Medical Devices Registration Steps According to Russian National Rules

Registration according to national rules makes it possible to obtain a Registration Certificate in a shorter time than registration in the EAEU, this procedure has been operating in Russia since 2013 and is currently the main registration procedure, Registration Certificates for it are issued every day. The procedure has been extended until the end of 2025; changes to Registration Certificates can be made until the end of 2026. Registration Certificates are valid indefinitely.
From 2024, before filing a dossier to Roszdravnadzor, it will be necessary to pass an inspection of manufacturing site(s)

Documents collection, import samples
The duration of stages 1 and 2 (run in parallel) is approximately 3 - 5 months

Collection and analysis of manufacturer's documents, preparation of a list of products for registration, import of samples for tests

Documents preparation
The duration of stages 1 and 2 (run in parallel) is approximately 3 - 5 months

Technical documentation and IFU* (Manual) preparation as well as collection of necessary reports and documents from the manufacturer
*IFU - instruction for use

Tests
2- 4 months

Carrying out technical, toxicological tests using product samples. At this stage, a clinical evaluation of the medical device is carried out (if there are analogues registered in the Russian Federation). In vitro diagnostic products require clinical and laboratory testing.

Filing to Roszdravnadzor
1 day

Technical documentation, IFU (Manuals), manufacturer's reports and certificates, as well as test reports and other necessary documents are filled to Roszdravnadzor*

*MoH division which is responsible for MD registration

Consideration of the case by Roszdravnadzor, verification of the completeness and reliability of the information provided
From 2 weeks to 2 months

At this stage, a request from Roszdravnadzor is possible, the response time is 30 calendar days

Examination of the case by an Expert Organization - verification of technical documentation and IFU (Manual), reports, test reports
2-5 months

At this stage a request from the Expert Organization is possible, the response time is 50 working days

Registration Certificate issue
several days

Medical Devices Registration Steps According to EAEU Rules

Registration according to the rules of the EAEU allows you to bring your medical device to the market of the EAEU countries (Russia, Belarus, Armenia, Kazakhstan and Kyrgyzstan), i.e. one Registration Certificate is valid in five countries at once. The registration procedure is relatively new - about 30 Registration Certificates have been received. The specialists of our company have a positive experience in filing dossiers in the EAEU, one of the cases has already passed an examination in Russia, the case is under examination in other countries (recognition countries) of the EAEU (stage 9 in the diagram below). This registration procedure takes longer than the national one; for medical devices of risk classes 2a sterile, 2b and 3, QMS audit (inspection) to the manufacturing site(s) is required as part of the registration procedure. QMS audit can be carried out with the departure of experts directly to the manufacturing site or online. For products of risk class 2b and 3, in some cases, it is necessary to conduct clinical trials with human participation in the territory of the EAEU countries. Registration Certificates are valid indefinitely. The state in which the applicant submits the registration dossier is called the reference country; countries where the expert opinion of the reference country is sent after the positive results of the examination are called recognition countries. The reference country can be any of the EAEU countries. An authorized representative of the manufacturer must be registered in the territory of any of the EAEU countries.

Documents collection, import samples
The duration of stages 1 and 2 (run in parallel) is approximately 3 - 6 месяцев

Collection and analysis of manufacturer's documents, preparation of a list of products for registration, import of samples for tests

Documents preparation
The duration of stages 1 and 2 (run in parallel) is approximately 3 - 6 месяцев

Technical documentation and IFU* (Manual) preparation as well as collection of necessary reports and documents from the manufacturer
*IFU - instruction for use

Tests
2- 4 months

Carrying out technical and toxicological tests using product samples, as well as preparing a report on clinical efficacy and safety in cooperation with clinics. In vitro diagnostic products require clinical and laboratory testing.

Human clinical trials
Timing is determined individually

For devices of risk classes 2b and 3, including implantable, clinical trials are required with human participation.

Filing to Roszdravnadzor
1 day

Registration documentation, reports and certificates of the manufacturer, as well as test reports and other necessary documents are submitted to Roszdravnadzor. Submissions may be made on paper and/or electronically. The number and composition of documents is greater than for national registration.

Consideration of the case by Roszdravnadzor, verification of the completeness and reliability of the information provided
1-3 months

At this stage, a request from Roszdravnadzor is possible, the response time is 30 working days

Consideration of the case by the Expert Organization - verification of the registration dossier, reports, test reports
2 - 6 months

At this stage, a request from the Expert Organization is possible, the response time is 60 working days

QMS audit (for risk classes 2a sterile, 2b and 3)
4-6 months

Departure of authorized inspectors for manufacturing site or online inspection

Duties payment to recognition countries and coordination of the expert conclusion with the recognition countries
2-3 months

Registration Certificate issue
1-1,5 months

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