GOST R Certification for Medical Devices Abolished. How to Notify Roszdravnadzor Within 15 Days
The GOST R certificate for medical devices no longer exists. Since March 1, 2022, manufacturers and importers have been required to notify Roszdravnadzor of each batch or series entering the market. The deadline for submitting information is 15 working days from the moment of introduction into circulation. Missing it is easy if the company has not established an internal process: the date is calculated from the first shipment or customs release, not from the date of manufacture.
The transition to a notification system occurred quietly, and enforcement case law is still thin. Some companies still do not know they have been obliged to comply for years. Fines are modest for now — up to 50,000 ₽ under the general rule on MD circulation — but if a batch is classified as unregistered product, the ceiling jumps to 5 million ₽.
How the System Looked Before
Before 2022, manufacturers and importers of medical devices (MDs) ran two procedures in parallel. State registration with Roszdravnadzor included technical, toxicological, and clinical testing. On top of that, companies were also required to obtain a certificate or declaration of conformity under RF Government Decree No. 982 dated December 1, 2009 — what the market referred to as a «GOST R certificate.»
These two procedures existed independently of each other. Market participants incurred double costs, even though registration with Roszdravnadzor already involved a comprehensive check of the device. After state registration, obtaining a GOST R declaration or certificate was duplication, plain and simple.
RF Government Decree No. 2425 dated December 23, 2021, replaced Decree No. 982 and excluded medical devices from the new lists of products subject to mandatory certification or declaration. Since September 1, 2022, when Decree No. 2425 came into full force, the GOST R requirement for MDs has become a thing of the past.
What Changed from March 1, 2022
The certificate has been replaced by a notification requirement. Roszdravnadzor Order No. 11020 dated November 25, 2021, obliged manufacturers and importers to submit information to Roszdravnadzor on every MD placed into civil circulation; the order is effective from March 1, 2022, to March 1, 2028.
The notification is tied to the point of introduction into circulation. Placing products in the manufacturer’s warehouse does not trigger the deadline:
for Russian manufacturers — from the date of the first transfer of the device to the buyer, confirmed by a universal transfer document (UTD, Russian: УПД);
for importers — from the date the goods are released by customs for domestic consumption, recorded in the customs declaration (CD, Russian: ГТД).
The deadline for submitting information is 15 working days from that date.
| Parameter | Before (until September 2022) | Now (since March 1, 2022) |
|---|---|---|
| Control format | GOST R certificate / declaration | Notification in the Roszdravnadzor AIS |
| Timing | Prior to sales | Within 15 working days of introduction into circulation |
| Obligated entity | Manufacturer or importer | Manufacturer or importer |
| Supporting document | Test protocols under GOST | UTD (manufacturers), CD (importers) |
| Platform | Certification body | GovTech portal of Roszdravnadzor |
| Regulatory instrument | RF Government Decree No. 982 | Roszdravnadzor Order No. 11020 |
What the Notification Must Include
The notification contains identification data for each batch or series:
full name of the MD and the registration certificate number (RU);
model, configuration, and accessories (if any);
batch or series number, or unique factory (serial) number;
date of manufacture and expiry or service life (if established; if not established, this must be explicitly stated);
quantity of units and the UTD or CD number.
One notification per batch or series. If devices are imported under multiple customs declarations, a separate notification is submitted for each.
Transition to the GovTech Portal from June 11, 2025
Until June 2025, notifications were submitted through the personal account in the Automated Information System (AIS) of Roszdravnadzor. From June 11, 2025, Roszdravnadzor transferred submission to the GovTech platform — a unified digital government portal.
Access to the system requires a Gosuslugi account and a qualified electronic signature (QES, Russian: УКЭП). The head of the organisation assigns responsible employees in the personal account, giving them authority to generate and sign notifications. For larger market participants, batch data upload in XML format is available — export from your ERP and upload to GovTech without manual entry.
What to Do
Determine the date of introduction into circulation for each batch. For importers — the date on the customs stamp in the CD. For manufacturers — the date of the first UTD for shipment. Record it in your accounting system as the starting point for the 15-day countdown.
Obtain a QES for the responsible employee. Signing a notification on the GovTech portal is impossible without it. Issuing a QES takes one to three working days — do not leave this until the last minute.
Configure role-based access in the personal account. The head of the organisation assigns an executor via Gosuslugi to handle notifications. If the responsible employee changes, access must be reassigned.
Automate data export. If the company handles more than 5–10 batches per month, manual form entry is a source of errors. Set up export of series numbers, dates, and document details in XML format from your accounting system.
Cross-check series numbers against labelling data. For MDs subject to mandatory labelling under the Chestny ZNAK system (hearing aids, coronary stents, syringes, and others), series numbers in the Roszdravnadzor notification must match the data aggregated in the DataMatrix codes. Any discrepancy is grounds for an unscheduled inspection.
Maintain an evidentiary record. Keep copies of all submitted notifications, quality certificates, UTDs, and CDs. During a Roszdravnadzor inspection, you will need to demonstrate not only that a notification was submitted but that the data it contained was accurate.
Liability for Violations
If a notification is not submitted on time or contains inaccurate information, the consequences depend on how the violation is classified:
Article 6.28 of the Code of Administrative Offenses of the Russian Federation (CAO RF) (violation of MD circulation rules): fine for legal entities from 30,000 to 50,000 ₽.
Article 6.33 of the CAO RF (circulation of unregistered or substandard MDs): fine from 1 million to 5 million ₽, or administrative suspension of operations for up to 90 days.
Article 238.1 of the Criminal Code of the Russian Federation — criminal liability if a connection to product falsification is established.
There is an opportunity to correct mistakes. If Roszdravnadzor identifies incomplete or inaccurate information, it must notify the manufacturer or importer within 5 working days of that identification. The company then has another 5 working days to correct the data and resubmit. If the errors remain uncorrected by that deadline, the information is treated as unsubmitted.
An MD batch for which no notification has been submitted falls into a regulatory grey area. If such a batch is discovered at a medical facility or pharmacy with no corresponding record in the AIS, that is grounds for an unscheduled audit of the manufacturer or importer.
The notification procedure has been in place since 2022, but enforcement case law is only beginning to build up. Don’t be complacent: in 2025, the regulator gained the GovTech toolset with automatic data validation, making it significantly easier to detect non-compliance. Companies that establish the process now will not find themselves scrambling to fix it after their first compliance notice.
Regulatory Framework:
1. Criminal Code of the Russian Federation, Article 238.1
2. Roszdravnadzor Order No. 11020 dated November 25, 2021 «On Approval of the Procedure for Submission by the Manufacturer (Producer) of a Medical Device (its Authorised Representative) or the Person Carrying out Importation into the Territory of the Russian Federation of Medical Devices, of Information to the Authorised Federal Executive Body Exercising Control and Supervision Functions in the Field of Healthcare» (effective March 1, 2022 – March 1, 2028)
3. RF Government Decree No. 2425 dated December 23, 2021 «On Approval of a Single List of Products Subject to Mandatory Certification, and a Single List of Products Subject to Declaration of Conformity»
4. Federal Law No. 323-FZ dated November 21, 2011 «On the Fundamentals of Health Protection of Citizens in the Russian Federation», Article 38
5. Code of Administrative Offenses of the Russian Federation, Articles 6.28 and 6.33