• Appoint a company as the Authorized Representative of the Manufacturer in the Russian Federation (for foreign manufacturers) or within the Eurasian Economic Union (for manufacturers from third countries who are non-residents of a member state);
• Undergo the registration procedure for the medical device according to either the national regulations of the Russian Federation or the rules of the Eurasian Economic Union.

According to Article 38 of Federal Law No. 323-FZ of November 21, 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation”:

• Clause 1. Medical devices are any instruments, apparatus, instruments, equipment, materials, and other products used for medical purposes alone or in combination, including necessary accessories and special software. They are intended by the manufacturer for the prevention, diagnosis, treatment, and medical rehabilitation of diseases; monitoring of the human body’s condition; conducting medical research; restoration, replacement, or modification of anatomical structure or physiological functions; or prevention or termination of pregnancy. Their functional purpose is not achieved through pharmacological, immunological, genetic, or metabolic influence on the human body;
• Clause 4. Only medical devices registered by the authorized federal executive body in accordance with the procedure established by the Government of the Russian Federation are permitted for circulation within the Russian Federation;
• Clause 5. Medical devices custom-made according to individual patient prescriptions from healthcare professionals and intended solely for personal use by a specific patient are exempt from state registration.

The Authorized Representative of the Manufacturer on the territory of the Russian Federation may be a legal entity or an individual entrepreneur, who are residents of the Russian Federation.

To undergo the state registration procedure for a medical device, a foreign manufacturer must appoint an Authorized Representative who will act during the entire period of the device’s circulation in Russia and keep the information about this representative in the registration dossier up to date.

If information about the Authorized Representative is not specified in the dossier documents or is outdated, the foreign manufacturer must appoint a representative or update the relevant information by September 1, 2026.

The Authorized Representative of the Manufacturer within the EAEU is a legal entity or an individual entrepreneur, who is a resident of a member state. They are authorized by the manufacturer via a contract or other legally recognized document to represent its interests and bear legal responsibility for the device’s circulation within the Union and for compliance with mandatory requirements for medical devices.

For Third-Country Manufacturers: Appointment of an Authorized Representative acting during the device’s circulation in the Union is mandatory. The information about this representative in the registration dossier must be kept up to date.

The registered medical device must comply with the General Safety and Efficacy Requirements, Labelling, and Operational Documentation Requirements approved by Eurasian Economic Commission (EEC) Council Decision No. 27 of February 12, 2016. The manufacturer (or its Authorized Representative) bears full responsibility for this compliance.

Yes, we provide services as an Authorized Representative of the Manufacturer. Our company is a legal entity and a resident of the Russian Federation.

• EAEU Registration, according to Eurasian Economic Commission (EEC) Council Decision No. 46 of February 12, 2016, is indefinite;
• Russian Registration, according to Government Resolution No. 1684 of November 30, 2024, is indefinite;
• Russian Registration, according to Government Resolution No. 552 of April 1, 2022, is valid until December 31, 2028;
• Russian Registration, according to Government Resolution No. 430 of April 3, 2020, is valid until January 1, 2028.

• 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;
• Conducting all required tests on device samples;
• Conducting a production inspection of the manufacturing site (if required for Russian national registration);
• Submission of the completed registration dossier to Roszdravnadzor (for Russia) or to the authorized body of the chosen Reference Member State (for the EAEU);
• Review of the dossier documents by Roszdravnadzor and its expert organization, or by the authorized body of the EAEU Reference State;
• Conducting a production inspection (if required for EAEU registration);
• Recognition Procedure: Recognition of the expert conclusion by authorized bodies (expert organizations) of Recognizing Member States (for EAEU registration, if applicable);
• The official entry of the medical device into the Russian State Register of Medical Devices or issuance of the unified EAEU Registration Certificate.

• Russian Registration, according to Government Resolution No. 1684 of November 30, 2024 (without production inspection): from 8 months;
• Russian Registration, according to Government Resolution No. 1684 of November 30, 2024 (with production inspection): from 12 months;
• Registration Dossier Amendment (requiring expert examination of Quality, Efficacy & Safety), according to Government Resolution No. 1684 of November 30, 2024: about 8 months;
• Registration Dossier Amendment (not requiring expert examination of Quality, Efficacy & Safety), according to Government Resolution No. 1684 of November 30, 2024: about 3 months;
• EAEU Registration (without production inspection): from 12-20 months;
• EAEU Registration (with production inspection): from 15-23 months;
• EAEU Registration Dossier Amendment: from 12-20 months;
• Submitting an application to Roszdravnadzor/Expert organization/Eurasian Economic Commission: from 2 months.

According to Section I, Clause 1 of 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”, only specific organizations subordinate to the Federal Service for Surveillance in Healthcare (Roszdravnadzor) are authorized. The Resolution states:

“These Rules establish the procedure for organizing and conducting inspections of medical device production by organizations subordinate to the Federal Service for Surveillance in Healthcare (hereinafter referred to as the inspecting organization) to assess compliance with the requirements for the implementation, maintenance, and evaluation of the quality management system of medical devices depending on the potential risk of their use, in accordance with the nomenclature classification of medical devices (hereinafter referred to respectively as production inspection, requirements).”

The authorized inspecting organizations are:

• The All-Russian Research and Testing Institute of Medical Equipment (VNIIIMT);
• The National Institute of Quality (NIK).

The legislation stipulates a specific period for this process. From the moment of submitting the application and required documents to the inspecting organization, until receiving the final inspection report, the established timeframe is 90 working days.

Yes, inspectors conduct visits to all production sites declared for inspection.

Providing production inspection results is mandatory for devices with a higher potential risk. Specifically, this requirement applies to medical devices of risk classes 2a (for devices released in a sterile condition), 2b, and 3 during registration under Russian national regulations.

No, there is no direct legal requirement for a manufacturer to hold a certificate of conformity to GOST ISO 13485-2017. However, if a manufacturer has implemented a quality management system that complies with this standard or equivalent standards, providing documented evidence of compliance significantly streamlines the regulatory assessment.

Yes, we provide comprehensive support. Our services include:

• Conducting a preliminary audit of your company’s existing documentation;
• Developing a quality management system (QMS) fully aligned with the GOST ISO 13485-2017 requirements;
• Implementing this system at your production facility;
• Training your staff on the new processes and requirements.

Furthermore, we assist in preparing for and obtaining the certificate of conformity for your implemented QMS from an accredited body.