Roszdravnadzor market access

Russia medical device registration resources

Research Roszdravnadzor registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Russia medical device resource.

44,350 registration records10 free resources24/25 requirements covered3 regulations trackedAug 2026 fees reviewed

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Medical device registration database

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Medical device registry insights

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Medical device regulations

Browse official Roszdravnadzor regulations and guidance documents.

AI medical device classifier

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Additional certification and licence checker

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Medical device regulation news

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Government registration fees

Review current Roszdravnadzor registration duties and expertise fees.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare official and realistic RZN approval times by device class and pathway.

Structured regulatory requirements

Explore all 43 source-linked facts →

24 of 25 research dimensions currently covered · 11 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified

Competent authority: Roszdravnadzor (Federal Service for Surveillance in Healthcare, Росздравнадзор) is the competent authority: it performs state registration of medical devices, controls their circulation, mo…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Current registration rules (Decree 1684/2024): 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.…
EAEU registration legal basis: 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; c…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Medical device definition and scope: 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, in…
IVD status stated in application: The national registration application must state whether the device can or cannot be classified as an in vitro diagnostics (IVD) device.

2 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes 1, 2a, 2b, and 3.: Class 1, Class 2a, Class 2b, Class 3

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Market-access route: 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…
Deficit-list fast-track registration: 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 ap…

3 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

EAEU common registration gives direct market access: 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…

1 source-linked fact

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Authorized representative of foreign manufacturer: Foreign manufacturers must appoint an authorized representative of the manufacturer (уполномоченный представитель производителя/изготовителя) who bears responsibility for the device's circu…
Authorized-representative information actualization deadline: 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. 120…

2 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Activity-start notification regime: Activities in the sphere of circulation of medical devices — except clinical trials, production, installation, commissioning, use, operation including maintenance and repair — start under a…
Production and maintenance licensing: 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 ex…

2 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Electronic dossier format specifications: 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.
Russian translation of foreign-language documents: Documents drawn up in a foreign language must be submitted with a translation into Russian certified by the applicant.

2 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Submission portal and official forms: 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);…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Russian-language marking for foreign devices: 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 R…
IFU / operating documentation requirement: The dossier must include the manufacturer's operating documentation (эксплуатационная документация) for the device, including the instructions for use (инструкция по применению) or operatin…

2 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

QMS evidence for market access: 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 inspection…

1 source-linked fact

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

EAEU medical-device safety evidence: Electrical safety
EAEU EAC LVD/EMC scope: Adapters / components
Radio/high-frequency import authorization: Wireless / radio

5 maintained overlays

Checked 2026-09-07

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D14

Fees

Verified

Registration certificate state duty: RUB 11,000
Expertise - Class 1: RUB 72,000

6 maintained fee lines

Checked 2026-08-25

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D15

Review clocks

Verified

Class 1 · RZN state registration (EAEU route): 31-50 working days
Class 2a · RZN state registration (EAEU route): 31-50 working days
Class 2b · RZN state registration (EAEU route): 31-50 working days

4 maintained pathways · 2 related facts

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

Authorization duration: 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 is…
Deficit-list RU conversion to unlimited term: 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 regi…

2 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Change-control outcomes: Roszdravnadzor splits registration dossier changes into: (1) changes not requiring expertise on quality, efficacy and safety (administrative update service); (2) changes requiring such expe…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

State Register of Medical Devices: 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 manu…
Mandatory identification marking categories and dates: 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. 885/20…

2 source-linked facts

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

National trials framework: 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 orga…

1 source-linked fact

Checked 2026-08-25

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D20

Special access & derogation

Verified

In-house IVD permits registry: 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 permi…
Import permit for vital indications: Roszdravnadzor issues permits to import a medical device into Russia to provide medical care by vital indications for a specific patient.

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Post-registration clinical monitoring duty: 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 cl…
Monitoring plan filed at registration: 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…

2 source-linked facts

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Reportable events: 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 devic…
Manufacturer reports on confirmed threat: 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 acti…

5 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Suspension and withdrawal powers: 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 pu…

1 source-linked fact

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Prohibited claims in medical-device advertising (Article 24, points 1-8): 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 cas…
Advertising statements bounded by the approved instructions for use: 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 th…

4 source-linked facts

Checked 2026-08-28

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D25

Submission communications & appeal

Verified

30-day deficiency rectification window: 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…
Single exhaustive query rule (domestic route): 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 3…

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (6 lines) →

Roszdravnadzor registration fees in RUB · reviewed 2026-08-25

Fee line	Amount	Provenance
Registration certificate state duty	RUB 11,000	Verified
Expertise - Class 1	RUB 72,000	Verified
Expertise - Class 2a	RUB 104,000	Verified
Expertise - Class 2b	RUB 136,000	Verified

2 more fee lines on the full schedule · 6 of 6 rows source-verified

Registration timeline

Full registration timeline →

Federal Service for Surveillance in Healthcare (RZN) review clocks and planning ranges · 4-class (1, 2a, 2b, 3) — EAEU classification classification

Class / pathway	Review clock	Planning total	Provenance
Class 1(RZN state registration (EAEU route))	31-50 working days	2-4 months	Verified
Class 2a(RZN state registration (EAEU route))	31-50 working days	3-5 months	Verified
Class 2b(RZN state registration (EAEU route))	31-50 working days	4-7 months	Verified
Class 3(RZN state registration (EAEU route))	31-50 working days	5-9 months	Verified