Russian Federation
- Regulatory Authority:
Federal Service for Healthcare Oversight of the Russian Federation (Roszdravnadzor of the Russian Federation)
- Registration period:
7–9 months
(the period of state registration depends on the risk class of the medical device and laboratory testing requirement)
- Legislations:
Resolution of the Government of the Russian Federation dated 27 December 2012, No.1416 “On Approval of the Rules of State Registration of Medical Devices”
Order of the Ministry of Health of the Russian Federation dated 30 June 202, No.661n “On Approval of the Procedure for Importation of Medical Devices into the Territory of the Russian Federation for the Purposes of State Registration”
Order of Roszdravnadzor dated 06 May 2019, No.3371 “On Approval of the Administrative Regulations of the Federal Service for Supervision in the Sphere of Healthcare for the Provision of State Service for State Registration of Medical Devices”
- Language of labeling and documentation:
Russian
- Certificate validity period:
Indefinitely
- Authorized Representative:
country resident
A brief algorithm for registration of medical devices in Russia:
Determining the purpose, type code, and risk class of the medical device in accordance with Federal law
Production inspection (as of January 1, 2024) for products of risk classes: 2a (sterile), 2b and 3
Expert examination of the quality, efficacy and safety of a medical device shall be conducted by the expert institution in stages in accordance with the established procedure:
at stage I the examination of the application for registration and documents is carried out
at stage II the expertise of completeness and results of the conducted technical tests, toxicological studies, clinical tests, as well as tests for the purpose of type approval of measuring instruments shall be carried out.
Adoption of a decision by Roszdravnadzor on state registration, making an entry in the Register of Medical Devices.
Types of registration procedures in the Russian Federation:
- State registration of medical devices (including medical devices for in vitro diagnostics) under the national procedure
- Simplified procedure for state registration of products jeopardized by the imposition of sanctions, according to Resolution No.552 of the Government of the Russian Federation
- State registration of medical devices according to the EAEU rules
- Simplified procedure for state registration of products used in the prevention and control of COVID-19 according to Russian Government Resolution No.430
- Introduction of amendments to the registration certificate and registration dossier