🇷🇺 Russia medical device regulatory data

National registration certificates (RU) are issued for an unlimited term with no periodic renewal; an RU for a series (batch) of a device under Government Decree No. 430 of 03.04.2020 is issued with validity limited to 01.01.2028, and the series/batch procedure itself is limited to 01.01.2028.

Holders of deficit-list RUs issued under Government Decree No. 552 of 01.04.2022 must undergo re-registration within a period not exceeding 150 working days to obtain an unlimited-term registration certificate.

Roszdravnadzor splits registration-dossier changes into: (1) changes not requiring expertise on quality, efficacy and safety (administrative update service); (2) changes requiring such expertise; (3) a special change procedure for software using artificial-intelligence technologies; a duplicate-RU issuance service also exists.

Foreign manufacturers must appoint an authorized representative of the manufacturer (уполномоченный представитель производителя/изготовителя) who bears responsibility for the device's circulation in Russia, including conformity-assessment and state-registration procedures; a copy of the document(s) confirming the representative's powers is a mandatory dossier item for foreign manufacturers.

Under the 2025 rules, authorized-representative information in registration dossiers had to be actualized by 01.09.2025; the deadline was extended to 01.09.2026 by Government Decree No. 1206 of 13.08.2025.

Roszdravnadzor (Federal Service for Surveillance in Healthcare, Росздравнадзор) is the competent authority: it performs state registration of medical devices, controls their circulation, monitors safety of devices in circulation, maintains the State Register of Medical Devices, accepts and records activity-start notifications, and licenses production and technical maintenance of medical equipment (Regulation approved by Government Decree No. 323 of 30.06.2004).

Rules of state registration of medical devices approved by Government Decree No. 1684 of 30.11.2024 are in force from 01.03.2025, replacing the rules under Government Decree No. 1416 of 27.12.2012; amended by Government Decree No. 1206 of 13.08.2025 (published on pravo.gov.ru 15.08.2025).

EAEU-route registration is governed by the Rules of registration and examination of safety, quality and efficacy of medical devices approved by EAEU Council Decision No. 46 of 12.02.2016; circulation of devices in the EAEU is regulated by the EAEU Treaty of 29.05.2014, the Agreement on unified principles and rules of circulation of medical devices of 23.12.2014, other Union-law treaties, Commission decisions, and member-state legislation.

Medical devices are any instruments, apparatus, devices, equipment, materials and other items used for medical purposes separately or in combination with each other and with accessories, including special software, intended by the manufacturer for prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the human body, medical research, restoration, replacement or modification of anatomical structures or physiological functions, contraception, whose intended function is not realized through pharmacological, immunological, genetic or metabolic action on the human body.

The national registration application must state whether the device can or cannot be classified as an in vitro diagnostics (IVD) device.

Devices may circulate in Russia only after state registration by Roszdravnadzor (national RU) or EAEU common registration. National routes from 01.03.2025: registration with clinical trials (≤50 working days), registration without clinical trials (≤31 working days), fast-track for deficit-list low-risk devices (≤5 working days, Decree No. 552/2022), series/batch registration (Decree No. 430/2020), and a single-expertise route for Russian-manufactured devices via FGBU VNIIMT.

Registration of low-risk devices on the deficit list approved by Government Decree No. 552 of 01.04.2022 is completed within no more than 5 working days; class-1 expertise fee 32,000 RUB applies.

A parallel EAEU common registration route exists alongside the national route, based on the EAEU Treaty of 29.05.2014, the Agreement on unified principles and rules of circulation of medical devices (23.12.2014) and other Union-law instruments, plus member-state legislation.

Roszdravnadzor publishes the unified EAEU register of medical devices registered under the EAEU common procedure; a device registered under EAEU rules circulates in Russia without separate national registration.

Activities in the sphere of circulation of medical devices — except clinical trials, production, installation, commissioning, use, operation including maintenance and repair — start under a notification regime; Roszdravnadzor accepts and records the notifications.

Production of medical devices and technical maintenance of medical equipment are licensed activities carried out by Roszdravnadzor; servicing performed for an organization's own needs is exempt.

Registration dossier documents must be submitted as colour PDF files with a text layer at resolution of at least 300 dpi; individual files must not exceed 100 MB.

Documents drawn up in a foreign language must be submitted with a translation into Russian certified by the applicant.

Applications and documents are submitted electronically through the applicant's unified personal cabinet subsystem of the Unified Portal of State and Municipal Services (EPGU / Госуслуги); Roszdravnadzor publishes official DOCX application forms on its page, including 'Application for state registration of a medical device' and 'Application for resumption of state registration'.

The dossier must include colour mock-ups of packaging and labels showing both the original marking text and the additional Russian-language marking applied to devices manufactured outside Russia.

The dossier must include the manufacturer's operating documentation (эксплуатационная документация) for the device, including the instructions for use (инструкция по применению) or operating manual (руководство по эксплуатации).

The national dossier must include copies of QMS certificates to interstate standard GOST ISO 13485-2017 or international standard ISO 13485:2016 plus copies of reports of earlier inspections; alternatively, QMS documents issued by an inspecting organization of an EAEU member state (other than Russia) are accepted.

The national registration review clock excludes time for: conduct of clinical trials; response to a request for additional materials and information; response to a notification to rectify identified violations within a 30-day period.

For the Russian-manufactured-device route, the time from FGBU VNIIMT of Roszdravnadzor sending a query to receipt of the answer is excluded from computation of the 25-working-day expertise period.

