A medical equipment maintenance license is a mandatory permit required for organizations that provide technical maintenance services for medical devices in the Russian Federation. This license confirms that the service provider meets all regulatory requirements for personnel qualifications, equipment, and quality management systems necessary to perform maintenance work.
What Is Licensed Medical Equipment Maintenance?
Licensed technical maintenance of medical devices includes:
- Periodic and unscheduled technical maintenance;
- Restoration of functionality (repair);
- Installation and commissioning;
- Maintenance work specified by the manufacturer’s regulatory, technical, or operational documentation.
The licensing authority for medical equipment maintenance activities is Roszdravnadzor (Federal Service for Surveillance in Healthcare).
Who Must Obtain a Medical Equipment Maintenance License?
Any legal entity or individual entrepreneur that provides technical maintenance services for medical devices for third parties must obtain a medical equipment maintenance license.
Exemption: Maintenance performed exclusively for the organization’s own needs does not require licensing.
The scope of licensable activities is defined in Government Resolution No. 2129 of November 30, 2021, with specific:
- Appendix 1: List of works and services within the licensed activity;
- Appendix 2: List of measuring instruments, technical means, and equipment required for maintenance by risk class.
- Equipment Scope Definition: Obtain from the client the list of medical equipment to be maintained and determine the risk class(es) of the devices
- Document Collection & Analysis: Gather and review all documentation required for the license application
- Preliminary QMS Audit: Conduct a pre-audit of the existing quality management system, prepare a report identifying gaps against ISO 13485 requirements, and provide recommendations
- Equipment Procurement/Lease: Source and acquire or lease the equipment necessary for maintenance activities
- Document Preparation: Prepare missing documents and refine existing documentation for the license application
- Application Submission: Submit the complete application package to Roszdravnadzor via the Government Services Portal (Gosuslugi) in the client’s personal account
- Audit Preparation: Prepare for the on-site audit of the applicant’s facilities and quality systems
- Audit Support: Accompany and support the applicant during the official Roszdravnadzor audit
- License Issuance: Obtain the medical equipment maintenance license upon successful completion of all requirements
Estimated Timelines for Medical Equipment Maintenance License:
| New medical equipment maintenance license acquisition |
4-6 months |
| License amendments (change of address, works/services) |
1-2 months |
| License amendments (other cases) |
2-4 months |
| License cancellation |
10-20 business days |
Official State Fee for Medical Equipment Maintenance License:
The state fee for obtaining a license, amending the license register, and terminating a license for medical equipment maintenance is not charged in accordance with paragraph 9 of Government Resolution No. 353 of March 12, 2022, “On the specifics of licensing activities in the Russian Federation”.
Our Service Fees for Medical Equipment Maintenance License:
| New medical equipment maintenance license acquisition |
from $3 750 |
| License amendments (change of address, works/services) |
from $625 |
| License amendments (other cases) |
from $1 850 |
| License cancellation |
from $185 |
Core Regulatory Framework for Medical Equipment Maintenance License:
- Government Resolution No. 2129 of November 30, 2021 “On Approval of the Regulation on Licensing of Medical Device Maintenance Activities (except for cases where maintenance is carried out to meet the in-house needs of a legal entity or individual entrepreneur, as well as for the maintenance of medical devices with a low degree of potential risk of their use)”;
- Government Resolution No. 1332 of August 12, 2023 “On Amendments to the Regulation on Licensing of Medical Device Maintenance Activities (except for cases where maintenance is carried out to meet the in-house needs of a legal entity or individual entrepreneur, as well as for the maintenance of medical devices with a low degree of potential risk of their use)”;
- Government Resolution No. 353 of March 12, 2022 “On the Specifics of Licensing Activities in the Russian Federation”;
- GOST R 57501-2017 “Maintenance of Medical Devices. Requirements for Public Procurement”;
- GOST R 58451-2019 “Medical Devices. Technical Maintenance. Basic Provisions”;
- GOST R 56606-2015 “Monitoring the Technical Condition and Functioning of Medical Devices. Basic Provisions”;
- GOST 18322-2016 “System for Technical Maintenance and Repair of Equipment. Terms and Definitions”.
Need to obtain a medical equipment maintenance license in Russia? Contact our experts for comprehensive support through every stage of the licensing process.
