Authorized Representative (AR) Services for Medical Devices in Russia & EAEU

The Authorized Representative in Russia is a legal entity or an individual entrepreneur who is a resident of the Russian Federation. They are formally empowered by the foreign manufacturer to represent its interests regarding all matters of the device’s circulation in Russia, including conformity assessment and state registration procedures with Roszdravnadzor.

The Authorized Representative 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 ensuring compliance with all mandatory requirements.

The Authorized Representative ensures compliance with the legal framework for medical devices, which includes:

• Product Legitimization (registration, dossier amendments – VIRD);
• Regulatory Liaison: Official communication with Roszdravnadzor and other regulatory bodies (EAEU);
• Post-Market Compliance: Handling control procedures, safety monitoring, and clinical trial oversight.

Key Terminology for Representing Foreign Medical Device Manufacturers in Russia/EAEU:

• AR: The Authorized Representative of the Medical Device Manufacturer (Producer);
• Medical Device Registration: A mandatory procedure to confirm a medical device’s quality, efficacy, and safety, granting the legal right to market it in Russia or EAEU member states;
• Federal Service for Surveillance in Healthcare (Roszdravnadzor): The federal executive body responsible for control and supervision in the field of healthcare in Russia, including medical device regulation;
• Registration Dossier: The complete set of documents submitted by an applicant for state registration of a medical device, amendments to it, or its cancellation. It includes copies of all decisions made by the registering authority and its expert institution;
• Falsified Medical Device: A medical device accompanied by false information about its characteristics and/or its manufacturer (producer);
• Substandard Medical Device: A medical device that fails to meet the safety and efficacy requirements, labelling requirements, regulatory, technical, and operational documentation requirements and cannot be used safely for its intended purpose established by the manufacturer (producer);
• Counterfeit Medical Device: A medical device circulated in violation of civil legislation;
• Adverse Event (Incident): Any malfunction and/or deterioration in characteristics, or disruption of the functioning of a medical device, or insufficiency or inaccuracy of the accompanying information (documentation) for a medical device, or adverse reaction not specified in the instructions for use, which directly or indirectly led or could have led to death or serious deterioration in the health of users or third parties (hereinafter, serious deterioration in health is understood to mean a life-threatening disease, persistent impairment of body function or irreversible damage to body structure, a condition requiring medical or surgical intervention to prevent a life-threatening disease, or persistent impairment of body function, or irreversible damage to body structure, a condition requiring hospitalization or a significant increase in the length of hospital stay of an already hospitalized patient, functional impairment in the fetus, its death, congenital anomaly or birth injury);
• Undesirable Event: Any unforeseen medical occurrence, illness, injury, or undesirable clinical sign (including abnormal lab findings) in a user or third party associated with the use of a medical device.

Important Note: The scope of services of the authorized representative of the manufacturer depends on the class of potential risk of using the medical device.

Services of an Authorized Representative (AR):

Terms for Authorized Representative (AR) Services:

The minimum contract term for Authorized Representative services is 12 months.

Pricing for Authorized Representative (AR) Services (Monthly Retainer Fee Based on Device Risk Class):

Pricing for Additional Authorized Representative (AR) Services:

Core Regulatory Framework for Authorized Representative (AR) Services:

1. Federal Law No. 323-FZ of November 21, 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation”;
2. Federal Law No. 294-FZ of December 26, 2008 “On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control”;
3. Government Resolution No. 1684 of November 30 2024, “On Approval of the Rules for State Registration of Medical Devices”;
4. Government Resolution No. 1066 of June 30, 2021 “On Federal State Control (Supervision) over the Circulation of Medical Devices”;
5. Government Resolution No. 145 of February 10, 2022 “On Approval of the Rules for Withdrawal from Circulation and Destruction of Counterfeit, Substandard, and Falsified Medical Devices”;
6. Order of the Ministry of Health No. 980n of September 15, 2020 “On Approval of the Procedure for Monitoring the Safety of Medical Devices”;
7. Order of the Ministry of Health No. 1113n of October 19, 2020 “On Approval of the Procedure for Notifying Entities Circulating Medical Devices of All Cases of Adverse Events Not Specified in the Instructions for Use or Operating Manual for a Medical Device, Adverse Reactions During Its Use, Interactions Between Medical Devices, and Facts and Circumstances Possibly Threating the Life and Health of Citizens and Healthcare Workers During the Use and Operation of Medical Devices”;
8. Order of Roszdravnadzor No. 11020 of November 25, 2021 “On Approval of the Procedure for Submission by the Manufacturer (Producer) of a Medical Device (their Authorized Representative) or by a Person Importing Medical Devices into the Russian Federation of Information to the Authorized Federal Executive Body Exercising Functions on Control and Supervision in the Sphere of Healthcare”;
9. Guideline on Compliance with Mandatory Requirements in the Field of Medical Device Circulation of November 14, 2022;
10. 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”;
11. Order of the Ministry of Health No. 368n of July 17, 2023 “On Approval of Risk Indicators for Violation of Mandatory Requirements Used by the Federal Service for Surveillance in Healthcare in the Implementation of Federal State Control (Supervision) over the Circulation of Medical Devices”;
12. Order of Roszdravnadzor No. 4513 of May 20, 2021 “On Approval of the Classification of Adverse Events Related to the Circulation of Medical Devices”;
13. Order of Roszdravnadzor No. 1 of January 10, 2022 “On Approval of Checklist Forms (Lists of Checklist Questions, the Answers to Which Indicate Compliance or Non-Compliance with Mandatory Requirements by the Supervised Entity) Used by the Federal Service for Surveillance in Healthcare and Its Territorial Bodies in the Implementation of Federal State Control (Supervision) over the Circulation of Medical Devices”;
14. EEC Council Decision No. 130 of November 12, 2021 “On the Procedure for Importing Products Subject to Mandatory Conformity Assessment into the Customs Territory of the Eurasian Economic Union”;
15. EEC Council Decision No. 141 of December 21, 2016 “On Approval of the Procedure for the Application by Authorized Bodies of the Eurasian Economic Union Member States of Measures to Suspend or Prohibit the Use of Medical Devices That Possess a Danger to Human Life and/or Health, Substandard, Counterfeit, or Falsified Medical Devices, and to Withdraw Them from Circulation in the Territories of the Eurasian Economic Union Member States”;
16. EEC Board Decision No. 174 of December 22, 2015 “On Approval of the Rules for Monitoring Safety, Quality and Efficacy of Medical Devices”.