Russian Mandatory Quarterly Statistical Reporting for Medical Device Manufacturers

If you manufacture medical devices in Russia, you're required to file a mandatory quarterly statistical report with the Ministry of Industry and Trade. This reporting obligation is implemented through a specialized form approved by Rosstat Order No. 292 (dated June 17, 2025), commonly known as Form No. 1 'Medical Devices' (1-medizdeliya). The report captures production and shipment data as part of Russia's State Information System of Industry (GISP) and is legally binding for all qualifying manufacturers.

The report must be filed by all legal entities and individual entrepreneurs who manufacture medical devices (medical equipment and medical-purpose products) in Russia, regardless of ownership structure or organizational form. Experts of Unified Center of Expertise and Certification «Quality» emphasize: even if you produce medical devices in small batches or engage in contract manufacturing, the reporting obligation still applies—there are no volume-based exemptions.

The report is due quarterly, no later than the 20th day of the month following each reporting quarter: Q1 by April 20, Q2 by July 20, Q3 by October 20, and Q4 by January 20 of the following year. Experts of Unified Center of Expertise and Certification «Quality» recommend submitting ahead of schedule if the 20th falls on a weekend or public holiday—an early submission provides a buffer for technical validation and allows time to address any system flags before the hard deadline.

The report is submitted electronically to the Ministry of Industry and Trade through the State Information System of Industry (GISP). Depending on your account setup, you can either complete the fields directly in the online interface or upload a file using the prescribed template format. Make sure you have active GISP credentials and that your reporting template matches the current year's approved structure.

The form requires comprehensive quarterly data for each medical device you manufacture: product name, registration certificate number, device classification details (nomenclature type, risk class), contract manufacturing indicator (if applicable), unit of measure (OKEI code), production and shipment volumes, export data with destination countries (if applicable), inventory balances, and other production-related metrics. Specialists of Unified Center of Expertise and Certification «Quality» advise maintaining a consistent internal data flow from production through warehouse and accounting systems to ensure all required fields are accurate and match validation rules.

Failure to submit on time or providing distorted data can result in administrative liability, including monetary fines that increase for repeat violations. In some cases, regulations also permit recovery of damages if late or incorrect submissions force authorities to redo consolidated statistical reporting. Beyond penalties, late or erroneous filings often trigger additional scrutiny, follow-up questions, and mandatory resubmissions—all of which create avoidable compliance risk.

To pass GISP validation checks, you must strictly follow the form's instructions, ensure all control ratios between indicators are correct, accurately enter OKEI codes and registration certificate data, and verify that production volumes align with shipment figures. If you're uncertain about proper completion or concerned about errors that could result in rejection, professional compliance support can help you correctly gather data, verify control relationships, and submit the form on time without rejections. Contact Unified Center of Expertise and Certification «Quality» to get help with all practical details of medical device reporting and compliance in Russia and EAEU.

Yes. The reporting obligation covers all medical devices you manufacture in Russia, regardless of whether they're sold domestically or exported. For exported products, you must include export volumes and destination countries in the appropriate fields. Unified Center of Expertise and Certification «Quality» experts note that export-only manufacturers sometimes overlook this requirement—but Russian law doesn't distinguish between domestic sales and exports for statistical reporting purposes.

Many manufacturers face uncertainty about which product lines must be included, how to handle contract manufacturing scenarios, or how to reconcile data from different internal systems. If you have questions about your specific situation or want to ensure your reporting is handled correctly from the start, experienced regulatory consultants can help you confirm your obligations, set up proper data collection workflows, and avoid common filing mistakes. Contact Unified Center of Expertise and Certification «Quality» to get help with all practical details of medical device reporting and compliance in Russia and EAEU.

If you want this reporting handled professionally—with accurate data, proper validation, and on-time submission—Unified Center of Expertise and Certification 'Quality' (UCEC 'Quality' LLC) supports medical device manufacturers end-to-end. We help you confirm filing requirements, set up clear internal data flows, prepare the reporting table to match form logic and validation checks, generate upload-ready files or assist with online completion, conduct pre-submission reviews, and respond quickly if the system returns the report for revision. Contact us, and we'll ensure your EAEU and Russian compliance runs smoothly with predictable, deadline-safe submissions.