Medical Device Registration in Russia is a mandatory prerequisite for the lawful circulation of medical devices within the Russian Federation. Only devices registered according to the procedure established by the Government of the Russian Federation and its authorized executive body (Roszdravnadzor) are permitted for the market.
The scope of “circulation of medical devices” encompasses the entire lifecycle: technical and toxicological testing, clinical trials, quality/expertise/safety assessment, state registration, manufacturing, import/export, conformity assessment, state control, storage, transportation, sales, installation, maintenance, application, and disposal.
According to Russian law, state registration applies to any instruments, apparatuses, devices, equipment, materials, and other items used for medical purposes—either alone or in combination—including necessary accessories and dedicated software. These are intended by the manufacturer for:
- Disease prevention, diagnosis, treatment, and medical rehabilitation;
- Monitoring of human physiological state;
- Conducting medical research;
- Restoring, replacing, or modifying anatomical structures or physiological functions;
- Preventing or terminating pregnancy.
A key criterion is that the device’s primary intended action is not achieved by pharmacological, immunological, genetic, or metabolic means within or on the human body. This distinguishes medical devices from pharmaceuticals.
The registration process is governed by the Government Resolution No. 1684 of November 30, 2024 (“On Approval of the Rules for State Registration of Medical Devices”). Successful registration is confirmed by an entry in the State Register of Medical Devices.
It is important to note that not all medical items require registration. Certain medical devices, as specified in Part 5, Article 38 of Federal Law No. 323-FZ of November 21, 2011 (“On the Fundamentals of Health Protection of Citizens in the Russian Federation”), are exempt from the state registration procedure. Determining whether your product falls under an exemption requires careful legal analysis.
Key Terminology for Medical Device Registration in Russian:
- Manufacturer: A legal entity or an individual entrepreneur, responsible for the design, production, and overall safety, quality, and efficacy of a medical device;
- Authorized Representative (AR): A legal entity or an individual entrepreneur, both being residents of the Russian Federation, officially authorized by the foreign manufacturer to represent its interests regarding device circulation, conformity assessment, and state registration;
- Registration Dossier: The complete set of documents submitted by the applicant for state registration, amendments, or cancellation of a medical device’s registration. It includes all decisions made by the regulator and the expert institution;
- Applicant: A legal entity or an individual entrepreneur submitting the registration application – this can be the Manufacturer or its Authorized Representative in Russia.
- Initial Document Collection & Analysis: Gathering and preliminary review of all technical and administrative documents provided by the manufacturer/AR
- Registration Dossier Preparation: Drafting missing documents and adapting submitted files to Russian requirements. Includes definitive Risk Class determination and assignment of the correct Nomenclature Code
- Testing Strategy & Planning: Evaluation of required sample quantities and budgeting for all necessary tests (technical, toxicological, clinical)
- Lab & Clinical Site Selection: Identifying and contracting with accredited Russian test labs and clinical centers. Managing invoicing and agreements
- Import Sample of MD: Organizing customs clearance and delivery of test samples to Russian territory (for foreign manufacturers)
- Testing Management & Oversight: Full coordination and supervision of all required laboratory tests and trials of device samples
- Production Site Audit Management: Organization and support during the mandatory Quality Management System (QMS) inspection of the manufacturing facility (if required by risk class)
- Dossier Submission & Fee Payment: Payment of state duties and final electronic submission of the complete Registration Dossier to Roszdravnadzor via the Government Services Portal
- Formal Review by Roszdravnadzor: Liaison with the regulator during their initial check for completeness and authenticity of the submitted documentation
- Deficiency Response: Professional preparation and timely submission of responses to any queries or deficiencies identified by Roszdravnadzor (if necessary)
