Medical Device Regulatory Requirements in Russia

Regulatory Authority Federal Service for Surveillance in Healthcare
Regulatory Authority Website Link Click Here
Device Classification I, IIa, IIb and III
Medical Device Regulations CE Marking process | Click Here
Device Classification Guidelines Guidelines for medical device classification | Click Here
Registration Process Medical Device Registration Registration certificate for medical devices | Click Here
Registration Timeline 10 to 16 months
Conformity Assessment Route

Conformity assessment of products may only be carried out by accredited (notified certification bodies) European certification bodies and testing laboratories.

Conformity assessment stages:
1) product identification and definition of normative documents;
2) preparation of technical documentation, i.e. "Technical dossier" (operating manual, instructions for use, technical passport, etc.);
3) submission of an application to the European certification body;
4) analysis of technical documentation and selection of a certification scheme (module);
5) testing of typical product samples in an accredited testing laboratory and/or analysis of the production state;
6) issuance of a CE certificate/declaration of conformity to the applicant.

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Technical Documentation Format

Required documentation
1) Technical documentation as per Reg. (EU) 2017/745 (Annex II)
2) ISO 13485 certificate (for classes IIa sterile, IIb and III)
3) Power of attorney with Apostille stamp*
4) Medical device samples

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Requirement of Authorized Representative Yes
Language Requirement Labels must be in Russian Language
Clinical Trials Information

The procedure of clinical trials of medical devices is regulated by the Order of the Ministry of Health of the Russian Federation dated January 9, 2014. “On Approval of the Procedure of Assessment of Compliance of Medical Devices in the form of Technical Tests, Toxicological Studies, Clinical Trials for the Purposes of the State Registration”.

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Fees for Submission

State fee for medical device registration in Russia:
Audit of the manufacturing plant for MD class IIa (sterile), IIb and III, max: 3.069.000 RUR (approx. 31.200 EURO)
Certificate issue: 11.000 RUR (approx. 110 EURO)
Certificate update or replacement: 2.500 RUR (approx. 25 EURO)

MD conformity assessment:
Class I: 72.000 RUR (approx. 720 EURO) 
Class IIa: 104.000 RUR (approx. 1.040 EURO)
Class IIb: 136.000 RUR (approx. 1.360 EURO)
Class III: 184.000 RUR (approx. 1.840 EURO)

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Additional Information

From 01.01.2024, domestic manufacturers of medical devices with risk class 2a (sterile) and 2b, when registering their products, must implement a quality management system (quality management system or QMS) that meets the requirements of the GOST ISO 13485 standard, with the exception of design and development processes, and for products with risk class 3, including these processes.
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 05/Jul/2025

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