A medical activity license is a mandatory permit required for any legal entity or individual entrepreneur providing medical services in the Russian Federation. This license confirms that the facility meets all regulatory requirements for equipment quality, premises safety, instrument sterilization, and staff qualifications.
Who Must Obtain a Medical Activity License?
All legal entities and individual entrepreneurs providing medical services must obtain a medical activity license. The scope of licensable activities is defined by Government Resolution No. 852 of June 1, 2021 “On the Licensing of Medical Activities (with the exception of the specified activities carried out by medical organizations and other organizations within the private healthcare system on the premises of the SKOLKOVO Innovation Center)”.
A service is considered “medical” if it falls under one of the following categories:
- Medical Care: Primary care, specialized care, emergency care, palliative care, pre-hospital care;
- Medical Expertise: Conducting medical evaluations and expert assessments;
- Medical Examinations: Conducting medical check-ups and official medical assessments;
- Inpatient Services: Services provided in hospital or inpatient settings.
- Entity Registration: Register a legal entity or individual entrepreneur in accordance with Russian law
- Facility Preparation: Purchase or lease premises and obtain a Sanitary and Epidemiological (SanPiN) compliance conclusion from Rospotrebnadzor
- Equipment & Maintenance: Acquire or lease medical equipment and sign a technical maintenance agreement with a licensed service provider
- Staffing: Hire qualified medical professionals with appropriate education and certification
- EGISZ Registration: Enter all required data into the Unified State Information System in Healthcare (EGISZ)*
- Application Submission: Paying the state fee and submitting the complete application package to Roszdravnadzor
- Document Review: Roszdravnadzor reviews the submitted documentation for completeness and compliance
- Deficiency Resolution: Address any queries or deficiencies identified by the authority (if required)
- License Issuance: The entity is entered into the Roszdravnadzor License Register, and the medical activity license is granted
*EGISZ including:
FRMR: Federal Register of Medical Workers (staff qualifications);
FRMO: Federal Register of Medical Organizations;
FER: Federal Electronic Registration System;
FIEMK: Federal Integrated Electronic Medical Record;
FREMD: Federal Register of Electronic Medical Documents.
It is necessary to enter data about the organization and its structural subdivisions (if any) into the Federal Register of Medical Organizations (FRMO), and then—information about employees holding medical positions, including details on their education and medical equipment, into the Federal Register of Medical Workers (FRMR).
Medical Activity License Verification
You can obtain an extract from the medical activity license register through:
- Gosuslugi Portal: gosuslugi.ru – provides extracts, copies of decisions, or confirmation of no information found;
- Roszdravnadzor Website: roszdravnadzor.gov.ru – access the “Unified License Register” section for PDF extracts.
Estimated Timelines for Medical Activity License:
| New medical activity license acquisition |
2-3 months |
| License amendments (single address, ≤10 outpatient services) |
up to 2 months |
| License amendments (multiple addresses, >10 services) |
up to 1 month |
| License amendments (cessation of activities) |
up to 1 month |
| License cancellation |
up to 1 month |
Official State Fee for Medical Activity License:
The state fee for obtaining a license, amending the license register, and terminating a license for medical activity 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 Activity License:
| New medical activity license acquisition |
from $2 500 |
| License amendments (single address, ≤10 outpatient services) |
from $625 |
| License amendments (multiple addresses, >10 services) |
from $1 250 |
| License amendments (cessation of activities) |
from $375 |
| License cancellation |
from $185 |
Penalties for Operating Without a Medical Activity License:
Providing medical services without a required medical activity license carries significant liability:
Administrative Liability (Article 14.1, Part 2 of the Code of Administrative Offenses):
- Fine for Individual: from $25 to $31;
- Fine for Individual Entrepreneur: from $50 to $63;
- Fine for Legal Entity: from $500 to $630.
Additionally, equipment and raw materials may be confiscated.
Criminal Liability (Articles 171 and 235 of the Criminal Code):
If unlicensed activity causes substantial harm to health, penalties may include:
- Fine up to $3 750 or in the amount of the salary or other income of the convicted person for a period of up to 2 years;
- Mandatory community service up to 480 hours or arrest up to 6 months.
Core Regulatory Framework for Medical Activity License:
- Federal Law No. 99-FZ of May 4, 2011 “On Licensing of Certain Types of Activities”;
- Federal Law No. 323-FZ of November 21, 2011 “On the Fundamentals of Health Protection in the Russian Federation”;
- Government Resolution No. 852 of June 1, 2021 “On Licensing Medical Activities (with the Exclusion of the Said Activities Carried Out by Medical Organizations and Other Organizations Part of the Private Healthcare System, on the Territory of the SKOLKOVO Innovation Center)”;
- Order of the Ministry of Health No. 866n of August 19, 2021 “On Approval of the Classifier of Works (Services) Constituting Medical Activities”;
- Government Resolution No. 609 of May 8, 2025 “On Amendments to Certain Acts of the Government of the Russian Federation”.
Need to obtain a medical activity license in Russia? Contact our experts for comprehensive support through every stage of the licensing process.