- Expert Assessment & Examination: Guiding the dossier through the expert assessment for quality, efficacy, and safety by the expert institution (VNIIIMT or the National Institute of Quality)
- Final Deficiency Response: Addressing any final remarks to secure a positive conclusion (if necessary)
- Registration & Entry into State Register: The official entry of the medical device into the Russian State Register of Medical Devices
Estimated Timelines for Medical Device Registration in Russia:
Medical device registration in Russia without QMS audit: from 8 months
Medical device registration in Russia with QMS audit: from 12 months
Official State Duty for Medical Device Registration in Russia (Registration Certificate Issuance):
About $135 (applies to all risk classes)
Official State Fees for Medical Device Registration in Russia (Dossier Expertise):
| Risk Class 1 |
about $885 |
| Risk Class 2a |
about $1 280 |
| Risk Class 2b |
about $1 670 |
| Risk Class 3 |
about $2 260 |
Our Service Fees for Medical Device Registration in Russia:
| Risk Class 1 |
from $4 900 |
| Risk Class 2a (non-sterile products) |
from $6 750 |
| Risk Class 2a (sterile products) |
from $7 950 |
| Risk Class 2b |
from $9 800 |
| Risk Class 3 |
from $11 650 |
Core Regulatory Framework for Medical Device Registration in Russia:
- Federal Law No. 323-FZ of November 21, 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation”;
- Government Resolution No. 1684 of November 30, 2024 “On Approval of the Rules for State Registration of Medical Devices”;
- Order of the Ministry of Health No. 181n of April 11, 2025 “On Approval of Requirements for the Content of Technical and Operational Documentation of a Medical Device Manufacturer”;
- Order of the Ministry of Health No. 885n of August 30, 2021 “On Approval of the Procedure for Conformity Assessment of Medical Devices in the Form of Technical Tests, Toxicological Studies, Clinical Trials for the Purpose of State Registration of Medical Devices”;
- Order of the Ministry of Health No. 4n of June 6, 2012 “On Approval of the Nomenclature Classification of Medical Devices”;
- Government Resolution No. 135 of February 9, 2022 “On Approval of the Rules for Organizing and Conducting Production Inspection of Medical Devices for Compliance with Requirements for the Implementation, Maintenance, and Evaluation of the Quality Management System of Medical Devices Depending on the Potential Risk of Their Use”;
- Government Resolution No. 136 of February 9, 2022 “On Approval of Requirements for the Implementation, Maintenance, and Evaluation of the Quality Management System of Medical Devices Depending on the Potential Risk of Their Use”;
- Order of the Ministry of Health No. 257n of April 29, 2025 “On Approval of the List of Medical Devices Classified as Measuring Instruments in the Sphere of State Regulation for Ensuring Uniformity of Measurements, and the Procedure for Their Testing for the Purpose of Type Approval of Measuring Instruments”;
- Order of the Ministry of Health No. 201n of May 2, 2023 “On Approval of the Procedure for Importing Medical Devices into the Territory of the Russian Federation for the Purpose of State Registration”.
Core Regulatory Framework for Medical Device Monitoring in Russia:
- Federal Law No. 248-FZ of July 31, 2020 “On State Control (Supervision) and Municipal Control in the Russian Federation”;
- Government Resolution No. 1066 of June 30, 2021 “On Federal State Control (Supervision) over the Circulation of Medical Devices”;
- Order of the Ministry of Health No. 980n of September 15, 2020 “On Approval of the Procedure for Monitoring the Safety of Medical Devices”;
- Order of the Ministry of Health No. 1113n of October 19, 2020 “On Approval of the Procedure for Reporting by Entities Involved in the Circulation of Medical Devices on All Cases of Detection of Side Effects Not Specified in the Instructions for Use or Operation Manual of a Medical Device, Adverse Reactions During Its Use, Specifics of Interaction Between Medical Devices, as Well as Facts and Circumstances That Pose a Threat to the Life and Health of Citizens and Medical Professionals During the Use and Operation of Medical Devices”;
- Order of Roszdravnadzor No. 11020 of November 25, 2021 “On Approval of the Procedure for Submission of Information by a Manufacturer of a Medical Device (Its Authorized Representative) or a Person Importing Medical Devices into the Territory of the Russian Federation to the Authorized Federal Executive Body Performing Control and Supervision Functions in the Field of Health Protection”.
