified digital identity system (ESIA) used for secure login.
• Role separation is possible (e.g., an “executor” prepares a draft; an “authorized employee” submits the final version).
• Submission formats commonly include: 1) manual entry (fill all fields in the portal); 2) batch upload (upload a prepared file in the permitted format); 3) copying a previous notification (when repeating a similar scenario with the same baseline data).

What Information Must Be Included in an Import or Market Release Notification for Medical Devices in Russia?

The required fields depend on whether you submit as manufacturer or importer of medical devices, but the core structure is consistent.

Required Data for Medical Device Import / Market Release Notifications typically includes:

1) Medical device identification and registration details

• full device name;
• model and variant (if applicable);
• registration certificate number and issue date.

2) Batch/lot/series (or factory/identification numbers)

• batch/lot/series number or factory (identification) number;
• quantity of units in the shipment/batch.

3) The supporting document (the most critical block)

• for manufacturers of medical devices: UTD (universal transfer document) details or another underlying document confirming release to the market;
• for importers of medical devices: customs declaration details (including the declaration reference).

What happens if You Don’t Submit Import and Market Release Notifications for Medical Devices in Russia?

In practice if you don’t submit import and market release notifications for medical mevices in Russia (or submit incorrectly), companies face two categories of risk:

1) Regulatory and administrative exposure

Failure to provide mandatory information to the competent authority may be treated as a violation (commonly referenced under administrative provisions such as Article 19.7 of the RF Administrative Code), leading to a warning or fines. Separate liability may also arise for violations of rules governing medical device circulation (often associated with provisions such as Article 6.28, including fines for officials and legal entities).

2) Operational disruptions (returns, corrections, inspections)

• your submission may be returned or require correction due to inconsistencies (registration certificate data, batch/lot, quantities, or document references);
• rework and resubmission create backlog and can slow down market release of batches;
• repeated errors increase the likelihood of follow-up requests and deeper scrutiny from regulators.

How UCEC “Quality” LLC Can Help You to Submit Import and Market Release Notifications for Medical Devices in Russia?

Submission of import and market release notifications for medical devices in Russia (Roszdravnadzor Order № 11020 reporting) looks “simple” on paper, but in real operations it requires clean alignment across production, warehouse/logistics, import/foreign trade, and accounting – and most returns happen because of mismatches in a few critical fields.

Unified Center of Expertise and Certification “Quality” (UCEC “Quality” LLC) supports manufacturers and importers of medical devices with end-to-end preparation and submission of mandatory medical device reporting (including Order No. 11020 reporting):

• confirm who must submit (manufacturer / authorized representative / importer) and for which registration certificates;
• organize a practical internal workflow for collecting source data;
• verify the “critical fields”: registration certificate, model/variant, batch/lot/series, quantity, UTD/customs declaration details;
• prepare notifications for manual submission or batch upload (depending on volume and scenario);
• assist with access and roles in the portal and the submission logic;
• quickly support corrections if the system/regulator returns the submission for clarification.

If you need help submitting any mandatory medical device reporting in Russia – contact us. We will clarify your specific scenario (manufacturing or import, product range, batch volumes), propose the most efficient workflow for preparing the required data, and support you in submitting the information correctly and on time.