On registration Roszdravnadzor enters a record in the State Register of Medical Devices (государственный реестр медицинских изделий), the public listing of registered devices and their manufacturers, searchable via a Roszdravnadzor e-service.

Identification marking (marking with identification means, Chestny ZNAK / GIS MT) is mandatory for listed device categories with staged dates: wheelchairs from 01.09.2024 (Decree No. 885/2023; rehab TSR per Decree No. 744/2024); orthopedic shoes, air disinfectant-purifiers, hearing aids, coronary stents, CT scanners, canes/crutches/supports/handrails, prosthetic parts, anti-decubitus mattresses and cushions, special excretion-disorder products, and sanitary chair-stools from 01.09.2025; incontinence hygiene products and gloves from 01.03.2026; experiment items (syringes, infusion systems, napkins, test tubes, respiratory equipment, neonatal incubators, fillers/cosmetic threads, medical masks) become mandatory from 01.09.2026 under Decree No. 620 of 17.05.2024 as amended by Decree No. 204 of 28.02.2026; stage II (glucose meters, test strips, tonometers, express tests) runs 02.03–31.08.2026 and stage III (IVD reagent kits) 02.04.2026–28.02.2027.

National conformity assessment is performed in the form of technical tests, toxicological studies and clinical trials per Minzdrav Order No. 885н of 30.08.2021; trials are conducted at organizations meeting the requirements of Minzdrav Order No. 300н of 16.05.2013; time for clinical trials is excluded from the review clock.

Unregistered IVD devices manufactured by a medical organization and used within that same organization may be applied under permits; Roszdravnadzor maintains a public registry of such permits.

Roszdravnadzor issues permits to import a medical device into Russia to provide medical care by vital indications for a specific patient.

For class 3 devices and implantable class 2б devices, the registration-certificate holder must conduct post-registration monitoring of safety and clinical effectiveness and submit annual clinical-monitoring reports to Roszdravnadzor for 3 years, no later than 1 February, starting from the year following the year of RU issuance.

Post-registration clinical monitoring is conducted under a Post-Registration Clinical Monitoring Plan submitted as part of the state-registration dossier; the registration guidance likewise requires a clinical-monitoring plan (план клинического мониторинга) in the dossier for class 3 and implantable class 2б devices.

All subjects of circulation of medical devices must report to Roszdravnadzor every case of identified side effects not indicated in the instructions for use or operating manual of the device.

Where a threat to life and health is confirmed, the manufacturer of the device (or its authorized representative) must provide Roszdravnadzor with an adverse-event report, a corrective-actions report, and a safety notice within the time limits set by the requirements.

The current procedure for subjects of circulation to report all cases of identified side effects not indicated in the IFU/operating manual is Minzdrav Order No. 1113н of 19.10.2020.

Minzdrav Order No. 541н of 26.05.2026 approves a new Procedure for reporting all cases of identified adverse events at all stages of circulation of the relevant medical device in Russia and the territories of other states; the order was published by Roszdravnadzor on 09.06.2026.

Reports are submitted electronically through the Automated System 'Monitoring of Safety of Medical Devices' (Автоматизированная система «Мониторинг безопасности медицинских изделий»); published e-forms include 'Submit adverse-event message' and 'Submit post-registration clinical-monitoring report', plus a notification-card (Карта-извещение) template for adverse events/incidents related to device use.

On confirmation of a threat, Roszdravnadzor decides to suspend circulation of the device and take samples, and may decide to withdraw the device from circulation with information letters published on its official website; withdrawal and destruction are governed by Government Decree No. 145 of 2022 and federal state control by Government Decree No. 1066 of 2021.

Where violations are identified during registration, the applicant is notified and must rectify them within a 30-day period; time to respond to that notification is excluded from the review clock; a dedicated official form 'Application for resumption of state registration of a medical device' exists.

On the Russian-manufactured-device route, the FGBU VNIIMT expertise query is sent once and must contain an exhaustive list of all questions; the applicant must respond within no more than 35 working days.

Federal Law No. 38-FZ 'On Advertising' extends points 1-8 of Article 24(1) to medical-device advertising (Article 24(4)). Device advertising must not: address minors; reference specific cases of cure or improved health from use of the advertised device; contain expressions of gratitude by consumers; create an impression of advantage by reference to research that is mandatory for state registration of the device; assert or suggest that consumers have particular diseases or health disorders; create in a healthy person the impression that the device is necessary; create the impression that seeing a physician is unnecessary; or guarantee positive action, safety, efficacy or absence of side effects.

Statements in advertising about the properties and characteristics of a medical device, including its methods of application and use, are allowed only within the indications contained in the approved instructions for use of the device.

Advertising of medical devices must be accompanied by a warning about contraindications to their use and the need to familiarize with the instructions for use or obtain consultation of specialists: at least 5% of the advertising area (space) in print and other media, at least 5 seconds and at least 7% of the frame area in television, cinema and video advertising, and at least 3 seconds in radio advertising. The warning requirement does not apply to advertising distributed at medical or pharmaceutical exhibitions, seminars, conferences and similar events, in specialized print intended for medical and pharmaceutical workers, or other advertising whose consumers are exclusively medical and pharmaceutical workers.

Advertising of medical devices whose use requires special training is not permitted other than at medical or pharmaceutical exhibitions, seminars, conferences and similar events, and in specialized print publications intended for medical and pharmaceutical workers. The same channel restriction covers prescription-only medicines and methods of prevention, diagnosis, treatment and medical rehabilitation.